SOP Title: Operation and Calibration of Compression Machine
- Objective:
To define procedure for Operation, Cleaning, Preventive Maintenance and Calibration of Compression Machine.
- Scope:
This SOP is applicable to compression machine used for compression of lubricated granules into tablet in compression area.
- 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 Compression Machine.
- Engineering Department: To perform the preventive maintenance and calibration of Compression Machine.
- Quality Control Department: To analyse and report the swab samples.
- Quality Assurance Department: To provide line clearance prior to operation. To collect the swab/rinse samples. To approve the Preventive Maintenance and Calibration reports. To review and approve the SOP and Annexure.
- 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.
- Tummy: Plain SS rod used for the setting or removal of dies.
- In-Process Parameters: As per the Scope of this SOP the In-Process parameters refers to Appearance of the tablet, Weight of the tablet, Hardness, Thickness, Friability, Disintegration time and likewise parameters.
- Non Recoverable Rejects: The tablets and granules which cannot be re processed, for example, tablets collected during the compression machine setting, tablets collected during first two rounds of compression cycle. The Non Recoverable Rejects are to be discarded.
- Recoverable Rejects: The tablets and granules 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 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.
- 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
| Precautions | ||
| 5.2.1 | Switch ‘OFF’ the main supply during machine setting, cleaning and product change over activity. | |
| 5.2.2 | Ensure that, the dimension, shape and embossing details of punches and dies are matching with the respective product BMR. | |
| 5.2.3
|
Rotate the machine turret manually by hand wheel and check visually for friction, loose parts of machine before commencing the operation. | |
| 5.2.4 | During operation of the machine do not touch the moving parts /do not put hand in the running machine. | |
| 5.2.5 | Use proper personal protective equipment example Masks, Gloves likewise while compression operation. | |
| 5.2.6 | Ensure that the validity of Calibration and Preventive Maintenance before starting any operations | |
| 5.3 | Setting of punches and dies: | |
| 5.3.1 | Issue the respective punches and dies as per BMR. Refer SOP ‘Inspection, utilization and cleaning of punches and dies’ | |
| 5.3.2 | Ensure that the dimension, shape and embossing detail of punches and dies matches with the respective product BMR. | |
| 5.3.3 | Visually ensure that all the punches and dies are clean. | |
| 5.3.4 | Remove the screw from the grove of the upper punch cam track to fit the upper punch. Smear the upper punch with food grade oil and place the upper punch in the cam track | |
| 5.3.5 | Place the die carefully in the die cavity of the turret, by matching the alignment with the upper punch. | |
| 5.3.6 | After placing the die on the turret, remove the upper punch and secure the die position by tapping it with tummy. Replace the upper punch on the cam track. | |
| 5.3.7 | Tighten the die screw using the align key | |
| 5.3.8 | Smear the lower punch with food grade oil. Insert the lower punch through lower punch guide hole of the lower cam track passing through the die. | |
| 5.3.9 | Secure the lower punch by tightening the nylon plugs with the spring steel strips in the lower cam track. | |
| 5.3.10 | Fix the cleaned and dried nylon plugs with spring steel strips in turret hole. | |
| 5.3.11 | Repeat the same procedure to fit all the die and punches. | |
| 5.3.12 | Replace the screw from the grove of the upper punch cam track. | |
| 5.3.13 | Rotate the turret manually using the hand wheel, to check for proper setting of die and punches, absence of friction, any loose parts and likewise. | |
| 5.4 | Setting of Feed Frame and Hopper: | |
| 5.4.1 | Place the right hand feed frame stand on the machine platform and fasten with screws. | |
| 5.4.2 | Place the right hand feed frame with proper alignment over the feed frame stand and the turret. Fasten with screws. | |
| 5.4.3 | Introduce the right hand side hopper from the top of the machine through the provision provided on the right hand side. | |
| 5.4.4 | Adjust the level of the right hand hopper using the screw and guide the tip of the hopper into the feed frame. | |
| 5.4.5 | Adjust the right hand scrapper plate in such a way that it prevents the excess flow of granules out of the feed frame. | |
| 5.4.6 | Repeat the step 5.4.1 upto 5.4.5 to set the left hand feed frame, left hand hopper and left hand scrapper blade. | |
| 5.4.7 | Rotate the turret manually using the hand wheel, to check for proper setting of feed frames, hoppers, absence of friction, any loose parts and likewise. | |
| 5.5 | Compression Cycle: | |
| 5.5.1 | Before starting the compression make sure that the line clearance is taken and recorded in the BMR
Record the activity in the equipment log book as per Annexure. |
|
| 5.5.2 | Before starting the operation ensure the temperature and relative humidity of the area is within the limit specified in the BMR. Refer SOP Temperature and Relative Humidity Monitoring | |
| 5.5.3 | Place a clean container with double polybag under the left hand and right hand tablet ejection ports of the machine before start of the operation. | |
| 5.5.4 | Load the lubricated granules, manually into the right hand and left hand hoppers with a clean SS scoop. | |
| 5.5.5 | Release the compression pressure on both the stations by rotating the respective hardness wheels anti-clockwise. | |
| 5.5.6 | Rotate the turret using the hand wheel, to allow the granules to completely fill both the feed frames. | |
| 5.5.7 | Switch “ON ‘the main electric line. Release the emergency stop button. | |
| 5.5.8 | Set the machine RPM between 5 to 10 by rotating the respective speed wheels clockwise. Press the start button (green coloured) provided on the machine panel | |
| 5.5.9 | Collect the tablets from the first two rounds of compression and label them as ‘Non Recoverable Rejects’. | |
| 5.5.10 | Set the machine parameters to achieve the in-process parameters as per BMR. First set the weight followed by hardness and thickness followed by machine speed. | |
| 5.5.11 | Weight Setting: To increase the weight of the tablet, slowly rotate the weight adjusting wheel in anti-clockwise direction. To decreasing the weight, rotate the weight adjusting wheel in clock wise direction. | |
| 5.5.12 | Hardness Setting: To increase the hardness of the tablet, slowly rotate the hardness adjusting wheel in Clockwise direction. To decreasing the hardness, rotate the hardness adjusting wheel in anti-clock wise direction. | |
| 5.5.13 | Speed Setting: To increase the RPM rotate the speed variable pulley in clockwise direction. To decrease the RPM rotate the speed variable pulley in anti-clockwise direction | |
| 5.5.14 | 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 full batch compression. | |
| 5.5.15 | Check the tablets ejecting out from both sides of the machine for all the In-Process Parameters as per interval mentioned in the BMR. Record the details in the BMR. | |
| 5.5.16 | Collect all the compressed tablets from both the sides of the machine in clean containers lined with double poly bag. Label the polybag and the container for ‘In Process Label’. | |
| 5.5.17 | After the completion of compression cycle, remove any un-compressed granules from the hopper and feed frame. Label them as ‘Non Recoverable Rejects’. | |
| 5.5.18 | Weigh the compressed tablets and rejected tablets and granules for yield reconciliation. Record the respective weight in the BMR | |
| 5.5.19 | After completion of compression activity, label the equipment as “To be Type A cleaned” or “To be Type B Cleaned”. | |
| 5.5.20 | Record the activity in equipment log book as per Annexure. | |
| 5.6 | Type A Cleaning | |
| 5.6.1 | Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process. | |
| 5.6.2 | Ensure that the electrical utilities to the compression machine are switched ‘off’ during the cleaning process | |
| 5.6.3 | Clean the outer surface of the compression machine with clean lint free cloth | |
| 5.6.4 | Dismantle both the hopper by loosening the round knob provided on the hopper stand. | |
| 5.6.5 | Dismantle the feed frame of both sides by loosening the two studs provided on the feed frame. | |
| 5.6.6 | Dry clean the hopper, feed frame externally and internally with clean duster. | |
| 5.6.7 | Remove the upper punches one by one and dry clean with soft clean duster then place them in to the respective punch guide hole. | |
| 5.6.8 | Remove any adhered powder to the turret with the vacuum cleaner and clean the turret with dry lint free cloth. | |
| 5.6.9 | Ensure the cleanliness by checking visually for the presence of any granules or particles, then affix “Type A Cleaned” label. | |
| 5.6.10 | Record the activity in equipment log book as per Annexure. | |
| 5.7 | Type B Cleaning | |
| 5.7.1 | Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process. | |
| 5.7.2 | Ensure that the electrical utilities to the compression machine are switched ‘off’ during the cleaning process | |
| 5.7.3 | Dismantle both the hopper by loosening the round knob provided on the hopper stand. | |
| 5.7.4 | Dismantle the feed frame and feed frame gauge of both sides by loosening the two studs provided on the feed frame. | |
| 5.7.5 | Dry clean the dismantled parts with dry duster/nylon brush / vacuum cleaner. | |
| 5.7.6 | Cover the above parts with clean poly bag and transfer these to the wash area. | |
| 5.7.7 | Remove the screw from the upper punch cam track and remove all the upper punch one by one by rotating the turret through the hand wheel. | |
| 5.7.8 | Loose the die screws of lower punches, and remove all the lower punches one by one by rotating the turret through the hand wheel. | |
| 5.7.9 | Loose the die by rotating the screw in anti-clockwise direction and remove the entire die one by one by tapping the die gently by means of tummy though the lower punch guide hole. | |
| 5.7.10 | Clean the upper punch, lower punch and die. Refer SOP, Inspection, utilization and cleaning of punches and dies. | |
| 5.7.11 | Keep the cleaned upper punch, lower punch and die in a punch tray. And store it in the respective cabinet | |
| 5.7.12 | Clean all the interior areas of the machine like base plate on which the turret is fitted, cam tracks, die seats, upper and lower punch holes, and turret surface, first with a dry nylon brush and then with soft cloth moistened with IPA. | |
| 5.7.13 | Wash the Feed frame, feed frame gauge and hopper 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. | |
| 5.7.14 | Finally rinse the cleaned parts with Purified water. | |
| 5.7.15 | Dry the cleaned parts with clean, dry duster/tray dryer. | |
| 5.7.16 | Fill the Swab / Rinse Sample Intimation Slip and submit to QA department for collection of samples. | |
| 5.7.17 | Record the activity in equipment log book as per Annexure. | |
| 5.7.18 | 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 5.4.1 to 5.4.16. | |
| 5.7.19 | After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”. | |
| 5.8 | Breakdown | |
| 5.8.1 | If breakdown occurs during operation, hold the compression process. Inform to the Head Production. | |
| 5.8.2 | Fill the “Complaint Note” and submit to Engineering Department. | |
| 5.8.3 | Fill the “Incident Report” and submit to Quality Assurance Department. | |
| 5.8.4 | Unload the granules only if required for breakdown rectification | |
| 5.8.5 | Store the unloaded granules in suitable SS closed container | |
| 5.8.6 | If breakdown occurs prior to start of operation, follow step 5.8.2 | |
| 5.8.7 | Record the breakdown activity in Equipment Log Book. | |
| 5.8.9 | 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. | |
| 5.8.10 | Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed. | |
| 5.8.11 | Record the repair completion activity in Equipment Log Book. | |
| 5.8.12 | Describe the breakdown activity in the respective product BMR. | |
| 5.9 | Preventive Maintenance | |
| 5.9.1 | Perform the preventive maintenance as per Annexure. | |
| 5.9.2 | If preventive maintenance activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached | |
| 5.9.3 | Attach the preventive maintenance label on the equipment. | |
| 5.10 | Calibration | |
| 5.10.1 | Perform the calibration as per Annexure . | |
| 5.10.2 | If calibration activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached | |
| 5.10.3 | Attach the calibration label on the equipment. |
- Abbreviation :
| Abbreviation | Expansion |
| TAB | Tablet |
| SS | Stainless Steel |
| LHS | Left Hand Side |
| RHS | Right Hand Side |
| BMR | Batch Manufacturing Record |
| IPA | Iso Propyl Alcohol |
CALIBRATION RECORD
FOR TURRET RPM
OBSERVATIONS
|
Sr. No. |
Standard Reading | Observed Reading |
Acceptance Criteria |
Deviation |
| 1 |
± 2 RPM |
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| 2 | ||||
| 3 | ||||
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Remarks: Calibration of compression machine for turret RPM is performed. 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.