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BPSA Releases Additional FAQs on Single-Use Systems for Integrity Assurance

Arlington, VA – The Bio-Process Systems Alliance (BPSA) has released the next five Frequently Asked Questions (#6–10) on Single-Use Systems (SUS) for Integrity Assurance. Developed by BPSA’s Integrity Assurance Committee, these FAQs address key industry concerns related to the integrity and testing of single-use systems and components. They are designed to assist both manufacturers and end-users in maintaining the integrity of SUS throughout the bioprocessing lifecycle.

The newly released FAQs include:

  • Do I have to perform an integrity test at the point of use (POU)?
  • Is there a difference between testing at the end-user site and testing at the SUS supplier’s manufacturing site?
  • When is it appropriate to perform a POU leak test vs. a POU integrity test?
  • Should integrity testing be performed at every stage of biologics manufacturing?
  • What information should suppliers provide to support the use of assemblies in sterile product manufacturing?

BPSA published the Design, Control, and Monitoring of Single-Use Systems for Integrity Assurance in 2017, that offered recommendations for both suppliers and end-users on strategies, tools, and procedures to enhance integrity assurance. In 2023, BPSA released Design, Control & Monitoring of SUS for Integrity Assurance: Volume 2 as a follow-up to the 2017 guide. View BPSA’s library of technical industry resources here.

“We would like to express our appreciation to the BPSA Integrity Assurance Committee and its Chair, Patrick Evrard of Cytiva, for their guidance and insight in preparing these FAQs,” said BPSA Executive Director Chris Clark. “These resources play an important role in helping companies strengthen the reliability of their single-use systems.”

Submit Your Questions:

If you have additional questions about SUS integrity assurance, you can submit them to bpsa@socma.org. All inquiries will be reviewed by BPSA’s Integrity Assurance Committee, and the most relevant questions will be added to the list of FAQs as the resource is updated.

For more information about BPSA industry resources or joining the BPSA member network and technical committees, visit the BPSA website or contact us at bpsa@socma.org.

About BPSA 

The Bio-Process Systems Alliance (BPSA), an affiliate of SOCMA, was formed in 2005 as an industry-led international industry association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines. www.bpsalliance.org. 

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BPSA Releases New One-Pager on the Sustainability of Single-Use Technologies

The Bio-Process Systems Alliance (BPSA) is pleased to announce the release of a new one-pager that highlights the critical role of Single-Use Technologies (SUTs) in advancing sustainability and innovation in bioprocessing.  

BPSA’s one-pager outlines the numerous benefits of SUTs:

Reducing resource consumption – lowering water, chemical, and energy usage
Minimizing environmental impact – generating low levels of plastic waste
Accelerating healthcare advancements – enabling faster vaccine and drug production
Driving continuous innovation – enhancing efficiency, recycling, and eco-design  

Access the full resource and references by scanning the QR code on the document.  

Download the new one-pager today and share it with your colleagues, customers, and networks. Learn more and join us in driving sustainable solutions in single-use bioprocessing!    

This resource was developed by BPSA’s Sustainability Committee. Learn more about BPSA’s committees and technical resources.  

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Bio-Process Systems Alliance Announces 2025/2026 Board Slate

Arlington, VA– The Bio-Process Systems Alliance (BPSA), the international association for the single-use bioprocessing industry, has announced its newly elected Board members for 2025–2026, following the December 5th Board meeting.

Mark Petrich, PhD, Vice President, Process Development & Validation, Krystal Biotech, Inc., was re-elected as Chair for a second two-year term, and Todd Kapp, CEO of Business Development at Wautoma Biotech LLC, was re-elected as First Vice Chair.

Brendan Lucey, Cross Business Unit Director of Marketing Strategy-Life Sciences, Entegris, Inc., and Ping Wang, PhD, Director, Material Sciences, Therapeutics Development & Supply (TDS), Discovery, Product Development & Supply, Johnson & Johnson Innovative Medicine, were elected to two-year terms as Directors at-large.

Lucey oversees the go-to-market strategy for Life Sciences at Entegris. He has previously served on the BPSA Board and currently chairs the BPSA Cell and Gene Therapy Committee. A biologist by training, he previously held positions at CDMOd, Lonza, Sartorius, ILC Dover and Gemini Bio.

Wang serves as a Scientific Director at Johnson & Johnson Innovative Medicine, responsible for the selection, qualification and investigation of single-use materials used for the J&J large molecules R&D and manufacturing network. Within BPSA, Ping is actively engaged in the BPSA Cell & Gene Therapy, End-user Committee and X-ray Sterilization Committees. Ping earned a PhD from the College of Pharmacy at University of Georgia, an MBA from Drexel University, and MS and BS degrees from Peking University.

Patrick Evrard, Quality Assurance/Regulatory Affairs, Cytiva; Charlott Masy, PhD, Senior Manager, GSK; Ralph Daumke, Market Manager EMEA, PendoTECH; Hernán Parma, Head of Sales-America, RENOLIT Healthcare and Stuart Tindal, EngD., PhD, Product Manager, Sartorius, were also re-elected as Directors-at-Large for two-year (2025-2026) terms.

“I extend my congratulations to Mark and Todd on their re-election as Chair and First Vice Chair,” said BPSA Executive Director Chris Clark. “As BPSA enters its 20th year, their extensive experience and leadership will be critical in guiding the Alliance as we move forward. I also congratulate our new and returning Board members and thank all our dedicated volunteer leaders for their time, expertise, and commitment to advancing BPSA’s mission.” Clark added, “A special thanks to Matt Sitcoske of High Purity New England and Danielle Arcuri of Qosina Corporation for their invaluable contributions as Directors-at-Large as their terms conclude this year.”

BPSA Executive Board Officers:

  • Chair: Mark Petrich, PhD, Krystal Biotech
  • 1st Vice Chair: Todd Kapp, Wautoma Biotech, LLC
  • 2nd Vice Chair: Kirsten Strahlendorf, Sanofi
  • Secretary: Todd Andrews, CPC
  • Treasurer: Ravi Narayanan, Dupont

At-Large Directors (newly elected) through 2026:

  • Brendan Lucey, Entegris
  • Ping Wang, PhD, Johnson & Johnson

At-Large Directors continuing through 2025 and/or 2026: 

  • Monica Cardona, Millipore Sigma
  • Brian Chung, Syensqo
  • Ralph Daumke, PendoTECH
  • Patrick Evrard, Cytiva
  • Jayanthi Grebin, Freudenberg Medical
  • Dianne Heiler, Repligen Corporation
  • Charlotte Masy, PhD, GSK
  • Hernán Parma, RENOLIT Healthcare
  • John Puglia, PhD, Thermo Fisher Scientific
  • Stuart Tindal, EngD, PhD, Sartorius
  • Thomas Vandromme, Meissner
  • Chris Wilkins, PhD, Filtration Group

Board members are elected by BPSA’s general membership to serve staggered two-year terms. They establish governing policies, determine budget priorities, and set strategic goals to advance the organization and its mission of supporting the single-use bioprocessing industry globally.

Please visit https://bpsalliance.org/about/board-of-directors/ for a complete list of BPSA Board of Directors.

About BPSA

An affiliate of SOCMA, the Bio-Process Systems Alliance, is an industry-led association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines. BPSA facilitates education, best practice sharing, development of consensus guides and networking opportunities among its member companies. For more information, visit www.bpsalliance.org.

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BPSA Releases Frequently Asked Questions about Single-Use Systems (SUS) for Integrity Assurance

Arlington, VA – The Bio-Process Systems Alliance (BPSA) is pleased to announce the release of a new FAQ resource on the integrity assurance of single-use systems (SUS). These FAQs, developed by BPSA’s Integrity Assurance Committee, address common industry questions about the integrity and testing of single-use systems and components. They are designed to assist both manufacturers and end-users in ensuring the integrity of their single-use systems throughout the bioprocessing lifecycle.

Key FAQs Include:

  • Is it possible to perform a leak/integrity test on SUS post-use?
  • Why is it often recommended to use a porous spacer when testing SUS in its container?
  • Does the compressed air used to perform a leak/integrity test at the supplier(s)’ site need to be filtered?
  • Will the leak/integrity test damage my SUS product?
  • What is the difference between a leak test and an integrity test?

These integrity assurance FAQs are the first in a series of FAQs and will be updated as needed by BPSA. In addition to these FAQs, BPSA offers comprehensive technical guides on SUS integrity assurance in its industry resources library. In 2017, BPSA published the Design, Control, and Monitoring of Single-Use Systems for Integrity Assurance, which provided recommendations for both suppliers and end-users regarding strategies, tools, and procedures to enhance the integrity assurance of single-use systems. In 2023, BPSA published Design, Control & Monitoring of SUS for Integrity Assurance: Volume 2, as a follow-up to the 2017 guide.

These resources are essential tools for companies looking to enhance the reliability and safety of their single-use technologies. “I want to thank the BPSA Integrity Assurance Committee, and its Chair, Patrick Evrard of Cytiva, for their leadership and hard work in developing these FAQs,” said BPSA Executive Director, Chris Clark. “SUS Integrity has always been a crucial quality attribute for suppliers, end-users, and regulatory authorities, and the new Annex 1 makes it even more critical.  These FAQs will play a key role in advancing both the use and integrity of single-use systems.”

Submit Your Questions:

If you have additional questions about SUS integrity assurance, you can submit them to bpsa@socma.org. All inquiries will be reviewed by BPSA’s Integrity Assurance Committee, and the most relevant questions will be added to the list of FAQs as the resource is updated.

For more information about BPSA industry resources or joining the BPSA member network and technical committees, visit the BPSA website or contact us at bpsa@socma.org.

About BPSA

The Bio-Process Systems Alliance (BPSA), an affiliate of SOCMA, was formed in 2005 as an industry-led international industry association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines. www.bpsalliance.org.

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BPSA 2024 International Single-Use Summit to be Held on July 22-24 in Washington, DC

Join BPSA for its 2024 International Single-Use Summit on July 22-24, at the Four Seasons Hotel in Washington, DC! BPSA’s annual Summit is the premier business and networking conference for users and suppliers in the single-use technology industry.

3 Reasons to Attend the BPSA Summit

1.Latest Industry Insights

The comprehensive two-and-a-half-day program will feature presentations from thought leaders and global industry experts on key issues and trends impacting the single-use eco-system.

Session topics include:
Economic Outlook for the Single-Use Industry
Advancing Sustainability in Single-Use
Manufacturing Capacity and Supply Chain Continuity
Navigating Key Global Regulatory Developments
Digitalization and the Role of AI in BioprocessingAnd More!

Check out the agenda at a glance for more details.

2.Industry Collaboration

Engage in dialogue and collaboration with industry experts. In addition to our program of education sessions and discussion panels, BPSA members are encouraged to attend and participate in BPSA’s technical committee meetings.

BPSA Committees include:
Automation Committee
Cell and Gene Therapy Committee
Continuous Bioprocessing Committee
Integrity Assurance Committee
Sustainability Committee
X-Ray Committee

Learn more about BPSA’s technical committees here.

3.Networking Opportunities

The BPSA Summit brings together over a hundred attendees, including suppliers, end-users, educators, regulators and industry partners! Learn more about BPSA members here and our network of 70+ companies worldwide.

Join us for the BPSA Summit Welcome Reception on Monday, July 22, at the Four Seasons Hotel, sponsored by Burkert, and kick-off your networking with additional networking opportunities throughout the event!

A special thanks to our Summit reception sponsor:
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Webinar Features BPSA Chair Mark Petrich and BPSA SAC Member Paul Priebe

Source: Bioprocess Online

Single-Use Technologies For Bioprocessing: An Essential Update

Mark Petrich, VP of Technical Operations, Krystal Biotech and Chairman, BioProcess Systems Alliance (BPSA) and Single-Use Expert Consultant, Scientific Advisory Council Member at Bio-Process Systems Alliance (BPSA), and ASME (The American Society of Mechanical Engineers) BPE Single-Use Subcommittee member Paul Priebe joined Bioprocess Online Live host, Matt Pillar, for Single-Use Technologies for Bioprocessing: An Essential Update. During this digital event, they covered the latest in standardization efforts around single-use in biopharma, regulatory considerations, single-use applications, supply security strategies, single-use economics, and more.

Click here to learn more and to access recording.

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Bio-Process Systems Alliance Announces the Election of Board Members (2024/2025)

ARLINGTON, VA – The Bio-Process Systems Alliance (BPSA), the international association of the single-use bio-processing industry, announced it expanded its Board of Directors to 19 members to lead the organization in 2024/2025 during its recent election.

Kirsten Strahlendorf, M.Eng., P.Eng., PMP, Senior Unit Head, BioProcess Engineering Unit, Sanofi, has been elected Second Vice Chair; Todd Andrews, Director Application and Business Development, Biopharma, CPC, has been re-elected Secretary, and Ravi Narayanan, Global Product Management Leadership-Biopharma & Medical Device, Nordson Medical has been re-elected Treasurer. Also, Chris Wilkins, PhD, Vice President, Strategic Marketing, Filtration Group; Jayanthi Grebin, Business Development Manager Pharmaceuticals NA, Freudenberg Medical; Thomas Vandromme, Business Development Director, Meissner; Monica Cardona, Global Senior Marketing Manager Single Use Systems, Millipore Sigma; Dianne Heiler, Global Head of Packaging Engineering and Sustainability, Repligen Corporation; Brian Chung, Senior Key Account Manager, Specialty Polymers, Solvay and John Puglia, PhD, Senior Director, Global R&D, Thermo Fisher Scientific were elected as Directors-at-Large.

“Congratulations to Kirsten, Todd and Ravi on being elected to the BPSA Executive Board and congratulations to our new and returning BPSA Board members,” said Mark Petrich of Krystal Biotech, BPSA Chair. “I want to thank each of our dedicated volunteer leaders who have chosen to contribute their time and expertise to the BPSA Board. I look forward to working together to advance the mission of BPSA. I would like to express my appreciation to Dan Rosen, Vice President & General Manager, Thermo Fisher Scientific and Scott Patterson, Vice President Pharma & Biotech Technical Support, ILC Dover, whose terms as Directors-at-Large are ending this year.”

BPSA Executive Board Officers:

  • Chair: Mark Petrich, PhD, Krystal Biotech
  • 1st Vice Chair: Todd Kapp, Entegris, Inc.
  • 2nd Vice Chair: Kirsten Strahlendorf, Sanofi
  • Secretary: Todd Andrews, CPC
  • Treasurer: Ravi Narayanan, Nordson Medical

At-Large Directors (newly elected) through 2025:

  • Chris Wilkins, PhD, Filtration Group
  • Jayanthi Grebin, Freudenberg Medical
  • Thomas Vandromme, Meissner
  • Dianne Heiler, Repligen Corporation
  • John Puglia, PhD, Thermo Fisher Scientific  

At-Large Directors continuing through 2024/2025:

  • Patrick Evrard, Cytiva
  • Charlotte Masy, GSK
  • Mark Sitcoske, High Purity New England
  • Monica Cardona, Millipore Sigma
  • Ralph Daumke, PendoTECH
  • Danielle Arcuri, Qosina Corporation
  • Hernán Parma, RENOLIT Healthcare
  • Elisabeth Vachette, Sartorius
  • Brian Chung, Solvay

Board members are elected by the general membership and serve staggered two-year terms. The Board determines the governing policies of BPSA, establishes the budget and priorities, and directs the organization’s goals and priority areas of focus.

Please visit https://bpsalliance.org/about/board-of-directors/ for a complete list of BPSA Board of Directors.

The Bio-Process Systems Alliance (BPSA), is an industry-led association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines. BPSA facilitates education, best practice sharing, development of consensus guides and networking opportunities among its member companies. For more information, visit www.bpsalliance.org, or contact Executive Director Chris Clark at cclark@socma.org.

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Bio-Process Systems Alliance Releases the 2023 Single-Use Manufacturing Component Quality Test Matrices

Arlington, VA – The Bio-Process Systems Alliance (BPSA), the international trade association of the single-use bio-processing industry, announced the release of the 2023 Single-Use Manufacturing Component Quality Test Matrices (QTM).

Originally developed in 2007, the BPSA QTM is designed as a technical guide to help facilitate the validation and qualification of single-use products. The latest third edition was necessitated by the rise in the number of components, the expansion of test practices, and the introduction of new standards.

The guide includes six comprehensive test categories—physical, functional, biological, chemical, regulatory, and sterilization/sanitization—commonly associated with single-use components. Additionally, it covers seven individual single-use component categories, including chromatography, connectors, valves and retainers, containers and film, sensors, tubing, filters, and single-use assemblies. The guide provides links to public domain test methods or source locations, detailed descriptions of how each test is applied (e.g., in material qualification, product qualification, and lot release), and a comprehensive list of terms and definitions in a dedicated reference section.

The 2023 QTM technical guide was developed by a volunteer committee of BPSA members, with leadership from the BioProcess Institute (North Kingstown, RI). “The BPSA QTM is a very important tool for single-use suppliers and end-users alike, and this update will help advance the single-use bioprocessing industry,” said Kirsten Strahlendorf of Sanofi, and Chair of the BPSA Scientific Advisory Board.

The updated QTM technical guide also accounts for changes to common practices by single-use component and assembly providers as well as sterilization process compatibility, pre-use treatment, as well as sterilization (irradiation and thermal) exposure to test samples.

The 2023 BPSA QTM technical guide is now available for download at https://bpsalliance.org/resources/technical-guides/ . For additional information, please contact BPSA Executive Director Chris Clark at cclarck@socma.org.

The Bio-Process Systems Alliance (BPSA), was formed in 2005 as an industry-led international industry association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines. BPSA facilitates education, sharing of best practices, development of consensus guides and business-to-business networking opportunities among its member company employees.  www.bpsalliance.org.

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Bio-Process Systems Alliance Responds to European Chemicals Agency’s Proposed Universal Ban on PFAS

Arlington, VA – The Bio-Process Systems Alliance (BPSA) has submitted comments in response to the European Chemical Agency’s (ECHA) proposed ban on per- and poly-fluoroalkyl substances (PFAS).

In February, ECHA announced its proposed restriction on PFASs, a unique family of nearly 10,000 substances, including fluoropolymers, under the European Union’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation which addresses the production and use of certain chemical substances, and their potential impacts on human health and the environment. PFAS are used extensively across multiple industries, including bioprocessing, due to their unique functional properties and low reactivity.

This restriction proposes a universal ban over time on the use of all fluoropolymers in all applications, without distinguishing between fluoropolymers and other PFAS substances. Fluoropolymers, including PTFE and PVDF, are some of the most common PFAS types understood to be used in the bioprocess industry, considered as polymers of low concern by the Organisation for Economic Co-operation and Development, and deemed to have insignificant environmental and human health impacts. In its response to ECHA, BPSA requested that pharmaceutical and biopharmaceutical processing, including its supporting supply chain, be regarded as a sector, and permitted the same exemption, or unlimited derogation, as medicinal products.

“BPSA maintains a commitment to sustainability and fully supports efforts to minimize and mitigate the presence of substances which pose a threat to human health and the environment. However, the proposed broad restriction of PFAS covering fluoropolymers would have unintended consequences on the global manufacturing of biopharmaceutical products ultimately impacting availability of existing medicinal therapies, including vaccines, as well as the development of new therapies,” said BPSA Executive Director, Chris Clark. “Let’s find solutions that better balance the environmental and health concerns with the needs of patients, consumers and the bioprocessing industry.”

BPSA is committed to working collaboratively to ensure any proposed restrictions consider the unique challenges of the bioprocessing industry and the needs of patients and consumers. We urge ECHA to reconsider its proposed restriction based on the available scientific data and risk assessments regarding PFAS substances, including fluoropolymers, used in bioprocessing.

BPSA also supports the positions of the European Federation of Pharmaceutical Industries and Associations, BioPhorum, the European Sealing Association, the American Chemistry Council, and the American Society of Mechanical Engineers – Biopharmaceutical Process Equipment sector.

The Bio-Process Systems Alliance (BPSA) was formed in 2005 as an industry-led international industry association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines. www.bpsalliance.org.

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BPSA Releases Volume 2 of Its Technical Guide for the Design, Control, and Monitoring of Single-Use Systems (SUS) for Integrity Assurance

ARLINGTON, VA – The Bio-Process Systems Alliance (BPSA) announced the release of its latest guide, Design, Control & Monitoring of SUS for Integrity Assurance: Volume 2, which serves to follow up to BPSA’s 2017 guide, Design, Control & Monitoring of SUS for Integrity Assurance.

The increasing use of single-use technologies (SUTs) in bioprocessing has made integrity assurance a critical quality attribute for both suppliers and end-users of SUTs. In 2017, the BPSA published the Design, Control, and Monitoring of Single-Use Systems for Integrity Assurance that provided recommendations to both suppliers and end-users in the single-use technology industry regarding strategies, tools and procedures that can assist in providing enhanced assurance of integrity of single-use systems.

This 49-page guide (Volume 2) provides case studies illustrating the principles developed in Volume 1; updates to key technologies used by the industry; updates to the regulatory landscape and industry guidance, and case studies covering specific applications such as elevated pressure situations and containment of powders. The guide also addresses essential concepts such as Quality by Design (QbD) and fostering collaboration between suppliers and end-users.

“The bioprocessing industry has made tremendous progress on leak and integrity testing of SUS over the past few years, and the examples and case studies included in this guide illustrate the progress the single-use industry has made,” said Patrick Evrard of Cytiva, and Chair of the BPSA Integrity Assurance Committee.

“I want to thank the BPSA Integrity Assurance Committee, and its Chair, Patrick Evrard of Cytiva, for their leadership and hard work on this guide,” said BPSA Executive Director, Chris Clark. “This guide is an important tool for suppliers and end-users alike and supports our mission of driving the adoption of SUS worldwide.”

Please visit  https://bpsalliance.org/technical-guides to download the guide.

About BPSA The Bio-Process Systems Alliance (BPSA), an affiliate of SOCMA, was formed in 2005 as an industry-led international industry association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines. www.bpsalliance.org.