SOP Title: Operation and Calibration of Strip Packing Machine
- Objective:
To define procedure for Operation, Cleaning, Preventive Maintenance and Calibration of Strip Packing Machine.
- Scope:
This SOP is applicable to Strip Packing Machine used for packing of tablet and capsule in between aluminium foil in the form of strip pack in packing section of the production area.
- Responsibility:
- Production Department: To prepare and review the SOP. To follow the procedures laid down for the operation and cleaning and to support for Preventive Maintenance and Calibration of Strip Packing Machine.
- Engineering Department: To perform the Preventive Maintenance and Calibration of Strip Packing Machine.
- Quality Control Department: To analyse and report the swab samples.
- Quality Assurance Department: To provide line clearance prior to operation. To collect the swab/rinse samples. To approve the Preventive Maintenance and Calibration reports. To review and approve the SOP and Annexure.
- 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 QC Department trained to perform duties as per this SOP.
- Engineering Associate: Executive or Operator of Engineering Department trained to perform duties as per this SOP.
- Type A Cleaning: Dry cleaning with clean lint free cloth in the following cases:-
- Remove the previous batch residue.
- During end of the shift.
- Before starting the next batch of the same product.
- Prior to execution of higher strength batches, after the execution of lower strength batches of the same product.
- Type B Cleaning: Wet cleaning by using soap solution in the following cases:-
- Removal of traces of the previous product, which is ensured by testing rinse /swab sample of the cleaned equipment.
- Change in product.
- Prior to execution of lower strength batches, after the execution of higher strength batches of the same product.
- After continuous five batches of the same product.
- After seven days of cleaning before use, if equipment is not in use.
- After replacement or repair of any product contact part.
- Monthly, if cleaned machine not used for packing activity.
- Cleaning Solution: 1 ml of Teepol ( soap solution) in 1000 ml of potable water (0.1% v/v)
- Breakdown: Any activity leading to operation of machine other than the set parameters and / or unusual sound or vibration observed in the machine.
- Preventive Maintenance: Maintenance activity performed to ensure that the equipment will function smoothly and to avoid breakdowns. These activities are performed monthly, quarterly and half yearly.
- Calibration: Tests performed to ensure that the equipment is functioning as per set parameters. These test are performed yearly and also after repair or replacement of parts coming in direct contact with product.
- Procedure:
- Definition:
| Precautions | ||
| 5.2.1 | Put “OFF” the main supply of the strip packing machine during cleaning. | |
| 5.2.2 | During setting and cleaning whenever required, run the machine in Inch mode by turning the toggle switch to Up position then press the green colour “ON” button provided on the machine. | |
| 5.2.3
|
During inserting aluminium foil web in-between sealing roller, care should be taken to avoid the fingers entering in-between the sealing roller. | |
| 5.2.4 | Care should be taken to avoid the accident such as burning of hands with sealing rollers. | |
| 5.2.5 | Use nose mask and hand gloves while handling the product. | |
| 5.2.6
|
Ensure the working of heaters, limit switches and proper fitting of change parts by starting machine in inch mode. | |
| 5.3 | Operation | |
| 5.3.1 | Before starting machine, check that the line clearance is taken as per checklist given in specific product BPR. | |
| 5.3.2 | Fit the change parts on machine as per product specification mentioned on specific product BPR. | |
| 5.3.3 | Switch “ON” the main electric supply then switch “ON’ the machine by turning key to the RHS side to the “ON” position provided on the machine panel. | |
| 5.3.4 | The phase indicator will glow red, yellow and green followed by red stop button provided on the panel. | |
| 5.3.5 | To start the machine in inch mode turn the toggle switch to the down position and to start the machine in run mode turn the toggle switch to the up position. | |
| 5.3.6 | Switch “ON” the sealing heater by turning knob to the RHS “ON” position, and then set the required temperature as mentioned in the product BPR. | |
| 5.3.7 | For setting the sealing temperature, press the push button and rotate the coarse /fine regulator to RHS to increase the temperature and LHS to decrease the temperature. | |
| 5.3.8 | Check that the sealing heaters are working properly by observing increase in the temperature controller display. | |
| 5.3.9 | Wait for 20 to 30 minutes to achieve the required temperature, the actual temperature will display on the temperature controller display on the panel board of the machine. | |
| 5.3.10 | Put the printed aluminium foil on the both holder arm, on LHS holder printed aluminium foil and RHS holder plain aluminium foil then pass the foil in-between the sealing roller. | |
| 5.3.11 | Sealed web pass through the dropping brush, then pass through the cutting assembly to cut the strip pack of uniform size. | |
| 5.3.12 | Issue the required number of stereos as per product requirement from QA. | |
| 5.3.13 | Fit the stereos on the stereo roller followed by the printed aluminium foil and plain aluminium foil such a way that the printed aluminium foil and plain aluminium foil should pass through roller having cavities and Plain aluminium foil should bear batch code. | |
| 5.3.14 | After fixing the stereos put the ink and thinner to the ink roller than start the machine to get the clear printing proof. | |
| 5.3.15 | Then send one over printed foil proof to packing officer / production officer and verified by QA officer for initial proof checking against BPR as mentioned in overprinting proof checking sheet. | |
| 5.3.16 | Packing officer, production officer and QA officer will check the overprinting quality, manufacturing date, expiry date, maximum retail price and other overprinting matter such as dot, coma, dash etc. | |
| 5.3.17 | After getting proof checking clearance from QA person, attach the checked proof with BPR. | |
| 5.3.18 | Start the printing and check the coded/overprinted matter routinely, as mentioned in specified product BPR. | |
| 5.3.19 | Load the tablets/capsules in to the hopper and set the chute with the centre of the cavity of the sealing roller. | |
| 5.3.20 | Start the vibrator by turning the toggle switch to the up position then adjust the vibration speed by turning the regulator knob to the RHS to increase and rotate the regulator to LHS decrease the vibrator speed. | |
| 5.3.21 | Set the chute in such a way, the tablet should be freely drop from the bowl dish in to the chute. | |
| 5.3.22 | The tablets from the chute passes in to the sealing roller cavity in which, the tablet packed in-between the aluminium foil. | |
| 5.3.23 | Visually check the printing and quality of strip packs. | |
| 5.3.24 | Check the Leak Test for number of strips and frequency as mentioned in the specific product BPR. | |
| 5.3.25 | Operate the Leak Test Apparatus as per SOP. | |
| 5.3.26 | If Leak Test fails clean the roller, set the machine and check again. | |
| 5.3.27 | After passing the leak test start the machine for packing activity. | |
| 5.3.28 | Check and record in-process test parameters as mentioned in the specific product BPR. | |
| 5.3.29 | Set the cutter for uniform cutting of strips as per pack size. | |
| 5.3.30 | Adjust the speed of the machine by turning the switch clockwise / Anti clock wise on the regulator provided. | |
| 5.3.31 | Printing rejects and missing tablet/capsule strips to be de-foiled and sorted. The sorted tablet /capsules should be checked by packing officer and packed at the end in the same batch. | |
| 5.3.32 | The de-foiled tablets/capsules packed shipper number should be noted down in the product BPR. | |
| 5.3.33 | Label the defective tablets/capsules as “rejects”. These rejects to be disposed in water and label the disposed container as “Hazardous Waste”. | |
| 5.3.34 | During packing activity tablet container should be kept in closed condition. | |
| 5.3.35 | At the end of batch, take overprinted proof as a last proof get it check and signed by packing officer, production officer and verified by QA and same should be kept along with initial proof. | |
| 5.3.36 | After completion of the packing activity, switch “OFF” the machine by turning the key to the LHS followed by main electric switch. | |
| 5.3.37 | Remove the stereo from the roller and handover to QA. | |
| 5.3.38 | Remove the remaining foil, tablet/capsules if any, and clean the machine with the nylon brush and clean dry duster.
Note: At the end of the day clean the machine as per “Type A Cleaning”. |
|
| 5.3.39 | After completion of batch, check the weight of the excess foil and details of the same to be mentioned on the label. | |
| 5.3.40 | Fill the Excess Material Return Note and return the excess material to Warehouse after authorisation of Production Head and QA. | |
| 5.3.41 | After completion of batch, label the equipment as “To be Type A cleaned” or “To be Type B Cleaned”. | |
| 5.3.42 | Record the activity in “Equipment log book”. | |
| 5.4 | Type A Cleaning | |
| 5.4.1 | Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process.. | |
| 5.4.2 | Switch “OFF” the mains of the machine and remove all documents, labels, containers of previous batch. | |
| 5.4.3 | Remove all stereos from the stereo roller and hand over to QA. | |
| 5.4.4 | Remove the scrap of foil and foil pieces in between the cutting tool. | |
| 5.4.5 | De-dust all the parts except heating roller with nylon brush / vacuum cleaner / dry duster. | |
| 5.4.6 | Clean the pressure sealing roller with metallic brush to remove the adhered residue of foil. | |
| 5.4.7 | Dry clean the outer surface, in between the parts of the machine with clean dry duster / nylon brush /vacuum cleaner. | |
| 5.4.8 | Ensure the cleanliness by checking visually for the presence of any tablets or particles in the blister pack machine, then affix “Type A Cleaned” label. | |
| 5.4.9 | Record the activity in Equipment Log Book as per Annexure. | |
| 5.5 | Type B Cleaning | |
| 5.5.1 | Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process. | |
| 5.5.2 | Switch “OFF” the machine by turning the key to the LHS followed by main electric switch. | |
| 5.5.3 | Remove all documents, labels, material, and containers of previous products from machine as well as from the area. | |
| 5.5.4 | Dry clean the machine as well as the area with vacuum cleaner and dry duster. | |
| 5.5.5 | Collect the tablets /capsules/powder and label as ‘Rejects’ and record the weight on the BPR. | |
| 5.5.6 | Dismantle the feed hopper and vibrating bowl by removing the relevant Ellen bolts. | |
| 5.5.7 | Dismantle the feeding chute, cover plate by loosening the screw provided. | |
| 5.5.8 | Cover the dismantled parts with poly bag and transfer to the wash area on trolley with “To be Type B Cleaned “label. | |
| 5.5.9 | Wash all the parts with 10 Litre of potable water then apply 0.1 % Soap (teepol) solution. | |
| 5.5.10 | Wash the parts with 20 Litre of potable water to remove the traces of soap solution. Finally rinse with 10 Litre of purified water. | |
| 5.5.11 | Fill the Swab / Rinse Sample Intimation Slip and submit to QA department to collect the samples. | |
| 5.5.12 | Record the activity in Equipment Log Book. | |
| 5.5.13 | Collect the Swab/Rinse sample result from QA. If the result is complying, label the equipment as “Type B Cleaned”. If the result is not complying repeat the steps 5.5.9 to 5.5.11. | |
| 5.5.14 | After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”. | |
| 5.5.15 | Affix ‘cleaned’ label and cover with fresh poly bag. Keep the cleaned parts to the spare parts room. | |
| 5.5.16 | Dismantle the both sealing roller, back gear and dropping cam with the help of Ellen key. | |
| 5.5.17 | Clean the Sealing rollers with metal wire brush to remove any residue of any molten polythene, dirt and pieces of laminate. | |
| 5.5.18 | Carefully inspect the knurled surface of the roller, The surface should not be damaged. Then clean with dry clean duster. | |
| 5.5.19 | Keep the change parts in the dedicated place in change parts room. | |
| 5.5.20 | Clean the outer surface, panel, platform, inside the machine with dry duster then clean the outer surface of the machine with moist duster. | |
| 5.5.21 | Ensure the cleanliness by visually and affix “Type B Cleaned” label to the machine. | |
| 5.6 | Breakdown | |
| 5.6.1 | If breakdown occurs during operation, hold the tablets/capsules in closed condition. Inform the Head Production. | |
| 5.6.2 | Fill the “Complaint Note” and submit to Engineering Department. | |
| 5.6.3 | Fill the “Incident Report” and submit to Quality Assurance Department. | |
| 5.6.4 | Unload the tablets/capsules only if required for breakdown rectification. | |
| 5.6.5 | Store the unloaded tablets/capsules separately in closed container with proper status label. | |
| 5.6.6 | If breakdown occurs prior to start of operation, follow step 5.6.2 | |
| 5.5.7 | Record the breakdown activity in Equipment Log Book. | |
| 5.6.8 | After completion of repairs, the operations can be resumed. Perform ‘Type A” or “Type B” cleaning if the tablets have been unloaded from the hopper. | |
| 5.6.9 | Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed. | |
| 5.6.10 | Describe the breakdown activity in the respective product BPR. | |
| 5.7 | Preventive Maintenance | |
| 5.7.1 | Perform the preventive maintenance as per Annexure. | |
| 5.7.2 | If preventive maintenance activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached. | |
| 5.7.3 | Attach the preventive maintenance label on the equipment. | |
| 5.8 | Calibration | |
| 5.8.1 | Calibrate the temperature controller once in a year by external approved party. | |
| 5.8.2 | If calibration activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached. | |
| 5.8.3 | Attach the calibration label on the equipment. | |
| 5.9 | Maintain the Issuance, Utilisation and Cleaning record of Strip Packing Machine Change Parts as per Annexure. | |
- Abbreviation
| Abbreviation | Expansion |
| BPR | Batch Packing Record |
| ml | Milliliter |
| LHS | Left Hand Side |
| RHS | Right Hand Side |
| QC | Quality Control |
| % | Percent |
| v/v | Volume by Volume |
CALIBRATION OF TEMPERATURE INDICATOR
OBSERVATIONS
| Sr. No. | Reading on UUC
(°C) |
Reading on Standard instruments
(°C) |
Deviation
± 4°C |
Remarks |
| 1 | ||||
| 2 | ||||
| 3 | ||||
| 4 | ||||
| 5 | ||||
| 6 | ||||
| UUC : Unit Under Calibration | ||||
| Result: The results Complies / Not Complies with the acceptance criteria. | ||||
*Note – Ready to use SOP available in “DOWNLOAD” Section.