Category: Production SOP

SOP Title: Inward, Handling and Cleaning of FBD Finger Bag

 

1. Objective:

To lay down a procedure for Inward, Handling and Cleaning of FBD Finger Bags.

2. Scope:

This SOP is applicable to Finger bags used in FBD for drying purpose.

3. Responsibility:
   • Production Department: To prepare and review the SOP. To follow the procedures laid down for the Inward, Handling and Cleaning of FBD Finger bag.
   • Quality Assurance Department: To review and approve the SOP and Annexure.
   • Quality Control Department: To collect the Sampling Intimation Slip and to perform the analysis.
   • Purchase Department: To share a copy of the Purchase Order to the Production department.
4. Accountability:

Head, Production.

Head, QA.

5. Procedure:
   • Definition:
     • Production Associate: Executive or operator of Production Department trained to perform duties as per this SOP.
     • QA Associate: Executive of QA department trained to perform duties as per this SOP.
     • Type A Cleaning: Dry cleaning with clean lint free cloth in the following cases,
       • Remove the previous batch residue.
       • During end of the shift.
       • Before starting the next batch of the same product.
       • Prior to execution of higher strength batches, after the execution of lower strength batch of the same product.
     • Type B Cleaning: Wet cleaning by using soap solution in the following cases,
       • Prior to execution of lower strength batches, after the execution of higher strength batches of the same product.
       • After continuous five batches of the same product.
       • After seven days of cleaning before use, if equipment is not in use.
       • After replacement or repair of any product contact part.
     • Procedure

	Precautions
5.2.1	Do not scrub the bag with metallic wire brush to remove the adhered material.
5.2.2	Check the integrity of finger bag before and after use.
5.2.3	Dry the finger bag properly before storage.
5.3	Inwarding
5.3.1	On receiving the new finger bag, physically check the bags for any damage.
5.3.2	Refer the received finger bag against the Specification and Purchase Order as received from the Purchase Department. In case of any discrepancy, consult the Purchase Department.
5.3.3	Upon ensuring the steps 5.3.1 and 5.3.2 accept the finger bag.
5.3.4	Issue the ‘Finger Bag Code’ from the production department and mark it in the finger bag.
5.3.5	The finger bag code will be the first two alphabets of the product code for which the finger bag been purchased. Eg: One Finger bag has been purchased for the product whose product code is ‘XYZ’, then the Finger bag code will be ‘XY-01’.Where as the number ‘01’ represents the number of finger bags purchased.
5.3.6	Enter the details in the ‘Inventory record of the Finger bag’ as per Annexure .
5.4	Handling
5.4.1	Wash and dry the new finger bag received as per Type- B cleaning procedure mentioned in this SOP.
5.4.2	Send the Rinse / Swab sample of the finger bags for Microbiological testing.
5.4.3	Collect the Swab/Rinse sample result from Quality Assurance department. If the result is complying, Store the finger bag in the designated place.
5.4.4	Whenever required, Issue the dedicated finger bag for the respective product use and enter the details as per Annexure.
5.4.5	Transfer the Issued finger bag to the FBD by means of trolley. Care should be taken not to damage the finger bag.
5.5	TYPE A Cleaning
5.5.1	Dry clean the outer portion of the FBD with dry clean duster. Physically check the integrity of the finger bag.
5.5.2	Fix the Finger bag as per SOP.
5.6	Type B Cleaning:
5.6.1	Dry clean the outer portion of the FBD with dry clean duster.
5.6.2	Remove any excess material adhered to the surface by Vacuum cleaner or dry duster.
5.6.3	Wash the finger bag from inside and outside using potable water to remove the adhered powder.
5.6.4	Scrub the finger bag with nylon scrubber/ nylon brush.
5.6.5	If the product is sticky to the finger bag, then soak the finger bags in hot water about 10-15 minutes. Then wash the finger bag with potable water till product residue is completely removed
5.6.6	Visually check the cleanliness and finally rinse with sufficient quantity of purified water.
5.6.7	Keep the finger bag in hanging position to remove water. Then dry the finger bag in clean tray dryer / dry by FBD about 70°C (without material).
5.6.8	Ensure the drying and cleanliness keep the cleaned FBD bag in poly bag in dedicated container with proper label.
5.6.9	Record the usage details in Annexure.

 

6. Abbreviation:

Abbreviation	Expansion
Eg.	Example
FBD	Fluid Bed Dryer
QA	Quality Assurance
QCD	Quality Control Department

 

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

SOP Title: Operation and Calibration of Coating Pan

 

1. Objective:

To define procedure for Operation, Cleaning, Preventive  Maintenance and Calibration of Coating Pan.

2. Scope:

This SOP is applicable to Coating Pan used for tablet coating process in coating section of the Production Department.

 

3. Responsibility:
   • Production Department: To prepare and review the SOP. To follow the procedures laid down for the operation and cleaning and to support for Preventive Maintenance and Calibration of Coating Pan.
   • Engineering Department: To perform the Preventive Maintenance and Calibration of Coating Pan.
   • Quality Control Department: To analyse and report the swab/rinse samples.
   • Quality Assurance Department: To provide line clearance prior to operation. To collect the swab/rinse samples. To approve the Preventive Maintenance and Calibration reports. To review and approve the SOP and Annexure.

 

4. Accountability:

Head, Production Department, Head,  Engineering Department and Head, Quality Assurance.

5. Procedure:
   • Definition:
     • Production Associate: Executive or Operator of Production Department or any personnel trained to perform duties as per this SOP.
     • Quality Assurance Associate: Executive of Quality Assurance Department or any personnel trained to perform duties as per this SOP.
     • Quality Control Associate: Executive of Quality Control Department or any personnel trained to perform duties as per this SOP.
     • Engineering Associate: Executive or Operator of Engineering Department trained to perform duties as per this SOP.
     • In-Process Parameters: As per the Scope of this SOP the In-Process parameters refers to appearance of the tablet, weight of the tablet, thickness, disintegration time and likewise parameters.
     • Non Recoverable Rejects: The tablets and granules which cannot be re processed, for example, tablets collected during the coating. The non recoverable rejects are to be discarded.
     • Type A Cleaning: Dry cleaning with clean lint free cloth in the following cases,
       • Remove the previous batch residue.
       • During end of the shift.
       • Before starting the next batch of the same product.
       • Prior to execution of higher strength batches, after the execution of lower strength batches of the same product.
     • Type B Cleaning: Wet cleaning by using soap solution in the following cases
       • Removal of traces of the previous product, and is ensured by testing rinse /swab sample of the cleaned equipment.
       • Change in product.
       • Prior to execution of lower strength batches, after the execution of higher strength batches of the same product.
       • After continuous five batches of the same product.
       • After seven days of cleaning before use, if equipment is not in use.
       • After replacement or repair of any product contact part.
       • Monthly, if there is no production activity.
     • Cleaning Solution: 1 ml of Teepol (soap solution) in 1000 ml of potable water (0.1% v/v).
     • Breakdown: Any activity leading to operation of machine other than the set parameters and / or unusual sound or vibration observed in the machine
     • Preventive Maintenance: Maintenance activity performed to ensure that the equipment will function smoothly and to avoid breakdowns. These activities are performed monthly and quarterly.
     • Calibration: Tests performed to ensure that the equipment is functioning as per set parameters. These test are performed half yearly, yearly and also after repair or replacement of parts coming in direct contact with product.

 

 

• Procedure

5.2.1	Precautions
5.2.1.1	Switch ‘OFF’ the main supply during machine setting, cleaning and product change over activity.
5.2.1.2	Before start of the activity ensure that, compressed air supplied to the coating Pan is within limit as mentioned on product BMR.
5.2.1.3	Ensure that compressed air is free from moisture  by draining the condensed water from the air filters.
5.2.1.4	During operation of machine do not touch moving parts .
5.2.1.5	Use proper personal protective equipment like Masks, Gloves and Safety Goggles during coating and cleaning activity.
5.2.1.6	Ensure that validity of calibration and Preventive maintenance before starting coating operation.
5.2.1.7	Ensure that, exhaust air filters are cleaned and exhaust system is working properly.
5.2.1.8	During handling of sodium hydroxide solution, use elbow size rubber gloves, goggles and other personal protective equipment to avoid the injuries.
5.2.1.9	During non – aqueous coating, use solvent vapour mask, safety goggles and follow other safety precautions as mentioned on product BMR.
5.3	Operation:
5.3.1	Before start of the coating activity, ensure that, line clearance is taken from  QA department on product BMR.
5.3.2	Switch “ON” the main electric supply then switch “ON” Coating Pan and blower.
5.3.3	Switch “ON” the exhaust of the Coating Pan.
5.3.4	Set the required Pan RPM and blower temperature as mentioned in the specific product BMR.
5.3.5	To increase the temperature, press the temperature controller button provided on the coating panel and rotate the temperature adjusting regulator knob to clockwise direction and to decrease the temperature rotate the temperature controller knob to anticlockwise direction.
5.3.6	To increase the RPM of the coating pan, rotate the speed adjusting wheel provided on the base of the platform to anticlockwise direction, to decrease the Pan RPM, rotate the speed adjusting wheel to the clockwise direction.
5.3.7	Check the spraying  gun for uniform solution spraying, by operating the gun.
5.3.8	Switch “OFF” the blower and Coating Pan and manually load one lot of de-dusted tablets in to the Coating Pan.
5.3.9	Start the hot air blower and inch the Pan to pre-heat the tablets for specified time as mentioned in specific product BMR.
5.3.10	Once the required tablet bed temperature attained, start coating process by spraying the coating solution on the tablet bed.
5.3.11	Check the tablet in-process parameters such as appearance, inlet temperature, weight gain/ group weight of 20 tablets, Pan RPM etc. as per frequency mentioned on specific on the product BMR .
5.3.12	After completion of coating ,remove  spra ying   gun from the Coating Pan.
5.3.13	Stop Pan rotation and switch “OFF” heaters of the inlet blower provided on the panel of the Coating Pan.
5.3.14	Keep the blower “ON” and inch the Pan to cool the tablets. After cooling, slowly unload the coated tablets in a cleaned container lined with double poly bag.
5.3.15	Weigh the coated tablet container and enter the weight details in product BMR.
5.3.16	Label dully filled “In-Process” to the tablet container.
5.3.17	Transfer the coated tablet container to inspection area to remove any defective tablets from the coated tablets.
5.3.18	After completion of coating activity, label the equipment as “To be Type A cleaned “or “To be Type B Cleaned”.
5.3.19	Record the activity in equipment log book as per Annexure.
5.4	Type A Cleaning
5.4.1	Mention on  area status board as “Under Cleaning” prior to initiation of cleaning process.
5.4.2	Remove all previous batch documents, container and labels from the area and affix “To be Type A Cleaned” label to the Coating Pan.
5.4.3	Dismantle the inlet blower pipe from the assembly.
5.4.4	Dry clean the blower pipe from inside an outside using vacuum cleaner and wipe the external surface with the duster.
5.4.5	Clean the external surface of  blower body with duster.
5.4.6	Wipe the Coating Pan with dry and clean lint free duster from inside and outside.
5.4.7	Record the activity in equipment log book as per Annexure No.01.
5.4.8	Ensure the cleanliness by checking visually for  presence of any previous batch tablets / particles, then affix “Type A Cleaned” label.
5.5	Type B Cleaning
5.5.1	Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process.
5.5.2	Remove all labels, container and documents of previous product from the area.
5.5.3	Cover the electrical switches with polybag.
5.5.4	Dry clean the internal and external surface of the Pan, panel, base and cover with dry clean duster.
5.5.5	Dismantle the inlet air pipes and cover the dismantled parts with a clean polybag  and transfer it  to the washing area with “To be Type B Cleaned “label.
5.5.6	Wash the  dismantled parts with potable water. Then clean with 0.1% soap (teepol) solution.
5.5.7	Again wash with sufficient quantity of potable water to remove the residue of soap solution.Finally rinse with purified water.
5.5.8	Dry the cleaned parts with dry duster/compressed air.
5.5.9	Ensure the cleanliness and affix “Type B Cleaned” label, then transfer to clean equipment room.
5.5.10	Take potable water in solution funnel of the spraying  gun for cleaning of spraying gun.
5.5.11	Clean the spraying gun as per SOP “Operation and Cleaning of Spraying Gun.’’
5.5.12	Clean the silicon tube with 0.1% of soap solution then  wash with potable water, finally rinse with purified water.
5.5.13	Fill approximately 30-40 litres of potable water in to the Coating Pan and allow the Coating Pan to rotate for about 10 minutes.
5.5.14	Clean the inner surface of the Pan with nylon scrubber dipped in 0.1% soap solution, then  remove water from the  Coating Pan.
5.5.15	Wash the Pan with sufficient quantity of potable water by rotating the Pan to remove  the cleaning agent solution. Finally rinse the Pan with purified water.
	Note: For enteric coated tablets: Coating Pan and other accessories first clean with 2% sodium hydroxide solution, then clean with potable water. Finally clean as per step no.5.5.6 to 5.5.15.
5.5.16	Fill  “Swab / Rinse Sampling Intimation Slip” and submit to QA Department for collection of samples.
5.5.17	Record the activity in equipment log book as per attached Annexure.
5.5.18	Collect Swab/Rinse sample result from Quality Assurance Department. If the result is complying, label the equipment as “Type B Cleaned”. If the result is not complying repeat the steps 5.5.6 to 5.5.15.
5.5.19	After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”.
5.5.20	Allow the coating Pan to rotate and wipe the inner surface of the Pan with a clean dry lint free cloth.
5.5.21	Ensure the cleanliness and drying of Coating Pan. Affix cleaned dismantled parts.
5.5.22	Record the activity in equipment log book as per Annexure.
5.5.23	Cover the mouth of the Coating Pan with a poly bag and affix dully filled “Type B Cleaned” label.
5.6	Breakdown
5.6.1	If breakdown occurs during operation, hold the coating process. Inform to Head Production.
5.6.2	Fill the “Complaint Note” and submit to Engineering Department.
5.6.3	Fill the “Incident Report” and submit to Quality Assurance Department.
5.6.4	Unload the tablets only, if required for breakdown rectification.
5.6.5	Store the unloaded tablets in closed container.
5.6.6	If breakdown occurs prior to start of operation, follow step 5.6.2.
5.6.7	Record the breakdown activity in Equipment Log Book.
5.6.8	After completion of repairs, the operations can be resumed. Perform “Type A or Type B” cleaning, if the material has been unloaded from the Coating  Pan.
5.6.9	Collect and file a copy of  “Complaint Note” certifying that repair works have been successfully completed.
5.6.10	Record  repair completion activity in Equipment Log Book.
5.6.11	Describe the breakdown activity in the respective product BMR.
5.7	Preventive Maintenance
5.7.1	Perform the preventive maintenance as per Annexure.
5.7.2	If preventive maintenance activity is outsourced, values are to be transcribed in the Annexure, and external party certificate to be attached.
5.7.3	Attach Preventive Maintenance label on the equipment.
5.8	Calibration
5.8.1	Calibrate temperature controller from external approved agency once in a year.
5.8.2	In house calibration of Coating Pan to be done for RPM once in a six month.
5.8.3	If calibration activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached.
5.8.4	Attach the calibration label on the equipment.

 

6. Abbreviation :

Abbreviation	Expansion
ml	Millilitre
%	Percentage
v/v	Volume by Volume
RPM	Rotation Per Minute
BMR	Batch Manufacturing Record
etc	Etcetra

 

 

External Party Calibration Record

TEMPERATURE CONTROLLER

        OBSERVATIONS

Sr. No.	Reading on UUC (°C)	Reading on Standard instruments (°C)	Deviation (± 4°C)	Remarks
1
2
3
4
5
UUC : Unit Under Calibration

 

Calibration RPM

Sr. No.	Standard Reading	Observed Reading	Acceptance Criteria	Deviation
1	8 RPM		± 1 RPM
2	8 RPM
3	8 RPM
Remarks:   Readings are Within limit / Not within limit and Can be Used /Cannot be use for regular activity.

 

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

SOP Title: Operation and Calibration of Fluid Bed Dryer

 

1. Objective:

To define procedure for Operation, Cleaning, Preventive Maintenance and Calibration of Fluid Bed dryer.

2. Scope:

This SOP is applicable to Fluid Bed Dryer, used for the drying of granules, installed at the granulation section.

 

3. Responsibility:
   • Production Department: To prepare and review the SOP. To follow the procedures laid down for the operation and cleaning and to support for Preventive Maintenance and Calibration of Fluid Bed Dryer.
   • Quality Assurance Department: To provide line clearance prior to operation. To collect the swab/rinse samples. To approve the preventive maintenance and calibration reports. To review and approve the SOP and Annexure.
   • Engineering Department: To perform the preventive maintenance and calibration of Fluid Bed Dryer wherever applicable.
   • Quality Control Department: To analyse and report the swab/rinse samples.

 

 

4. Accountability:

Head Production Department, Head Engineering Department and Head Quality Assurance.

5. Procedure:
   • Definition:
     • Production Associate: Executive or Operator of Production Department or any personnel trained to perform duties as per this SOP.
     • Quality Assurance Associate: Executive of Quality Assurance Department or any personnel trained to perform duties as per this SOP.
     • Quality Control Associate: Executive of Quality Control Department or any personnel trained to perform duties as per this SOP.
     • Engineering Associate: Executive or operator of Engineering Department trained to perform duties as per this SOP.
     • Type A Cleaning: Dry cleaning with clean lint free cloth in the following cases:-
       • Remove the previous batch residue.
       • During end of the shift.
       • Before starting the next batch of the same product.
       • Prior to execution of higher strength batches, after the execution of lower strength batches of the same product.
     • Type B Cleaning: Wet cleaning by using soap solution in the following cases:-
       • Removal of traces of the previous product, which is ensured by testing rinse /swab sample of the cleaned equipment.
       • Change in product.
       • Prior to execution of lower strength batches, after the execution of higher strength batches of the same product.
       • After continuous five batches of the same product.
       • After seven days of cleaning before use, if equipment is not in use.
       • After replacement or repair of any product contact part.
       • Monthly, if cleaned Fluid Bede Dryer is not used for production activity.
     • Cleaning Solution: 1 ml of Teepol (soap solution) in 1000 ml of potable water (0.1% v/v).
     • Breakdown: Any activity leading to operation of machine other than the set parameters and / or unusual sound or vibration observed in the machine.
     • Preventive Maintenance: Maintenance activity performed to ensure that the equipment will function smoothly and to avoid breakdowns. These activities are performed monthly and quarterly..
     • Calibration: Tests performed to ensure that the equipment is functioning as per set parameters. These test are performed half yearly, yearly and also after repair or replacement of parts coming in direct contact with product.
   • Procedure

Precautions
5.2.1		Switch ‘OFF’ the main supply during machine setting, cleaning and product change over activity.
5.2.2		Ensure that earthling studs are properly connected to FBD bowl.
5.2.3		Use proper personal protective equipment. For  example:- Nose masks, gloves during compression operation.
5.2.4		Ensure that the finger bag is properly fitted and not damaged.
5.2.5		Switch ‘OFF’ the machine while cleaning.
5.2.6		Ensure that the steam supply is switched ‘OFF’ ,during cleaning / fixing of the finger bag.
5.2.7		During operation of the machine, do not touch the moving parts /do not put hand in the running machine.
5.2.8		Ensure the validity of calibration and preventive maintenance before starting any operation.
5.3         Operation of Fluid Bed dryer
5.3.1		Before commencing the operation ensure that the FBD, Finger bag and the area is cleaned.
5.3.2		Before starting FBD make sure that the line clearance is taken and recorded in the BMR.
5.3.3		Ensure the temperature and relative humidity of the area is within specified limit as mentioned in the product  BMR.
5.3.4		Fix the SS Rim into the finger bag.
5.3.5		Lower the Finger bag hook assembly by means of the pulley.
5.3.6		Tie the finger bag to the hooks. Tie it with nylon tag if required to avoid the finger bag from falling down during operation.
5.3.7		Once hooked, lift and fix the finger bag by the pulley provided at the side of the Fluid Bed Dryer.
5.3.8		Push the finger bag firmly into the groove such that the finger bag is fixed firmly.
5.3.9		Push the dryer bowl  filled with  material ,inside the Fluid Bed Dryer.
5.3.10		Lift the bowl by means of the lever provided.
5.3.11		Ensure proper fixing of bowl before switching “ON” the blower.
5.3.12		Switch “ON ‘the main electric line.
5.3.13		Set up the timer as required by rotating the knob provided. The number represented is in minutes i.e.10 means 10 min.
5.3.14		Now switch “ON” the blower by pressing the green button marked as ‘Blower ON’ in the main panel and the fluidization will start.
5.3.15		Turn the steam valve by rotating the Red colour Steam Valve located behind the Fluid Bed Dryer to set the required temperature.
5.3.16		The pressure of the steam can be noted from the pressure gauge.
5.3.17		The Inlet and Outlet temperature will be displayed in the indicator provided at the top of the dryer. The unit of measurement is °C.
5.3.18		The required inlet temperature as per BMR can be maintained by controlling the inlet Steam Valve.
5.3.19		Open or close the Steam Valve to control the required inlet and outlet temperature.
5.3.20		Check the Inlet, Outlet temperature and record the total drying time in product BMR.
5.3.21		Observe the fluidisation and condition of the bag from the viewing window.
5.3.22		After completion of set time the FBD blower will stop automatically.
5.3.23		Shake the finger bag and take out the FBD bowl. Then rack or mix the material for uniform drying.
5.3.24		Check the LOD of dried material; it should be within limit as mentioned in product BMR. Operate the IR moisture as per SOP.
5.3.25		If required, again put the material for drying and maintain the inlet and outlet temperature till the LOD of dried material is within specified limit as mentioned in product BMR.
5.3.26		Once the drying is completed, close the Steam Valve.
5.3.27		Switch ‘OFF’ the blower and allow the material to settle down.
5.3.28		Tap the side of the dryer if required, to remove the material sticking to the side of the dryer.
5.3.29		Shake the filter bag by means of the pulley such that, the material sticking to the finger bag is removed.
5.3.30		Once all the material settles down release the bowl by turning the lever to the opposite direction.
5.3.31		Carefully remove the dryer bowl from the dryer .Take out the  FBD bowl and check for uniform drying.
5.3.32		Once the bowl is removed, bring the filter bag down by the pulley and carefully unhook the bag and send it for washing.
5.3.33		Record the activity in Equipment Log Book as per Annexure.
5.3.34		After completion of drying activity, label the equipment as “To be Type A cleaned” or “To be Type B Cleaned”.
5.4        Type A Cleaning( Batch change over)
5.4.1		Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process.
5.4.2		Switch “OFF” the steam supply and electrical main of the FBD. (if it is ON).
5.4.3		Remove all previous batch documents, containers and labels from the area.
5.4.4		Remove the finger bag from the dryer and clean it as per SOP.
5.4.5		Dry clean the outer surface, Dryer bowl with the help of clean duster and record the cleaning activity in the “Equipment Log Book”.
5.4.6		Ensure the cleanliness and affix “Type A Cleaned” label as per SOP.
5.5      TYPE B Cleaning (Product change over)
5.5.1		Remove all labels, containers and documents of previous product.
5.5.2		Clean the external surfaces and ducts of the dryer with a dry clean duster/vacuum. Then wipe it with a duster dipped in 0.1% soap solution followed by lint free cloth.
5.5.3		Remove the finger bag from the dryer and clean it as per SOP.
5.5.4		Wash the dryer bowl and other parts with 30-40 litres of potable water then clean with 0.1% soap (teepol) solution then wash with 30-40 litres of potable water to remove the traces of soap solution. Finally rinse with 30-40 litres of purified water.
5.5.5		Fill the Swab / Rinse Sample Intimation Slip and submit to QA Department for collection of samples.
5.5.6		Record the activity in Equipment Log Book as per Annexure.
5.5.7		Collect the Swab/Rinse sample result from Quality Assurance Department. If the result is complying, label the equipment as “Type B Cleaned”.
5.5.8		If the result is not complying repeat the steps 5.5.4 to 5.5.5.
5.5.9		After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”.
5.5.10		After passing the rinse / swab sample dry the FBD outer surface with dry clean cloth.
5.6      Breakdown
5.6.1		In case of breakdown of FBD, inform the department head, QA and the Engineering Department.
5.6.2		Record the drying time and outlet temperature on the product BMR.
5.6.3		Fill the “Complaint note” and submit to Engineering Department.
5.6.4		Fill the “Incident Report” and submit to Quality Assurance Department..
5.6.5		Keep the product in closed condition as per requirement.
5.6.6		If breakdown occurs during operation follow the step 5.6.2 to 5.6.5.
5.6.7		Record breakdown activity in Equipment Log Book.
5.6.8		Inform to Engineering Department and check the type of breakdown and the time required for repair.
5.6.9	Till rectification, next lot should not be taken for granulation.
5.6.10		After completion of repairs, the operations can be resumed. If break down is major perform Type A or Type B cleaning as per the requirement.
5.6.11		Before restart of drying   check the cleanliness  from QA Department.
5.7		Preventive Maintenance:
5.7.1		Perform the preventive maintenance as per Annexure.
5.8		Calibration:
5.8.1		Perform the calibration for Analogue Timer as per Annexure.
5.8.2		Perform the calibration for Steam Pressure Gauge as per Annexure.
5.8.3		Perform the calibration for Inlet Temperature Indicator as per Annexure.
5.8.4		Perform the calibration for Outlet Temperature Indicator as per Annexure.

 

6. Abbreviation

Abbreviation	Expansion
SOP	Standard Operating Procedure
FBD	Fluid Bed Dryer
SS	Stainless Steel
LHS	Left Hand Side
RHS	Right Hand Side
BMR	Batch Manufacturing Record
°C	Degree centigrade
LOD	Loss On Drying
%	Percent
kg	Kilo Gram
v/v	Volume by Volume
ml	Milliliter

 

 

 

CALIBRATION FOR ANALOG TIMER OF FLUID BER DRYER

OBSERVATIONS

Sr. No	Reading on the UUC MIN	Reading on Standard instruments HRS:MIN:SEC:MINI SEC.	Deviation ± 2 min	Remarks
1
2
3
4
5
UUC : Unit under calibration

 

 

CALIBRATION OF FLUID BED DRYER

STEAM PRESSURE GAUGE

OBSERVATIONS

Sr. No	Reading on UUC (Kg/Cm2)	Reading on Standard instruments (Kg/Cm2)	Deviation ±0.2 Kg/Cm2	Remarks
1
2
3
4
5
6
UUC : Unit Under Calibration

 

 

CALIBRATION FOR INLET TEMPERATURE INDICATOR OF FLUID BER DRYER

OBSERVATIONS

Sr. No.	Reading on UUC (°C)	Reading on Standard instruments (°C)	Deviation ± 2°C	Remarks
1
2
3
4
5
UUC : Unit Under Calibration

 

CALIBRATION FOR OUTLET TEMPERATURE INDICATOR OF FLUID BER DRYER

OBSERVATIONS

Sr. No.	Reading on UUC (°C)	Reading on Standard instruments (°C)	Deviation ± 2°C	Remarks
1
2
3
4
5
UUC : Unit Under Calibration
Result: The results Complies / Not Complies with the acceptance criteria.

 

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

SOP Title: Operation And Cleaning Of Colloidal Mill

 

1. Objective:

To define procedure for Operation, Cleaning and Preventive Maintenance of Colloidal Mill

2. Scope:

This SOP is applicable to Colloidal Mill used for milling of coating material during coating process in production department.

 

3. Responsibility:
   • Production Department: To prepare and review the SOP. To follow the procedures laid down for the operation cleaning and preventive maintenance of colloidal Mill.
   • Engineering Department: To perform the preventive maintenance of Colloidal Mill.
   • Quality Assurance Department: To provide line clearance prior to operation. To collect the swab/rinse samples. To approve the Preventive Maintenance reports. To review and approve the SOP and Annexure.
   • Quality Control Department: To analyse and report the swab samples.
4. Accountability:

Head Production Department, Head Engineering Department and Head Quality Assurance

5. Procedure:
   • Definition:
     • Production Associate: Executive or Operator of Production department or any personnel trained to perform duties as per this SOP.
     • Quality Assurance Associate: Executive of Quality Assurance department or any personnel trained to perform duties as per this SOP.
     • Quality Control Associate: Executive of Quality Control department or any personnel trained to perform duties as per this SOP.
     • Engineering Associate: Executive or operator of engineering department trained to perform duties as per this SOP.
     • Type A Cleaning: Dry cleaning with clean lint free cloth from outer surface and circulating the water in the milling chamber in the following cases,
       • Remove the previous batch residue.
       • During end of the shift.
       • Before starting the next batch of the same product.
     • Type B Cleaning: Wet cleaning by using soap solution in the following cases
       • Removal of traces of the previous product, and is ensured by testing rinse /swab sample of the cleaned equipment.
       • Change in product
       • Prior to execution of lower strength batches, after the execution of higher strength batches of the same product if there is change in coating material.
       • After continuous five batches of the same product.
       • After seven days of cleaning before use, if equipment is not in use.
       • After replacement or repair of any product contact part.
     • Cleaning Solution: 1 ml of Teepol (soap solution) in 1000 ml of potable water (0.1% v/v)
     • Breakdown: Any activity leading to operation of machine other than the set parameters and / or unusual sound or vibration observed in the machine.
     • Preventive Maintenance: Maintenance activity performed to ensure that the equipment will function smoothly and to avoid breakdowns. These activities are performed monthly, quarterly and half yearly.
   • Procedure

	5.2.1		Precautions
	5.2.1.1		Use safety goggles, nose mask and hand gloves during milling activity.
	5.2.1.3		Keep the container below the out let of the colloidal mill.
	5.3		Operation
	5.3.1		Ensure that the colloidal mill is cleaned and line clearance is obtained from QA department on BMR.
	5.3.2		Start and check the rotation of rotor and free movement.
	5.3.3		Switch ‘ON’ the Colloidal Mill and slowly add the material to be milled in to the hopper of the mill as mentioned in product BMR.
	5.3.4		Mill the material in circulation mode by operating the valve for about 15 minutes or as mentioned on the BMR.
	5.3.5		Visually check the milled material for fineness and absence of black particles.
	5.3.6		After completion of milling, collect the milled solution in separate containers.
	5.3.7		Rinse the colloid mill with circulating the solvent or water used for the preparation of solution.
	5.3.8		After completion of the milling switch “OFF” the colloidal mill switch, then main supply.
	5.3.9		Label the colloidal mill as “ To be Type A cleaned” or “To be Type B Cleaned”.
	5.3.10		Record the activity in equipment log book.
5.4		Cleaning:
5.4.1		Type A Cleaning ( Batch to Batch Cleaning)
	5.4.1.1		Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process.
	5.4.1.2		Clean the external surface of the Colloidal Mill with moist clean duster.
	5.4.1.3		Switch “ON” the colloid mill and Pour approximately 2-4 litres of purified water into the Colloidal Mill hopper and circulate for about 5 minutes.
	5.4.1.4		Drain and collect the used turbid water from opening of the circulating pipe in to the container.
	5.4.1.5		Switch “OFF” the colloid mill and affix “Type A Cleaned” label to the colloid mill.
5.4.2		For Type B Cleaning (Product to Product):
	5.4.2.1		Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process.
	5.4.2.2		Clean the external surface of the Colloidal Mill with moist duster.
	5.4.2.3		Pour approximately 2-4 litres of purified water into the Colloidal Mill and put ’ON’ for about 5 minutes  in circulation and  drain the  turbid water from the out let pipe. Repeat the above step for 2-3 times for colour product till the clear water obtained from the colloid mill.
	5.4.2.4		Dismantle the hopper and wash the hopper with approx.10 litres of potable water. Apply 0.1% soap (teepol) solution and then wash with 10 litres of potable water to remove the traces of the soap solution.
	5.4.2.5		Finally rinse with 10 litres of purified water.
	5.4.2.6		Wash the Colloidal mill outlet pipe with 5-7 litres of potable water then clean with 0.1% soap solution (teepol).
	5.4.2.7		Again clean with 5-7 litres of potable water to remove traces of the soap solution. Finally rinse the Colloidal Mill outlet pipe with5-7 litres of Purified water.
	5.4.2.8		Fill the Swab / Rinse Sample Intimation Slip and submit to QA department to collect the samples.
	5.4.2.9		Collect the Swab/Rinse sample result from QA. If the result is complying, label the equipment as “Type B Cleaned”. If the result is not complying repeat the steps 5.4.2.3 to 5.4.2.8.
	5.4.2.10		Wipe the outer body with moist clean duster.
	5.4.2.11		Dry the outside of Colloidal Mill by using dry and clean duster.
	5.4.2.12		After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”.
	5.4.2.13		Cover the Colloidal mill with clean poly bag.
	5.4.2.14		Record the activity in equipment log book as per Annexure.
			Frequency: Clean the colloidal mill 1. During product changeover 2. Whenever major maintenance done to the colloidal mill 3. After continuous five batches of the same product. 4. Same product with change in coating colour. 5. Monthly, if it is not used for production activity.
5.5		Breakdown
	5.5.1		If breakdown occurs during operation, hold the milling activity. Inform to the Head Production.
	5.5.2		Fill the “Complaint Note” and submit to Engineering Department.
	5.5.3		Fill the “Incident Report” and submit to Quality Assurance Department.
	5.5.4		If the breakdown is major, unload the material from the colloid mill only, if required for breakdown rectification.
	5.5.5		Store the solution in a closed container with proper status label.
	5.5.6		If breakdown occurs prior to start of operation, follow step 5.5.2
	5.5.7		After completion of repairs, the operations can be resumed. Perform Type A or Type B cleaning if the solution has been unloaded from the colloidal mill.
	5.5.8		Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed.
	5.5.9		Record the repair completion activity in Equipment Log Book.
	5.5.10		Describe the breakdown activity in the respective product BMR.
5.6		Preventive Maintenance
	5.6.1		Perform the preventive maintenance as per Annexure.
	5.6.2		If preventive maintenance activity is outsourced, the values are to be transcribed in the Annexure and external party certificate to be attached.

 

6. Abbreviation :

Abbreviation	Expansion
SOP	Standard Operating Procedure
%	Percentage
BMR	Batch Manufacturing Record

 

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

SOP Title: Operation and Cleaning of Vibratory Sifter

1. Objective:

To lay down procedure for Operation, Cleaning, Preventive  Maintenance of Vibratory Sifter and Sieve Integrity.

2. Scope:

This SOP is applicable to vibratory sifter used for sifting of granules/raw material located at granulation section of the production department.

 

3. Responsibility:
   • Production Department: To prepare and review the SOP. To follow the procedures laid down for the Operation, Cleaning and to support the Preventive Maintenance.
   • Quality Control Department: To analyse and report the swab/rinse samples.
   • Engineering Department: To perform the Preventive Maintenance.
   • Quality Assurance Department: To provide line clearance prior to operation. To collect the swab/rinse samples. To review and approve the SOP and Annexure.
4. Accountability:

Head, Production.

Head, Engineering.

Head, Quality Assurance.

5. Procedure:
   • Definition:
     • Production Associate: Executive or Operator of Production department trained to perform duties as per this SOP.
     • QA Associate: Personnel of QA department trained to perform duties as per this SOP.
     • QC Associate: Personnel of QC department trained to perform duties as per this SOP.
     • Engineering Associate: Personnel or operator of engineering department trained to perform duties as per this SOP.
     • Type A Cleaning: Dry cleaning with clean lint free cloth in the following cases,
       • Remove the previous batch residue.
       • During end of the shift.
       • Before starting the next batch of the same product, same strength and colour.
       • Prior to execution of higher strength batches, after the execution of lower strength batches of the same product.
     • Type B Cleaning: Wet cleaning by using soap solution in the following cases,
       • Removal of traces of the previous product, and is ensured by testing rinse /swab sample of the cleaned equipment.
       • Change in product or change in colour.
       • Prior to execution of lower strength batches, after the execution of higher strength batches of the same product.
       • After continuous five batches of the same product .
       • After seven days of cleaning before use, if equipment is not in use.
       • After replacement or repair of any product contact part.
       • Monthly, if it is not used after cleaning.
     • Cleaning Solution: 1 ml of Teepol (soap solution) in 1000 ml of potable water (0.1% v/v)
     • Breakdown: Any activity leading to operation of machine other than the set parameters and / or unusual sound or vibration observed in the machine.
     • Preventive Maintenance: Maintenance activity performed to ensure that the equipment will function smoothly and to avoid breakdowns. These activities are performed monthly, quarterly and half yearly.
   • Procedure:

	Precautions
5.2.1	Switch “OFF” the electrical mains during cleaning, setting and dismantling of Sifter.
5.2.2	Before starting operation ensure that the clamps of the sifter is fitted properly.
5.2.3	Do not over load the sifter by adding more materials to the sieve.
5.2.4	Use proper personal protective equipment as per respective product.
5.2.5	Before starting sifter, connect static discharge clip to the sieve as well as to the sifter body to discharge the static charge if developed during sifting operation.
5.3	Operation of Sifter
5.3.1	Check cleanliness of vibratory Sifter and sieves before start of the operation.
5.3.2	Before starting the sifting process make sure that the line clearance is taken and recorded in the respective BMR. Record the activity in the equipment log book as per Annexure.
5.3.3	Before starting the operation ensure that the temperature and relative humidity of the area is within the limit specified in the BMR.
5.3.4	Check and get the sieve issued as per respective product BMR from the production department. Record the issuance and integrity details in ‘Usage and Cleaning Record of Sieves” as per Annexure.
5.3.5	Place the respective sieve over the vibratory sifter.
5.3.6	Place the lid of the vibratory sifter over the sieve. Place the silicon gasket and fix it tightly by means of the clamps provided.
5.3.7	Tie a clean double polybag to the discharge port of the vibratory sifter to collect the sifted materials and also tie a clean double polybag to the discharge port provided at the lid of the vibratory sifter to collect any oversized or excess materials.
5.3.8	Place a SS container below the polybag tied to the discharge port of the vibratory sifter to avoid any spillage or damage to the poly bag.
5.3.9	Switch ‘ON’ the main electric switch, and then push the green button to start the Sifter.
5.3.10	Load the material to be sifted by clean SS scoop over the sieve.
5.3.11	Material will be sifted by vibratory movement and are collected through the discharge port. Label the polybag and the container for ‘In Process Label’.
5.3.12	If required mill the oversized or retained material if any collected in the poly bag fitted in the lid of the vibratory sifter and can be added back for further sifting. (Milling procedure to be performed as per respective product BMR).
5.3.13	Continue the sifting process until all the materials are sifted.
5.3.14	After completion of sifting process push the red colour button to stop the sifter followed by the main electric supply.
5.3.15	Unclamp, remove gasket from the sifter, remove the top lid and take out the sieve. Remove any sifted granules/material remained in the bottom of the lid and to the discharge port.
5.3.16	Record the activity in equipment log book as per Annexure No 01 Label the equipment as “To be Type A cleaned” or “To be Type B Cleaned”.
5.4	Type A Cleaning
5.4.1	Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process.
5.4.2	Ensure that the electrical utilities to the vibratory sifter are switched ‘off’ during the cleaning process.
5.4.3	Clean the outer surface of the vibratory sifter with dry, clean lint free cloth.
5.4.4	Remove adhered previous batch granules/powder present inside the Sifter with vacuum cleaner or dry clean duster.
5.4.5	Dismantle the Sieve locking clamps, top lid. Remove the sieve and bottom lid.
5.4.6	Dry clean the above dismantled parts with the help of clean dry duster / Vacuum cleaner.
5.4.7	Ensure the cleanliness by checking visually for the presence of any granules or material on the sifter, then affix “Type A Cleaned” label.
5.4.8	Record the activity in equipment log book as per Annexure.
5.5	TYPE B Cleaning (Product to Product Cleaning)
5.5.1	Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process.
5.5.2	Ensure that the electrical utilities to the vibratory sifter are switched ‘off’ during the cleaning process.
5.5.3	Clean the outer surface of the vibratory sifter with dry, clean lint free cloth.
5.5.4	Remove adhered previous batch granules/powder present inside the Sifter with vacuum cleaner or dry clean duster.
5.5.5	Dismantle the Sieve locking clamps, top lid. Remove the sieve and bottom lid.
5.5.6	Dry clean the above dismantled parts with the help of clean dry duster / Vacuum cleaner.
5.5.7	Cover the dismantled parts with clean poly bag and transfer to the wash area with “To Be Type B Cleaned” label.
5.5.8	Clean the outer surface of the sifter body and motor cover with vacuum cleaner followed by moist clean duster then with dry clean duster.
5.5.9	Wash the dismantled parts with 15-20 litres of potable water and clean with nylon scrubber dipped in 0.1% soap (teepol) solution.
5.5.10	Wash again with 25-30 litres of potable water to remove the traces of soap solution.
5.5.11	Finally rinse with 20-25 litres purified water.
5.5.12	Dry the cleaned parts with clean, dry duster/tray dryer.
5.5.13	Do not use any, metal of hard brush to clean the sieves.
5.5.14	Fill the Swab / Rinse Sample Intimation Slip and submit to QA department to collect the samples.
5.5.15	Collect the Swab/Rinse sample result from QA. If the result is complying, label the equipment as “Type B Cleaned”. If the result is not complying repeat the steps 5.5.7 and 5.5.8.
5.5.16	After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”.
5.5.17	Record the cleaning activities of Sifter in “Equipment Log Book” refer Annexure.
5.6	Sieve Integrity
5.6.1	Sieve integrity to be checked before start and after the completion of sifting activity.
5.6.2	Sieves should be checked visually for the following, a)      Adhered particles, b)      Cut or damage to the surface of the sieve, c)      Intactness of the sieve.
5.6.3	Record the observation in the Annexure.
5.6.4	Record the inventory of the sieve as per Annexure. Update the inventory details monthly.
5.7	Breakdown
5.7.1	If breakdown occurs during operation, hold the material in closed condition. Inform to the Head Production.
5.7.2	Fill the “Complaint Note” and submit to Engineering Department.
5.7.3	Fill the “Incident Report” and submit to Quality Assurance Department.
5.7.4	Unload the material/granules only, if required for breakdown rectification.
5.7.5	Store the unloaded material/granules separately in closed container with proper status label.
5.7.6	If breakdown occurs prior to start of operation, follow step 5.7.2.
5.7.7	Record the breakdown activity in Equipment Log Book
5.7.8	After completion of repairs, the operations can be resumed. Perform “Type A” or “Type B’ cleaning if the material have been unloaded from the Sifter.
5.7.9	Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed.
5.7.10	Describe the breakdown activity in the respective product BMR.
5.8.	Preventive Maintenance
5.8.1	Perform the preventive maintenance as per attached Annexure.
5.8.2	If preventive maintenance activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached.
5.8.3	Attach the preventive maintenance label on the equipment.

 

6. Abbreviation:

Abbreviation	Expansion
SS	Stainless Steel
BMR	Batch Manufacturing Record
QA	Quality Assurance
QC	Quality Control
ml	Milliliter
%	Percent
v/v	Volume by Volume

 

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

SOP Title: Operation and Cleaning of Tablet De-dusting Machine

 

1. Objective:

To define procedure for Operation, Cleaning and Preventive Maintenance of Tablet Dedusting Machine.

2. Scope:

This SOP is applicable to De-dusting Machine used for de-dusting of uncoated tablets in compression section.

 

3. Responsibility:
   • Production Department: To prepare and review the SOP. To follow the procedures laid down for the operation cleaning and preventive maintenance of Tablet Dedusting Machine
   • Engineering Department: To perform the preventive maintenance and calibration of Tablet Dedusting machine.
   • Quality Control Department: To analyse and report the swab samples.
   • Quality Assurance Department: To provide line clearance prior to operation. To collect the swab/rinse samples. To approve the preventive maintenance and calibration reports. To review and approve the SOP and Annexure.
4. Accountability:

Head Production Department  Head Engineering Department and Head Quality Assurance

5. Procedure:
   • Definition:
     • Production Associate: Executive or Operator of Production Department or any personnel trained to perform duties as per this SOP.
     • Quality Assurance Associate: Executive of Quality Assurance Department or any personnel trained to perform duties as per this SOP.
     • Quality Control Associate: Executive of Quality Control Department or any personnel trained to perform duties as per this SOP.
     • Engineering Associate: Executive or operator of Engineering Department trained to perform duties as per this SOP.
     • Non Recoverable Rejects: The tablets and powder which cannot be re processed, for example, black spot tablets, broken, and powder collected during the dedusting activity. The Non Recoverable Rejects are to be discarded.
     • Type A Cleaning: Dry cleaning with clean lint free cloth in the following cases:-
       • Remove the previous batch residue.
       • During end of the shift.
       • Before starting the next batch of the same product.
       • Prior to execution of higher strength batches, after the execution of lower strength batches of the same product.
     • Type B Cleaning: Wet cleaning by using soap solution in the following cases:-
       • Removal of traces of the previous product, and is ensured by testing rinse /swab sample of the cleaned equipment.
       • Change in product.
       • Prior to execution of lower strength batches, after the execution of higher strength batches of the same product.
       • After continuous five batches of the same product.
       • After seven days of cleaning before use, if equipment is not in use.
       • After replacement or repair of any product contact part.
       • Monthly, If cleaned machine is not used for de-dusting activity.
     • Cleaning Solution: 1 ml of Teepol (soap solution) in 1000 ml of potable water (0.1% v/v).
     • Breakdown: Any activity leading to operation of machine other than the set parameters and / or unusual sound or vibration observed in the machine.
     • Preventive Maintenance: Maintenance activity performed to ensure that the equipment will function smoothly and to avoid breakdowns. These activities are performed monthly and quarterly.
   • Procedure

	Precautions
5.2.1	During operation, adjust the tablet flow shutter in such a way that the tablets should not over flow  or tablet should not block the brush unit.
5.2.2	Keep the vibrator speed as per the requirement of the tablet flow.
5.2.3	Do not rub the tablet on the perforated plate.
5.2. 4	Visually, check the filter bag of the dust extractor for cleanliness and integrity.
5.2.5	Use proper personal protective equipment like Nose Masks, Gloves during dedusting operation.
5.2.6	Fix the suction nozzle of the dust extractor to the de-duster properly.
5.3	Operation
5.3.1	Before operation visually check, De-dusting machine is cleaned and line clearance is taken on specific product BMR.
5.3.2	Ensure  that, filter bag of the dust collector is properly fitted.
5.3.3	Check the temperature and humidity of the area is within the limit (25±2oC and 55± %RH) by observing on hygrometer provided in the cubicle.
5.3.4	As per the size of the tablet fix the perforated plate on the vibrator assembly.
5.3.5	Bring the tablet to be de-dusted in the area and check the container .
5.3.6	Switch “ON” the MCB and switch “ON” green press switch to check the rotation of brush.
5.3.7	Switch ‘OFF” the de-duster and fix the brush cover.
5.3.8	Load the tablets manually in to the hopper with the help of scoop.
5.3.9	Place the metal detector at the outlet chute of the de duster to pass the de-dusted tablets through metal detector.
5.3.10	Keep cleaned container lined with poly bag at the outlet chute of the metal detector to collect the de-dusted and metal detected tablets. Switch “ON’ the metal detector and check the sensitivity and operate the metal detector as per the SOP.
5.3.11	Switch “ON” the main MCB followed by the green push button of the starter.
5.3.12	Switch “ON” the toggle switch to up position to start the vibrator. Adjust the vibrator speed so that tablet should be de-dusted properly.
5.3.13	Switch “ON’ the dust extractor by pushing green colour start button provided on the dust extractor.
5.3.14	Slightly open and adjust the shutter of the hopper till the flow of tablets as per requirement.
5.3.15	Set the speed of the vibrator with speed regulator knob (RHS side to increase the speed and LHS to decrease the speed).
5.3.16	The shutter should be adjusted in such a way that the tablet should not block the brush unit.
5.3.17	Check the de-dusted tablets visually for absence of powder / dust.
5.3.18	Remove the defective tablets (broken / black spot) on the perforated plate and should be labelled as ‘Non Recoverable Rejects’.
5.3.19	If dedusting is not proper, check the suction of dust extractor and filter bag for choking.
5.3.20	After completion of dedusting, press the red colour “stop” button of the de-duster then switch “OFF” the vibrator followed by the main MCB.
5.3.21	After completion of dedusting and metal detection check the sensitivity of metal detector as per SOP.
5.3.22	After completion of de-dusting activity, label the equipment as “To be Type A cleaned” or “To be Type B Cleaned”.
5.3.23	Record the activity in Equipment Log Book as per Annexure.
5.4	Cleaning:
5.4.1	Type A Cleaning( Batch to Batch Cleaning)
5.4.1.1	Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process.
5.4.1.2	Switch “OFF” the red colour stop button of the de-duster, Then switch down the toggle switch to stop the vibrator.
5.4.1.3	Switch “OFF” the dust extractor and then switch off the MCB.
5.4.1.4	Remove all tablets container from the area.
5.4.1.5	Remove the powder collection tray from the clamp, dismantle the perforated plate, hopper by loosening the relative bolts.
5.4.1.6	Dry clean the dismantled parts with the help of clean dry duster.
5.4.1.7	Clean the outer surface of the vibrating assembly, table top, and stand with dry clean duster.
5.4.1.8	Remove and clean the powder collection tray of dust extractor with dry duster.
5.4.1.9	Ensure the cleanliness visually and fix all the dismantled parts in proper place.
5.4.1.10	Weigh the collected powder and label as “Rejects” and record the weight in the BMR.
5.4.1.11	Ensure the cleanliness by checking visually for the presence of any granules or particles, then affix “Type A Cleaned” label.
5.4.1.12	Record the activity in Equipment Log Book as per Annexure.
5.5	Type B Cleaning(Product to product Cleaning)
5.5.1	Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process. Refer
5.5.2	Switch “OFF” the main followed by switching “OFF” the machine.
5.5.3	Remove the entire tablet container from the area and dry clean the surface of machine with the help of vacuum cleaner / dry clean duster.
5.5.4	Remove the powder collection tray from the clamp.
5.5.5	Dismantle the perforated plate hopper, brush unit by loosening the relative bolts. Dry clean the dismantled parts with the help of clean dry duster / nylon brush.
5.5.6	Cover the dismantled parts with fresh poly bag and transfer to the wash area with “ To Be Type B Cleaned” status label.
5.5.8	Wash all the parts with 15-20 litres of potable water, and then clean with 0.1% soap (teepol) solution.
5.5.9	Wash the above parts with 15-20 litres of potable water to remove the traces of soap solution. Finally rinse all the parts with 15- 20 Litres of purified water.
5.5.10	Fill the Swab / Rinse Sample Intimation Slip and submit to QA Department for collection of samples.
5.5.11	Record the activity in Equipment Log Book as per Annexure.
5.5.12	Collect the Swab/Rinse sample result from Quality Assurance Department. If the result is complying, label the equipment as “Type B Cleaned”.
5.5.13	If the result is not complying repeat the steps 5.5.8 to 5.5.9.
5.5.14	After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”.
5.5.15	Dry the brushes with the help of compressed air and dry duster. Ensure the drying of brushes before fixing to the machine.
5.5.16	Affix “Cleaned” status label to the parts and transfer to the clean equipment room by covering with clean poly bag.
5.5.17	Clean the vibratory base, mounting stand, table top of the de duster with moist lint free cloth followed by dry lint free cloth.
5.5.18	Record the usage and cleaning activity in Equipment Log Book as per Annexure.
5.6	Breakdown
5.6.1	If breakdown occurs during operation, hold the dedusting activity. Inform the Head Production.
5.6.2	Fill the “Complaint Note” and submit to Engineering Department.
5.6.3	Fill the “Incident Report” and submit to Quality Assurance Department.
5.6.4	If the breakdown is major unload the tablets from the machine only if required for breakdown rectification.
5.6.5	Store the tablets in a closed container with proper status label.
5.6.6	If breakdown occurs prior to start of operation, follow step 5.6.2.
5.6.7	After completion of repairs, the operations can be resumed. Perform Type A or Type B cleaning if the tablet has been unloaded from the machine.
5.6.8	Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed.
5.6.9	Record the repair completion activity in Equipment Log Book. Refer Annexure  No.01.
5.6.10	Describe the breakdown activity in the respective product BMR.
5.7	Preventive Maintenance
5.7.1	Perform the preventive maintenance as per Annexure.
5.7.2	If preventive maintenance activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached.
5.7.3	Attach the preventive maintenance label on the equipment.

 

6. Abbreviation :

Abbreviation	Expansion
LHS	Left Hand Side
RHS	Right Hand Side
SOP	Standard Operating Procedure
%	Percent
±	Plus or Minus
BMR	Batch Manufacturing Record

 

 

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

SOP Title: Operation, and Cleaning of Vacuum Cleaner

1. Objective:

To define procedure for  Operation, Cleaning and Preventive Maintenance of Vacuum Cleaner.

2. Scope:

This SOP is applicable to Vacuum Cleaner used for cleaning of machine and Area in Production Department.

 

3. Responsibility:
   • Production Department: To prepare and review the SOP. To follow the procedures laid down for the operation and cleaning and to supportive preventive maintenance of Vacuum Cleaner.
   • Engineering Department: To perform the preventive maintenance of Vacuum Cleaner.
   • Quality Assurance Department: To provide line clearance prior to operation. To review and approve the SOP and Annexure.
4. Accountability:

Head Production Department , Head Engineering Department and Head Quality Assurance.

5. Procedure:
   • Definition: Production Associate: Executive or Operator of Production Department or any personnel trained to perform duties as per this SOP.
   • Quality Assurance Associate: Executive of Quality Assurance Department or any personnel trained to perform duties as per this SOP.
   • Engineering Associate: Executive or operator of Engineering Department trained to perform duties as per this SOP.
   • Type A Cleaning: Dry cleaning with clean lint free cloth in the following cases:-
     • During batch change over.
     • After replacement or repair of any part.
     • If suction is poor due to blocking of filter pores.
   • Type B Cleaning: Wet cleaning by using soap solution in the following cases:-
     • Removal of traces of the previous product.
     • Change in product.
     • After continuous five batches of the same product.
     • After seven days of cleaning before use, if equipment is not in use.
     • After replacement or repair of any product contact part.
     • Monthly, if cleaned vacuum cleaner not used.

 

• Clean the Vacuum cleaner once a week ,if it is continuous use and there is no product changeover.

• Cleaning Solution: 1 ml of Teepol (soap solution) in 1000 ml of potable water (0.1% v/v).
• Breakdown: Any activity leading to operation of machine other than the set parameters and / or unusual sound or vibration observed in the machine.
• Preventive Maintenance: Maintenance activity performed to ensure that the equipment will function smoothly and to avoid breakdowns. These activities are performed half yearly.

• Procedure

	Precautions
5.2.1	Before starting the vacuum cleaner, check the filter bag of vacuum cleaner for its cleanliness and integrity.
5.2.2	Do not plug the vacuum cleaner to the three phase connection.
5.2.3	Do not start the vacuum cleaner continuously for more than the 30 minutes.
5.2.4	Do not wash the motor assembly with water.
5.3            Operation
5.3.1	Prior to use, take the line Clearance of Vacuum Cleaner then switch “ON” the main electric line.
5.3.2	Pull the Knob of the hose pipe connector and insert the hose pipe in to the connector.
5.3.3	Connect the nozzle / connector (flat, pointed, round) as per the requirement.
5.3.4	Fix the plug to the single phase current, Switch ‘ON’ the main switch and start the vacuum by pressing the switch to the “ON” position.
5.3.5	Start the vacuum cleaner and hold the suction nozzle in a place, where cleaning needs to be done.
5.3.6	Note: i)  For cleaning of machine, use pointed hollow type nozzle, and for floor / surface cleaning use brush type flat nozzle. ii) Clean the nozzle (extension) of the vacuum cleaner after every use.
5.3.7	After completion of the operation, stop the vacuum cleaner using ON/OFF switch.
5.3.8	Switch “OFF” the main electrical power supply. Unclamp the motor assembly with the help of clamp provided and remove the filter bag.
5.3.9	Unclamp the motor assembly with the help of clamp provided and remove the filter bag.
5.3.10	Remove the collected powder from the chamber in to the poly bag.
5.3.11	The powder collected in the vacuum cleaner should not be used.
5.3.12	Record the Usage  and Cleaning Activity in Annexure.
5.3.13	Label the vacuum cleaner as “To Be Type A cleaned or To Be type B cleaned “.
5.4	Type A Cleaning
5.4.1	Switch “OFF” the main electric supply followed by machine.
5.4.2	Affix “To be Type A” cleaned label.
5.4.3	Switch “OFF’ and take the vacuum cleaner to the filter cleaning area.
5.4.4	Unclamp the motor assembly and remove the filter.
5.4.5	Remove the collected powder from the filter bag in to a poly bag and label the powder as “Non Recoverable rejects” refer SOP.
5.4.6	Dry clean the filter bag with smooth nylon brush and de-dust using mild compressed air 1 to 2 kg/cm2.
5.4.7	Clean the outer body, hose pipe, nozzles, handle and wheels of the vacuum cleaner with dry clean duster.
5.4.8	Check the cleaning and intactness of the filter bag.
5.4.9	Affix “ Type A Cleaned” label.
5.5	Type B Cleaning
5.5.1	Switch “OFF” the main electric supply followed by machine then affix “To be Type B” cleaned label.
5.5.2	Clean the vacuum cleaner externally (including wheels) with dry duster, then transfer to the wash area by covering with poly bag.
5.5.3	Dismantle the hosepipe by lifting knob of vacuum cleaner.
5.5.4	Remove the filter bag from container and then clean the filter bag in filter cleaning booth using compressed air and nylon brush.
5.5.4.1	Cleaning of filter bags: Initially remove the dust accumulated on filter by using compressed air 1 to 2 kg/cm2 from either side.
5.5.4.2	Wash the filter with 10 Litre of potable water and then apply 0.1% soap solution. Then wash with10 Litre potable water.
5.5.4.3	Finally clean the filter bag with 10 litre of purified water. Dry the filter bag using compressed air/tray dryer.
5.5.4.4	Collect the dust/powder from the container in a polythene bag and  should be labelled as “Non Recoverable rejects”
5.5.4.5	Rejects should be dispose “off” by putting in to “Hazardous Waste” container provided in the wash area, after approval from Production officer.
5.5.5	Cleaning of vacuum cleaner body (chamber): Wash the container (chamber), hosepipe and nozzle from inside and outside with potable water.
5.5.6	Clean the above parts with soap solution then wash with potable water.
5.5.7	Pass the approximately 10 litres of potable water from the hose pipe and nozzle.
5.5.8	Finally rinse with purified water and dry using dry lint free duster/compressed air.
5.5.9	Unclamp the top lid from the chamber (container) and clean  lid from outside  with wet duster and then with clean dry duster.
5.5.10	Fix the clean filter bag on the vacuum cleaner.
5.5.11	Fix top lid (with motor assembly) with the help of clamp.
5.5.12	Fix hosepipe and nozzle to the container.
5.5.13	Start the vacuum cleaner and check for its proper working and suction
5.5.14	Affix ‘Type B Cleaned” status label and transfer the vacuum cleaner to the area.
5.5.15	Record the Usage and Cleaning activity in Annexure.
5.6	Preventive maintenance:
5.6.1	Perform the preventive maintenance as per  Annexure.
5.7	Breakdown
5.7.1	Fill the “Complaint Note” and submit to Engineering Department.
5.7.2	Record completion of repair, record the activity in “Usage and cleaning of Vacuum Cleaner”.

 

6. Abbreviation:

Abbreviation	Expansion
SOP	Standard Operating Procedure
PDD	Production
CAP	Capsule
TAB	Tablet
Kg/cm2	Kilo gram per square Centimetre
%	Percentage

 

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

SOP Title: Operation and Calibration of Strip Packing Machine

1. Objective:

To define procedure for Operation, Cleaning,  Preventive Maintenance and Calibration of Strip Packing Machine.

2. Scope:

This SOP is applicable to Strip Packing Machine used for packing of tablet and capsule in between aluminium foil in the form of strip pack in packing section of the production area.

 

3. Responsibility:
   • Production Department: To prepare and review the SOP. To follow the procedures laid down for the operation and cleaning and to support for Preventive Maintenance and Calibration of Strip Packing Machine.
   • Engineering Department: To perform the Preventive Maintenance and Calibration of Strip Packing Machine.
   • Quality Control Department: To analyse and report the swab samples.
   • Quality Assurance Department: To provide line clearance prior to operation. To collect the swab/rinse samples. To approve the Preventive Maintenance and Calibration reports. To review and approve the SOP and Annexure.
4. Accountability:

Head Production  Department ,Head Engineering Department and Head Quality Assurance.

5. Procedure:
   • Definition:
     • Production Associate: Executive or Operator of Production Department or any personnel trained to perform duties as per this SOP.
     • Quality Assurance Associate: Executive of Quality Assurance Department or any personnel trained to perform duties as per this SOP.
     • Quality Control Associate: Executive of QC Department trained to perform duties as per this SOP.
     • Engineering Associate: Executive or Operator of Engineering Department trained to perform duties as per this SOP.
     • Type A Cleaning: Dry cleaning with clean lint free cloth in the following cases:-
       • Remove the previous batch residue.
       • During end of the shift.
       • Before starting the next batch of the same product.
       • Prior to execution of higher strength batches, after the execution of lower strength batches of the same product.
     • Type B Cleaning: Wet cleaning by using soap solution in the following cases:-
       • Removal of traces of the previous product, which is ensured by testing rinse /swab sample of the cleaned equipment.
       • Change in product.
       • Prior to execution of lower strength batches, after the execution of higher strength batches of the same product.
       • After continuous five batches of the same product.
       • After seven days of  cleaning before use, if equipment is not in use.
       • After replacement or repair of any product contact part.
       • Monthly, if cleaned machine not used for packing activity.
     • Cleaning Solution: 1 ml of Teepol ( soap solution) in 1000 ml of potable water (0.1% v/v)
     • Breakdown: Any activity leading to operation of machine other than the set parameters and / or unusual sound or vibration observed in the machine.
     • Preventive Maintenance: Maintenance activity performed to ensure that the equipment will function smoothly and to avoid breakdowns. These activities are performed monthly, quarterly and half yearly.
     • Calibration: Tests performed to ensure that the equipment is functioning as per set parameters. These test are performed yearly and also after repair or replacement of parts coming in direct contact with product.
   • Procedure:

	Precautions
5.2.1	Put “OFF” the main supply of the strip packing machine during cleaning.
5.2.2	During setting and cleaning whenever required, run the machine in Inch mode  by turning the toggle switch to Up position then press the green colour “ON” button provided on the machine.
5.2.3	During inserting aluminium foil web in-between sealing roller, care should be taken to avoid the fingers entering in-between the sealing roller.
5.2.4	Care should be taken to avoid the accident such as burning of hands with sealing rollers.
5.2.5	Use nose mask and hand gloves while handling the product.
5.2.6	Ensure the working of heaters, limit switches and proper fitting of change parts by starting machine in inch mode.
5.3	Operation
5.3.1	Before starting machine, check that the line clearance is taken as per checklist given in specific product BPR.
5.3.2	Fit the change parts on machine as per product specification mentioned on specific product BPR.
5.3.3	Switch “ON” the main electric supply then switch “ON’ the machine by turning key to the RHS side to the “ON” position provided on the machine panel.
5.3.4	The phase indicator will glow red, yellow and green followed by red stop button provided on the panel.
5.3.5	To start the machine in inch mode turn the toggle switch to the down position and to start the machine in run mode turn the toggle switch to the up position.
5.3.6	Switch “ON” the sealing heater by turning knob to the RHS “ON” position, and then set the required temperature as mentioned in the product BPR.
5.3.7	For setting the sealing temperature, press the push button and rotate the coarse /fine regulator to RHS to increase the temperature and LHS to decrease the temperature.
5.3.8	Check that the sealing heaters are working properly by observing increase in the temperature controller display.
5.3.9	Wait for 20 to 30 minutes to achieve the required temperature, the actual temperature will display on the temperature controller display on the panel board of the machine.
5.3.10	Put the printed aluminium foil on the both holder arm, on LHS holder printed aluminium foil and RHS holder plain aluminium foil then pass the foil in-between the sealing roller.
5.3.11	Sealed web pass through the dropping brush, then pass through the cutting assembly to cut the strip pack of uniform size.
5.3.12	Issue the required number of stereos as per product requirement from QA.
5.3.13	Fit the stereos on the stereo roller followed by the printed aluminium foil and plain aluminium foil such a way that the printed aluminium foil and plain aluminium foil should pass through roller having cavities and Plain aluminium foil should bear batch code.
5.3.14	After fixing the stereos put the ink and thinner to the ink roller than start the machine to get the clear printing proof.
5.3.15	Then send one over printed foil proof to packing officer / production officer and verified by QA officer for initial proof checking against BPR as mentioned in overprinting proof checking sheet.
5.3.16	Packing officer, production officer and QA officer will check the overprinting quality, manufacturing date, expiry date, maximum retail price and other overprinting matter such as dot, coma, dash etc.
5.3.17	After getting proof checking clearance from QA person, attach the checked proof with BPR.
5.3.18	Start the printing and check the coded/overprinted matter routinely, as mentioned in specified product BPR.
5.3.19	Load the tablets/capsules in to the hopper and set the chute with the centre of the cavity of the sealing roller.
5.3.20	Start the vibrator by turning the toggle switch to the up position then adjust the vibration speed by turning the regulator knob to the RHS to increase and rotate the regulator to LHS decrease the vibrator speed.
5.3.21	Set the chute in such a way, the tablet should be freely drop from the bowl dish in to the chute.
5.3.22	The tablets from the chute passes in to the sealing roller cavity in which, the tablet packed in-between the aluminium foil.
5.3.23	Visually check the printing and quality of strip packs.
5.3.24	Check the Leak Test for number of strips and frequency as mentioned in the specific product BPR.
5.3.25	Operate the Leak Test Apparatus as per SOP.
5.3.26	If Leak Test fails clean the roller, set the machine and check again.
5.3.27	After passing the leak test start the machine for packing activity.
5.3.28	Check and record in-process test parameters as mentioned in the specific product BPR.
5.3.29	Set the cutter for uniform cutting of strips as per pack size.
5.3.30	Adjust the speed of the machine by turning the switch clockwise / Anti clock wise on the regulator provided.
5.3.31	Printing rejects and missing tablet/capsule strips to be de-foiled and sorted. The sorted tablet /capsules should be checked by packing officer and packed at the end in the same batch.
5.3.32	The de-foiled tablets/capsules packed shipper number should be noted down in the product BPR.
5.3.33	Label the defective tablets/capsules as “rejects”. These rejects to be disposed in water and label the disposed container as “Hazardous Waste”.
5.3.34	During packing activity tablet container should be kept in closed condition.
5.3.35	At the end of batch, take overprinted proof  as a last proof get it check and signed by packing officer, production officer and verified by QA and same should be kept along with initial proof.
5.3.36	After completion of the packing activity, switch “OFF” the machine by turning the key to the LHS followed by main electric switch.
5.3.37	Remove the stereo from the roller and handover to QA.
5.3.38	Remove the remaining foil, tablet/capsules if any, and clean the machine with the nylon brush and clean dry duster. Note: At the end of the day clean the machine as per “Type A Cleaning”.
5.3.39	After completion of batch, check the weight of the excess foil and details  of the same to be mentioned on the label.
5.3.40	Fill the Excess Material Return Note and return the excess material to Warehouse after authorisation of Production Head and QA.
5.3.41	After completion of batch, label the equipment as “To be Type A cleaned” or “To be Type B Cleaned”.
5.3.42	Record the activity in “Equipment log book”.
5.4	Type A Cleaning
5.4.1	Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process..
5.4.2	Switch “OFF” the mains of the machine and remove all documents, labels, containers of previous batch.
5.4.3	Remove all stereos from the stereo roller and hand over to QA.
5.4.4	Remove the scrap of foil and foil pieces in between the cutting tool.
5.4.5	De-dust all the parts except heating roller with nylon brush / vacuum cleaner / dry duster.
5.4.6	Clean the pressure sealing roller with metallic brush to remove the adhered residue of foil.
5.4.7	Dry clean the outer surface, in between the parts of the machine with clean dry duster / nylon brush /vacuum cleaner.
5.4.8	Ensure the cleanliness by checking visually for the presence of any tablets or particles in the blister pack machine, then affix “Type A Cleaned” label.
5.4.9	Record the activity in Equipment Log Book as per Annexure.
5.5	Type B Cleaning
5.5.1	Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process.
5.5.2	Switch “OFF” the machine by turning the key to the LHS followed by main electric switch.
5.5.3	Remove all documents, labels, material, and containers of previous products from machine as well as from the area.
5.5.4	Dry clean the machine as well as the area with vacuum cleaner and dry duster.
5.5.5	Collect the tablets /capsules/powder and label as ‘Rejects’ and record the weight on the BPR.
5.5.6	Dismantle the feed hopper and vibrating bowl by removing the relevant Ellen bolts.
5.5.7	Dismantle the feeding chute, cover plate by loosening the screw provided.
5.5.8	Cover the dismantled parts with poly bag and transfer to the wash area on trolley with “To be Type B Cleaned “label.
5.5.9	Wash all the parts with 10 Litre of potable water then apply 0.1 % Soap (teepol) solution.
5.5.10	Wash the parts with 20 Litre of potable water to remove the traces of soap solution. Finally rinse with 10 Litre of purified water.
5.5.11	Fill the Swab / Rinse Sample Intimation Slip and submit to QA department to collect the samples.
5.5.12	Record the activity in Equipment Log Book.
5.5.13	Collect the Swab/Rinse sample result from QA. If the result is complying, label the equipment as “Type B Cleaned”. If the result is not complying repeat the steps 5.5.9 to 5.5.11.
5.5.14	After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”.
5.5.15	Affix ‘cleaned’ label and cover with fresh poly bag. Keep the cleaned parts to the spare parts room.
5.5.16	Dismantle the both sealing roller, back gear and dropping cam with the help of Ellen key.
5.5.17	Clean the Sealing rollers with metal wire brush to remove any residue of any molten polythene, dirt and pieces of laminate.
5.5.18	Carefully inspect the knurled surface of the roller, The surface should not be damaged. Then clean with dry clean duster.
5.5.19	Keep the change parts in the dedicated place in change parts room.
5.5.20	Clean the outer surface, panel, platform, inside the machine with dry duster then clean the outer surface of the machine with moist duster.
5.5.21	Ensure the cleanliness by visually and affix “Type B Cleaned” label to the machine.
5.6	Breakdown
5.6.1	If breakdown occurs during operation, hold the tablets/capsules in closed condition. Inform the Head Production.
5.6.2	Fill the “Complaint Note” and submit to Engineering Department.
5.6.3	Fill the “Incident Report” and submit to Quality Assurance Department.
5.6.4	Unload the tablets/capsules only if required for breakdown rectification.
5.6.5	Store the unloaded tablets/capsules separately in closed container with proper status label.
5.6.6	If breakdown occurs prior to start of operation, follow step 5.6.2
5.5.7	Record the breakdown activity in Equipment Log Book.
5.6.8	After completion of repairs, the operations can be resumed. Perform ‘Type A” or “Type B” cleaning if the tablets have been unloaded from the hopper.
5.6.9	Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed.
5.6.10	Describe the breakdown activity in the respective product BPR.
5.7	Preventive Maintenance
5.7.1	Perform the preventive maintenance as per Annexure.
5.7.2	If preventive maintenance activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached.
5.7.3	Attach the preventive maintenance label on the equipment.
5.8	Calibration
5.8.1	Calibrate the temperature controller once in a year by external approved party.
5.8.2	If calibration activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached.
5.8.3	Attach the calibration label on the equipment.
5.9	Maintain the Issuance, Utilisation and Cleaning record of Strip Packing Machine Change Parts  as per Annexure.

 

6. Abbreviation

Abbreviation	Expansion
BPR	Batch Packing Record
ml	Milliliter
LHS	Left Hand Side
RHS	Right Hand Side
QC	Quality Control
%	Percent
v/v	Volume by Volume

     

 

CALIBRATION OF TEMPERATURE INDICATOR

 OBSERVATIONS

Sr. No.	Reading on UUC (°C)	Reading on Standard instruments (°C)	Deviation ± 4°C	Remarks
1
2
3
4
5
6
UUC : Unit Under Calibration
Result: The results Complies / Not Complies with the acceptance criteria.

 

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

 

SOP Title: Operation and Calibration of Weighing Balance

  

1. Objective: To lay down the procedure for Operation, Cleaning and Calibration of Electronic Weighing Balance.
2. Scope: This SOP is applicable for Operation, Cleaning and Calibration of Electronic Weighing Balance in the Production Department.

 

3. Responsibility :
   • Production Department: To prepare and review the SOP. To follow the procedures for the Operation, Cleaning and Calibration of Electronic Weighing Balance.
   • Quality Assurance Department: To review and approve the SOP and Annexure.
4. Accountability:

Head, Production Department / Head, Quality Assurance Department.

5. Procedure:
   • Definitions:

5.1.1    Breakdown: Any activity leading to operation of machine other than the set parameters and / or unusual readings displayed on balance.

5.1.2 Calibration: Tests performed to ensure that the instrument is functioning as per set   parameters. These tests are performed daily, quarterly and also after repair or replacement of parts.

5.2.    Procedure:              

	Safety Precaution
5.2.1	Inspect electrical cables and connectors for any sign of damage or wear prior to use.
5.2.2	Do not disengage electrical connection unit during weighing operation.
5.2.3	Never overload balance beyond its capacity to avoid potential damages to load cells.
	Checks before switching “ON” the Electronic Weighing Balance (EWB)
5.2.4	Do not keep the EWB near source of vibration /strong air drift.
5.2.5	Ensure that the EWB is clean and if not, clean the balance using a non-static brush.
5.2.6	Always start the weighing balance 30 minutes prior to use.
5.2.7	Do not keep weight on balance during “OFF” condition.
	Weighing Operation
5.2.8	Connect the power supply cord to the switch board.
5.2.9	Switch “ON” the main power supply of the Electronic Weighing Balance. Then switch “ON” the balance by pressing ON/OFF switch provided at the bottom of the balance.
5.2.10	The balance starts with displaying. 1234567890 Then stabilises zero with beep sound.
5.2.11	Allow the Electronic Weighing Balance to stabilize for 30 minutes before carrying out the any operation.
5.2.12	Ensure that, the balance is calibrated by checking the calibration status label on the balance.
5.2.13	Check the zero error, if there is error adjusts it by levelling the adjustment screw of the balance provided bottom the platform.
5.2.14	Introduction To Keys: TARE         =            Zero-Setting Key MODE        =            Gross Weight.
5.2.15	Place appropriate Container/Shipper/Box in the centre of the pan of the Electronic Weighing Balance.
5.2.16	Tare the weight of the Container/Shipper/Box by pressing the ‘TARE’ key.
5.2.17	Check that the display shows zeros.
5.2.18	If the display is not showing zero reading then press ‘TARE’ key to zero the display.
5.2.19	To take tare weight, remove the tarred Container/Shipper/Box from the EWB, display shows the tare weight of the Container/Shipper/Box.
5.2.20	Transfer the required quantity of the material to be weighed into the tarred Container/Shipper/Box and allow the display to stabilize.
5.2.21	The display shows the net weight of the material/product.
5.2.22	To check the gross weight, remove the weighed Container/Shipper/Box including the material and press the ‘TARE’ key for auto zero. Check that the display shows zero and keep the previously weighed Container /Shipper /Box with material, display will show the sum of weights of the both Container/Shipper/Box and material.
5.2.23	To check gross weight of the Container/Shipper/Box press the mode key, display will show the gross weight of the material for a few second then displays the net weight.
5.2.24	After completion and before weighing of every Container/Shipper / Box, balance should be display Zero. (applicable during gross weight checking) If shows zero error, make it zero by pressing “TARE” key of the balance.
5.2.25	After completion of weighing remove the weighed material/ container from the balance. If the balance not to be used for full day, then switch “OFF” the balance and switch ‘OFF’ the main supply.
	Calibration
	Daily Calibration:
5.2.26	Calibration to be performed every day before the start of the work.
5.2.27	Calibration is performed using standard calibrated weight box.
5.2.28	Place 0.100 kg of calibrated weight on the pan of the balance using hand gloves and record the weight as per Annexure. Ensure that the value meets with the acceptance limits.
5.2.29	Place 1.000 Kg of calibrated weight on the pan of the balance using hand gloves and record the weight as per Annexure. Ensure that the value meets with the acceptance limits.
5.2.30	Place 10.000 Kg of calibrated weight on the pan of the balance using hand gloves and record the weight as per Annexure. Ensure that the value meets with the acceptance limits.
5.2.31	Place 20.000 Kg of calibrated weight on the pan of the balance using hand gloves and record the weight as per Annexure. Ensure that the value meets with the acceptance limits.
5.2.32	Permissible tolerance for verification should be as per Annexure.
5.2.33	If daily calibration complies with permissible tolerance, affix / update the ‘Calibration Status Label (Daily)’ as per Annexure.
5.2.34	In case of non-compliance in step nos. 5.2.28 to 5.2.32, inform “Head of Department” and “Quality Assurance”. Label the balance as ‘Balance Under Maintenance’.
	Quarterly [03 months ± 3 Days]
5.2.35	Perform the complete calibration once in three months.
5.2.36	Following parameters should be checked: Weighing performance / Accuracy across the operating range, Repeatability / Precision, and Eccentricity / Corner
	Weighing performance / Accuracy across the operating range
5.2.37	Set the balance to Zero before the start of the weighing performance test.
5.2.38	The standard weights should be distributed evenly on the balance pan.
5.2.39	Calibration should be carried out by using calibrated standard weights as per Annexure.
	Repeatability / Precision
5.2.40	Load standard calibrated weight [20.000 Kg] on weighing pan and record the reading displayed after stabilization.
5.2.41	Remove the weight and ensure that reading returns back to Zero.
5.2.42	Re – place the same weight and repeat the above steps 5 more times.
5.2.43	Record the reading displayed as per Annexure.
5.2.44	Permissible tolerance for verification should be as per Annexure.
	Eccentricity / Corner
5.2.45	Load standard calibrated weight [20.000 Kg] in the centre of weighing pan and record the stabilized reading displayed as per Annexure.
5.2.46	Repeat the procedure by placing the standard weight at different corners [as displayed below] of weighing pan.
5.2.47	1                                                   2 C 3                                                     4 Weighing Pan  C – Centre, 1, 2, 3, 4 – Corners.
5.2.48	Record the readings displayed in each location of weight placement as per Annexure.
5.2.49	If quarterly calibration complies with permissible tolerance, affix / update the ‘Calibration Status Label (Quarterly)’as per Annexure.
5.2.50	If the test does not comply with permissible tolerance, affix ‘Balance Under Maintenance’ as per Annexure and inform Engineering Department and Service Engineer for rectification.
5.2.51	Switch “OFF” the balance, (if it is not using for full day) and cover with clean poly bag.
	Cleaning
5.2.52	Switch “OFF” the balance during cleaning.
5.2.53	Cleaning of the balance should be done daily before calibration, after each weighing activity or whenever necessary.
5.2.54	First remove the dust and powder with the help of soft nylon brush.
5.2.55	Clean the balance (except display) with soft cloth soaked and squeezed in IPA to remove any oily substances or spots from the balance and clean with dry lint free cloth.
	Action plan during Break down of Balance
5.2.56	If any breakdown occurs, inform to Head of the Department / QAD / Engineering Department. Put the tag “Balance Under Maintenance” as and inform to Service Engineer for rectification.
5.2.57	After rectification calibrate the balance with full scale before use.

 

6. Abbreviation:

Abbreviation	Expansion
IPA	Isopropyl Alcohol
Kgs	Kilo Grams
EWB	Electronic Weighing Balance
QAD	Quality Assurance Department

 

Balance Calibration Record (Daily)

Date	Calibrated Weights	Acceptance    criteria (± 0.1% of certified value in Kg)			Observed value (Kg)	Compliance (Pass/Fail)			Done By	Checked By
		From		To
	0.100 kg		0.099	0.100
	1.000 Kg		0.999	1.001
	10.000 Kg		9.990	10.010
	20.000 Kg		19.980	20.020

 

                 Balance Calibration Record (Quarterly)

1. Weighing performance / Accuracy across the operating range

Date	Calibrated Weights	Acceptance    criteria (± 0.1% of certified value in Kg)		Observed value (Kg)	Compliance (Pass/Fail)
		From	To
	0.050 Kg	0.049	0.050
	0.100  Kg	0.099	0.100
	0.500 Kg	0.499	0.500
	1.000 Kg	0.999	1.001
	2.000 Kg	1.998	2.002
	5.000 Kg	4.995	5.005
	10.000 Kg	9.990	10.010
	15.000 Kg	14.985	15.015
	20.000 Kg	19.980	20.020
	25.000 Kg	24.975	25.025

 

1. Repeatability / Precision

 

Date	Calibrated Weights	Acceptance    criteria (± 0.1% of certified value)		Observed value (Kg)	Compliance (Pass/Fail)
		From	To
	20.000 Kg	19.980 Kg	20.020 Kg

  

III. Eccentricity / Corner

 

Date	Calibrated Weights	Acceptance    criteria (± 0.1% of certified value)		Location	Observed value (Kg)	Compliance (Pass/Fail)
		From	To
	20.000 Kg	19.980 Kg	20.020 Kg	Centre
				Corner 1
				Corner 2
				Corner 3
				Corner 4

 

CONCLUSION: The quarterly calibration of balance is found to be SATISFACTORY/ NOT SATISFACTORY.

*Note – Ready to use SOP available in “DOWNLOAD” Section.

 

SOP Title: Operation, And Calibration Of Blister Packing Machine

1. Objective:

To define procedure for Operation, Cleaning, Preventive Maintenance and Calibration of Blister Packing Machine Double Track Conveyor Belt.

2. Scope:

This SOP is applicable to Blister Packing Machine used for blister packing of Tablet and Capsules in packing section.

 

3. Responsibility:
   • Production Department: To prepare and review the SOP. To follow the procedures laid down for the operation and cleaning and to support for preventive maintenance and calibration of Blister Packing Machine.
   • Engineering Department: To perform the preventive maintenance and calibration of Blister Packing Machine.
   • Quality Control Department: To analyse and report the swab samples.
   • Quality Assurance Department: To provide line clearance prior to operation. To collect the swab/rinse samples. To approve the preventive maintenance and calibration reports. To review and approve the SOP and Annexure.
4. Accountability:

Head Production Department, Head Engineering Department and Head Quality Assurance.

5. Procedure:
   • Definition:
     • Production Associate: Executive or Operator of Production Department or any personnel trained to perform duties as per this SOP.
     • Quality Assurance Associate: Executive of Quality Assurance Department or any personnel trained to perform duties as per this SOP.
     • Quality Control Associate: Executive of QC Department trained to perform duties as per this SOP.
     • Engineering Associate: Executive or Operator of Engineering Department trained to perform duties as per this SOP.
     • Type A Cleaning: Dry cleaning with clean lint free cloth in the following cases:-
       • Remove the previous batch residue.
       • During end of the shift.
       • Before starting the next batch of the same product.
       • Prior to execution of higher strength batches, after the execution of lower strength batches of the same product.
     • Type B Cleaning: Wet cleaning by using soap solution in the following cases:-
       • Removal of traces of the previous product which is ensured by testing rinse /swab sample of the cleaned equipment.
       • Change in product.
       • Prior to execution of lower strength batches, after the execution of higher strength batches of the same product.
       • After continuous five batches of the same product.
       • After cleaning validity before use, if equipment is not in use.
       • After replacement or repair of any product contact part.
     • Cleaning Solution: 1 ml of Teepol ( soap solution) in 1000 ml of potable water (0.1% v/v).
     • Breakdown: Any activity leading to operation of machine other than the set parameters and / or unusual sound or vibration observed in the machine.
     • Preventive Maintenance: Maintenance activity performed to ensure that the equipment will function smoothly and to avoid breakdowns. These activities are performed monthly, quarterly and half yearly.
     • Calibration: Tests performed to ensure that the equipment is functioning as per set parameters. These test are performed yearly and also after repair or replacement of parts coming in direct contact with product.
   • Procedure

	Precautions
5.2.1	Put “OFF” the main supply of the blister packing machine during cleaning.
5.2.2	During setting and cleaning whenever required, run the machine in Inch mode by pressing red colour stop button and ON / Inch button provided on the machine.
5.2.3	During inserting PVC / PVDC web in the sealing roller, care should be taken to avoid the fingers entering in-between the sealing roller.
5.2.4	Care should be taken to avoid the accident such as burning of hands with heating rollers.
5.2.5	Use nose mask and hand gloves while handling the product.
5.2.6	During idle condition of machine, always keep the pressure sealing roller in disengaged position, by operating the toggle switch of sealing heater in Auto / Manual mode, provided on the machine.
5.2.7	Ensure the working of heaters, limit switches and fitting of required change parts as per the specific product BPR by starting the machine in inching mode.
5.2.8	Before start packing  operation ensure that line clearance is taken on product BPR.
5.3	Operation
5.3.1	Before start of the packing operation, check all machine parts are fitted properly.
5.3.2	Switch “ON” the Main power supply, and then switch “ON” the machine main by turning knob to the “ON” position provided on the panel.
5.3.3	Inform to Engineering Department to start the chilled water supply.
5.3.4	Ensure that chilled water supply is “ON” by touching the hand to the blister forming roller.
5.3.5	Switch “ON” the forming and sealing roller heater by turning knob to right hand side, the roller temperature will display on the individual indicator.
5.3.6	Setting of  blister forming temperature: Set the required temperature  as given in the BPR.For setting of  forming temperature, press the “push to set” button and rotate the regulator to right hand side to increase the temperature, and rotate to left hand side to decrease the temperature.
5.3.7	Setting of sealing temperature: Press and hold the square ■ button and press the ▼ (down) key to decrease and press ▲ key to increase the temp. The display will show the set temp.
5.3.8	Wait for 15- 20 minutes to attain the set temperature, the actual temperature will displayed on the temperature controller display, provided on the panel board of the machine.
5.3.9	Setting of PVC FILM: Place the product PVC / PVDC roll on the holder arm and lock the roll with ring by tightening the screw.
5.3.10	Pull the one end of the PVC / PVDC film and pass the film on the guide roller through the limit switch of PVC film then it passes through the heating roller and forming roller to form the blister pocket.
5.3.11	After formation of blister, web passes through the guide track to in-between pressure sealing roller and counter sealing roller.
Note: Manually pull the Pressure Sealing Roller locking assembly to engage the Pressure Sealing Roller on Counter Sealing Roller. To engage or disengage on auto mode, turn the auto/ manual knob to the required mode.
5.3.12	Setting of printed foil: Place the printed foil roll on the holder arm at the top of the machine then pass the foil outside the batch code printing unit.
5.3.13	Then pass though guide roller to in-between the pressure sealing roller and counter sealing roller in which sealing of foil and PVC takes place.
5.3.14	Remove the stereo holding drum unit by removing the Ellen screw provided on the Batch Code Printing unit.
5.3.15	Loose the ring by loosening the screws of stereo drum, then fix batch stereos issued from the QA on the stereo drum.
5.3.16	Fix the stereo by in such a way, that the over printing matter should be printed over the space provided on the foil.
5.3.17	After fixing the stereos put the ink in to the ink roller then run the machine to get the clear over printed proof.
5.3.18	Take the clear over printed proof and get it checked by Packing, Production and QA officers against the over printing detail mentioned in the specific product BPR.
5.3.19	After certifying the printed matter from QA start the machine and put PVC blister web and printed foil in-between the pressure sealing roller and counter sealing roller to set the pack size.
5.3.20	The web is then passed through the pusher plate. Loose the pusher knob and decrease/increase the distance as per the pack size.
5.3.21	Adjust the pusher arm forward /backward with bolt to set the cutting of blister pack at the centre.
5.3.22	Set the side plate of the blister web in such a way, that both side foil edge are same.
5.3.23	Pusher plate pushes the web in to the punching/cutting tool to cut the blister web in to a uniform pack size / blister pack.
5.3.24	After setting pack size, fix the feeder assembly and load the tablets in to the hopper then set the chute with blister pocket.
5.3.25	Slowly, feed the tablets by manually in to the feeder to set the loading of tablets in to the chute.
5.3.26	Set the alignment of the pocket with the tablet by adjusting the chute with the blister pocket, tablets should be freely loaded in to the pocket.
5.3.27	Set the feeding, and then start the vibrator controller to flow the tablets from bowl dish to feeder roller. To increase the vibration, rotate the regulator to right hand side and to decrease vibration, rotate the regulator to left hand side.
5.3.28	Switch “ON’ the toggle switch of the photo cell, switch “ON’ the in-feed motor toggle switch.
5.3.29	Tablet should load in to the blister pocket freely then the web moving forward on the guide track, then passes in-between pressure sealing roller and counter sealing roller along with printed foil.
5.3.30	Touch the scoring blade pointer to the blister web on the guide track to score the blisters (applicable to combi pack products only).
5.3.31	Check the scoring by cutting the combi pack with hands. It should freely cut in the centre of the combi pack.
5.3.32	After sealing the printed foil and PVC / PVDC film in between the sealing roller, the web passes through the pusher plate to punching tool, to cut the web in to the blister pack.
5.3.33	Check the printing and quality of blisters for sealing visually.
5.3.34	Check the leak test of the  number Blister pack ,it should be one and half round of the circumference of the pressure sealing roller.
5.3.35	Operate the Leak Test Apparatus as per operating SOP. The test passes when the water should not enter in to the blister pocket / none of the tablet should wet inside the pocket.
5.3.36	If the leak test passes, start the machine for regular packing activity.
5.3.37	Switch “ON” the packing hall conveyer belt with the help of starter provided inside the conveyor table.
5.3.38	Adjust the speed of the machine by turning the switch clockwise / Anti clock wise on the scale provided.
5.3.39	Continue the packing, check and record all the in-process tests parameters as mentioned in product BPR.
5.3.40	Keep the rejection tablets / blisters separately duly labelled with details. The defoilled tablets /capsules should be packed  at the end of the batch and to be mention in the product BPR.
5.3.41	During packing tablet container should be kept in closed condition.
5.3.42	After completion of batch, label the equipment as “To be Type A cleaned” or “To be Type B Cleaned”.
5.3.43	Record the activity in “Equipment log book”
5.4	Type A Cleaning
5.4.1	Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process.
5.4.2	Switch “OFF” the mains of the machine and remove all documents, labels, containers of previous batch.
5.4.3	Remove all stereos from the stereo drum and hand over to QA.
5.4.4	Remove the scrap of foil and foil pieces in between the punching tool.
5.4.5	De-dust all the parts except heating roller with nylon brush / vacuum cleaner / dry duster.
5.4.6	Clean the pressure sealing roller with metallic brush to remove the adhered residue of PVC.
5.4.7	Dry clean the outer surface, in between the parts of the machine with clean dry duster / nylon brush /vacuum cleaner.
5.4.8	Ensure the cleanliness by checking visually for the presence of any tablets or particles in the blister pack machine, then affix “Type A Cleaned” label.
5.4.9	Record the activity in Equipment Log Book.
5.5	Type B Cleaning
5.5.1	Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process.
5.5.2	Switch “OFF” the main supply of the machine and remove all documents, labels, containers of previous products from machine as well as from the area.
5.5.3	The extra Foil / PVC remained should be recorded in BPR and returned to the Warehouse Department after authorisation of the department head and QA.
5.5.4	Dry clean the machine as well as the area with vacuum cleaner and dry duster.
5.5.5	Collect the tablets / powder and label as ‘Rejects’ and record the weight on the BPR.
5.5.6	Dismantle the feed hopper, chute, guide track, feeder roller and bowl dish by removing the relevant Ellen bolts.
5.5.7	Dry clean the dismantled parts and cover with poly bag and transfer it to the wash area with “To be Type B cleaned” label.
5.5.8	Clean the feeder roller with clean soft duster moistened with Iso Propyl Alcohol.
5.5.9	Dismantle and clean the blister forming roller, counter sealing roller with potable water and drain the water from the blister forming roller then dry with compressed air.
5.5.10	Dismantle and clean the punching tool with nylon brush and dry duster.
5.5.11	Prepare an approx. 0.1% v/v cleaning solution (1 ml of Teepol in 1000 ml of potable water)
5.5.12	Wash the guide track, chute with 10 litres of potable water then apply 1% soap solution (teepol). Again wash with 10 litres of potable water to remove the traces of soap solution. Finally rinse with purified water.
5.5.13	Wash the feed hopper and bowl dish with approximately 10 Litre of running potable water. Then clean with nylon scrubber / dipped in soap (teepol) solution.
5.5.14	Again wash with 10 Litre of potable water to remove the traces of cleaning agent solution. Finally rinse with 5 Litre of purified water.
5.5.15	Fill the Swab / Rinse Sample Intimation Slip and submit to QA Department to  collect the samples.
5.5.16	Record the activity in Equipment Log Book.
5.5.17	Collect the Swab/Rinse sample result from QA. If the result is complying, label the equipment as “Type B Cleaned”. If the result is not complying repeat the steps 5.4.11 to 5.4.15.
5.5.18	After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”.
5.5.19	Affix ‘cleaned’ label and cover with fresh poly bag. Keep the cleaned parts to the spare parts room.
5.5.20	Clean the Sealing rollers with metal wire brush to remove any residue of any molten polythene, dirt and pieces of laminate. Carefully inspect the knurled surface of the roller the surface should not be damaged.
5.5.21	Clean the outer surface, panel, plat form, inside the machine with dry duster then clean the outer surface of the machine with moist duster.
5.5.22	Ensure the cleanliness by visually and affix “Cleaned” label to the machine.
5.6	Breakdown
5.6.1	If breakdown occurs during operation, hold the batch in closed condition. Inform to the Head Production.
5.6.2	Fill the “Complaint Note” and submit to Engineering Department.
5.6.3	Fill the “Incident Report” and submit to Quality Assurance Department. Refer Annexure.
5.6.4	Unload the tablets only if required for breakdown rectification.
5.6.5	Store the unloaded tablets separately in closed container with proper status label.
5.6.6	If breakdown occurs prior to start of operation, follow step 5.5.2.
5.5.7	Record the breakdown activity in Equipment Log Book.
5.6.8	After completion of repairs, the operations can be resumed. Perform Type A or Type B cleaning if the tablets has been unloaded from the hopper.
5.6.9	Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed.
5.6.10	Record the repair completion activity in Equipment Log Book.
5.6.11	Describe the breakdown activity in the respective product BPR.
5.7	Preventive Maintenance
5.7.1	Perform the preventive maintenance as per Annexure.
5.7.2	If preventive maintenance activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached.
5.7.3	Attach the preventive maintenance label on the equipment.
5.8	Calibration
5.8.1	Calibration: Calibrate the Pneumatic gauges and temperature controller from external party once in a year.
5.8.2	If calibration activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached.
5.8.3	Attach the calibration label on the equipment.
5.9	Maintain the Issuance, Utilisation and Cleaning Record of Blister packing change parts per SOP.

 

6. Abbreviation

Abbreviation	Expansion
Temp.	Temperature
BPR	Batch Packing Record
QA	Quality Assurance
PVC	Polyvinyl Chloride
PVDC	Polyvinyl Di Chloride
QC	Quality Control
%	Percent
v/v	Volume by Volume

     

 

    CALIBRATION OF PNEUMATIC PRESSURE GAUGE

OBSERVATIONS

Sr. No	Reading on UUC (Kg/Cm2)	Reading on Standard Instruments (Kg/Cm2)	Deviation (Kg/Cm2)	Remarks
1
2
3
4
5
6
7
UUC : Unit under calibration

 

CALIBRATION OF FORMING TEMPERATURE INDICATOR CONTROLLER

 OBSERVATIONS

Sr. No.	Reading on UUC (°C)	Reading on Standard instruments (°C)	Deviation ± 3°C	Remarks
1
2
3
4
5
6
UUC : Unit Under Calibration

 

 CALIBRATION OF SEALING TEMPERATURE INDICATOR CONTROLLER

OBSERVATIONS

Sr. No.	Reading on UUC (°C)	Reading on Standard instruments (°C)	Deviation ± 3°C	Remarks
1
2
3
4
5
6
UUC : Unit Under Calibration

 

CALIBRATION OF VACUUM GAUGE

 

OBSERVATIONS

Sr. No.	Reading on UUC (mmHg)	Reading on Standard Instruments (mmHg)	Deviation (± mmHg)	Remarks
1
2
3
4
5
6
7
UUC : Unit Under Calibration
Result: The results Complies / Not Complies with the acceptance criteria.

 

Checked By/Date:________      Verified By QA/Date:________

 

*Note – Ready to use SOP available in “DOWNLOAD” Section.