Categories
Production SOP

SOP Title: Coding, Utilisation and Cleaning of Accessories

SOP Title: Coding, Utilisation and Cleaning of Accessories

 

  1. Objective:

To lay down procedure for Coding, Utilisation and Cleaning of Accessories.

  1. Scope:

This SOP is applicable to all Accessories used for production activities in Production Department.

  1. Responsibility:
    • Production Department: To prepare and review the SOP. To follow the procedures laid down for Coding, Utilisation and Cleaning of Accessories.
    • Quality Assurance Department: To review and approve the SOP and Annexes. To ensure compliance of the SOP.
  2. Accountability:

Head, Production and Head Quality Assurance Department

  1. 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.
      • Accessories: Includes Bin, Scoops, Spatula, Spoons, Jug/Jar, Container, Bowl, Sampling Device, Sample collection containers etcetera, which are used for production activity in Production Department.
      • Type A Cleaning: Dry cleaning with clean lint free cloth/ Vacuum Cleaner and removing the previous batch powder/material in the following cases:
        • Remove the previous batch material.
        • During end of the shift.
        • Before starting the next batch of the same product.
      • Type B Cleaning: Wet cleaning using water and/or cleaning agent which includes removal of traces of the previous product and ensured by visual inspection of cleaned equipment in the following cases:
        • Change in next product or
        • Prior to execution of lower strength batches subsequently to higher strength batches of the same product.
        • After continuous five batches of the same product.
        • After each seven days of cleaning, if equipment is not in use.
        • Monthly, if the cleaned Accessory is not used for production activity.
        • Change in colour, if next product is same
      • Cleaning Solution: 1 ml of Teepol (soap solution) in 1000 ml of potable water (0.1% v/v)
    • Procedure
  Precautions  
5.2.1 All newly received accessories are to be cleaned as per Type B Cleaning procedure and check for quality as per requirement.  
5.2.2 Any damaged accessory should be immediately removed from the production usage and record should be maintained in inventory record.  
5.2.3 Coding of Accessories:  
5.2.3.1 All new received accessories are to be checked for its quality and design as per requirement then clean before use.  
5.2.3.2 Inventory to be maintained every month in “Accessories Inventory Record” as per SOP.  
5.2.3.3 Damaged accessory should not be used for production activity and that particular code number to be made obsolete with remark, on inventory record.  
5.2.3.4 All accessories are to be coded section wise as per below given pattern.  
5.2.3.5 Coding of accessories:

Sr. No. Name of accessory Coding pattern
01 Tool Box TB
02 Table TL
03 Bowl BL
04 Spoon SP
05 Accessory Box AB
06 Scoops SC
07 Waste Bin WB
08 Dust Bin DB
09 Document Stand DS
10 Gloves Box GB
11 Ladle LD
12 Jug /Jar JG
13 Bin BN
 
5.2.3.6 Area codes to be used for accessory coding:

For Granulation  Section              : GRN

Compression Section             : COM

Coating Section                     : COA

Capsules Section                   :  CAP

Packing Section                     :  PKG

For example: Scoop of granulation section : SC/COA/01

Accessory name / Section / Serial number

SC – for Scoop, COA – for Coating 01 for Serial number

 
5.2.4 Usage of Accessories for Production activity  
5.2.4.1 Use coded accessory dedicated area wise.  
5.2.4.2 Before use, ensure that the Accessory is clean and dry.  
5.2.4.3 After usage label the accessory as “To BE Type A Cleaned” or “To BE Type B Cleaned” label as per requirement.  
5.3 Cleaning of Accessories Used for Production Activity
5.3.1 Type A Cleaning
5.3.1.1 Clean inside and outside of accessory with dry clean duster.

Note: If the accessory has been used for the liquid/semi solid material, then clean the accessory with potable water finally with purified water.

 
5.3.1.2 Ensure the cleanliness and label the Accessory as “Type A cleaned”  
5.3.1.3 Transfer the cleaned Accessory to the respective area.  
5.3.1.4 Record the cleaning activity in “Utilisation and Cleaning Record of Accessories” as per Annexure.  
5.3.2 Type B Cleaning
5.3.2.1 Clean inside and outside of container with dry clean duster/ vacuum cleaner.  
5.3.2.2 Wash the Accessory with 0.1% soap (Teepol) solution by scrubbing with nylon scrubber.  
5.3.2.3 Then wash with sufficient quantity of potable water till it is visibly clean for absence of powder / dust.  
5.3.2.4 Finally rinse with purified water.  
5.3.2.5 Wipe the Accessory with dry clean duster to remove the traces of water and dry clean with compressed air/in tray dryer.  
5.3.2.6 Label the Accessory as “Type B Cleaned” .  
5.3.2.7 Record the cleaning activity in “Utilisation and Cleaning Record of Accessories” as per Annexure.  

 

  1. Abbreviation :
Abbreviation Expansion
SOP Standard Operating Procedure
% Percentage
v/v Volume By Volume
ml Millilitre
PD Production Department
No. Number

 

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

 

Categories
Production SOP

SOP Title: Operation and Cleaning of Empty Capsule Sorter

SOP Title: Operation and Cleaning of  Empty Capsule Sorter

 

  1. Objective:

To define a procedure for Operation, Cleaning and Preventive Maintenance of Empty Capsule Sorter.

  1. Scope:

This SOP is applicable to Empty Capsule Sorter used for sorting (separating) empty unfilled capsules from the filled capsules by means of air blower located in capsule department.

 

  1. Responsibility:
    • Production Department: To prepare and review the SOP. To follow the procedures laid down for the operation cleaning and preventive maintenance of Empty Capsule Sorter.
    • Engineering Department: To perform the preventive maintenance and calibration of Empty Capsule Sorter.
    • 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.
  2. Accountability:

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

  1. Procedure:
    • Definition:
      • 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.
      • 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 main supply during machine setting, cleaning and product change over activity.  
5.2.2 During operation of the machine do not touch the moving parts /do not put hand in the running machine.  
5.2.3 Visually ensure that, all parts are connected properly.  
5.2.4 Use proper personal protective equipment like Nose Masks, Gloves during operation of Empty Capsule Sorter.  
5.3 Operation  
5.3.1 Before starting the activity ensure that the line clearance is taken and recorded in the BMR

Record the activity in the equipment log book as per Annexure.

 
5.3.2 Before starting the operation ensure the temperature and relative humidity of the area is within the limit specified in the BMR.  
5.3.3 Fix the empty capsule rejection hopper over the main frame of the equipment. Fix the empty capsule collection container to the side of the hopper by the screw provided.  
5.3.4 Fix the main hopper over the empty capsule rejection hopper and tighten it with then screw provided.  
5.3.5 Place the equipment exactly below the outlet of the Capsule polishing machine or Metal detector such the filled capsules flows into the hopper for sorting.  
5.3.6 Place a clean container with double polybag under the sorted filled capsules ejection port of the machine before start of the operation.  
5.3.7 Switch ‘ON’ the main electric supply then turn the toggle switch to “ON” position.  
5.3.8 Set the blower voltage as per requirement or as mentioned in the BMR  
5.3.9  The Filled capsule ejecting out of the Polishing machine or Metal detector will be passed through the Empty Capsule Sorter.  
5.3.10 Due to air stream generated by the Empty Capsule Sorter, empty capsules if any will be separated from the filled capsules.  
5.3.11 All rejected empty capsules will be collected in the empty capsule collection box.  
5.3.12 All Filled capsules will be collected in a clean container with double polybag placed under the sorted filled capsules ejection port.  
5.3.13 If required the empty capsules collected in rejection box can be again passed through the empty capsule sorter to separate any filled capsules.  
5.3.14 Upon completion of activity, switch “OFF” the machine as well as main supply.  
5.3.15 Label the rejected capsules as ‘Non Recoverable Rejects’.  
5.3.16 Weigh the Filled capsules and rejected empty capsules for yield reconciliation. Record the respective weight in the BMR.  
5.3.17 After completion activity, label the equipment as “To be Type A cleaned” or “To be Type B Cleaned”.  
5.3.18 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 equipment and dismantle the Empty capsule collection box, Main hopper and Empty capsule rejection hopper.  
5.4.3 Clean the outer surface of the equipment and the dismantled parts with the help of dry clean duster or vacuum cleaner.  
5.4.4 Ensure the cleanliness, by checking visually for the presence of any granules or particles, then affix “Type A Cleaned” label.  
5.4.5 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 equipment and dismantle the Empty capsule collection box, Main hopper and Empty capsule rejection hopper.  
5.5.3 Clean the outer surface of the equipment and the dismantled parts with the help of dry clean duster or vacuum cleaner.  
5.5.4 Cover the dismantled parts with poly bag and transfer to the wash area with “To Be cleaned” label.  
5.5.5 Clean the dismantled parts with 0.1% soap (teepol) solution.  
5.5.6 Then wash these parts with potable water to remove the soap solution.  
5.5.7 Finally rinse above cleaned parts with sufficient quantity of purified water.  
5.5.8 Dry the cleaned parts with dry clean duster/ tray dryer.  
5.5.9 Fill the Swab / Rinse Sample Intimation Slip and submit to QA department for collection of samples.  
5.5.10 Record the activity in equipment log book.  
5.5.11 Collect the 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 5.5.3 to 5.5.9.  
5.5.12 After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”.  
5.6 Breakdown  
5.6.1 If breakdown occurs during operation, hold the sorting activity. 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.  
5.6.4 If breakdown occurs prior to start of operation, follow step 5.6.2  
5.6.5 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.  
5.6.6 Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed.  
5.6.7 Record the repair completion activity in Equipment Log Book.  
5.6.8 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.  

 

  1. Abbreviation:
Abbreviation Expansion
SOP Standard Operating Procedure
PDD Production Department
o C Degree Centigrade
% Percent
± Plus or Minus
ml Milliliter
v/v Volume By Volume

 

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

 

Categories
Production SOP

Title: Operation and Calibration of Capsule Filling Machine

Title: Operation and Calibration of Capsule Filling Machine

  1. Objective:

To define a procedure for Operation, Cleaning, Preventive Maintenance and Calibration of Capsule Filling Machine.

  1. Scope:

This SOP is applicable to Capsule Filling Machine, used for capsule filling and is installed at the Capsule Section of the Production area.

 

  1. Responsibility:
    • Production Department: To prepare and review the SOP. To follow the procedures laid down for the operation, cleaning and to support for Calibration, Preventive Maintenance of Capsule Filling Machine.
    • Engineering Department: To perform the Calibration and Preventive Maintenance of Capsule Filling Machine.
    • Quality Control Department: To analyse and report the Rinse / Swab samples.
    • Quality Assurance Department: To provide line clearance prior to operation. To collect the Swab / Rinse samples. To approve the Calibration and Preventive Maintenance Reports. To review and approve the SOP and Annexure.
  2. Accountability:

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

 

  1. 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 Capsules, Weight of the Capsules, and Length of filled Capsules, Disintegration time and likewise parameters.
      • Non Recoverable Rejects: The Capsules and Blend which cannot be re processed, for example, Capsules collected during the Capsules filling machine setting, Capsules collected during first rounds of Capsule filling cycle. The Non Recoverable Rejects are to be discarded.
      • Recoverable Rejects: The Capsules and Blend which can be re processed or re use.
      • 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 cleaning 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 and 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.
      • 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.
      • Calibration: Tests performed to ensure that the equipment is functioning as per set parameters. These tests are performed half yearly, yearly and also after repair or replacement of parts coming in direct contact with product.
      • 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 Ensure that machine is cleaned and line clearance is taken.  
5.2.2 Ensure that all parts are properly fitted by rotating the hand wheel. Ensure that the vacuum pressure is within the limit of 500 – 600 mm of Hg.  
5.2.3 Do not touch the moving parts or put hand during the running of the machine.  
5.2.4 During cleaning/dismantling of machine switch ‘OFF’ the mains of the machine.  
5.2.5 Ensure that the limit switches are working properly. Use Hand wheel during setting/cleaning.  
5.2.6 Before starting the Operation make sure that the line clearance is taken and recorded in the BMR and Record the activity in the equipment log book.  
5.2.7 Before starting the operation ensure the temperature and relative humidity of the area is within the limit specified in the BMR.  
5.2.8 Place a clean container lined with double poly bag below the Capsule ejection ports of the machine before start of the operation.  
5.3 Setting of Loading Station  
5.3.1 Issue the change parts of the machine as per respective product BMR. Record the Issuance details in  Annexure.  
5.3.2 Rotate the hand wheel and bring the magazine to the bottom most position over the rectifier raceway.  
5.3.3 At this moment, one capsule from each slot of magazine is released.  
5.3.4 The capsule releasing pin can be pushed in and pulled out.  
5.3.5 To facilitate the release of capsules from the magazine the pin should be pushed in  
5.3.6 Continue the Hand wheel rotation and the slide will start moving back.  
5.3.7 Simultaneously the vertical blades will start moving down.  
5.3.8 The tips of the blades will touch the capsules at its cap edge and capsules starts tilting in the cap up and body down position. This is called rectification.  
5.3.9 Ensure that the required vacuum is available at the vacuum slot.  
5.3.10 Now place the loading ring on the loading table.  
5.3.11 When the hand wheel is rotated the loading table also indexes anti-clock wise and stops before the capsules are loaded.  
5.3.12 At this moment, one row of holes on loading rings is totally aligned with the vacuum slot.  
5.4 Setting for Proper Rectification  
5.4.1 Once the capsules are released from the magazine in to the rectifier raceway slot, they are pushed forward by the slide.  
5.4.2 The setting of the slide determines the position of the capsule over the slot.  
5.4.3 The correct position of the capsule is ensured when the tip of the blade touched the body just near the cut edge of the capsule.  
5.4.4 For proper loading of the capsules the alignment of the loading ring holes with the vacuum slot is important.  
5.4.5 In case the alignment is disturbed, this can be set right using the centring gauge.  
5.4.6 Remove the rectifier block assembly fitted on the front face of the magazine.  
5.4.7 Fix the centring block at the same location with the screws  
5.4.8 Insert the centring pins in to the holes of the centring block and align the block with the slots of the rectifier raceway.  
5.4.9 Turn the hand wheel and check that the open end of both the pins enter into the holes of the loading ring  
5.4.10 Care should be taken to remove the pins from the block before forward indexing of the loading ring. Failing to do so the pins will get struck and bent.  
5.4.11 In case the pins do not enter the loading ring re align the loading table.  
5.4.12 To facilitate loading table realignment adjust kidney slot position on loading table with respect to fixing screws.  
5.5 Operation of Loading Station  
5.5.1 Put the machine in Auto mode and load the loading ring with capsules.  
5.5.2 Press the rest (yellow) button first and then rectifier start (Green) button. The loading cycle will start.  
5.5.3 The cycle will stop after completing one rotation of the loading ring consisting of 60 indexings.  
5.5.4 During the loading cycle press the Rectifier Stop (Red) button to stop the loading cycle midway.  
5.5.5 Again press the Rectifier start (Green) button to start the loading cycle. The loading cycle will restart and continue till completion of remaining strokes.  
5.5.6 Once the cycle is completed, rotate the loading ring manually for 2 turns before lifting to ensure complete separation of capsules.  
5.6 Operation of Filling Station  
5.6.1 Place the body of the loading ring on the filling table and check the gap between the proximity switch and body ring is around 1 to 2 mm.  
5.6.2 As soon as the body ring is placed, LED of proximity switch will glow.  
5.6.3 Ensure that all the body ring holes are filled with bodies of the empty capsule and their top edges are below the top surface of the body ring.  
5.6.4 Fill the drug hopper with the powder to be filled.  
5.6.5 Select one Medium speed (say 8.1 RPM) for the filling table. Select the minimum speed (310/288) for the auger.  
5.6.6 Press the powder table start (Green) Button, the Hopper will swing over the body ring placed on the filling table.  
5.6.7 The Auger will start rotating in clockwise direction and will push the powder into the body of the capsule.  
5.6.8 When the filling table completes one rotation the hopper returns to its initial position and the Auger rotation stops.  
5.6.9 Scrape off the extra powder from the surface of the body ring with Teflon dispenser.  
5.7 Operation of Closing Station  
5.7.1 Place the Cap ring on the body ring matching the respective lugs and place it on the locating table of the closing unit.  
5.7.2 Gently push in the unit by the handle.  
5.7.3 The capsules will get locked by pin plate assembly operated by the pneumatic cylinder.  
5.7.4 The closing length of the capsules can be set by adjusting the position of the nut on the threaded shaft.  
5.7.5 Pull out the closing unit and place the stopper on the lugs of the loading ring.  
5.7.6 Turn the trolley anti clockwise to eject the locked capsules into the chute from where the capsule rolls down into the collection box.  
5.7.7 The loose powder is collected in the powder tray provided below the exit chute.  
5.8 Fill Weight Control  
5.8. The fill weight can be controlled by the speed of rotation of the Auger present in the hopper.  
5.8.1 If the fill weight of the capsule is marginally less then shift to the next lower speed of the gerar box.  
5.8.2 If the fill weight of the capsule is more than the theoretical fill weight then shift to the next higher speed of the gear box.  
5.8.3 Check for all the In-Process parameters as per product BMR. If all the parameters comply as per the limit mentioned in the BMR then continue the capsule filling activity.  
5.8.4 Collect all the Capsules from the ejection station of the machine in clean containers lined with double poly bag.  
5.8.5 After the completion of filling cycle, remove any un-filled blend from the hopper and turn-table. Label them as ‘Non Recoverable Rejects’.  
5.8.6 Weigh the filled capsules and rejected Capsules and Blend for yield reconciliation. Record the respective weight in the BMR.  
5.8.7 After completion of Capsule Filling activity, label the equipment as “To be Type A cleaned” or “To be Type B Cleaned”.  
5.8.8 Record the activity in the equipment log book.  
5.9 Type A Cleaning  
5.9. Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process.  
5.9.1 Remove empty capsules and powder from hopper and Dismantle the machine as follows  
5.9.2 Turn the hand wheel and bring the magazine to the uppermost position  
5.9.3 Remove the rectifier raceway with allen key (two screws)  
5.9.4 Remove the slide using  allen key (two screws)  
5.9.5 Then turn the hand wheel and bring the magazine to the bottommost position  
5.9.6 Remove the whole magazine assembly with a 6mm allen key (Two screws from front and one from side)  
5.9.7 Clean all the dismantle parts with clean dry lint free cloth or vacuum cleaner.  
5.9.8 Align all the parts again in the reverse order of dismantling.  
5.9.9 Ensure the cleanliness by checking visually for the presence of any granules or particles, then affix “Type A Cleaned” label. Refer  
5.9.10 Record the activity in equipment log book.  
5.10 Type B Cleaning  
5.10. Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process.  
5.10.1 Remove empty capsules and powder from hopper.  
5.10.2 Follow step no 5.9.2 to 5.9.7 for the dismantling of the machine.  
5.10.3 Wash the dismantled parts with 30-40 litres of potable water then clean with 0.1% soap (teepol) solution then wash the parts with 30-40 litres of potable water to remove the traces of soap solution  
5.10.4 Finally rinse the cleaned parts with purified water.  
5.10.5 Remove any spilled powder over the machine by vacuum cleaner or lint free cloth.  
5.10.6 Wipe the entire outer surface with wet lint free cloth soaked in purified water.  
5.10.7 Fill the Swab / Rinse Sample Intimation Slip and submit to QA department for collection of samples.  
5.10.8 Record the activity in equipment log book as per Annexure.  
5.10.9 Collect the 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 5.10.3 to 5.10.6.  
5.10.10 After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”.  
5.11 Breakdown  
5.11.1 If breakdown occurs during operation, hold the capsules in closed condition. Inform to the Head Production.  
5.11.2 Fill the “Complaint Note” and submit to Engineering Department.  
5.11.3 Fill the “Incident Report” and submit to Quality Assurance Department.  
5.11.4 Unload the powder, empty capsules from hopper only if required for breakdown rectification.  
5.11.5 Store the unloaded Blend/Capsules separately in closed container separately with proper status label.  
5.11.6 If breakdown occurs prior to start of operation, follow step 5.11.2.  
5.11.7 Record the breakdown activity in Equipment Log Book.  
5.11.8 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.  
5.11.9 Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed.  
5.11.10 Describe the breakdown activity in the respective product BMR.  
5.11.11 Inform to department head, QA and Engineering Department.  
5.11.12 Dry clean the machine after rectified the problem.  
5.11.13 After completion of repairs, the operations can be resumed. Perform “Type A or Type B” cleaning if the material has been unloaded from the machine.  
5.11.14 Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed.  
5.11.15 Record the repair completion activity in Equipment Log Book.  
5.11.16 Describe the breakdown activity in the respective product BMR.  
5.12 Preventive Maintenance  
5.12.1 Perform the preventive maintenance as per Annexure.  
5.12.2 If preventive maintenance activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached.  
5.12.3 Attach the preventive maintenance label on the equipment.  
5.13 Calibration  
5.13.1 Perform the calibration as per Annexure.  
5.13.2 If calibration activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached.  
5.13.3 Attach the calibration label on the equipment.  

 

  1. Abbreviation:
Abbreviation Expansion  
  % Percentage.
  RH Relative Humidity.
  mm Millimetre.
  CAP Capsule.
  PD Production Department.
  QAD Quality Assurance Department.

 

CALIBRATION VACUUM GAUGE

                     OBSERVATIONS

Sr. No Standard Reading

(mm Hg)

Observed Reading

(mm Hg)

Deviation

(mm Hg)

1      
2      
3      
4      
5      
6      
UUC : Unit under calibration

 

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

 

Categories
Production SOP

SOP Title: Operation and Calibration of Double Cone Blender

SOP Title: Operation and Calibration of Double Cone Blender

 

  1. Objective:

To define a procedure for Operation, Cleaning, Preventive Maintenance and Calibration of Double Cone Blender.

  1. Scope:

This SOP is applicable to Double Cone Blender, used for the mixing of granules/raw material and is installed at the Capsule Section of the Production area.

 

  1. Responsibility:
    • Production Department: To prepare and review the SOP. To follow the procedures laid down for the operation and cleaning and to support the Preventive Maintenance and Calibration of Double Cone Blender.
    • 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 Double Cone Blender, wherever applicable.
    • Quality Control Department: To analyse and report the swab/rinse samples.

 

  1. Accountability:

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

  1. Procedure:
    • Definition:
      • Type A Cleaning: Dry cleaning with clean lint free cloth in the following cases,
        • Remove the previous batch residue.
        • 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 and 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 or change in colour.
        • Monthly, if it is not in 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.
      • Calibration: Tests performed to ensure that the equipment is functioning as per set parameters. These tests 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 mains of the double cone blender during loading, unloading and manual cleaning.  
5.2.2 Always rest the Blender vertically, such a way that the butterfly valve is at the bottom.  
5.2.3 Always engage the safety guard before starting the blending operation.  
5.2.4 Wear proper Personal protective equipment (as per product requirement) during loading and unloading of materials.  
5.3         Operation of Double Cone Blender  
5.3.1 Before starting the blending process make sure that the line clearance is taken and recorded in the respective BMR.

Record the activity in the equipment log book.

 
5.3.2 Before starting the operation ensure that the temperature and relative humidity of the area is within the limit specified in the BMR.  
5.3.3 Remove “Cleaned” status label and affix “In-process” label.  
5.3.4 Close the butterfly valve before loading the materials into the blender.  
5.3.5 Open the loading lid of the blender by loosening the screws of the lid. Keep the blender in inclined position for loading of material by rotating the blender manually.  
5.3.6 Manually load the materials to be blended into the blender by means of Polybag / Clean SS Scoops.  
5.3.7 Close the lid of the blender by tightening the screws provided.  
5.3.8 Visually check the lid and the butterfly valve for tightness and no spillage should occur during the blending process.  
5.3.9 Engage the safety guard and switch ON the mains of the machine.  
5.3.10 Set the required time as per the respective product BMR. The timer is to be set in minutes Eg. If the time required for blending is 10 minutes then ‘010’ is to be set in the timer.  
5.3.11 Now push the forward button to start the blending process.  
5.3.12 The elapsed time will be displayed in the digital display in minutes.  
5.3.13 The machine will stop automatically upon the completion of set time.  
5.3.14 Before proceeding for unload, switch OFF the mains and remove the safety guard.  
5.3.15 If required Rotate the blender manually to place the blender in an inclined position such that the butterfly valve is at the bottom.  
5.3.16 Hold a clean polybag to the mouth of the butterfly valve and check the integrity. Place a clean container beneath the poly bag to prevent any damage to the poly bag  
5.3.17 Open the butterfly valve slowly such that the blended material will be unloaded into the polybag.  
5.3.18 Control the flow of the materials by butterfly valve such that the blended materials are unloaded completely without any spillage.  
5.3.19 Upon completion of unloading, close the butterfly valve and remove the polybag.  
5.3.20 Tie, label properly and secure the poly bag.  
5.3.21 Record the usage time in equipment log book as per attached Annexure.  
5.3.22 After completion of blending activity, 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 Remove all previous batch documents, containers and labels from the area.  
5.4.3 Dry clean the blender with vacuum cleaner /dry clean duster.  
5.4.4 Ensure the cleanliness and affix “Type A CLEANED” label as per SOP.  
5.4.5 Record the cleaning time 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 Remove all previous batch documents, containers and labels from the area.  
5.5.3 Dry clean the blender with vacuum cleaner /dry clean duster.  
5.5.4 Wash the blender inner and outer surface with potable water to remove any traces of powder.  
5.5.5 Wash the inner and outer surface with 0.1%Teepol solution and then wash with potable water to remove any traces of soap solution.  
5.5.6 Wash the lid of the blender with potable water followed by 0.1%Teepol solution.  
5.5.7 Finally rinse the blender and lid with purified water.  
5.5.8 Fill the Swab / Rinse Sample Intimation Slip and submit to QA department to collect the Swab / Rinse samples.  
5.5.9 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 5.5.1 to 5.5.5  
5.5.10 Record the activity in equipment log book.  
5.5.11 After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”.  
5.6 Breakdown  
5.6.1 If breakdown occurs during operation, switch “OFF” the main supply and inform to Head Production and QA Associate.  
5.6.2 Record the blending time in 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 Unload the product / material only if required and keep the product/ material in closed condition as per requirement.  
5.6.6 If breakdown occurs prior to start of operation, follow step 5.6.3.  
5.6.7 Record breakdown activity in Equipment log book .  
5.6.8

 

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.  
5.7 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 Timer and RPM once in a year as per Annexure.  
5.8.2 If calibration activity is outsourced, the values are to be transcribed in the Annexure and external party certificate to be attached.  

 

  1. Abbreviation:
Abbreviation Expansion
TAB Tablet.
BMR Batch Manufacturing Record.
% Percent.
v/v Volume by Volume.
ml Milliliter.
RPM Rotation per Minute

 

CALIBRATION OF DIGITAL TIMER

OBSERVATIONS

Sr. No. Reading on the UUC

MIN

Reading on Standard instruments

HRS:MIN:SEC:MSEC.

Deviation

± 2 min

Remarks
1        
2        
3        
4        
5        
UUC : Unit Under Calibration  

 

CALIBRATION OF RPM

Sr.No. Standard RPM Observed RPM     Acceptance Criteria Deviation
1      

± 1 RPM

 
2      
3      

 

Remark :

Calibration of Blender is performed successfully and readings are within limit / not within limit and Can be Used / Do Not Use for regular activity.

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

Categories
Production SOP

SOP Title: Operation And Cleaning of Polishing Machine for Capsules

SOP Title: Operation And Cleaning of Polishing Machine for Capsules

 

  1. Objective:

To define a procedure for the Operation, Cleaning and Preventive Maintenance of Dedusting and Polishing Machine for Capsules.

  1. Scope:

This Procedure is applicable to Dedusting and Polishing machine used for the dedusting and polishing of filled Hard Gelatin Capsules located in Capsule section of Production Department.

 

  1. 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 of Dedusting and Polishing Machine for capsules.
    • Engineering Department: To perform the preventive maintenance of Dedusting and Polishing Machine.
    • 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 reports. To review and approve the SOP and Annexure.

 

  1. Accountability:

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

  1. 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 / Vacuum 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 the cleaned machine 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, quarterly and half yearly.
    • Procedure
  Precautions  
5.2.1  Do not stop the vacuum cleaner and the polishing machine simultaneously after the end of production run.  
5.2.2 Run the polishing machine for 2 – 3 min after the stoppage of capsule in feed to ensure that all the capsules in polishing chamber will come out.  
5.2.3 After switching of the polishing machine let the vacuum cleaner run for 3 – 5 minutes and then switch it off .  
5.2.4 Drain the filter regulator at regular intervals.  
5.3 Setting of Brush Assembly  
5.3.1 Mount the in feed end locks on the brush shaft and tighten the grub screw.  
5.3.2 Position the lock such that the grub screw is tighten on the notch provided on the shaft.  
5.3.3 Slide the brush on the brush shaft gently to the in feed end and lock it in the in feed end lock.  
5.3.4 Ensure that the end of the brush has properly entered the groove of the lock.  
5.3.5 Put them in feed end Baffle cover from the delivery end.  
5.3.6 Ensure that the bristles of the brush are completely out of the baffle cover.  
5.3.7 Mount the delivery end lock on the shaft.  
5.3.8 Insert the open end of the brush in the grove of the lock properly.  
5.3.9 Press the lock in, to compress the brush and holding the in feed end of the brush.  
5.3.10 Turn the delivery end lock clockwise to bring the grub screw position over the notch provided on the shaft.  
5.3.11 Tighten the grub screw, this will keep the brush in position and avoid possible slipping of the brush during running.  
5.3.12 Mount the delivery end nylon spacer on the shaft by tightening the grub screw in position.  
5.4 Setting of Net Assembly  
5.4.1 The net is provided with a Velcro arrangement and a hinge pin.  
5.4.2 Form a cylindrical shape of the net by joining the Velcro.  
5.4.3 Insert the hinge pin in the eyelet provided in the net.  
5.4.4 Slide the net into the perforated tube with the hinge pin properly positioned in the channel of the perforated tube.  
5.4.5 Match the openings provided in the net with that of the perforated tube.  
5.4.6 Ensure that the net has a snug fit with the perforated tube.  
5.4.7 If the net sit loose in the perforated tube, asjust the diameter of the net by shifting the Velcro position to get a snug fit.  
5.4.8 Insert the spring slowly by rotating it into the net care should be taken to ensure that the spring does not cross the in feed opening of the perforated tube.  
5.5 Setting of Perforated Tube and Brush assembly  
5.5.1 Holding the shaft vertical, slide the perforated tube and net assembly over the shaft.  
5.5.2 Locate the in feed end baffle cover in the perforated tube.  
5.5.3 Assemble the delivery and baffle cover on the brush shaft locating it in the perforated tube.  
5.5.4 Assemble the timer pulley on to the brush shaft and fix it with grub screw over the notch provided on the shaft.  
5.5.5 Place the assembly in the trough locating the in feed and bearing in the split bearing block.  
5.5.6 Mount the delivery and bearing on the hexagonal bush, and the bush on to the shaft.  
5.5.7 Locate the delivery and bearing in the split bearing block.  
5.5.8 Place the cover on the trough and fix it with the locks.  
5.5.9 Connect the rotary Gland to the brush Shaft and the Air pipe to the coupling.  
5.5.10 Mount the infeed chute.  
5.5.11 Rotate the spiral brush by rotating the belt by hand in the anti clockwise direction (looking from motor end) and ensure that the movement is free.  
5.5.12 Fit the drive cover and clamp with the locks.  
5.6 Operation  
5.6.1 Before starting the machine make sure that the line clearance is taken and recorded in the BMR.

Record the activity in the equipment log book.

 
5.6.2 Before starting the operation ensure the temperature and relative humidity of the area is within the limit specified in the BMR.  
5.6.3 Set the angle of polishing chamber at intermediate position.  
5.6.4 Set the height of the machine as required.  
5.6.5 If the machine is in the bottom most position, unlock the locking stud from the guide tube and raise the machine holding the main frame.  
5.6.6 Tighten the locking stud, ensure that the stud is in the slot of the shaft.  
5.6.7 To lower the machine, loosen the locking stud and gently press the machine from the top and then tighten the locking stud.  
5.6.8 Keep the potentiometer knob of the thyristor drive at zero position.  
5.6.9 Connect the machine to a vacuum cleaner with a hose pipe.  
5.6.10 First start the vacuum cleaner and ensure correct direction of rotation of the motor by checking the direction of air flow.  
5.6.11 Switch on the Mains of the machine by the toggle switch. The mains ON (red) LED will glow indicating the main supply.  
5.6.12 Then Press the push button (RED) to start the motor. The motor ON (Green) LED will glow indicating the supply to the motor.  
5.6.13 Slowly turn the potentiometer knob clockwise and set it at the middle speed.  
5.6.14 Start compressed air supply and set the pressure regulator at about 5Kg/cm2 pressure.  
5.6.15 Start the feeding of Capsules from sorting machine to inlet chute of the polishing machine at a uniform rate.  
5.6.16 Check the polishing quality of the polished Capsules. If the quality is not satisfactory then vary the polishing chamber inclination and the speed of the brush.  
5.6.17 For Hygroscopic powders a steeper angle is recommended.  
5.6.18 The motor can be stopped by switching “OFF” the main supply with the help of toggle switch.  
5.6.19 Record the activity in equipment log book as per Annexure.  
5.7 Type A Cleaning  
5.7.1 Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process.  
5.7.2 Ensure that capsule inspection cum polishing machine main switch is “OFF” and affix “To Be Cleaned” status label.  
5.7.3 Remove the in feed chute by gently lifting it from the machine.  
5.7.4 Remove the drive cover and cover of the polishing cover by unlocking the mechanical locks (just pull the cap of the lock upwards and guide it through the slot).  
5.7.5 Disconnect the air pipe connected to the rotary gland by pushing in the collet and pulling out the pipe.  
5.7.6 With the help of hexagonal spanner disconnect the rotary gland from the brush shaft.  
5.7.7 Lift the brush shaft by holding it at the delivery end and remove the timer belt.  
5.7.8 Take the perforated tube assembly out of the trough and holding it vertically, in pulley down position, remove the bearing from the delivery end and remove the delivery end baffle cover.  
5.7.9 Remove the perforated tube from the top, holding the brush shaft down vertically, in pulley down position.  
5.7.10 Then remove the nylon spacer and deliver end lock from the haft, that are fitted with grub screws.  
5.7.11 Turn the brush anti clockwise to disengage the brush from the in feed end lock removing the grub screw and slide it off gently from the brush shaft.  
5.7.12 Holding the shaft upside down, remove the bearing and timer pulley by unscrewing the grub screw of the pulley.  
5.7.13 Take out the spring from the perforated tube assembly by slowly rotating and pulling it.  
5.7.14 Remove the nylon net from the perforated tube.  
5.7.15 Lift the trough from the trough support and take out the delivery chute by unscrewing from the main frame.  
5.7.16 Clean all the dismantled parts with dry clean lint free cloth or by vacuum cleaner.  
5.7.17 De-dust external surfaces of machine with vacuum cleaner.  
5.7.18 De-dust the conveyor belt with vacuum cleaner.  
5.7.19 Ensure the cleanliness by checking visually for the presence of any powder or particles, then affix “Type A Cleaned” label.  
5.7.20 Record the activity in equipment log book as per Annexure.  
5.8 Type B Cleaning  
5.8.1 Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process.  
5.8.2 Follow step 5.7.2 to 5.7.18 for dismantling of the polishing machine.  
5.8.3 Wash the dismantled parts with 30-40 litres of potable water then clean with 0.1% soap (teepol) solution then wash the parts with 30-40 litres of potable water to remove the traces of soap solution. Finally rinse with Purified water.  
5.8.4 Fill the Swab / Rinse Sample Intimation Slip and submit to QA Department for collection of samples.  
5.8.5 Record the activity in equipment log book.  
5.8.6 Collect the 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 5.8.3 to 5.8.5.  
5.8.7 Dry the cleaned parts with clean, dry duster/tray dryer.  
5.8.8 After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”.  
5.8.9 Dry the cleaned parts with clean, dry duster/tray dryer.  
5.9 Breakdown  
5.9.1 If breakdown occurs during operation, hold the polishing activity. Inform to the Head Production.  
5.9.2 Fill the “Complaint Note” and submit to Engineering Department.  
5.9.3 Fill the “Incident Report” and submit to Quality Assurance Department.  
5.9.4 Unload the Capsules only, if required for breakdown rectification.  
5.9.5 Store the unloaded capsules in suitable SS closed container.  
5.9.6 If breakdown occurs prior to start of operation, follow step 5.9.2.  
5.9.7 Record the breakdown activity in Equipment Log Book.  
5.9.8 After completion of repairs, the operations can be resumed. Perform “Type A or Type B” cleaning if the capsules has been unloaded from the machine.  
5.9.9 Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed.  
5.9.10 Record the repair completion activity in Equipment Log Book.  
5.9.11 Describe the breakdown activity in the respective product BMR.  
5.10 Preventive Maintenance  
5.10.1 Perform the preventive maintenance as per Annexure.  
5.10.2 If preventive maintenance activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached.  
  1. Abbreviation:
Abbreviation Expansion
CAP Capsule
SS Stainless Steel
% Percent
v/v Volume By Volume
ml Millilitre
BMR Batch Manufacturing Record
QA Quality Assurance

 

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

 

 

 

Categories
Production SOP

SOP Title: Operation and Calibration of Digital Vernier Calliper

SOP Title: Operation and Calibration of Digital Vernier Calliper

 

  1. Objective:

To define procedure for Operation, Cleaning and Calibration of Digital Vernier Calliper.

  1. Scope:

This SOP is applicable to digital Vernier Calliper used for measuring dimension of tablets and capsules in Production Department.

 

  1. Responsibility:
    • Production Department: To prepare and review the SOP. To follow the procedures laid down for the operation, cleaning and preventive maintenance of digital Vernier Calliper.
    • Quality Assurance Department: To review and approve the SOP and Annexure.
    • Engineering Department: To perform the preventive maintenance and calibration of digital Vernier Calliper.
  2. Accountability:

Head, Production.

Head, Engineering.

Head, QA.

  1. 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.
        • 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 moist clean duster in the following cases:-
        • 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 it is not in use.
      • 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 Vernier Calliper when not in use.  
5.2.2 After every use dry clean the Vernier Calliper with soft cloth.  
5.2.3 Do not use solvent or water to clean the display.  
5.2.4 Do not  try to move the thumb wheel of instrument forcefully when the top screw is tightly fitted.  
5.2.5 If the reading shows on the display is not clear, check the battery and replace.  
5.2.6 External and internal jaws have sharp edge ,handle with care to avoid injury.  
5.2.7 Before start of every measurement ensure that zero 0.00mm / 0.0000in displayed on Vernier Calliper.  
5.3            Operation
5.3.1 Ensure that the Vernier Calliper is cleaned and calibrated.  
5.3.2 Before putting “ON” instrument ensure that, both upper and lower jaws of the Vernier Calliper should touch each other.  
5.3.3 Following are the buttons and their functions.  
5.3.4 ▀▀▀ “ON/OFF”   :   Press button to ON / OFF the Vernier Calliper.  
5.3.5 ▀        ” in/mm”     :   Press button to measure the reading in inch / mm alternatively  
5.3.6             “ZERO”,   Press button of this key to set zero.

 

 
5.3.7 Vernier   Calliper can be used to take measurement in mm OR inch depending upon the requirement by pressing the (in/mm) required button .  
5.3.8 Switch “ON” the Vernier Calliper by pressing the “ON / OFF” press button .

 

 
5.3.9 Loose the top screw slightly to move the display block smoothly.  
5.3.10 Push the movable jaw on the scale with the help of thumb so that, the movable jaw of lower side should touch the fixed jaw at zero on the scale.  
5.3.11 Hold the jaw with thumb and Press the “zero” Yellow colour press button to set the display zero.  
5.3.12 Press the in/mm button, the display should show the selected mode in inch / mm only (0.0000 in/ 00.00mm).  
5.3.13 Select the required mode mm/inch by pressing the in/mm button to measure the thickness / dimension.  
5.3.14 Ensure the zero setting on Vernier display.  
5.3.15 For External Measurement: Open  the  movable jaw and hold the tablet / capsule  firmly in-between the lower jaws of the Vernier Calliper with the help of thumb, to measure the dimension /thickness of the tablet / capsules or any  change parts.  
Note:

The tablet/capsule should be held firmly in such a way, that test sample should not fall down and it should not get damaged in between the jaws.

 
5.3.15.1 Actual measured value of the tablet / capsule in inch/mm should be displayed on the Vernier.  
5.3.15.2 Note down the reading displayed on the Vernier Calliper on the product BMR.  
5.3.16 For Internal measurement: Open movable jaws of Vernier Calliper by thumb, carefully insert the top grooves of Vernier Calliper into the sample, and pull to hold firmly so that, jaws should touch both side of the sample .  
5.3.17 Reading should show the actual internal diameter of the measured test sample.  
5.3.18 After completion of measurement, remove sample from the instrument, bring the jaws to initial position at zero on the scale and press the ON / OFF button to put “OFF” instrument.  
  5.4     TYPE A Cleaning
5.4.1 Switch “OFF” the Vernier Calliper by pressing ON / OFF button.  
5.4.2 Dry clean, the Vernier Calliper with soft clean duster/soft brush. .  
 5.5      TYPE B Cleaning
5.5.1 Switch “OFF” the Vernier Calliper by pressing “ON / OFF “ button.  
5.5.2 Dry clean, the Vernier Calliper with soft clean duster / soft brush.  
5.5.3 Clean the Vernier jaws, scale and display with soft moist duster then with soft dry duster.  
5.5.4 Keep the Vernier in dedicated box with “Cleaned “status label.  
5.6 Action in case of breakdown or out of calibration:
5.6.1 If Vernier Calliper shows error, inform the department head, Quality Assurance and Engineering Department.  
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 Rectify the problem and check zero setting. If the breakdown is major, test can be continued on another calibrated Vernier Calliper.  
5.6.5 Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed  
5.6.6 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.  
5.7 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 Vernier Calliper once in a year by approved external party for length 0-200 mm(±0.01mm).  
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 Affix the calibration label on the equipment.  

 

  1. Abbreviation
Abbreviation        Expansion
in Inch
mm Millimetre
 ± Plus or minus

 

 CALIBRATION OF DIGITAL VERNIER CALIPER OBSERVATIONS

Sr. No. For External Measurement (mm)

 

      For Internal Measurement (mm)
Reading on UUC in mm Reading on standard slip guage in mm Deviation

(± 0.2mm)

Reading on UUC in mm Reading on standard slip guage in mm Deviation

(± 0.2mm)

1            
2            
3            
4            
5            
6            
7            
8            
9            
mm : Millimeter
Remarks: The results comply / Not comply with the acceptance criteria

 

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

 

Categories
Production SOP

SOP Title: Operation and Cleaning of Stirrer

SOP Title: Operation and Cleaning of Stirrer

  1. Objective:

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

  1. Scope:

This SOP is applicable to Stirrer used for stirring of coating solution during coating activity in coating area of Production Department.

  1. Responsibility:
    • Production Department: To prepare and review the SOP. To follow the procedures laid down for the operation and cleaning and to support preventive maintenance of stirrer.
    • Engineering Department: To perform the preventive maintenance of stirrer.
    • 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 reports. To review and approve the SOP and Annexure.
  2. Accountability:

Head, Production, Engineering and QA Department

  1. 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.
      • QC 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: Wet cleaning with clean moist duster and purified water 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 cleaning 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 and colour.
        • After continuous five batches of the same product.
        • After seven days of cleaning before use, if cleaned equipment not in use.
        • After replacement or repair of any product contact part.
        • Monthly , if cleaned equipment not in use.
      • 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.

 

  • Procedure:
  Precautions
5.2.1 Switch “OFF” the main supply of the Stirrer during cleaning, assembling and dismantling.  
5.2.2 Do not wash the motor assembly with water or IPA.  
5.2.3 Ensure that Stirrer fan is not touching to the bottom or side of the container during stirring.  
5.2.4 During stirring use safety goggles, gloves and nose masks.  
5.3       Operation
5.3.1 Visually ensure that, the Stirrer is cleaned and line clearance is taken on specific product BMR from QA Department.  
5.3.2 In a clean SS container take required quantity of solvent/ water to prepare the solution as mentioned in the BMR.  
5.3.3 1.      Place the Stirrer rod with fan inside the container in which solution to be prepared and fix the Stirrer blade assembly (rod) to the motor shaft by tightening the bolt provided on the shaft.  
5.3.4 Adjust the height of the Stirrer with the help of adjusting arm by loosening the clamp screw provided on the stand.  
5.3.5 Check the required height and tight the arm screw of the stirrer stand.  
5.3.6 Keep the Stirrer at the centre of the solution container.  
5.3.7 Switch “ON” the Stirrer and check the proper working.  
5.3.8 Start the Stirrer and slowly add the material to be mixed in to the container and cover the solution with cleaned poly bag to avoid the spillage from the container.  
5.3.9 Stir the solution for specified time as mentioned in specific product BMR. Note down the stirring time on the product BMR.  
5.3.10 After completion of stirring, switch “OFF’ the main supply and dismantle the fan rod from the motor shaft.  
5.3.11 Remove the solution tank and check for proper mixing. Transfer the solution for further process.  
5.3.12 Record the activity in “Equipment Log Book”, refer attached Annexure.  
5.3.13 After completion of batch, label the equipment as “To be Type A cleaned” or “To be Type B Cleaned”.  
5.4  Cleaning
5.4.1 Type A ( Batch to Batch) Cleaning:
5.4.1.1 Dismantle the stirrer fan rod from the motor shaft, and then clean with purified water.  
5.4.1.2 Wipe the stand and motor assembly with dry clean duster.  
5.4.1.3 Ensure the absence of previous batch solution on the stirrer and affix “Type A Cleaned “label.  
5.4.2  Type B (Product to Product) Cleaning
5.4.2.1 Switch “OFF” the main supply of Stirrer and disconnect from electrical socket.  
5.4.2.2 Dismantle the fan rod from the motor shaft, with the help of bolt provided on the shaft.  
5.4.2.3 Clean the stand and motor cover by using moist clean duster and then dry with dry clean duster.  
5.4.2.4 Clean fan and rod with 5-7 litres potable water using 0.1% soap (teepol) solution, then wash with 10-12 litres of potable water to remove the traces of the soap solution .Finally rinse the Stirrer with 5-7 litres of purified water.  
5.4.2.5 Fill the Swab / Rinse Sample Intimation Slip and submit to QA Department to  collect the samples.  
5.4.2.6 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 step No.5.4.2.4.  
5.4.2.7 After successful completion of cleaning process, mention on the area status board “Type B Cleaned”.  
5.4.2.8 Affix “Type B Cleaned ‘label to the Stirrer and cover it with a fresh poly bag.  
5.4.2.9 Record the cleaning and usage activity in “Equipment Log Book” refer annexure.  
5.5 Breakdown
5.5.1 If breakdown occurs during operation, hold the solution in closed condition. Inform 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 Remove the stirrer from solution, only if required for breakdown rectification.  
5.5.5 Store the solution separately in 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 Record the breakdown activity in ‘Equipment Log Book”.  
5.5.8 After completion of repairs, the operations can be resumed. Perform ‘Type A” or “Type B” cleaning if the solution has been removed from the Stirrer.  
5.5.9 Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed.  
5.6 Preventive Maintenance  
5.6.1 Perform the preventive maintenance as per attached 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.  
5.6.3 Attach the preventive maintenance label on the equipment.  

 

  1. Abbreviation:
Abbreviation Expansion
%  Percent
SS Stainless Steel
SOP Standard Operating Procedure
IPA  Iso Propyl Alcohol

 

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

 

Categories
Production SOP

SOP Title: Operation and Cleaning Calibration of Tray Dryer

SOP Title: Operation and Cleaning Calibration of Tray Dryer

 

  1. Objective:

To define a procedure for Operation, Cleaning, Preventive  Maintenance and Calibration of Tray Dryer.

  1. Scope:

This SOP is applicable to Tray Dryer, used for the drying of granules/raw material and cleaned accessories, installed at the  Production area.

  1. 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 Tray 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 Tray Dryer, wherever applicable.
    • Quality Control Department: To analyse and report the swab/rinse samples.

 

  1. Accountability:

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

  1. 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.
        • 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 or change in colour.
        • Monthly, if it is not in 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.
      • Calibration: Tests performed to ensure that the equipment is functioning as per set parameters. These tests 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 cleaning, loading and unloading of material in to the Tray Dryer.  
5.2.2 Use proper personal protective equipment like nose Masks, Gloves, while handling the material.  
5.2.3 Do not over fill the material in to the trays to avoid the spillage of material.  
5.2.4 During drying, flap of the inlet air should be open as per requirement.  
5.2.5 Set temperature controller as per requirement of material to be dried or as mentioned in product BMR.  
5.2.6 Switch OFF the heater while drying the material/ accessories/ product which contains IPA  
5.2.7 Ensure that, after attaining set temperature heater should be cut “OFF”.  
5.2.8 Ensure the validity of Calibration and Preventive Maintenance before starting any operations.  
5.3         Operation of Tray Dryer  
5.3.1 Visually check and ensure that, Tray Dryer is cleaned and line clearance is taken as per line clearance checklist on specific product BMR.  
5.3.2 Remove “Cleaned” status label and affix “In-process” label to the tray dryer.  
5.3.3 Ensure that Tray Dryer main is switched “OFF”. Then open the Tray Dryer door by pulling the handle provided on the door.  
5.3.4 Remove the tray one by one from the dryer and load the required quantity of material to be dried in the trays. Spread the material evenly for uniform drying.  
5.3.5 Insert the material filled trays in the tray cabinet in proper sequence and close the door of the Tray Dryer.  
5.3.6 Switch “ON” the main electric switch then switch ON the toggle switch.  Push the green colour button to switch “ON” the blower.  
5.3.7 Set the required temperature by rotating the temperature controller Knob  
5.3.8 Rotate the temperature controller knob clockwise to increase the temperature and rotate it in anti-clockwise to decrease the temperature. The set value will be displayed.  
5.3.9 After attaining the set temperature, heater wills automatically cut-off, to maintain the set temperature inside the tray dryer.  
5.3.10 In-between rack (mix) the material and check for proper drying.  
5.3.11 Dry the material till the LOD is Attained as per the respective BMR / as per the material requirement  
5.3.12 Dry the machine accessories or parts till it get dried completely without any water traces.  
5.3.13 After drying unload the material from the tray one by one in to the cleaned container lined with double poly bag.  
5.3.14 Affix dully filled status label to the container in which, the material is unloaded.  
5.3.15 Record the total drying time in the product BMR.  
5.3.16 Record the usage time in equipment log book as per attached Annexure.  
5.3.17 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 to Batch Cleaning)  
5.4.1 Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process.  
5.4.2 Remove all previous batch documents, containers and labels from the area.  
5.4.3 Clean the trays with the help of clean dry duster.  
5.4.4 Dry clean the drier grooves /cabinet, inner surface and outer surface of the dryer with the help of vacuum cleaner /dry clean duster.  
5.4.5 Ensure the cleanliness and affix “Type A CLEANED” label as per SOP.  
5.4.6 Record the cleaning time in equipment log book as per  Annexure.  
5.5      TYPE B Cleaning (Product to Product Cleaning)  
5.5.1 Switch “OFF” the main switch, and then remove the trays one by one from the tray compartment.  
5.5.2 Remove in process status label and affix “To be Type B cleaned” status label.  
5.5.3  Remove all labels, containers and documents of previous product.  
5.5.4 Keep the trays on trolley and transfer to the wash area for cleaning by covering with poly bag with “To Be Type B Cleaned label.  
5.5.5 Cleaning of trays: Clean the trays first with potable water to remove the adhered powder then apply 0.1 % soap (teepol) solution then wash with sufficient quantity of potable water. Finally rinse with purified water.  
5.5.6 Fill the Swab / Rinse Sample Intimation Slip and submit to QA department to collect the Swab / Rinse samples of the trays.  
5.5.7 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 5.5.5.  
5.5.8 Cleaning of External Surfaces of the tray dryer: Clean the outer surface of the tray dryer, exhaust flap, using moist duster then wipe with clean dry lint free duster.  
5.5.9 Cleaning of Chamber:  Clean the chamber with Vacuum Cleaner followed by moist duster.  
5.5.10 Drying of trays: Wipe all trays with a clean dry lint free duster then put the trays in tray cabinet in reverse position.  
5.5.11 Switch “ON” the tray dryer for drying. After drying of trays switch “off” the tray dryer followed by main switch.  
5.5.12 Record the activity in equipment log book. Refer Annexure.  
5.5.13 After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”.  
5.6 Breakdown  
5.6.1 If breakdown occurs during operation, switch “OFF” the main supply and inform to Head Production and QA Associate.  
5.6.2 Record the drying time in 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 Unload the product / material only if required and keep the product/ material in closed condition as per requirement.  
5.6.6 If breakdown occurs prior to start of operation, follow step 5.6.3.  
5.6.7 Record breakdown activity in Equipment log book .  
5.6.8

 

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.  
5.7 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 from external approved agency once in a year as per Annexure.  
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.  

 

  1. Abbreviation:
Abbreviation Expansion
BMR Batch Manufacturing Record
LOD Loss On Drying
% Percent
QAD Quality assurance Department
IPA Iso Propyl Alcohol
v/v Volume by Volume
ml Mili Litre

 

 

CALIBRATION FOR TEMPERATURE CONTROLLER OF TRAY DRYER

OBSERVATIONS

Sr. No Standard Temperature (°C) Observed Temperature on UUC (°C) Deviation  (± 2°C)
1 25    
2 50    
3 100    
4 150    
UUC : Unit under calibration
Remarks: The results comply / Not comply with the acceptance criteria

 

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

 

Categories
Production SOP

SOP Title: Cleaning and Sanitation in Production Area

SOP Title: Cleaning and Sanitation in Production Area

 

  1. Objective:

To define a procedure for Cleaning and Sanitation to be followed in Production Area.

  1. Scope:

This SOP is applicable for cleaning of all Production area.

 

  1. Responsibility:
    • Production Department: To prepare and review the SOP. To follow the procedures laid down for the Cleaning and Sanitation in Production Area.
    • Engineering Department: To support for the Maintenance of area and providing required utilities.
    • Quality Control Department: To monitor the microbial contamination of the area.
    • Quality Assurance Department: To provide line clearances prior to operation.To review and approve the SOP and Annexure. To monitor the activities performed in the area as per SOP.
  2. Accountability:

Head, Production Department.

Head, Engineering Department.

Head, Quality Assurance.

  1. 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.
      • Quality Control Associate: Executive of Quality Control Department or any personnel trained to perform duties as per this SOP.
      • Disinfectant: The term Disinfectant refers to Savlon solution or Dettol solution at 2.5% v/v (25 ml of disinfectant in 1000 ml of Potable water) of concentration as per the Scope of this SOP.
      • Cleaning Solution: 25 ml of Teepol (soap solution) in 1000 ml of potable water (2.5% v/v).
      • Type A Cleaning: Cleaning the area with 2.5% v/v of Cleaning Solution in the following cases:-
        • To remove the previous batch residue.
        • Before starting the next batch of the same product.
        • After End of the shift or before the start of the Shift, if the same product to be continued.
      • Type B Cleaning: Cleaning the area with 2.5% v/v of Cleaning Solution followed by Sanitation with Disinfectant solution in the following cases:-
        • Removal of traces of the previous product.
        • Change in product if any.
        • After continuous five batches of the same product.
        • Daily at the start of the Shift and at the end of the shift in the area.
        • After any repair work carried out in the area.
      • Procedure:
  Precautions  
5.2.1 Switch “OFF’ the equipments before proceeding to cleaning.  
5.2.2 During wet cleaning cover the electrical panel, switches and other sensitive components with fresh poly bag.  
5.2.3 Do not flush the water / solvent on the electrical switches or tube lights.  
5.3 Cleaning of Production Area:  
5.3.1 Update the area status board as “Under cleaning”.  
5.3.2 Remove all the material, documents, and labels of the previous Batch / Product from the area before proceeding for cleaning.  
5.3.3 Perform either “TYPE A” cleaning or “TYPE B” cleaning as applicable.  
5.4 TYPE A Cleaning:  
5.4.1 Remove any spilled material from the area with clean duster / Vacuum Cleaner.  
5.4.2 Clean the Items as per Annexure  with Vacuum Cleaner/dry lint free cloth.  
5.4.3 After ensuring Step no 5.4.2, clean those items with lint free cloth / Mob soaked in potable water. Followed by clean lint free cloth soaked in 2.5% of cleaning solution.  
5.4.4 Finally clean with clean lint free cloth soaked in potable water followed by purified water.  
5.4.5 Record the cleaning activity in the Area cleaning and Sanitisation record as per Annexure.  
5.4.6 Update the area status board as “TYPE A Cleaned”  
5.4.7 Allow the area to dry before start of the next batch.  
5.5 TYPE B Cleaning:  
5.5.1 Remove any spilled material from the area with clean lint free cloth / Vacuum Cleaner.  
5.5.2  Before starting cleaning of the area cover the PLC, Electrical fixtures, panel boards of the equipments in the area with clean poly bag.  
5.5.3 Clean the Area as per Annexure  with Vacuum Cleaner/dry lint free cloth.  
5.5.4 After ensuring Step no 5.5.3, clean those items with lint free cloth soaked in potable water. Followed by clean lint free cloth soaked in 2.5% of cleaning solution.  
5.5.5 Finally clean with clean lint free cloth soaked in potable water followed by purified water.  
5.5.6 Allow the floor to dry and sanitize the floor with 2.5% v/v of disinfectant solution.  
5.5.7 Sanitize the floor with 2.5%v/v of Dettol solution for one week and 2.5% v/v of Savlon solution for the next one week.  
5.5.8 Follow Step No. 5.5.7 alternatively for every week.  
5.5.9 Allow the floor to dry before start of the activity.  
5.5.10 Update the area status board as “TYPE B Cleaned”  
5.5.11 Record the cleaning activity in the Area Cleaning and Sanitisation record as per Annexure.  

 

  1. Abbreviation:
Abbreviation Expansion
ML Millilitre
QA Quality Assurance
% Percentage
v/v Volume by Volume
PLC Programmable Logical Control

 

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

 

Categories
Production SOP

SOP Title: Operation and Cleaning of Dust Extractor

SOP Title: Operation and Cleaning of  Dust Extractor

 

  1. Objective:

To define procedure for Operation, Cleaning and Preventive Maintenance of Dust Extractor.

  1. Scope:

This SOP is applicable to Dust Extractor, used for extraction of dust generated during de-dusting and compression activity, in compression section.

  1. Responsibility:
    • Production Department: To prepare and review the SOP. To follow the procedures laid down for the operation cleaning and preventive maintenance of Dust Extractor.
    • Engineering Department: To perform the preventive maintenance of Dust Extractor.
    • Quality Assurance Department: To provide line clearance prior to operation. To approve the Preventive Maintenance reports. To review and approve the SOP and Annexure.
  2. Accountability:

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

  1. 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/ vacuum cleaner and removing the previous batch powder/material in the following cases,
        • Remove the previous batch material.
        • During end of the shift.
        • Before starting the next batch of the same product.
      • Type B Cleaning: Wet cleaning by using water in the following cases
        • Removal of traces of the previous product, and is ensured by visually of the cleaned equipment.
        • Change in product and same product having 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 the cleaned machine 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, quarterly and half yearly.
    • Procedure
  Precautions  
5.2.1 Wear proper personal protective equipment like nose mask and gloves before starting the cleaning operation.  
5.2.2 Check that, dust extractor suction pipe is properly fitted to the nozzle of the dust extractor.  
5.3 Operation  
5.3.1 Before starting the operation, visually check the Dust Extractor is properly cleaned and line clearance is taken from QA.  
5.3.2 Switch “ON” the MCB then   switch “ON” the machine by pressing green colour start button provided on the dust extractor.  
5.3.3 During operation, shake the filter bag manually after two hours with the help of handle provided.  
5.3.4 After completion of de-dusting Switch “OFF” by pressing red colour push button.  
5.3.5 Label the as Dust Extractor “ To be Type A cleaned” or “To be Type B Cleaned”.  
5.3.6 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 `Main’ switch of the  Dust Extractor.  
5.4.1.3 Clean the external surface of the Dust Extractor with dry clean duster.  
5.4.1.4 Shake the filter bags with the hand then open the door of filter bag chamber by unscrewing   the wing nuts.  
5.4.1.5 Clean the dust adhered to inside part of chamber with vacuum cleaner.  
5.4.1.6 Remove dust from dust tray with vacuum cleaner.  
5.4.1.7 Remove the filter bags and clean it with vacuum cleaner.  
5.4.1.8 Clean the outer side of filter bag chamber with clean dry duster.  
5.4.1.9  Fix the filter bags properly after checking its cleanliness and intactness.  
5.4.1.10 Fix the door of filter bag chamber by tightening the wing nuts.  
5.4.1.11 Start the dust extractor and check for its proper working and suction at usage point.  
     Note: Before use, ensure that tray of dust collector is clean. Check that filter bag chamber is clean and filter bags are intact.

 

 
5.4.2 For Type B (Product to Product) Cleaning:
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 Dust Extractor with moist duster.  
5.4.2.3 Remove all labels, documents, products from the machine as well as from the area.  
5.4.2.4 Affix “To be Type B”   Cleaned” status label and switch “OFF” the main electric supply.  
5.4.2.5 Open the door of filter bag chamber by unscrewing the wing nuts.  
5.4.2.6 Shake the filter bags with hand.  
5.4.2.7 Clean the dust adhered to inside part of chamber with  nylon brush/vacuum cleaner.  
5.4.2.8 Remove dust from dust tray with vacuum cleaner.  
5.4.2.9 Remove the filter bag and transfer in a poly bag and shift to the cleaning area.  
5.4.2.10 Clean the dust extractor outer surface  and chamber initially with moist clean cloth ,then with dry clean cloth.  
5.4.2.11 Cleaning of filter bags:  
5.4.2.11.1 Initially remove the dust accumulated on filter bag by using compressed air at pressure  1-2 kg/cm2 from either side.  
5.4.2.11.2 Wash the filter bag with 15-20 litres of potable.  
5.4.2.11.3 Dry the cleaned filter bag with compressed air then with humidifier.(mild compressed air should be applied during drying to avoid damage of filter bag)  
5.4.2.11.4 After drying the filter bag, transfer the cleaned filter bag to the dedicated area of the dust extractor.  
5.4.2.11.5 Wash the suction pipe with potable water and apply 0.1% cleaning solution Finally wash with potable water to remove the traces of soap solution.  
5.4.2.12 Record the usage and cleaning activity in equipment log book refer  Annexure.  
5.4.2.13 After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”.  
5.4.2.14 Cover the dust collector  with clean poly bag.  
  Frequency: Clean the dust extractor

1. During product changeover

2. Whenever major maintenance done to the dust extractor

3. After continuous five batches of the same product.

4. Same product with change in colour.

5.Monthly, if it is not  used for production  activity.

 
5.5 Breakdown
5.5.1 If breakdown occurs during operation, hold the 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, stop the dedusting /compression  activity. Unload the tablet /granules from the compression machine/dedusting machine only, if required for breakdown rectification.  
5.5.5 Store the tablet/granules unloaded in a closed container with proper status label.  
5.5.6 After completion of repairs, the operations can be resumed. Perform Type A or Type B cleaning.  
5.5.7 Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed.  
5.5.8 Record the repair completion activity in Equipment Log Book.  
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.  

 

  1. Abbreviation :
Abbreviation Expansion
SOP Standard Operating Procedure
% Percentage
v/v Volume By Volume
kg/cm2 Kilogram Per Square Centimetre
TAB Tablet
BMR Batch Manufacturing Record

 

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

 

error: Content is protected !!