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Multisite Qualification of an Automated Incubator and Colony Counter for Environmental and Bioburden Applications in Pharmaceutical Microbiology.

Autor: Anders HJ; Novartis Pharma Stein AG, Stein CH4332, Switzerland., Männle D; Novartis Pharma Stein AG, Stein CH4332, Switzerland., Carpenter W; Biogen, Durham, NC., Eder W; Roche Diagnostics GmbH, Nonnenwald 2, 82377 Penzberg, Germany., Heckel I; Lonza, Visp, Valais, Switzerland., Götzen T; Lonza, Visp, Valais, Switzerland., Oechslin C; Lonza, Visp, Valais, Switzerland., Joossen C; Janssen Pharmaceutica NV, Beerse, Belgium., Parra MEG; Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany., Rose J; GlaxoSmithKline, Upper Merion, PA., Shah V; Kite Pharma, Santa Monica, CA; and., Jones DL; Rapid Micro Biosystems, Lowell, MA, USA djones@rapidmicrobio.com.

Publikováno v: PDA journal of pharmaceutical science and technology [PDA J Pharm Sci Technol] 2023 May-Jun; Vol. 77 (3), pp. 236-247. Date of Electronic Publication: 2022 Nov 15.