SOP Title: Operation and Calibration of Coating Pan
- Objective:
To define procedure for Operation, Cleaning, Preventive Maintenance and Calibration of Coating Pan.
- Scope:
This SOP is applicable to Coating Pan used for tablet coating process in coating section of the Production Department.
- 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.
- Accountability:
Head, Production Department, Head, Engineering Department and Head, Quality Assurance.
- 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.
- Definition:
- 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. |
- 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. |
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*Note – Ready to use SOP available in “DOWNLOAD” Section.