Starting on May 1, 2026, pharmaceutical and biopharmaceutical manufacturers must meet new regulatory standards for plastic components used in both single-use and multi-use product manufacturing systems. USP <1665> entitled Characterization and Qualification of Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products and USP <665> entitled Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products establish risk assessment, extraction testing, and leachable evaluation of all plastic components involved in drug substance and drug product manufacturing. These requirements place increased emphasis on Process Equipment-Related Leachables (PERLs) assessments, making expert guidance critical to ensure regulatory compliance and product safety.

Scientech Laboratories provides comprehensive analytical support for plastic components and polymeric materials used in pharmaceutical manufacturing systems, helping drug manufacturers, CMOs, and suppliers meet evolving regulatory expectations.

Our Capabilities

Our experienced technical team utilize advanced instrumentation to evaluate extractables, assess potential leachables, and define material compatibility:

• ICP-MS for elemental impurities and heavy metals.

• GC-MS for volatile and semi-volatile compounds.

• LC-MS and LC-MS/MS for non-volatile organic extractables.

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Services Offered

• Risk-based evaluation for single-use systems.

• Extractables screening studies.

• Chemical characterization of polymeric materials.

• Method development and validation.

• Regulatory-ready analytical reports.

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Why Choose Scientech Laboratories

- 45 years experience.

- Experienced analytical scientists.

- State-of-the-art instrumentation.

- Flexible project design based on risk assessment.

- Reliable support for regulatory submissions.

Whether you are qualifying for single-use systems, tubing, filters, bags, or plastic process components, our laboratory can provide the analytical insight needed to demonstrate compliance and product safety. Contact us today at info@Scientech-labs.com  to discuss your USP <665>/<1665> testing requirements.

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