Ensure compliance with USP <665>, USP <1665>, and BPOG guidelines for single-use systems (SUS). Our testing services provide high-quality results, safeguarding patient safety, fulfilling your regulatory requirements, and expedited time to market. As your risk management partner, we provide expert support in navigating pharmaceutical regulation for global market access.
What are the USP 665 and BPOG Guidelines?
The USP <665> standard details the analytical testing requirements for the qualification of plastic components for use in the manufacturing of pharmaceutical and / or biopharmaceutical drug products.
This standard, along with USP <1665> and the Biophorum Operations Group (BPOG) extractable protocol, sets forth mandatory guidelines regarding the risk of extractables and leachables in plastic components and systems utilized in pharmaceutical manufacturing.
Key Benefits of USP 665, USP 1665 and BPOG Testing with Element
- Safeguarding Patient Safety: Using accurate test data to determine potential risk to patients and ensure end-user safety.
- High-Quality Results: Highly experienced laboratory team delivering industry-leading, accurate data every time.
- Meet Regulatory Requirements: Navigate the most efficient path to compliance with regulatory agencies.
- Expedited Time to Market: Facilitating the swift and efficient completion of testing programs to ensure timely regulatory approval and market entry.
- Complex Study Protocol Understanding: Providing in-depth understanding of acceptable protocols and reports, crucial to avoiding costly delays in regulatory submissions.
Are you ready for USP 665 and USP 1665?
USP <665> and USP <1665> standards were recently approved to address the risk of extractables and leachables in plastic components and systems used in the manufacture of pharmaceutical products. USP <665> is mandatory and will be official on May 1, 2026. Applicable products include tubing, filter & pump components, containers, etc.
Ensure safety while expediting time to market
Test protocols for USP <665>, USP <1665>, and BioPhorum (BPOG) studies require expert knowledge of extractables and leachables testing and pharmaceutical/biopharmaceutical manufacturing components. Our experienced subject matter experts provide the support you need to comply with industry requirements and achieve regulatory approval for your products.
Our USP 665, USP 1665 and BPOG services
- Extractables and Leachables Testing
- Analytical Method Development and Validation
- Characterization of Unknowns
- Risk Assessment
- Consultancy
Extraction studies for single use manufacturing systems
USP <665> testing addresses the evolving landscape of pharmaceutical production, which increasingly relies on polymeric single-use equipment. These standards aim to ensure the safety, efficacy, and quality of pharmaceutical and biopharmaceutical products by providing a framework for characterizing and qualifying plastic components in single-use bioprocessing systems.
The USP <665> standard details the approach needed for risk assessment and analytical testing of plastic SUS components including extraction procedures and testing methods.
Typical SUS components include;
- Tubing & connectors
- Tank liners & mixing bags
- Sensors & valves
- Elastomeric components e.g. O-rings, gaskets
- Process filters, filtration cassettes & chromatography columns
In 2014 BPOG, a collaboration between global biopharmaceutical and medical device industries , published a proposal outlining standardized methods for extractables testing of SUS components (not including container closure systems) that come into contact with either product or process related fluids during the production of biopharmaceutical products. In 2020 a further guidance document was published providing additional test procedures applicable to both drug substance & drug product manufacturing processes.
As per USP <665> the general approach is based on matrix of model extract conditions simulating a broad range of buffer-based process fluids. The guidelines include a comprehensive test matrix (physical, chemical & biological) cross-referencing methods from USP, EP, ASTM and ISO.
Choose Element as your risk management partner for single-use systems (SUS)
Risk management is critical in the lifecycle of SUS to ensure manufacturing processes are safe and compliant and meet the latest regulatory expectations.
Element provides a full range of E&L testing services in accordance with the latest regulatory guidelines including ISO 10993, USP <1663> and USP <1664>. Our experts can provide support with study design and consultancy services for all aspects of E&L testing.
Why Choose Element?
Element brings cutting-edge methodologies, state-of-the-art equipment, and knowledge of regulatory standards to provide high quality analytical data to help you make key decisions on your product.
Our team of engaged experts has directly contributed to the industry for years, serving as active participants in several working groups that have developed the PQRI, USP Expert Panels, ELSIE, CEN and ISO extractable and leachable best practices.
For more information about our USP 665, USP 1665, BPOG, or to request a quote, contact us today.
Are you ready for USP 665? Download our 'Implementation of USP 665' white paper
Increased use of single-use technologies in the biopharmaceutical industry has led to a shift in the end-user/supplier relationship. This paper, authored by our laboratory experts, provides an overview of USP<665>, USP<1665>, and the Biophorum (BPOG) Extractable protocol.
Learn more about single-use bioprocessing systems used in the production of biopharmaceutical drug products and how the risk management process defined in USP<665> and USP<1665> can be implemented using a hypothetical scenario.
download this white paperWatch our webinar on 'Material Changes'
In this webinar titled 'E&L Material Changes - Staying Agile When Supply Chains are Fragile', Nick Morley, principal scientist at Element Manchester, shares insights gained from over 20 years of experience in extractable and leachable (E&L) testing, particularly in the pharmaceutical industry.
This webinar outlines the steps of change management, from planning to evaluation and implementation, highlighting the need for meticulous risk assessment. Through case studies of past failures, we underscore the necessity of thorough evaluation and proactive risk management in navigating material changes effectively.
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USP 665, 1665 and BPOG Services
Ensure compliance for single-use systems (SUS). Our testing services provide high-quality results, safeguarding patient safety, fulfilling your regulatory requirements, and expediting time to market.
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