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

Alternate Approach for Defining Worst Case in Steam Sterilization Validation of Porous/Hard Goods Loads

Subrata Chakraborty, Vaidehi Soman and Vinayak Dhumal
PDA Journal of Pharmaceutical Science and Technology January 2021, 75 (1) 91-99; DOI: https://doi.org/10.5731/pdajpst.2019.011304
Subrata Chakraborty
1GxPFONT Consulting Group, Casa Lakeside, Lakeshore Greens, Palava Phase-II, Dombivali, Thane-421204, India;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: emailsubrato@gmail.com
Vaidehi Soman
2Cipla Ltd., Verna Industrial Area, Verna, GOA- 403722, India.
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Vinayak Dhumal
2Cipla Ltd., Verna Industrial Area, Verna, GOA- 403722, India.
  • 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

References

  1. 1.↵
    Parenteral Drug Association Inc. Technical Report No. 1: Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control; Bethesda, MD, 2007.
  2. 2.↵
    1. Agalloco J.
    Maximum and Minimum Loads in Steam Sterilization: Establishing a Cycle Development Strategy That Fulfills Regulatory Requirements. Pharmaceutical Manufacturing [Online] 2018, https://www.pharmamanufacturing.com/articles/2018/maximum-and-minimum-loads-in-steam-sterilization/ (accessed November 5, 2019).
  3. 3.↵
    BS EN 285:2015: Sterilization—Steam Sterilizers—Large Sterilizers. BSI Standards Limited, 2015. 
  4. 4.↵
    International Organization for Standardization, ISO 17665-1: Sterilization of Health Care Products—Moist Heat—Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices. ISO: Geneva, 2006.
  5. 5.↵
    International Organization for Standardization, ISO 17665-2. Sterilization of Health Care Products—Moist Heat—Part 2: Guidance on the Application of ISO 17665-1. ISO: Geneva, 2009.
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 75 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 1
January/February 2021
  • Table of Contents
  • Index by Author
  • Complete Issue (PDF)
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.
Alternate Approach for Defining Worst Case in Steam Sterilization Validation of Porous/Hard Goods Loads
(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.
2 + 1 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Alternate Approach for Defining Worst Case in Steam Sterilization Validation of Porous/Hard Goods Loads
Subrata Chakraborty, Vaidehi Soman, Vinayak Dhumal
PDA Journal of Pharmaceutical Science and Technology Jan 2021, 75 (1) 91-99; DOI: 10.5731/pdajpst.2019.011304

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
Alternate Approach for Defining Worst Case in Steam Sterilization Validation of Porous/Hard Goods Loads
Subrata Chakraborty, Vaidehi Soman, Vinayak Dhumal
PDA Journal of Pharmaceutical Science and Technology Jan 2021, 75 (1) 91-99; DOI: 10.5731/pdajpst.2019.011304
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • Introduction
    • Materials and Methods
    • Results and Observations
    • Conclusion
    • Recommendations
    • Conflict of Interest Declaration
    • Acknowledgements
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • A Method to Investigate Sterilization Processes and the Bacterial Inactivation Resolved in Time and Space
  • 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

Keywords

  • Autoclave
  • Steam sterilizer
  • Porous/hard goods loads
  • Minimum load
  • Maximum load

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