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- Published online October 9, 2019.
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- previous version (August 16, 2019 - 04:26).
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© PDA, Inc. 2019
Author Information
- Richard Denk1,*,
- Andreas Flückiger2,
- Hirokazu Kisaka3,
- Stephan Krause4,
- Reinhold Maeck5,
- Lars Restetzki6,
- Andreas Schreiner7 and
- Rico Schulze8
- 1SKAN AG, Binningerstrasse 116, 4123 Allschwil, Switzerland;
- 2F. Hoffmann-La Roche Ltd., Switzerland;
- 3Takeda, Japan;
- 4AstraZeneca;
- 5Boehringer Ingelheim GmbH, Germany;
- 6F. Hoffmann-La Roche Ltd., Switzerland;
- 7Novartis, Switzerland; and
- 8GMP Inspectorate at Landesdirektion Sachsen, Germany
- ↵* Corresponding Author: SKAN AG, Binningerstrasse 116, 4123 Allschwil, Switzerland. Telephone: +41 61 485 44 44 (main #); e-mail: Richard.Denk{at}skan.ch
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- Article
- Abstract
- Introduction
- Areas of Use of Lyophilization in Aseptic Manufacture and Lyophilizer Design
- Cleaning the Lyophilizers
- Unloading Lyophilizers
- Risk Assessment Requirements from a GMP Perspective
- Cleanliness of Nonproduct-Contact Surfaces after Cleaning: Bringing Worker Protection and GMP Together
- Requirements from GMP and Occupational Health Perspectives
- PDE/Acceptable Daily Exposure to Occupational Exposure Limit (OEL) in Simplified Form Assuming No Differences in Bioavailability between the Routes of Exposure
- Breaking Vials Artificially may Not Adequately Simulate Real-life Events
- Storybook and Results
- Summary
- Conflict of Interest Declaration
- Acknowledgements
- References
- Figures & Data
- References
- Info & Metrics
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