The implementation of USP 665 and BPOG
This paper provides critical information about USP 665, USP 1665, and the Biophorum (BPOG) extractable protocol, to support the pharmaceutical manufacturing sector in complying with these new, mandatory standards. Learn more about single-use bioprocessing systems used in the production of biopharmaceutical drug products and how the risk management process is defined.
Are you ready for USP 665 and BPOG?
USP 665 and USP 1665 standards were approved in early 2023 to address the risk of extractables and leachables (E&L) in plastic components and systems used in the manufacture of pharmaceutical products. USP 665 is mandatory and comes into effect on May 1, 2026.
Why are regulations changing?
Pharmaceutical manufacturing processes traditionally used glass and stainless-steel equipment. Today, polymeric single-use manufacturing equipment is seen as advantageous over traditional materials. The Increased use of single-use technologies in the biopharmaceutical industry has led to a shift in the end-user/supplier relationship. USP 665 outlines considerations for characterizing and qualifying plastic components.
Why download this white paper?
This white paper addresses the challenges of E&L testing for plastic components subject to USP 665, USP1665 and BPOG guidance.
Our industry-leading research analyzes test protocols implemented to achieve regulatory compliance for the manufacture of pharmaceutical/biopharmaceutical products.
To make informed decisions about your product, extractables must be identified and characterized through testing. Our team is focused on helping you achieve regulatory approval and by downloading this paper, you’re one step closer to achieving your goals.
For more information about this white paper or about our services, speak to us today.
Find related Resources
The implementation of USP 665 and BPOG: abstract
Through a hypothetical case study, this Whitepaper provides an overview of USP<665>, USP<1665> and the Biophorum (BPOG) Extractable protocol for Single-Use bioprocessing systems used in the production of biopharmaceutical drug products.
Additionally, this paper highlights how the risk management process, defined in USP<665> and USP<1665>, can be implemented using a hypothetical scenario.
The implementation of USP 665 and BPOG: excerpt
'Regulatory agencies require end-users to ensure that the materials used to manufacture the pharmaceutical/biopharmaceutical product are suitable for their intended use. In this regard USP<665> has been drafted with the end process in mind, the level of testing and reporting thresholds required for data are therefore, process-specific.'
Extractables & Leachables Studies
Element has one of the largest and most experienced extractables and leachables (E&L) practices in the world.
Backed by regulatory expertise, extensive experience, and a vast extractables database, our comprehensive E&L solutions ensure the safety of materials used across the healthcare sector.
We deliver tailored studies for pharmaceutical, biologic, medical device, reduced risk, combination products and more, in accordance with regulatory expectations.
READ MORERelated Resources
White Paper
Related Pages
Extractables and Leachables Studies
Element's extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.
Medical Device Testing
As a comprehensive testing partner, you’ll enjoy the benefit of a single supplier source for all of your testing needs, from mechanical testing and environmental simulation to EMC and wireless device testing.
Pharmaceutical Testing
Element’s pharmaceutical laboratories provide specialist pharmaceutical testing services, including chemical, physical, microbial, and stability testing on a vast array of products, from raw materials to finished products.
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.
Excipient Raw Materials and Container Testing
Find out how we make certain that quality and safety of your excipient raw materials and containers are maintained.
Chemistry, Manufacturing, and Controls (CMC) Consulting Services
We provide consulting services for Chemistry, Manufacturing, and Controls (CMC) product development in the pharmaceutical and biotechnological industries.
ICH Stability Testing of Pharmaceuticals and Biologics
We'll help you develop comprehensive stability programs that meet ICH Q1A-F requirements for IND, ANDA, and NDA approvals of small and large molecule drugs.