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 ArticleTechnology/Application

Evaluation of the Microbial Growth Potential of Pharmaceutical Drug Products and Quality by Design

Anastasia G. Lolas and John W. Metcalfe
PDA Journal of Pharmaceutical Science and Technology January 2011, 65 (1) 63-70;
Anastasia G. Lolas
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: anastasia.lolas@fda.hhs.gov
John W. Metcalfe
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • References
  • Info & Metrics
  • PDF
Loading

References

  1. 1.↵
    AAPS Workshop on Pharmaceutical Quality Assessment—A Science and Risk-Based CMC Approach in the 21st Century; North Bethesda, MD, October 5–7, 2005.
  2. 2.↵
    Federal Register, Vol. 70, No. 134; 2005. U.S. Department of Health and Human Services, Food and Drug Administration. Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Notice of Pilot Program.
  3. 3.↵
    Federal Register, Vol. 73, No. 128; 2008. U.S. Department of Health and Human Services, Food and Drug Administration. Submission of Quality Information for Biotechnology Products in the Office of Biotechnology Products; Notice of Pilot Program.
  4. 4.↵
    U.S. Department of Health and Human Services, Food and Drug Administration. International Conference on Harmonization, Guidance for Industry: Q8 Pharmaceutical Development (2006) and Q8(R1) Pharmaceutical Development Revision 1 (2007). Rockville, MD.
  5. 5.↵
    1. Metcalfe J. W.
    Microbiological quality of drug products after penetration of the container system for dose preparation prior to patient administration. American Pharmaceutical Review 2009, 12 (1), 84–89.
    OpenUrl
  6. 6.↵
    1. Friedel R. R.,
    2. Cundell A. M.
    The application of water activity measurement to the microbiological attributes testing of nonsterile over-the-counter drug products. Pharmacopeial Forum 1998, 24 (2), 6087–6090.
    OpenUrl
  7. 7.↵
    1. Fontana A. J.
    Understanding water activity for reduced microbial testing using USP Method 〈1112〉. Pharmaceutical Microbiology Forum Newsletter 2006, 12 (10), 2–5.
    OpenUrl
  8. 8.↵
    United States Pharmacopeia—National Formulary (USP 29-NF 24) 2006. 〈1112〉 Application of Water Activity Determination to Nonsterile Pharmaceutical Products. Washington, D.C., p. 3802–3803.
  9. 9.↵
    1. Snider B.,
    2. Liang P.,
    3. Pearson N.
    Implementation of water-activity testing to replace Karl Fischer water testing for solid oral-dosage forms. Pharmaceutical Technology 2007, 31 (2).
  10. 10.↵
    U.S. Department of Health and Human Services, Food and Drug Administration. International Conference on Harmonization, Guidance on Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances. Rockville, MD, 2000.
  11. 11.↵
    U.S. Department of Health and Human Services, Food and Drug Administration. Guidance for Industry: Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes. Rockville, MD, 2010.
  12. 12.↵
    1. Noecker R.
    Effects of common ophthalmic preservatives on ocular health. Adv. Ther. 2001, 18 (5), 205–215.
    OpenUrlPubMedWeb of Science
  13. 13.↵
    1. Graf P.,
    2. Hallen H.,
    3. Juto J.-E.
    Benzalkonium chloride in a decongestant nasal spray aggravates rhinitis medicamentosa in healthy volunteers. Clin. Exp. Allergy 1995, 25 (5), 395–400.
    OpenUrlCrossRefPubMedWeb of Science
  14. 14.↵
    1. Perrenoud D.,
    2. Bircher A.,
    3. Hunziker T.,
    4. Suter H.,
    5. Bruckner-Tuderman L.,
    6. Stäger J.,
    7. Thürlimann W.,
    8. Schmid P.,
    9. Suard A.,
    10. Hunziker N.
    Frequency of sensitization to 13 common preservatives in Switzerland. Contact Dermatitis 1994, 30 (5), 276–279.
    OpenUrlCrossRefPubMedWeb of Science
  15. 15.↵
    Anonymous. Infections linked to lax handling of propofol. Am. J. Health Syst. Pharm. 1995, 52 (19), 2061–2066.
    OpenUrlPubMed
  16. 16.↵
    1. McNeil M. M.,
    2. Lasker B. A.,
    3. Lott T. J.,
    4. Jarvis W. R.
    Postsurgical Candida albicans infections associated with an extrinsically contaminated intravenous anesthetic agent. J. Clin. Microbiol. 1999, 37 (5), 1398–1403.
    OpenUrlAbstract/FREE Full Text
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 65 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 65, Issue 1
January/February 2011
  • 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.
Evaluation of the Microbial Growth Potential of Pharmaceutical Drug Products and Quality by Design
(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.
5 + 4 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Evaluation of the Microbial Growth Potential of Pharmaceutical Drug Products and Quality by Design
Anastasia G. Lolas, John W. Metcalfe
PDA Journal of Pharmaceutical Science and Technology Jan 2011, 65 (1) 63-70;

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
Evaluation of the Microbial Growth Potential of Pharmaceutical Drug Products and Quality by Design
Anastasia G. Lolas, John W. Metcalfe
PDA Journal of Pharmaceutical Science and Technology Jan 2011, 65 (1) 63-70;
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • Introduction
    • Microbial Growth Studies
    • Water Activity as a Tool for Evaluating the Microbial Growth Potential of Nonsterile Pharmaceutical Dosage Forms
    • Sterile Pharmaceutical Dosage Forms
    • Microbial Growth Potential and QbD—Examples and Case Studies
    • Summary
    • Disclaimer
    • Conflict of Interest Declaration
    • References
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • Best Practices for Microbial Challenge In-Use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations
  • The Application of Noninvasive Headspace Analysis to Media Fill Inspection
  • In-use physicochemical and microbiological stability of biological parenteral products
  • Google Scholar

More in this TOC Section

  • Mechanical Container Closure Integrity Test: A Method for Cartridge Systems
  • A Container Closure Integrity Test Method for Vials Stored at Cryogenic Conditions Using Headspace Oxygen Analysis
  • Best Practices for Microbial Challenge In-Use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations
Show more Technology/Application

Similar Articles

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

© 2025 PDA Journal of Pharmaceutical Science and Technology Print ISSN: 1079-7440  Digital ISSN: 1948-2124

Powered by HighWire