1.0 OBJECTIVE
To lay down the procedure for Operation of Alu Alu blister pack machine.2.0 SCOPE
This SOP shall be applicable for Alu-Alu blister packing machine in packing area at Production department.3.0 RESPONSIBILITY
3.1 Execution: Operator3.2 Checking: Production Pharmacist & Above
4.0 ACCOUNTABILITY
HOD-Production / Assigned Designee5.0 PROCEDURE
5.1 Check for the cleanliness of the machine and Put ‘ON’ the compressed air supply.5.2 Put ‘ON’ Main electrical supply.
5.3 Put ‘ON’ Cooling unit.
5.4 Turn ‘ON’ Sealing Heaters & set the temperature between 180 to 200°C.
5.5 Set knob to starting speed.
5.6 Electronic supply – ‘ON’, Press both clear buttons – ‘ON’.
5.7 Ensure the punching unit is cleaned and lubricated.
5.8 On attaining operating temperature,
5.8.1 Start machine for fresh blister web.
5.8.2 Stop machine & insert aluminium foil for sealing.
5.8.3 Insert sealed web in punching unit (open position) & check web tension behind indexing roller.
5.8.4 Start the machine & adjust idler roller of BCP unit to get uniform over-printing. After satisfactory batch printing, engage tablet feeding unit & open gate for filling tablets after 2 revolutions (approx.) of blister forming roller.
5.9 BASE LAMINATED FOIL CHANGE
5.9.1 Stop tablet feeding just before roll ending.5.9.2 Stop machine and reduce speed setting.
5.9.3 Disengage Idler Roller to stop printing.
5.9.4 Change Base Laminated Foil by lap joining.
5.9.5 Start the machine with PRC.
5.9.6 Start machine till joint reaches indexing roller.
5.9.7 Insert web into the punch and ensure that joint is outside the punch.
5.9.8 Start tablet feeding. Increase speed after smooth running only.
5.10 ALUMINIUM FOIL ROLL CHANGE
5.10.1 Stop tablet feeding.5.10.2 Stop machine and reduce speed setting.
5.10.3 Switch PRC “off”.
5.10.4 Switch off printing unit.
5.10.5 Change rolls (measure previous roll position).
5.10.6 Load foil through BCP unit and sealing roller.
5.10.7 Set for PRC operation.
5.10.8 Ensure foil path is even and straight.
5.10.9 Start machine and switch PRC ON.
5.10.10 Remove unsealed aluminum Foil.
5.10.11 Observe printing operating and foil path between guide covers.
5.10.12 Adjust the BCP pressure roller for printing.
5.10.13 Start tablet feeding and then increase speed after smooth running.
5.11 MACHINE STOPPING PROCEDURE
5.11.1 Stop tablet feeding. (Ensure no loose tablets in the hopper).5.11.2 Stop machine and shut off printing only after packed tablets are out of the machine.
5.12 MACHINE SHUT DOWN PROCEDURE
Follow the procedure as per point 5.115.12.1 Switch ‘OFF’ electronic units.
5.12.2 Switch ‘OFF’ sealing heaters.
5.12.3 Clean tablet feeding channels from dust.
5.12.4 Clean BCP printing drum and rollers. (Do not disengage the drive gears).
5.12.5 Clean sealing roller thoroughly, by using a brass brush.
5.12.6 Switch ‘OFF’ compressed air supply.
5.12.7 Turn ‘OFF’ compressed air supply.
5.12.8 Switch ‘OFF’ Isolator.
5.12.9 Switch ‘OFF’ mains.
5.13 NOTE:
• Do not start the machine without water circulation.
• Always check the cooling of the blister forming roller.
• Never engage sealing roller without aluminum foil.
• Remove water collected in moisture entrapper frequently.
• Sufficient trial run should be taken to ensure satisfactory stripping 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 Coda reel on the plain foil is obtained. There after commence regular blistering of tablets.
• During the trial, the blister should be collected from the machine. It should not send out to packing hall and de-foiled immediately.
5.15 After completion of the operation, fill “Equipment Log Book”.
6.0 ABBREVIATIONS
6.1 SOP: Standard Operating Procedure6.2 IPA: Isopropyl Alcohol
6.3 BPR: Batch Packing Record
6.4 QA: Quality Assurance
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