Integrity Assurance for Single-Use Systems: End-User Perspective

Single-use technologies are more and more used in critical sterile applications, for example, close to the final drug product manufacturing steps, leading to increasing concern related to integrity. In this presentation, we make a review of the regulatory environment and present key elements to consider when defining and applying a sound integrity control strategy.
The regulatory environment has significantly evolved in the last few years, with the publication of new guidance and standards and additional ones in preparation.  The current draft of EU GMP Annex 1 illustrates the increased scrutiny of regulatory authorities on this topic.
We will position integrity tests in the global picture around integrity strategy. Concepts such as Quality by Design (QbD) and Quality Risk Management (QRM), as well as close collaboration between supplier and end-user, are required to build a good strategy and enhance the integrity assurance for processes using single-use systems. A defined integrity control strategy is very important for critical applications where single-use systems are used after the last sterile filtration step or in a process where no sterile filtration is possible.
We will discuss the different technologies available on the market to control integrity of single-use systems and key parameters that are affecting integrity measurements, on the supplier’s and end-user’s side.
Several case studies will be shared, illustrating how integrity concerns can be practically addressed for cGMP manufacturing applications, and what are the results observed after a few years of use.
Presented by Charlotte Masy, Senior Manager in Manufacturing Science and Technology GSK Vaccines

Charlotte Masy is a BioEngineer with a Ph.D. in material science on surface chemistry. She has spent her career in material science with over 20 years working on the investigation, research and services for all sectors but mainly for pharmaceutical products at Solvay, Ajinomoto, Pall and GSK Vaccines. She has 15 years of experience in cGMP in various positions including QC, QA and Engineering. She is an expert on single-use at GSK Vaccines since 2010 and has been working on integrity testing for 7 years.
She is a member of the Board of the Bio-Process Systems Alliance (BPSA), and of several working groups in the BioPhorum (previously BPOG). Charlotte is contributing to articles, white papers and ASTM Standard associated with single-use technologies.
Followed by Patrick Evrard, Senior Principal Engineer, Single-Use Technologies in Technical Communication and Regulatory Strategy, Pall Corporation

Patrick Evrard joined Pall Corporation in 2017, to provide expert technical support to Pall’s biotech customers on single-use systems. At the end of 2018 he joined the newly formed Technical Communication and Regulatory Strategy team, combining technical content with validation and regulatory perspectives.
Before joining Pall, he led a technical team in charge of developing and implementing at global level single-use technologies in GSK Vaccines’ commercial manufacturing operations, including critical sterile applications, for more than 10 years.
Patrick is author or co-author of several articles, white papers, ASTM Standard and PDA Technical Reports associated with single-use technologies.  He is member of the Board of Directors of the Bio-Process Systems Alliance (BPSA). He has been participating since 2012 in several single-use technology industry work groups from BPSA, BioPhorum (previously BPOG), American Society of Mechanical Engineers (ASME BPE), ASTM International and PDA.
Sponsored by Pall Corporation

Pall Corporation provides critical filtration, separation, and purification solutions to meet the demanding needs of a broad spectrum of life sciences and industrial customers around the globe.
Across 80 locations and 10,000 people worldwide, we are unified by a singular drive: to solve our customers’ biggest fluid management challenges. And in doing so advance health, safety, and environmentally responsible technologies.
Together, our Life Sciences and Industrial teams serve a diverse range of customers including biotechnology, pharmaceutical, medical, food and beverage, laboratory, microelectronics, aerospace, fuels, petrochemical, chemical, automotive, and power generation industries.
Our industry-leading technologies and solutions are at work in countless applications, protecting critical operating assets, improving product quality, safeguarding the health, and minimizing emissions and waste.