Process Equipment Related Leachables & Single Use Systems
Materials used in manufacturing can introduce extractable compounds that may persist into process streams or the final product.
Teleios supports analytical evaluation of process equipment, tubing, assemblies, and single use components.
What We Can Support
- Material extractables studies
- Process component screening
- Single use system investigations
- Potential leachable assessment
- Targeted follow up analysis
- Volatile and semi volatile compounds
- Elemental analysis where appropriate
Typical Analytical Questions
- What compounds can migrate from a process component?
- Could a single use material contribute an observed impurity?
- Which compounds should be monitored in the process or product?
- Are process conditions increasing extractable release?
Analytical Approach
Evaluations are scoped to the component, process conditions, and contact duration, combining screening analyses with targeted confirmation of compounds of interest.
Regulatory & Compendial Framework
Depending on the program, material, and intended use, studies may consider:
- USP <665> Plastic Components and Systems Used to Manufacture Biopharmaceutical Drug Substances and Biopharmaceutical and Pharmaceutical Drug Products
- USP <1665> Characterization of Plastic Components and Systems Used to Manufacture Biopharmaceutical Drug Substances and Biopharmaceutical and Pharmaceutical Drug Products
- Risk based E&L principles
- Relevant process and product specific requirements
Not every listed framework applies to every study. Applicable expectations depend on product type, development stage, route of administration, material, intended use, and jurisdiction.