E&L testing on Single-Use Systems

The use of single-use systems or multiple-use systems (SUS, MUS) to manufacture drugs and biopharmaceutical products has increased significantly. These disposable systems, which typically consist of items such as tubing, filters, o-rings/gaskets, storage bags and connectors as well as more complex components such as bioreactors, offer many advantages. They facilitate faster, more flexible production and are a cost-effective solution. They also carry a lower cross-contamination risk, enhancing patient safety.

The implementation of multiple-use systems, in the pharmaceutical and biopharmaceutical process, requires careful consideration in the selection of materials. It is imperative to avoid the risk of chemical compounds leaching from polymeric components and entering in the process stream.

Both single-use and multiple-use systems are under USP <665> scope which is mandatory and will become effective on May 1, 2026:

• The USP <665> enables a standardized extraction procedure to determine these potential contaminants using analytical methods
• The USP <1665> contains guidance on risk assessment approaches and how to implement this chapter beginning with an initial assessment and a risk assessment. Depending on the risk classification as low, medium and high risk, the standard test procedures of USP <665> are applied

Pharmaceutical and biopharmaceutical manufacturers should select processing materials that limit extractables and leachables. Thorough testing ensures that single-use and multiple-use systems are suitable for the intended purpose. Now it's time to complete risk assessments and verify that your single-use and multiple-use systems are compliant with regulatory expectations.

Looking for a winning team in the race towards USP <665>? Let us drive you on a smooth and successful journey!

At Eurofins BioPharma Product Testing in Italy, we have actively aligned with regulatory updates from USP to ensure the best testing approach for our clients. With over 472 analytical studies and 263 toxicological evaluations performed last year, we have the expertise and know-how to help you achieve your unique development timelines.

Thanks to our outstanding analytical and toxicology assessment experience on E&L, across the largest panel of products, we can ensure the optimum strategy to avoid product withdraw from the market. 

Performing analytical evaluations to detect extractables and leachables for all components that come into contact with the process stream can be expensive and time-consuming. As a result, a risk-based approach should be taken when determining what testing is necessary to support the selection of each manufacturing component. An effective strategy ensures that all the items belonging to a specific manufacturing process are evaluated for their regulatory compliance and potential to interact with the process stream.

This risk assessment process enables the end user to prioritise the items to be tested and select the most appropriate analytical approach.

Download our Whitepaper: A risk-based approach to extractable and leachable evaluations of in-process materials

• Existing data gap analysis and data quality review
  If extractables data are already available from previous studies or from the item manufacturers, it is important to verify the quality of the data and anything missing in the strategical approach.
• Full risk assessment on the drug manufacturing process items
  A complete analysis of the customer’s process in order to define the most concerning items in terms of the potential release of extractables should be a priority.
• Extractables study design in compliance with the most updated regulation (USP665-1665-BPOG)
• Expert toxicological evaluations
  Performed on already existing data or on extractables data generated from new study. Cumulative assessment of the extractables from the process items and primary packaging. 
• Leachables assessment
  Definition of the most adequate strategy in accordance with the primary packaging evaluation and ongoing leachables studies.

• USP <665> Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products
• USP <1665> Characterization and Qualification of Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products
• Biophorum Operation Group (BPOG) – standard protocol for Extractables testing on SUS/MUS
• ICH guideline Q9 on quality risk management