To lay down the procedure for the Blister Pack Machine.
This SOP shall be applicable for operation of Blister Pack Machine in Packing area at production department.
3.1 Execution : Operator
3.2 Checking : Production Pharmacist & Above
HOD-Production / Assigned Designee
5.1 MACHINE STARTING
5.1.1 Production person shall ensure the cleanliness of the Blister Pack Machine, its part & area and ‘CLEANED’ label on it.
5.1.2 Before starting the operation production person get the line clearance from Q.A person by writing the status label with Product Name, Batch Details to equipment & area as per BMR.
5.1.3 Compressed air supply – “ON”.
5.1.4 Cooling unit – “ON”.
5.1.5 Mains – “ON” then control unit “ON”,
PLC screen show. Press the
main (F4), then select Manual / Auto mode.
5.1.6 Vacuum “ON”, then Contact Heaters “ON” and Set temperature.
5.1.7 Sealing Heaters – “ON”.
5.1.8 Set knob to starting speed.
5.1.9 Lubricates Punch unit and web transport plate.
5.1.10 On attaining operating temperature.
18.104.22.168 Engage Blister Sealing Roller.
22.214.171.124 Start Machine for fresh blister web.
126.96.36.199 Stop machine and insert Al Foil for sealing.
188.8.131.52 Insert sealed web in punching unit (Open position) and check web tension behind ratchet.
184.108.40.206 Start machine and adjust Idler roller of Batch code printing unit to get even over-printing.
220.127.116.11 After satisfactory batch printing, engage tablet feeding unit and open gate for filling tablets after 2 revolutions (approx.) of blister forming roller & record it in format.
5.2.1 Stop tablet feeding just before roll ending.
5.2.2 Stop machine.
5.2.3 Disengage Idler Roller to stop printing.
5.2.4 Change PVC roll by lap joining.
5.2.5 Loosen pressure plate on guide track.
5.2.6 Switch on PRC start button.
5.2.7 Start machine till joint reaches transport ratchet.
5.2.8 Lift Ratchet.
5.2.9 Stop machine only after required length of web is accumulated behind rachete.
5.2.10 Insert web into punch and ensure that joint is outside the punch.
5.2.11 Start the machine with PRC.
5.2.12 Start tablet feeding. Increase speed after smooth running only.
5.3.1 Stop tablet feeding.
5.3.2 Stop machine.
5.3.3 Switch PRC “OFF”.
BCP pressure roller.
5.3.5 Change rolls (measure previous roll position).
5.3.6 Load foil through
BCP unit and sealing roller.
5.3.7 Set for PRC operation.
5.3.8 Ensure foil path is even and straight.
5.3.9 Start machine and switch PRC ‘ON’.
5.3.10 Remove unsealed Aluminium Foil.
5.3.11 Observe printing operating and foil path between guide covers.
5.3.12 Adjust the
BCP pressure roller for
5.3.13 Start tablet feeding and then increase speed after smooth running.
5.4 MACHINE STOPPING
5.4.1 Stop tablet feeding. (Ensure no loose tablets in hopper & feeder).
5.4.2 Stop machine and shut “off” printing only after packed tablets are out of the machine.
5.5 MACHINE SHUT DOWN PROCEDURE
5.5.1 Switch ‘OFF’ electronic units.
5.5.2 Switch ‘OFF’ contact heater.
5.5.3 Switch ‘OFF’ sealing heaters.
5.5.4 Clean tablet feeding channels from dust.
BCP printing drum and
rollers.(Do not disengage the drive gear).
5.5.6 Clean sealing roller thoroughly, by using brass brush.
5.5.7 Switch ‘OFF’ compressed air supply.
5.5.8 Turn ‘OFF’ compressed air supply.
5.5.9 Switch ‘OFF’ Isolator and switch ‘OFF’ mains.
5.5.10 Record the starting & ending time of machine & Affix “To be Cleaned" label and fill the “Equipment Log Book”.
• Do not start the machine without water circulation.
• Always check the cooling of blister forming roller.
• Never engage sealing roller without Aluminium foil.
• Remove water collected in moisture entrapper frequently.
• Sufficient trial run should be taken to ensure satisfactory blistering before starting actual blister packing operation.
• Written line clearance should be obtained from Q.A personnel before commencing blister packing and also prior to change over to another Batch of same product or to a new product.
• When blister packing is stopped during Tea/Lunch breaks, ensure that no tablets are left in the feed channel as otherwise tablets coming in contact with hot rollers may melt/get spoiled. When the machine is re-started, initially run some blank blister & ensure that proper overprinting of batch details from Idler reel on plain foil is obtained, there after commence regular blistering of tablets. During trial, blisters should be collected from the machine. It should not allow going out to packing hall and de-foiled immediately.
6.1 SOP: Standard Operating Procedure
6.2 BMR: Batch Manufacturing Record
6.3 Q.A.: Quality Assurance
6.4 HOD: Head of The Department
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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