Dieter Bachmann, PhD

Johnson & Johnson
Director, Aseptic Processing
Dieter is Director Aseptic Processing at J&Js corporate Microbiological Quality & Sterility Assurance.He is a Pharmacist by training with 30+ years of experience and holds a PhD in Pharmaceutical Formulation Technologies. Since joining Johnson & Johnson in 1998 he held several positions in R&D, Operations and Quality of J&Js Pharma and Medical Device franchises. Alongside business Dieter always engaged in associations work. For 10 years Dieter used to work as a Swiss national delegate for the European Pharmacopeia (EP) at EDQM in Strassburg. He is a frequent presenter and active member of ISPE. Dieter engages at the German DIN/NA063 and ISO TC198 and ASTM, being Chair at E55-06. Since 2019 Dieter is the global convenor for ISO TC198/WG9 Aseptic Processing.

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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...