SOP Title: Operation, And Calibration Of Blister Packing Machine
- Objective:
To define procedure for Operation, Cleaning, Preventive Maintenance and Calibration of Blister Packing Machine Double Track Conveyor Belt.
- Scope:
This SOP is applicable to Blister Packing Machine used for blister packing of Tablet and Capsules in packing section.
- Responsibility:
- Production Department: To prepare and review the SOP. To follow the procedures laid down for the operation and cleaning and to support for preventive maintenance and calibration of Blister Packing Machine.
- Engineering Department: To perform the preventive maintenance and calibration of Blister Packing Machine.
- Quality Control Department: To analyse and report the swab samples.
- Quality Assurance Department: To provide line clearance prior to operation. To collect the swab/rinse samples. To approve the preventive maintenance and calibration reports. To review and approve the SOP and Annexure.
- 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 cleaning validity before use, if equipment is not in use.
- After replacement or repair of any product contact part.
- Cleaning Solution: 1 ml of Teepol ( soap solution) in 1000 ml of potable water (0.1% v/v).
- Breakdown: Any activity leading to operation of machine other than the set parameters and / or unusual sound or vibration observed in the machine.
- Preventive Maintenance: Maintenance activity performed to ensure that the equipment will function smoothly and to avoid breakdowns. These activities are performed monthly, quarterly and half yearly.
- Calibration: Tests performed to ensure that the equipment is functioning as per set parameters. These test are performed yearly and also after repair or replacement of parts coming in direct contact with product.
- Procedure
- Definition:
| Precautions | ||
| 5.2.1 | Put “OFF” the main supply of the blister packing machine during cleaning. | |
| 5.2.2 | During setting and cleaning whenever required, run the machine in Inch mode by pressing red colour stop button and ON / Inch button provided on the machine. | |
| 5.2.3
|
During inserting PVC / PVDC web in the sealing roller, care should be taken to avoid the fingers entering in-between the sealing roller. | |
| 5.2.4 | Care should be taken to avoid the accident such as burning of hands with heating rollers. | |
| 5.2.5 | Use nose mask and hand gloves while handling the product. | |
| 5.2.6
|
During idle condition of machine, always keep the pressure sealing roller in disengaged position, by operating the toggle switch of sealing heater in Auto / Manual mode, provided on the machine. | |
| 5.2.7 | Ensure the working of heaters, limit switches and fitting of required change parts as per the specific product BPR by starting the machine in inching mode. | |
| 5.2.8 | Before start packing operation ensure that line clearance is taken on product BPR. | |
| 5.3 | Operation | |
| 5.3.1 | Before start of the packing operation, check all machine parts are fitted properly. | |
| 5.3.2 | Switch “ON” the Main power supply, and then switch “ON” the machine main by turning knob to the “ON” position provided on the panel. | |
| 5.3.3 | Inform to Engineering Department to start the chilled water supply. | |
| 5.3.4 | Ensure that chilled water supply is “ON” by touching the hand to the blister forming roller. | |
| 5.3.5 | Switch “ON” the forming and sealing roller heater by turning knob to right hand side, the roller temperature will display on the individual indicator. | |
| 5.3.6 | Setting of blister forming temperature: Set the required temperature as given in the BPR.For setting of forming temperature, press the “push to set” button and rotate the regulator to right hand side to increase the temperature, and rotate to left hand side to decrease the temperature. | |
| 5.3.7 | Setting of sealing temperature: Press and hold the square ■ button and press the ▼ (down) key to decrease and press ▲ key to increase the temp. The display will show the set temp. | |
| 5.3.8 | Wait for 15- 20 minutes to attain the set temperature, the actual temperature will displayed on the temperature controller display, provided on the panel board of the machine. | |
| 5.3.9 | Setting of PVC FILM: Place the product PVC / PVDC roll on the holder arm and lock the roll with ring by tightening the screw. | |
| 5.3.10 | Pull the one end of the PVC / PVDC film and pass the film on the guide roller through the limit switch of PVC film then it passes through the heating roller and forming roller to form the blister pocket. | |
| 5.3.11 | After formation of blister, web passes through the guide track to in-between pressure sealing roller and counter sealing roller. | |
| Note: Manually pull the Pressure Sealing Roller locking assembly to engage the Pressure Sealing Roller on Counter Sealing Roller. To engage or disengage on auto mode, turn the auto/ manual knob to the required mode. | ||
| 5.3.12 | Setting of printed foil: Place the printed foil roll on the holder arm at the top of the machine then pass the foil outside the batch code printing unit. | |
| 5.3.13 | Then pass though guide roller to in-between the pressure sealing roller and counter sealing roller in which sealing of foil and PVC takes place. | |
| 5.3.14 | Remove the stereo holding drum unit by removing the Ellen screw provided on the Batch Code Printing unit. | |
| 5.3.15 | Loose the ring by loosening the screws of stereo drum, then fix batch stereos issued from the QA on the stereo drum. | |
| 5.3.16 | Fix the stereo by in such a way, that the over printing matter should be printed over the space provided on the foil. | |
| 5.3.17 | After fixing the stereos put the ink in to the ink roller then run the machine to get the clear over printed proof. | |
| 5.3.18 | Take the clear over printed proof and get it checked by Packing, Production and QA officers against the over printing detail mentioned in the specific product BPR. | |
| 5.3.19 | After certifying the printed matter from QA start the machine and put PVC blister web and printed foil in-between the pressure sealing roller and counter sealing roller to set the pack size. | |
| 5.3.20 | The web is then passed through the pusher plate. Loose the pusher knob and decrease/increase the distance as per the pack size. | |
| 5.3.21 | Adjust the pusher arm forward /backward with bolt to set the cutting of blister pack at the centre. | |
| 5.3.22 | Set the side plate of the blister web in such a way, that both side foil edge are same. | |
| 5.3.23 | Pusher plate pushes the web in to the punching/cutting tool to cut the blister web in to a uniform pack size / blister pack. | |
| 5.3.24 | After setting pack size, fix the feeder assembly and load the tablets in to the hopper then set the chute with blister pocket. | |
| 5.3.25 | Slowly, feed the tablets by manually in to the feeder to set the loading of tablets in to the chute. | |
| 5.3.26 | Set the alignment of the pocket with the tablet by adjusting the chute with the blister pocket, tablets should be freely loaded in to the pocket. | |
| 5.3.27 | Set the feeding, and then start the vibrator controller to flow the tablets from bowl dish to feeder roller. To increase the vibration, rotate the regulator to right hand side and to decrease vibration, rotate the regulator to left hand side. | |
| 5.3.28 | Switch “ON’ the toggle switch of the photo cell, switch “ON’ the in-feed motor toggle switch. | |
| 5.3.29 | Tablet should load in to the blister pocket freely then the web moving forward on the guide track, then passes in-between pressure sealing roller and counter sealing roller along with printed foil. | |
| 5.3.30 | Touch the scoring blade pointer to the blister web on the guide track to score the blisters (applicable to combi pack products only). | |
| 5.3.31 | Check the scoring by cutting the combi pack with hands. It should freely cut in the centre of the combi pack. | |
| 5.3.32 | After sealing the printed foil and PVC / PVDC film in between the sealing roller, the web passes through the pusher plate to punching tool, to cut the web in to the blister pack. | |
| 5.3.33 | Check the printing and quality of blisters for sealing visually. | |
| 5.3.34 | Check the leak test of the number Blister pack ,it should be one and half round of the circumference of the pressure sealing roller. | |
| 5.3.35 | Operate the Leak Test Apparatus as per operating SOP. The test passes when the water should not enter in to the blister pocket / none of the tablet should wet inside the pocket. | |
| 5.3.36 | If the leak test passes, start the machine for regular packing activity. | |
| 5.3.37 | Switch “ON” the packing hall conveyer belt with the help of starter provided inside the conveyor table. | |
| 5.3.38 | Adjust the speed of the machine by turning the switch clockwise / Anti clock wise on the scale provided. | |
| 5.3.39 | Continue the packing, check and record all the in-process tests parameters as mentioned in product BPR. | |
| 5.3.40 | Keep the rejection tablets / blisters separately duly labelled with details. The defoilled tablets /capsules should be packed at the end of the batch and to be mention in the product BPR. | |
| 5.3.41 | During packing tablet container should be kept in closed condition. | |
| 5.3.42 | After completion of batch, label the equipment as “To be Type A cleaned” or “To be Type B Cleaned”. | |
| 5.3.43 | Record the activity in “Equipment log book” | |
| 5.4 | Type A Cleaning | |
| 5.4.1 | Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process. | |
| 5.4.2 | Switch “OFF” the mains of the machine and remove all documents, labels, containers of previous batch. | |
| 5.4.3 | Remove all stereos from the stereo drum and hand over to QA. | |
| 5.4.4 | Remove the scrap of foil and foil pieces in between the punching tool. | |
| 5.4.5 | De-dust all the parts except heating roller with nylon brush / vacuum cleaner / dry duster. | |
| 5.4.6 | Clean the pressure sealing roller with metallic brush to remove the adhered residue of PVC. | |
| 5.4.7 | Dry clean the outer surface, in between the parts of the machine with clean dry duster / nylon brush /vacuum cleaner. | |
| 5.4.8 | Ensure the cleanliness by checking visually for the presence of any tablets or particles in the blister pack machine, then affix “Type A Cleaned” label. | |
| 5.4.9 | Record the activity in Equipment Log Book. | |
| 5.5 | Type B Cleaning | |
| 5.5.1 | Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process. | |
| 5.5.2 | Switch “OFF” the main supply of the machine and remove all documents, labels, containers of previous products from machine as well as from the area. | |
| 5.5.3 | The extra Foil / PVC remained should be recorded in BPR and returned to the Warehouse Department after authorisation of the department head and QA. | |
| 5.5.4 | Dry clean the machine as well as the area with vacuum cleaner and dry duster. | |
| 5.5.5 | Collect the tablets / powder and label as ‘Rejects’ and record the weight on the BPR. | |
| 5.5.6 | Dismantle the feed hopper, chute, guide track, feeder roller and bowl dish by removing the relevant Ellen bolts. | |
| 5.5.7 | Dry clean the dismantled parts and cover with poly bag and transfer it to the wash area with “To be Type B cleaned” label. | |
| 5.5.8 | Clean the feeder roller with clean soft duster moistened with Iso Propyl Alcohol. | |
| 5.5.9 | Dismantle and clean the blister forming roller, counter sealing roller with potable water and drain the water from the blister forming roller then dry with compressed air. | |
| 5.5.10 | Dismantle and clean the punching tool with nylon brush and dry duster. | |
| 5.5.11 | Prepare an approx. 0.1% v/v cleaning solution (1 ml of Teepol in 1000 ml of potable water) | |
| 5.5.12 | Wash the guide track, chute with 10 litres of potable water then apply 1% soap solution (teepol). Again wash with 10 litres of potable water to remove the traces of soap solution. Finally rinse with purified water. | |
| 5.5.13 | Wash the feed hopper and bowl dish with approximately 10 Litre of running potable water. Then clean with nylon scrubber / dipped in soap (teepol) solution. | |
| 5.5.14 | Again wash with 10 Litre of potable water to remove the traces of cleaning agent solution. Finally rinse with 5 Litre of purified water. | |
| 5.5.15 | Fill the Swab / Rinse Sample Intimation Slip and submit to QA Department to collect the samples. | |
| 5.5.16 | Record the activity in Equipment Log Book. | |
| 5.5.17 | Collect the Swab/Rinse sample result from QA. If the result is complying, label the equipment as “Type B Cleaned”. If the result is not complying repeat the steps 5.4.11 to 5.4.15. | |
| 5.5.18 | After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”. | |
| 5.5.19 | Affix ‘cleaned’ label and cover with fresh poly bag. Keep the cleaned parts to the spare parts room. | |
| 5.5.20 | Clean the Sealing rollers with metal wire brush to remove any residue of any molten polythene, dirt and pieces of laminate. Carefully inspect the knurled surface of the roller the surface should not be damaged. | |
| 5.5.21 | Clean the outer surface, panel, plat form, inside the machine with dry duster then clean the outer surface of the machine with moist duster. | |
| 5.5.22 | Ensure the cleanliness by visually and affix “Cleaned” label to the machine. | |
| 5.6 | Breakdown | |
| 5.6.1 | If breakdown occurs during operation, hold the batch in closed condition. Inform to the Head Production. | |
| 5.6.2 | Fill the “Complaint Note” and submit to Engineering Department. | |
| 5.6.3 | Fill the “Incident Report” and submit to Quality Assurance Department. Refer Annexure. | |
| 5.6.4 | Unload the tablets only if required for breakdown rectification. | |
| 5.6.5 | Store the unloaded tablets separately in closed container with proper status label. | |
| 5.6.6 | If breakdown occurs prior to start of operation, follow step 5.5.2. | |
| 5.5.7 | Record the breakdown activity in Equipment Log Book. | |
| 5.6.8 | After completion of repairs, the operations can be resumed. Perform Type A or Type B cleaning if the tablets has been unloaded from the hopper. | |
| 5.6.9 | Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed. | |
| 5.6.10 | Record the repair completion activity in Equipment Log Book. | |
| 5.6.11 | Describe the breakdown activity in the respective product BPR. | |
| 5.7 | Preventive Maintenance | |
| 5.7.1 | Perform the preventive maintenance as per Annexure. | |
| 5.7.2 | If preventive maintenance activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached. | |
| 5.7.3 | Attach the preventive maintenance label on the equipment. | |
| 5.8 | Calibration | |
| 5.8.1 | Calibration: Calibrate the Pneumatic gauges and temperature controller from external party once in a year. | |
| 5.8.2 | If calibration activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached. | |
| 5.8.3 | Attach the calibration label on the equipment. | |
| 5.9 | Maintain the Issuance, Utilisation and Cleaning Record of Blister packing change parts per SOP. | |
- Abbreviation
| Abbreviation | Expansion |
| Temp. | Temperature |
| BPR | Batch Packing Record |
| QA | Quality Assurance |
| PVC | Polyvinyl Chloride |
| PVDC | Polyvinyl Di Chloride |
| QC | Quality Control |
| % | Percent |
| v/v | Volume by Volume |
CALIBRATION OF PNEUMATIC PRESSURE GAUGE
OBSERVATIONS
| Sr. No | Reading on UUC
(Kg/Cm2) |
Reading on Standard Instruments
(Kg/Cm2) |
Deviation
(Kg/Cm2) |
Remarks |
| 1 | ||||
| 2 | ||||
| 3 | ||||
| 4 | ||||
| 5 | ||||
| 6 | ||||
| 7 | ||||
| UUC : Unit under calibration | ||||
CALIBRATION OF FORMING TEMPERATURE INDICATOR CONTROLLER
OBSERVATIONS
| Sr. No. | Reading on UUC
(°C) |
Reading on Standard instruments
(°C) |
Deviation
± 3°C |
Remarks |
| 1 | ||||
| 2 | ||||
| 3 | ||||
| 4 | ||||
| 5 | ||||
| 6 | ||||
| UUC : Unit Under Calibration | ||||
CALIBRATION OF SEALING TEMPERATURE INDICATOR CONTROLLER
OBSERVATIONS
| Sr. No. | Reading on UUC
(°C) |
Reading on Standard instruments
(°C) |
Deviation
± 3°C |
Remarks |
| 1 | ||||
| 2 | ||||
| 3 | ||||
| 4 | ||||
| 5 | ||||
| 6 | ||||
| UUC : Unit Under Calibration | ||||
CALIBRATION OF VACUUM GAUGE
OBSERVATIONS
| Sr. No. | Reading on UUC
(mmHg) |
Reading on Standard Instruments
(mmHg) |
Deviation
(± mmHg) |
Remarks |
| 1 | ||||
| 2 | ||||
| 3 | ||||
| 4 | ||||
| 5 | ||||
| 6 | ||||
| 7 | ||||
| UUC : Unit Under Calibration | ||||
| Result: The results Complies / Not Complies with the acceptance criteria. | ||||
Checked By/Date:________ Verified By QA/Date:________
*Note – Ready to use SOP available in “DOWNLOAD” Section.