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Research ArticleResearch

Preventing Cross-Contamination during Lyophilization: GMP and Occupational Cleaning Requirements for Nonproduct and Indirect Product-Contact Parts

Richard Denk, Andreas Flückiger, Hirokazu Kisaka, Stephan Krause, Reinhold Maeck, Lars Restetzki, Andreas Schreiner and Rico Schulze
PDA Journal of Pharmaceutical Science and Technology September 2019, 73 (5) 487-495; DOI: https://doi.org/10.5731/pdajpst.2018.009530
Richard Denk
1SKAN AG, Binningerstrasse 116, 4123 Allschwil, Switzerland;
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  • For correspondence: Richard.Denk@skan.ch
Andreas Flückiger
2F. Hoffmann-La Roche Ltd., Switzerland;
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Hirokazu Kisaka
3Takeda, Japan;
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Stephan Krause
4AstraZeneca;
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Reinhold Maeck
5Boehringer Ingelheim GmbH, Germany;
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Lars Restetzki
6F. Hoffmann-La Roche Ltd., Switzerland;
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Andreas Schreiner
7Novartis, Switzerland; and
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Rico Schulze
8GMP Inspectorate at Landesdirektion Sachsen, Germany
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References

  1. 1.↵
    1. Denk R.,
    2. Flueckinger A.,
    3. Kisaka H.,
    4. Maeck R.,
    5. Restetzki L.,
    6. Schreiner A.,
    7. Schulze R.
    Isolator Surfaces and Contamination Risk to Person-nel. PDA Letter [Online] 2017. https://www.pda.org/pda-letter-portal/archives/full-article/isolator-surfaces-and-contamination-risks-to-personnel (ac-cessed Nov 6, 2017).
  2. 2.
    1. Denk R.,
    2. Pernau M.,
    3. Maeck R.,
    4. Zimmermann H. F.,
    5. Schönberger G.,
    6. Flückiger A.,
    7. Rückert M.,
    8. Kovats D.,
    9. Redmer J.
    Joint Assessment of Occupational Safety and GMP Aspects. Pharm. Ind. (Engl. Transl.) 2017, 79 (4), 492–498.
  3. 3.↵
    European Medicines Agency. Guideline on Setting Health-Based Exposure Limits for Use in Risk Identification in the Manufacture of Different Medicinal Products in Shared Facilities: EMA/CHMP/CVMP/SWP/169430/2012 [Online]; EMA: London, 2012 (accessed Nov 20, 2014).
  4. 4.↵
    ISPE/D/A/CH Affiliate Containment Manual (Engl. Transl.) [Online]; ISPE/D/A/CH Working Group: Offenbach/Main, Germany, 2016; www.ispe.org (accessed March 31, 2017).
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PDA Journal of Pharmaceutical Science and Technology: 73 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 5
September/October 2019
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Preventing Cross-Contamination during Lyophilization: GMP and Occupational Cleaning Requirements for Nonproduct and Indirect Product-Contact Parts
Richard Denk, Andreas Flückiger, Hirokazu Kisaka, Stephan Krause, Reinhold Maeck, Lars Restetzki, Andreas Schreiner, Rico Schulze
PDA Journal of Pharmaceutical Science and Technology Sep 2019, 73 (5) 487-495; DOI: 10.5731/pdajpst.2018.009530

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Preventing Cross-Contamination during Lyophilization: GMP and Occupational Cleaning Requirements for Nonproduct and Indirect Product-Contact Parts
Richard Denk, Andreas Flückiger, Hirokazu Kisaka, Stephan Krause, Reinhold Maeck, Lars Restetzki, Andreas Schreiner, Rico Schulze
PDA Journal of Pharmaceutical Science and Technology Sep 2019, 73 (5) 487-495; DOI: 10.5731/pdajpst.2018.009530
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Jump to section

  • 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
  • PDF

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Keywords

  • Cleaning
  • Cross-contamination
  • Isolators
  • Lyophilization
  • Nonproduct-contact surfaces
  • Operator protection

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