To lay down the procedure for Operation of Strip Packing Machine.
This SOP shall be applicable for the operation of Strip Packing Machine in Packing Area in Production department.
3.1 Execution : Operator
3.2 Checking : Production Pharmacist & Above
HOD-Production / Assigned Designee
5.1 STRIP PACKING MACHINE OPERATION
5.1.1 Production person shall ensure the cleanliness of the Strip 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.
5.1.3 Set up the strip-packing machine using appropriate change parts according to product.
5.1.4 Adjust the issued stereos on roller by double side adhesive tape.
5.1.5 Set the roller and back gear then set printed and plain
ALU- ALU foil on roller.
5.1.6 Set the cutting gear, pinion gear and set vertical cutting manually or by adjusting the cutting gear.
5.1.7 Put “ON” the main switch, push button glowing in green color.
5.1.8 Put “ON” the heater & adjusts the temperature as per batch packing record.
5.1.9 Apply ink & thinner on the felt roller as and when required to get proper letter overprinting quality.
5.1.10 Start strip packing and collect specimen sample for checking of overprinting batch detail by operator / two production persons and Q.A person.
5.1.11 Attached the signed specimen to the BPR (batch packing record).
5.1.12 While the strip-pack machine is running, monitor on the indicator lamps of heater to ensure that the heaters are working satisfactorily as otherwise cooled down heater may result in bad sealing of strips. Record the actual temperature of sealing rollers in BPR. Record at specified intervals.
5.1.13 During the course of strip-packing at every half an hour to one hour interval pharmacist should conduct random checks of the strips and counter check for:
• Overprinted batch details on strips.
• Sealing Quality.
• Presence of any cut pockets/ Burst pocket.
• No. of cuts per minute.
• Result of leak test.
5.1.14 Perform leak test on strips at specified intervals with specified No. of strips in batch packing record or No. of strips in one sealing cycle. Record the results in batch record.
5.1.15 After completion of operation, Put “OFF” the main supply.
5.1.16 Affix “To be Cleaned” status label and fill the “Equipment Log Book”.
• Sufficient trial run should be taken to ensure satisfactory stripping before starting actual strip packing operation.
• Written line clearance should be obtained from Q.A personnel before commencing strip packing and also prior to change over to another batch of same product or to a new product.
• When strip 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 strips & ensure that proper overprinting of batch details from printing drum on plain foil is obtained, there after commence regular stripping of tablets.
During trial, strip should be collected from the machine. It should not send 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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