Jun 10 2021 8 mins
In this episode, Adele Gisselmann (Global Product Manager with Merck KGaA Darmstadt, Germany) describes the challenges of performing environmental monitoring in isolators, like manipulation with thick gloves and the effect of VHP, and explains how smart product design overcomes these challenges.
Timestamps:
[0:40] - Differences between environmental monitoring (EM) in isolator and cleanroom
[2:05] - Performing EM with thick neoprene gloves
[2:53] - Handling air samplers
[3:38] - What impact does VHP have on EM?
[5:11] - Neutralization of VHP residues
[6:10] - Storing material for EM during the production run
[7:25] - Taking away swabs and plates safely after sampling
[8:05] - Guidance in Annex I?
Timestamps:
[0:40] - Differences between environmental monitoring (EM) in isolator and cleanroom
[2:05] - Performing EM with thick neoprene gloves
[2:53] - Handling air samplers
[3:38] - What impact does VHP have on EM?
[5:11] - Neutralization of VHP residues
[6:10] - Storing material for EM during the production run
[7:25] - Taking away swabs and plates safely after sampling
[8:05] - Guidance in Annex I?