Skip to main content
  • Main menu
  • User menu
  • Search

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
Review ArticleReview

Increasing Patient Safety by Closing the Sterile Production Gap—Part 2. Implementation

James P. Agalloco
PDA Journal of Pharmaceutical Science and Technology July 2017, 71 (4) 269-273; DOI: https://doi.org/10.5731/pdajpst.2016.007112
James P. Agalloco
Agalloco & Associates Inc., 22 Carriage Trail, Belle Mead, NJ 08502
BE, MS, MBA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Figures & Data
  • References
  • Info & Metrics
  • PDF
Loading

Reference

  1. 1.↵
    <1229> Sterilization. United States Pharmacopeia, 36, 1st supplement, 2013.
    Google Scholar
  2. 2.↵
    1. Agalloco J.,
    2. Akers J.
    The Myth Called Sterility. Pharmaceutical Technology 2010, 34 (3), Suppl., S44–S45. Continued online at Pharmtech.com.
    OpenUrlGoogle Scholar
  3. 3.↵
    Parenteral Drug Association (PDA). Technical Report No. 36. Current Practices in the Validation of Aseptic Processing—2001. PDA J. Pharm. Sci. Technol. 2002, 56 (3).
    Google Scholar
  4. 4.↵
    1. Pflug I. J.
    Microbiology and Engineering of Sterilization Processes; Environmental Sterilization Laboratory: Minneapolis, MN, 1995.
    Google Scholar
  5. 5.↵
    1. Patashnik M.
    A Simplified Method for Thermal Process Evaluation. Food Technol. 1953, 7, 1–6.
    OpenUrlGoogle Scholar
  6. 6.↵
    ISO 15883-1:2006. Washer-disinfectors—Part 1: General requirements, terms and definitions and tests, 2006.
    Google Scholar
  7. 7.↵
    1. Agalloco J.
    Terminal Sterilization for 2008 and Beyond. PDA Conference on Sterilization, Milan, Italy, 2008.
    Google Scholar
  8. 8.↵
    <1229.2> Steam Sterilization of Aqueous Liquids. United States Pharmacopeia, 36, 1st supplement, 2013.
    Google Scholar
  9. 9.↵
    1. Pflug I.,
    2. Odlaug T.
    Biological Indicators in the Pharmaceutical Industry. J. Parenteral Sci. Technol. 1986, 40 (5), 242–248.
    OpenUrlGoogle Scholar
  10. 10.↵
    1. Agalloco J.
    Personal communications, 2009–2016.
    Google Scholar
  11. 11.↵
    1. Izumi M.,
    2. Fujifuru M.,
    3. Okada A.,
    4. Takai K.,
    5. Takahashi K.,
    6. Udagawa T.,
    7. Miyake M.,
    8. Naruyama S.,
    9. Tokuda H.,
    10. Nishioka G.,
    11. Yoden H.,
    12. Aoki M.
    Evaluation of Bacillus oleronius as a Biological Indicator for Terminal Sterilization of Large-Volume Parenterals. PDA J. Pharm. Sci. Technol. 2016, 70 (1), 30–38.
    OpenUrlAbstract/FREE Full TextGoogle Scholar
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 71 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 4
July/August 2017
  • Table of Contents
  • Index by Author
Print
Download PDF
Article Alerts
Email Article
Citation Tools
Share
Increasing Patient Safety by Closing the Sterile Production Gap—Part 2. Implementation
James P. Agalloco
PDA Journal of Pharmaceutical Science and Technology Jul 2017, 71 (4) 269-273; DOI: 10.5731/pdajpst.2016.007112
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget

Jump to section

  • Article
    • Abstract
    • Bioburden Population
    • Bioburden Resistance
    • Process Lethality Estimation
    • Biological Indicator (BI) Choices
    • Process Equipment
    • Conclusion
    • Conflict of Interest Declaration
    • Reference
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • Sterility Assurance--Current and Future State
  • Google Scholar

More in this TOC Section

  • The Role of Microbiologists in Drug Product Development
  • A Risk Assessment and Risk-Based Approach Review of Pre-Use/Post-Sterilization Integrity Testing (PUPSIT)
  • Recommendations for Artificial Intelligence Application in Continued Process Verification: A Journey Toward the Challenges and Benefits of AI in the Biopharmaceutical Industry
Show more Review

Similar Articles

Keywords

  • Terminal sterilization
  • Aseptic processing
  • Sterilization
  • Biological indicator
  • Bioburden
  • Probability of a non-sterile unit (PNSU)
  • Regulation
  • Sterility assurance

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
Alerts for this Article
Sign In to Email Alerts with your Email Address
Email this 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.
Increasing Patient Safety by Closing the Sterile Production Gap—Part 2. Implementation
(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 + 9 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Increasing Patient Safety by Closing the Sterile Production Gap—Part 2. Implementation
James P. Agalloco
PDA Journal of Pharmaceutical Science and Technology Jul 2017, 71 (4) 269-273; DOI: 10.5731/pdajpst.2016.007112

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero

We use cookies on this site to enhance your user experience

By clicking any link on this page you are giving your consent for us to set cookies.