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

Radiation Sterilization of Aseptically Manufactured Products

Barry P. Fairand and Niki Fidopiastis
PDA Journal of Pharmaceutical Science and Technology July 2010, 64 (4) 299-304;
Barry P. Fairand
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Niki Fidopiastis
  • 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

Abstract

This paper discusses an approach for establishing a sterilization dose for an aseptically processed product after the product is in its final packaged state, in other words, terminal sterilization. It applies to aseptic processes where the fill/finish operation is conducted in a closed system using isolator or restricted access barrier technology, that is, no human intervention. The example that is given in this paper uses gamma radiation as the sterilizing agent. Other forms of radiation such as high-energy electrons or X-rays also could serve as the sterilizing agent. The proposed approach involves irradiation of the aseptically processed product at very low doses of radiation, which is possible due to the extremely low levels of bioburden that may be present on the product following a fill/finish operation. Rather than sacrificing a large number of product units that may be required to obtain a statistically significant sampling of the product for bioburden analysis and other test purposes, the test unit is a surrogate consisting of actual pharmaceutical product that was inoculated with a highly radiation-resistant micro-organism. Selection of the microorganism was based on analysis of a library of environmental monitoring data taken from the aseptic area. Because of microbial diversity between different aseptic processing facilities, selection of the test microorganism would depend on the aseptic area under study. The approach that is discussed in this paper addresses selection and preparation of the surrogate, test of sterility of the surrogate following irradiation, determination of the radiation resistance of the test microorganism, and application of the approach to calculate a sterilization dose that is less than 10 kGy. At this low dose, it may be possible to terminally sterilize radiation-sensitive pharmaceutical products, for example, those in liquid form. Additional studies are warranted to determine the general applicability of the proposed approach.

  • Aseptic area
  • SAL
  • Radiation sterilization
  • Gamma irradiator
  • Surrogate
  • D10 value
  • © PDA, Inc. 2010
View Full Text

PDA members receive access to all articles published in the current year and previous volume year. Institutional subscribers received access to all content. Log in below to receive access to this article if you are either of these.  

If you are neither or you are a PDA member trying to access an article outside of your membership license, then you must purchase access to this article (below). If you do not have a username or password for JPST, you will be required to create an account prior to purchasing. 

Full issue PDFs are for PDA members only.

Note to pda.org users

The PDA and PDA bookstore websites (www.pda.org and www.pda.org/bookstore) are separate websites from the PDA JPST website. When you first join PDA, your initial UserID and Password are sent to HighWirePress to create your PDA JPST account. Subsequent UserrID and Password changes required at the PDA websites will not pass on to PDA JPST and vice versa. If you forget your PDA JPST UserID and/or Password, you can request help to retrieve UserID and reset Password below.

Log in using your username and password

Forgot your user name or password?

Log in through your institution

You may be able to gain access using your login credentials for your institution. Contact your library if you do not have a username and password.
If your organization uses OpenAthens, you can log in using your OpenAthens username and password. To check if your institution is supported, please see this list. Contact your library for more details.

Purchase access

You may purchase access to this article. This will require you to create an account if you don't already have one.

patientACCESS

patientACCESS - Patients desiring access to articles

Full issue PDFs are for PDA members only. You can join PDA at www.pda.org. 

PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 64 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 64, Issue 4
July/August 2010
  • 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.
Radiation Sterilization of Aseptically Manufactured Products
(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 + 0 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Radiation Sterilization of Aseptically Manufactured Products
Barry P. Fairand, Niki Fidopiastis
PDA Journal of Pharmaceutical Science and Technology Jul 2010, 64 (4) 299-304;

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
Radiation Sterilization of Aseptically Manufactured Products
Barry P. Fairand, Niki Fidopiastis
PDA Journal of Pharmaceutical Science and Technology Jul 2010, 64 (4) 299-304;
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • Introduction
    • Experimental Method
    • Results and Discussion
    • Conclusions
    • Acknowledgments
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • No citing articles found.
  • Google Scholar

More in this TOC Section

  • A Holistic Approach for Filling Volume Variability Evaluation and Control with Statistical Tool
  • A Proof-of-Concept Study on a Universal Standard Kit to Evaluate the Risks of Inspectors for Their Foundational Ability of Visual Inspection of Injectable Drug Products
  • Quantitative and Qualitative Evaluation of Microorganism Profile Identified in Bioburden Analysis in a Biopharmaceutical Facility in Brazil: Criteria for Classification and Management of Results
Show more Research

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