Integrity test/Inprocess test -Media fill

Quality Assurance
1

Dear All,

How you are performing integrity test for the following after filling/ sealing:

  1. Vial products
    2.Plastic LDPE white bottles-Eye drops
    3.Ampoule.
    4.injectable powder product
    5.freee dried product.
    6.Sterile ointment aluminium filled tubes.

What are the inprocess tests you are conducting while media fill run?

  1. Vial products
    2.Plastic LDPE white bottles-Eye drops
    3.Ampoule.
    4.injectable powder product
    5.freee dried product.
    6.Sterile ointment aluminium filled tubes.

Thanks

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2

To check the integrity of vials and ampoules ,leak test is performed.

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3

for checking integrity we can choose dyingress method, pressure decay method, voltage variance method by using different type od machines. If we looking for container closer integrity test then we need to challenge the filled container with positive and negative control units immersed in media and incubate for growth promotion.

inprocess checks should be no defect containers, proper sealing and visual fill volume verification

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