How to learn about PUPSIT in terminal sterilizing filtration – the science, implications and implementation

newsJul 1, 2020 | Phorum : Cell & Gene Therapy | Phorum : Fill Finish | News | Sterile Filtration QRM & PUPSIT | Phorum : Technology Strategy

How to learn about PUPSIT in terminal sterilizing filtration – the science, implications and implementation

Pre-use post-sterilization integrity testing (PUPSIT) continues to generate considerable debate in the industry. Committing to a PUPSIT strategy is no mean feat because, while some regulatory bodies are asserting its need, it may compromise downstream sterility and it is expensive to mitigate these risks.

To help clarify industry thinking, the Sterile Filtration Quality Risk Management (SFQRM) Consortium is sharing its knowledge and expertise on PUPSIT through a series of online webinars, a session at a major European conference and a host of articles and best practice papers.

Would you like to know more about how to use PUPSIT? Understand its use and implications? See expert speakers share their knowledge and read about PUPSIT best practice?

Read on to find out more about SFQRM activities and how you can learn about the latest thinking on PUPSIT.

The SFQRM Consortium at the BPI Europe Conference

On 13-17 July 2020, Europe’s leading experts on biologics, mAbs, vaccines and novel products will gather for the BioProcess International Europe virtual conference.

On 14 July, Marjo Peters, Director Drug Product Technical Steward Europe at AstraZeneca, will present a session on The Use of Scientific Data to Assess and Control Risks Associated with Sterilizing Filtration – a PDA and BioPhorum collaboration.

The session will be an essential introduction to PUPSIT and sterilizing filtration and will help you learn more about the SFQRM Consortium recent PUPSIT studies and publications.

To book your place and learn more, visit here.

SFQRM webinar series on the use and implications of PUPSIT in terminal sterilizing filtration

If you are in any of these pharmaceutical manufacturing functional roles:

  • Global corporate quality group
  • Local quality overseeing validation
  • Local quality overseeing operations
  • Process owner’s production area
  • Technical support groups in manufacturing, science and technology
  • Process development…

…you would want to get into the detail of PUPSIT, sterilizing filtration, the risks of filter masking and the practical consequences of using this integrity testing and attend the new webinar series on The Science, Implementation, and Implications of PUPSIT in Terminal Sterilizing Filtration on 1, 8 and 21 September.

Each 90-minute webinar includes expert presentations and panel discussions to provide the latest information on PUPSIT and will allow plenty of time for questions from attendees.

“The efforts of these working groups are designed to provide the scientific evidence needed to make informed decisions about the risk and control of filtration, as a means to sterilize biopharmaceutical products,” said Hal Baseman, Principal at ValSource, Inc. “The workstream outcomes successfully provide a roadmap to improved process understanding, better risk-based decisions, and achieving the objectives of improved product quality, patient safety and public health.”

Webinar 1: The role of PUPSIT within assurance in sterilizing filtration

Date: 1 September 2020

Time: 10:00–11:30am EDT

Speaker: Will Peterson, Associate Director – Sterile & Validation COE, Merck MSD

The first webinar in this series will help you understand the background, reasons, challenges and approach for mitigating the risk of sterilizing filtration that has prompted the use of PUPSIT. Attendees will gain an overview of the fundamentals of PUPSIT and:

  • The regulatory history and context
  • The role of PUPSIT in the assurance of sterilizing filtration
  • The fear of masking – is PUPSIT justified?
  • The business case for a risk-based approach
  • The Annex 1 revision – feedback based on the comments submitted by the SFQRM) Consortium.

For more information and to register for this webinar, visit here.

Webinar 2: Assessing the risk of filter masking – test description and results

Date: 8 September 2020

Time: 10:00–11:30am EDT

Speaker:Maik Jornitz, CEO, G-CON Manufacturing Inc.

Delve into the science behind PUPSIT with this webinar on the test protocol and the results of the SFQRM Consortium masking trials and bacterial challenge test data-mining exercise. It will help you understand whether pre-use integrity tested flawed filters could be masked and pass the post-use integrity test. The session will explain the background to PUPSIT and Annex 1 and:

  • How the sporadic enforcement of PUPSIT started to happen
  • The impact of the EMA’s 2007 Good Manufacturing Practice Q&A document on post-use integrity tests
  • Why the SFQRM Consortium decided to perform masking trials
  • See the masking studies test protocol and results of the trials.

For more information and to register for this webinar, visit here.

Webinar 3: The practical implications and decision-making of PUPSIT

Date: 21 September 2020

Time: 10:00–11:30am EDT

Speaker:Steve Ensign, Senior Consultant Engineer Aseptic Fill Finish Indianapolis, Eli Lilly

The final webinar in the series will build on the information presented in the first two sessions. The SFQRM Consortium will present and moderate a discussion on how to make informed decisions on how best to control and present sterilizing-grade filter failures or improve the detection of failures.

This webinar will help you develop a strategy for using scientific data and use quality risk management principles to answer these questions:

  • What are the risks associated with sterile filtration of your products?
  • What controls are needed to mitigate those risks?
  • Is a pre-use post-sterilization integrity test an effective strategy to control the process and mitigate those risks?
  • If so, what is the best way to implement it?
  • If not, then what is a sound justification for that decision?

For more information and to register for this webinar, visit here.

Don’t miss your chance to hear directly from the experts on what PUPSIT means for your sterilization filtration operations and how you can make it work for you. You can register for individual webinars or take advantage of a package discount when you register for all three by visiting here.

PUPSIT publications

BioPhorum, the Parenteral Drug Association (PDA) and the SFQRM Consortium has been busy sharing its expertise on all things PUPSIT – here are just a few of the articles and papers where you can download expert analysis, best practice and commentary:

The SFQRM Consortium was formed by BioPhorum and the Parenteral Drug Association to provide objective, unbiased, scientific data to help guide informed decisions about sterile filtration control measures. It consists of more than 50 subject matter experts from 25 biopharmaceutical manufacturing companies and filter suppliers.

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Related tags

Annex 1 | Post sterilization pre integrity testing | PUPSIT | QRM | Sterile filtration

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