SOP for Strip Packing Machine : Pharmaguideline -->

Editable Pharmaceutical Documents in MS-Word Format


SOP for Strip Packing Machine

Standard operating procedure of Strip Packing Machine used for packing of tablets in blisters.


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



5.1.1 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 the product.
5.1.4 Adjust the issued stereos on the roller by double-sided adhesive tape.
5.1.5 Set the roller and back gear then set printed and plain ALU-ALU foil on the 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 the 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 the 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 the 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 the plain foil is obtained, thereafter commencing regular stripping of tablets.
During the trial, the 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
Get ready to use editable documents in MS-Word FormatView List

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question

No comments: Read Comment Policy ▼

Post a Comment

Please don't spam. Comments having links would not be published.

Popular Categories

QA SOPs QC SOPs Micro SOPs HVAC Production SOPs Stores SOPs Checklists Maintenance SOPs HPLC Sterile GLP Validation Protocols Water System GDP Regulatory Maintenance Calibration Warning Letters Education B.Pharmacy
Video Tutorials
Subscribe on Youtube

Submit Guest Posts

Follow Pharmaguideline



Editable Pharmaceutical Documents in MS-Word Format. Ready to use SOPs, Protocols, Master Plans, Manuals and more...




Pharmaceutical Updates

✔ Worldwide Regulatory Updates
✔ Pharmaceutical News Updates
✔ Interview Questions and Answers
✔ All Guidelines in One Place


Recent Posts