Knap Test for Vial Visual Inspection

GOOD MANUFACTURING PRACTICE (cGMP)
1

The Knapp-Test is performed using a test set with 80 injection vials containing particles and 170 non inspected vials of the same product. The statistical rejection probability of each vial is determined first by the manual inspection (4x magnifying lens), whereas 5 inspectors have to inspect each test vial 10 times, and then by the new automatic inspection machine, whereas the machine has to inspect each vial 10 times. The efficiency is calculated with defined formulas.
I saw there was a discussion about Knap Test few months ago and as I serached I could not figure that out. Its a follow-up of same discussion.

Regards

2

Dear Sir,
May I get some information about these vials? I want to purchase test kit, plz suggest me vender name.

3

If you are looking for Type-1 Tubular from Overseas Vendors :

SCHOTT
CORNING
Pacific Vial
Gerresheimer Glas AG
PPI Pharma Packaging GmbH
Phoenix Glass

If you look in India its

[COLOR=“darkred”]Kapoor Glass
SK Glass International.
Kishore Group[/color]

There are many moulded glass vial manufacturers in India.
You need to know the non-corfirmities in Vials for that you need to look PDA technical report. This helps you in validation of your Glass vial supplier.