1. Objective: To describe the procedure for strip packing of Tablets/Capsules.
2. Scope: The procedure is applicable to strip packing machine.
Operator: To follow as per the written down procedure
Packing Supervisor: To monitor and execute the written down procedure.
Head of the Department: Implementation of procedure.
6.1 Clean the hopper and chute with nylon brush or scrubber using 0.5% Sodium Lauryl Sulphate (SLS) solution. Clean with portable water and Rinse with purified water and wipe it using a clean dry lint free cloth. Clean the vibrator with clean damp cloth and then with clean dry cloth.
6.2 Maintain the temperature and humidity if necessary as specified in Batch Manufacturing Record.
6.3 Set the rollers, chute, back gear, cutting gear suitable for the product to get desired Pack size. Check the release status of Bulk tablets/filled capsules from QC.
6.4 Get line clearances from QA regarding cleanliness of area & machine.
6.5 Start the mains of the machine and set the temperature of the roller by adjusting thermostat as follows:
a) For Glassine poly foil : 1350C to 1450C
b) For Aluminium foil : 1450C to 1550C
6.6 Load the Aluminium/Glassine Poly foil and corresponding plain/printed foil rolls depending upon the product specification.
6.7 Obtain corresponding rubber stereos from Department, and set the printing unit. Mix ink and thinner in right proportion so as to give sharp printing on the foil. Get some printed foil (representing not less than one complete rotation of the printing cylinder ), check it for overprinted batch details like B.No., Mfg. Dt., Mfg. Lic. No. , Code No., Expiry date, price, Physician Sample (PS) (if required) etc. and sign. Get it counter checked and signed by QC chemist. Attach the approved specimen to batch manufacturing record.
6.8 Load the hopper with tablets/capsules and label the hopper, with product name, Batch No., B.Size, and date.
6.9 Adjust the vibrator so that the tablets/capsules shall pass through chute and get trapped in the cavity between the foils.
6.10 Carry out the leak test on the initial strips as per the standard operating procedure for Leak testing of strips whenever applicable (PDN/069/R1). Number of strips taken should cover the total cavities on the roller. In case of failure in leak test, reset the machine and repeat the leak test.
6.11 Once the machine gets set, perform leak test every two hours and keep a record of the same in Packing record.
6.12 Collect the stripped tablets/capsules into the drum duly labeled with all relevant details.
6.13 Check the strips intermittently for correctness of overprinted details tablet/capsules fall, cut pockets, printed details etc.
Batch Manufacturing Record:
8. Revision History