SOP on Setting of Blister Packing Machine
1.0 Purpose: This SOP describes the procedure for setting of blister packing machine.
2.0 Scope: This SOP applies to operating staff of the production department.
3.0 Responsibility: It is the responsibility of the Production Supervisor to ensure that the procedure is followed.
4.0 Materials and Equipment: None
5.01 The machine should be set up in accordance with the manufacturing instructions and with the relevant packing material as detailed in pack specification.
5.02 The printed aluminum foil/PVC should be checked and stored on the foil stand.
5.03 The stereos on the over printing unit should be checked to ensure that the over printing details are correct and are in accordance with the batch packing orders for the product.
5.04 The machine log book should have the following details:
a. The name of the product being packed.
b. The strength and unit pack.
c. Batch details.
d. Date of manufacture & expiry.
e. The price details.
f. The quantity packed
5.05 While the rollers have attained the right temperature, the channel should be fitted on the machine.
5.06 The requisite number of operators and inspectors should be stationed on the line before packing commences.
5.07 The product to be packed should be transferred to the hopper of the machine. It must be ensured that the capsules/tablets flow smoothly from the hopper through the vibratory bowl into feed channel.
5.08 After machine starts, the first twenty strips should be collected and examined critically for all the overprinting and examined critical for all the overprinting and other details, for clarity of overprinting and for good sealing.
5.09 If these preliminary checks are satisfactory, the strip packing should be continued. At regular intervals of time, the leak test on strips should be carried out to ensure freedom from leaks.
5.10 If the strips pass the leak test, packing should continue. If the strips fail the test, the strips which have been packed between the test and the previous one should be isolated for recovery of the product and repacking. Corrective action particularly in relation to sealing conditions, should be taken and only then packing should continue.
5.11 The strips coming out of the machine should be inspected on belt for defects such as misprint, cuts on foil, missing product, improper seals and blister defect. The good strips should be collected, counted and packed in cartons.
5.12 At the end of working shift, the product left in the hopper and channel should be removed. Any strips lying on the packing line should also be removed.
5.13 The materials used for blister i.e. PVC and aluminum/paper foil should be reconciled at the end of each batch and discrepancy if any, investigated.