What are the check points for filling giving to line clearance for filling as side of IPQA??
Anybody tell the answer for me.
Please make clear your question. It is not clear to understand. I have some experience about injectable vial filling
How to give the line clearance for vial filling(injectables) and what are the check points?
Daily check point of vial filling room-
1.check the area cleaning, equipment cleaning.
2.check the log record and bmr it should be online.
3.check the differential pressure of room and LAF.
4. There should be no items of previous product.
5. check the temperature , RH , and particle count of room.
6. Inprocess check- fill weight of powder or fill volume of liquid, sealing quality, leak test of sealed vials, visual inspection of filled vials, reconstitution test for dry powder filled vials,
7. check proper gowning of person.
8. check the all sterilized items,garments are under validity period.
9.check the printout of integrity test of filter.
10 check the steam sterilizer printout of sterilized material.
11.check the size of vials, colour of seal as per batch filling record.
12.settle plate should be exposed before assembling and filling.
13.All sterilized material should be stored under LAF.
14.Only qualified person should enter in aseptic filling area.
15.There should be no maintenance activity during filling operation.
16.Garments should not be torned.
17.settle plate should not be exposed for more than 4 hours.
18.Ensure the fogging operation was done before start of filling.
19.All LAF should be start 30 minute before, starting any activity under it.
20.check rubber stoppers and seals are stored under LAF.
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