USP 665 Analytical Laboratory
The regulatory framework for polymers in contact with biological products is evolving. The chapter USP <665>, approved in 2024, is becoming the first binding compendial standard (official as of May 1, 2026) dedicated to plastic components used in the manufacture of drugs and biologic substances.
Would you like to carry out an analysis of the plastic materials used in your pharmaceutical products according to USP 665?
USP 665: compendial framework for bioprocess systems
Unlike USP <1663> and <1664>, which focus on primary packaging, USP <665> applies specifically to materials in contact with the product during manufacturing.
USP <665> defines strict regulatory requirements ("what to do"): chemical characterization, extraction conditions, and analytical testing according to the risk level.
USP <1665> provides the scientific approach ("how to do it"): risk assessment principles, E&L analytical strategies, and data interpretation (toxicology, AET).
The PERLs concept: beyond simple extractables
USP <665> introduces a key concept: PERLs (Process Equipment-Related Leachables). These are compounds originating from plastic materials, extracted under the actual conditions of your process, and potentially migrating into the final product or its intermediates.
They differ from packaging leachables because they concern production equipment (Single-Use Systems).
They require a specific assessment because they may accumulate during manufacturing.
What are the key points addressed by USP 665?
To ensure the safety of polymeric materials used in the pharmaceutical industry, USP 665 develops two main areas:
A comprehensive assessment of material safety to prevent drug contamination by harmful substances through leachability tests
Physicochemical tests to verify material properties, ensuring their suitability for the intended pharmaceutical use
The FILAB laboratory supports you in the analysis of your products according to USP 665
Analytical protocol and multi-technique screening by the FILAB laboratory
COFRAC ISO 17025 accredited laboratory, FILAB carries out your studies under standardized extraction conditions (solvents aligned with the BPOG protocol: pH 3, pH 10, 50% EtOH).
| Technique | Analytical Targets | Performance |
| HS-GC-MS | VOCs, monomer residues, process solvents | sub-ppb LOQ |
| GC-MS Full Scan | Antioxidants, plasticizers, slip agents | LOQ <0.1 µg/mL |
| LC-HRMS (Orbitrap) | Polar non-volatiles, oligomers (NTA) | High resolution |
| ICP-MS | Catalyst metals (Pd, Rh, Ni, Ti) | ICH Q3D compliance |
| TOC | Overall extraction control | LOQ 50 µg/L C |
Our technical resources for analysis according to USP 665
To provide you with reliable analyses and interpretations, FILAB has a complete analytical platform suited to the analysis. This includes in particular:
- the GC-MS, HPLC or UHPLC/MS/MS for the detection, identification, and quantification of organic compounds present in solvents, UV stabilizers, antioxidants, colorants, inks, detergent residues, sterilization residues, polymer residues… that have been extracted and/or released from the material by a standardized simulant
- the ICP-AES and ICP-MS particularly suited to mineral or metallic contaminants or additives, such as heavy metals, mineral or metallic fillers, colorants…
- microscopy SEM-EDX, a truly rapid and versatile diagnostic tool for assessing the material surface condition after aging, and for observing particles, deposits…
Let's discuss your project
Do you have analysis needs according to USP 665?
For the pharmaceutical sector, the FILAB laboratory follows the ICH Q3E guideline.
- Identification of extractables according to USP <1663>
- Evaluation of leachables according to USP <1664>
- Extractables & Leachables analysis according to BPOG (Good Operating Practices)
- Analysis of plastic material components according to USP <661.1>
- Analysis and packaging verification: interactions with the drug according to USP <661.2>
- Identification of extractables according to USP <1665>
Why choose FILAB for the chemical characterization of your materials according to USP 665
- COFRAC ISO 17025 accreditation and GMP environment
Guarantees technical competence, the traceability of our measurements, and the enforceability of our analytical results with French and European regulatory authorities, as well as the U.S. FDA. - Complete multi-technique analytical platform
- Mastery of regulatory thresholds (AET, SCT…)
- Support from an expert laboratory in the analysis of plastic materials to better understand the strategic challenges and changes in the pharmaceutical sector.
- Structured reports for your regulatory submissions
Each FILAB report is structured for direct integration into your submissions: Module 3 CTD, IMPD, STED, BER, 510(k) or PMA dossier. Our deliverables include detailed operating conditions, annotated chromatograms, identification/quantification tables, and toxicological assessment of the detected compounds.
Our FAQ
USP 665 aims to provide guidance for the characterization of plastic materials and systems used in the production, processing, and packaging of pharmaceutical products.
It focuses in particular on assessing the risks associated with potential interactions between plastic materials and pharmaceutical products, such as the release of extractables and/or leachables that could affect product quality or patient safety.
It applies to all polymer components that come into direct contact with manufacturing streams, including:
Single-Use Systems (Single-Use Systems - SUS).
Tubing and filters.
Intermediate storage tanks and mixing bags.
Plastic seals and valves.
No. USP 665 is a binding compendial standard. The BPOG protocol remains an industry best-practice guide, particularly suited to SUS suppliers wishing to provide a standardized extractables package. The two protocols use identical extraction solvents and are largely compatible.
Not necessarily. The BPOG report provided by your supplier covers the extractables level of the component, but USP 665 requires the end user to complete the assessment with a specific risk study for their process (evaluation of PERLs under actual conditions). FILAB helps you complete this step.
To get a quote, you can contact our teams via our contact form, by phone, or by email.
All you need to do is send us your requirements (material type, analysis requested, applicable standard, urgency, number of samples, etc.). We will then send you a tailored technical and pricing proposal within 24-48 hours.
Turnaround times vary depending on the nature of the analysis and the complexity of the expert assessment project.
However, FILAB is committed to providing fast turnaround times adapted to your constraints and industrial urgencies.
