A VHP validation approach to a multi chamber and complex flexible filling line with Q&A

Isolator technology is now the expectation in fill finish. The sterility assurance this technology offers greatly reduces contamination risk and offers clients a much higher quality product.
But, how do you validate a multi-chamber filling line with multiple pieces of complex equipment? How do you ensure that a sufficient sanitization level is met?
In this one hour webinar, Berkshire Sterile Manufacturing and Steriline will discuss their validation approach for BSM's new filling line that will begin operations in 2022. This new line will be validated to a 6-log reduction in geobacillus spores, which is far greater than any SAL that could be reached with a closed RABs system.
Contents of this Video:
00:00 - Intro
01:29 - Why are we discussing VHP validation?
02:28 - What is VHP sanitization and how is it performed?
11:28 - How do you validate a VHP cycle for a new line?
21:11 - Closing Remarks
23:15 - Q&A

[@user-us7yy2lq8i]

Excellent subjective presentation.

[@benekcik]

Very useful information. Thank you...

[@Pharma_Education_by_Sameer]

Very valuable information

[@Victoriawakeup]

I've heard that geobacillus is now not acceptable and in turn bi's are not ideal indicators of activity - what the heck do regulators expect people to use!!??