Thomas Schreiner, PhD

Fresenius-Kabi
Executive Vice President, Head of Quality Management, Vigilance & EHS
Thomas Schreiner is a Pharmacist with 23 years experience in the Pharmaceutical Industry, focusing on sterile manufacturing. He is currently the Head of Quality Management Dvision Pharmaceutical with Fresenius Kabi. Mr. Schreiner holds a PhD in Pharmaceutical Technology from the University Saarbrücken Germany.

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Air Speed Qualification: At Working Position or Working Level?
Features
Air Speed Qualification: At Working Position or Working Level?

The new European Commission GMP Annex 1 “Manufacture of Sterile Medicinal Products” and the equivalent Annex 2 from the World Health Organization (WHO) triggered a discussion in ISPE’s Germany/Austria/Switzerland (D/A/CH) Aseptic Processing Community of Practice (CoP) Steering Committee about where to qualify air speed: “at working position” versus “at working level.” This article provides...