In-Process Checks During Blister Packaging
During Blister packing of solid oral dosage followings are the In-process checkpoints:
- After running the machine in initial, a piece of blister foil to be collected for inspection, the piece of length should covering two impression of total number of mats mounted on the roller with overprinting instruction printed on it.
- Correct positioning of the overprinted matter and proper sealing of Aluminum foil with PVC shall check. The knurling impressions should specifically checked.
- overprinted matter with the over printing instructions should check as in-process check, as per quality system, collected and inspected piece of blister foil should signed by IPQA, counter sign by Packing section in-charge and finally this signed foil is a specimen and should affixed in BMR.
- When the specimen of foil checked, packing shall start and initially packed medicine shall be checked for leak test.
- Leak test shall be done to check integrity of sealing of Blister Pack, after checking it shall be recorded in BMR.
- Total no. of sample to be tested for leak test shall calculate as follows:
Total number of packs to be tested = Number of cavities per track on the roller (for pack with 2 rows)
(OR)
Number of packs from each side = Total number/2 single row)
Total number of packs to be tested = 2xNumber of cavities per track roller (for pack with 2 rows)
