Skip to main content

Main menu

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore

User menu

  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart

Search

  • Advanced search
PDA Journal of Pharmaceutical Science and Technology
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore
  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart
PDA Journal of Pharmaceutical Science and Technology

Advanced Search

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • Follow pda on Twitter
  • Visit PDA on LinkedIn
  • Visit pda on Facebook
Research ArticleResearch

Continuous Microbiological Environmental Monitoring for Process Understanding and Reduced Interventions in Aseptic Manufacturing

Jeffrey Weber, James Hauschild, Pieta Ijzerman-Boon, Ren-Yo Forng, Jeff Horsch, Lisa Yan, Aditya Prasad, Robert “Bo” Henry, Marja Claassen, Philip Villari, Shebeer Shereefa, Jane Wyatt, Jay S. Bolden, Jean-Thierry Pycke and Dawood Dassu
PDA Journal of Pharmaceutical Science and Technology March 2019, 73 (2) 121-134; DOI: https://doi.org/10.5731/pdajpst.2018.008722
Jeffrey Weber
1Pfizer, Kalamazoo, MI, USA;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
James Hauschild
2Johnson & Johnson, East Raritan, NJ, USA;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Pieta Ijzerman-Boon
3Merck, Sharp & Dohme, The Netherlands;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Ren-Yo Forng
4Amgen, Thousand Oaks, CA, USA;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Jeff Horsch
5Bristol-Myers Squibb, New Brunswick, NJ, USA;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Lisa Yan
6Takeda Pharmaceutical Company limited, Los Angeles, CA, USA;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Aditya Prasad
7AstraZeneca, Philadelphia, PA, USA;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Robert “Bo” Henry
8Catalent Biologics, Bloomington, IN, USA;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Marja Claassen
3Merck, Sharp & Dohme, The Netherlands;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Philip Villari
9Merck Inc., West Point, PA, USA;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Shebeer Shereefa
10Abbvie, North Chicago, IL, USA;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Jane Wyatt
11Alexion, Blanchardstown, Dublin, Ireland;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Jay S. Bolden
12Eli Lilly, Indianapolis, IN, USA;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Jean-Thierry Pycke
13GSK Vaccines, Belgium; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Dawood Dassu
14BioPhorum, The Gridiron Building, One Pancras Square, London N1C 4AG
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: dawood@biophorum.com
  • Article
  • Figures & Data
  • References
  • Info & Metrics
  • PDF
Loading

Article Information

vol. 73 no. 2 121-134
DOI 
https://doi.org/10.5731/pdajpst.2018.008722
PubMed 
30361285

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online April 8, 2019.

Article Versions

  • previous version (October 25, 2018 - 06:38).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2019

Author Information

  1. Jeffrey Weber1,
  2. James Hauschild2,
  3. Pieta Ijzerman-Boon3,
  4. Ren-Yo Forng4,
  5. Jeff Horsch5,
  6. Lisa Yan6,
  7. Aditya Prasad7,
  8. Robert “Bo” Henry8,
  9. Marja Claassen3,
  10. Philip Villari9,
  11. Shebeer Shereefa10,
  12. Jane Wyatt11,
  13. Jay S. Bolden12,
  14. Jean-Thierry Pycke13 and
  15. Dawood Dassu14,*
  1. 1Pfizer, Kalamazoo, MI, USA;
  2. 2Johnson & Johnson, East Raritan, NJ, USA;
  3. 3Merck, Sharp & Dohme, The Netherlands;
  4. 4Amgen, Thousand Oaks, CA, USA;
  5. 5Bristol-Myers Squibb, New Brunswick, NJ, USA;
  6. 6Takeda Pharmaceutical Company limited, Los Angeles, CA, USA;
  7. 7AstraZeneca, Philadelphia, PA, USA;
  8. 8Catalent Biologics, Bloomington, IN, USA;
  9. 9Merck Inc., West Point, PA, USA;
  10. 10Abbvie, North Chicago, IL, USA;
  11. 11Alexion, Blanchardstown, Dublin, Ireland;
  12. 12Eli Lilly, Indianapolis, IN, USA;
  13. 13GSK Vaccines, Belgium; and
  14. 14BioPhorum, The Gridiron Building, One Pancras Square, London N1C 4AG
  1. ↵* Corresponding Author: BioPhorum Operations Group, 5 Westbrook Court, Sharrow Vale Road, Sheffield S11 8YZ, UK; e-mail: dawood{at}biophorum.com
View Full Text

Cited By...

  • Citations
  • Google Scholar

This article has not yet been cited by articles in journals that are participating in Crossref Cited-by Linking.

PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 73 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 2
March/April 2019
  • Table of Contents
  • Index by Author
Print
Download PDF
Article Alerts
Sign In to Email Alerts with your Email Address
Email Article

Thank you for your interest in spreading the word on PDA Journal of Pharmaceutical Science and Technology.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
Continuous Microbiological Environmental Monitoring for Process Understanding and Reduced Interventions in Aseptic Manufacturing
(Your Name) has sent you a message from PDA Journal of Pharmaceutical Science and Technology
(Your Name) thought you would like to see the PDA Journal of Pharmaceutical Science and Technology web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
1 + 10 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Continuous Microbiological Environmental Monitoring for Process Understanding and Reduced Interventions in Aseptic Manufacturing
Jeffrey Weber, James Hauschild, Pieta Ijzerman-Boon, Ren-Yo Forng, Jeff Horsch, Lisa Yan, Aditya Prasad, Robert “Bo” Henry, Marja Claassen, Philip Villari, Shebeer Shereefa, Jane Wyatt, Jay S. Bolden, Jean-Thierry Pycke, Dawood Dassu
PDA Journal of Pharmaceutical Science and Technology Mar 2019, 73 (2) 121-134; DOI: 10.5731/pdajpst.2018.008722

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
Continuous Microbiological Environmental Monitoring for Process Understanding and Reduced Interventions in Aseptic Manufacturing
Jeffrey Weber, James Hauschild, Pieta Ijzerman-Boon, Ren-Yo Forng, Jeff Horsch, Lisa Yan, Aditya Prasad, Robert “Bo” Henry, Marja Claassen, Philip Villari, Shebeer Shereefa, Jane Wyatt, Jay S. Bolden, Jean-Thierry Pycke, Dawood Dassu
PDA Journal of Pharmaceutical Science and Technology Mar 2019, 73 (2) 121-134; DOI: 10.5731/pdajpst.2018.008722
Reddit logo Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • Introduction to Biofluorescent Particle Counting
    • Opportunities and Challenges of Settle Plates and Active Air Sampling
    • Role of the Bfpc In Manufacturing
    • Potential Implementation Strategy
    • Data Collection and Presentation
    • Grade A Manufacturing Areas, Restricted Access Barrier System, and Isolators
    • Data Sets
    • Grade B/C/D Areas
    • Regulatory Perception
    • Business Benefits
    • Conclusions
    • Conflicts of Interest Declaration
    • Acknowledgements
    • References
  • Figures & Data
  • Info & Metrics
  • References
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • A Discussion on Bio-Fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team
  • Environmental and Personnel Monitoring Programs--A Risk-Based Case Study of Cutibacterium acnes
  • Practical Applications of Biofluorescent Particle Counting in Environmental Monitoring Investigations
  • Google Scholar

More in this TOC Section

  • Container Closure Integrity of Vial Primary Packaging Systems under Frozen Storage Conditions: A Case Study
  • Advances in Large Volume Subcutaneous Injections: A Pilot Tolerability Study of an Innovative Needle-Free Injection Platform
  • Quantification and Stability Impact Assessment of Drop Stresses in Biologic Drug Products
Show more Research

Similar Articles

Keywords

  • Rapid microbiology
  • Environmental Monitoring
  • Biofluorescent particle counters

Readers

  • About
  • Table of Content Alerts/Other Alerts
  • Subscriptions
  • Terms of Use
  • Contact Editors

Author/Reviewer Information

  • Author Resources
  • Submit Manuscript
  • Reviewers
  • Contact Editors

Parenteral Drug Association, Inc.

  • About
  • Advertising/Sponsorships
  • Events
  • PDA Bookstore
  • Press Releases

© 2023 PDA Journal of Pharmaceutical Science and Technology ISSN: 1079-7440

Powered by HighWire