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:
Une évaluation approfondie de la sécurité des matériaux pour prévenir la contamination des médicaments par des substances nocives grâce à des tests de lixiviation
Des tests physico-chimiques pour vérifier les propriétés des matériaux, assurant leur adéquation avec l'usage pharmaceutique envisagé
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
L'USP 665 a pour objectif de fournir des directives pour la caractérisation des matériaux en plastique et des systèmes utilisés dans la production, le traitement, et l'emballage de produits pharmaceutiques.
Elle traite plus particulièrement de l'évaluation des risques liés aux interactions potentielles entre les matériaux en plastique et les produits pharmaceutiques. Comme par exemple la libération de substances extractibles et/ou relargables qui pourraient affecter la qualité du produit ou la sécurité des patients.
Elle s'applique à tous les composants en polymère qui entrent en contact direct avec les flux de fabrication, notamment :
Les systèmes à usage unique (Single-Use Systems - SUS).
Les tubulures et les filtres.
Les réservoirs de stockage intermédiaires et les sacs de mélange.
Les joints et les vannes en plastique.
Non. L’USP 665 est un standard compendial contraignant. Le protocole BPOG reste un guide de bonnes pratiques industrielles, particulièrement adapté aux fournisseurs de SUS souhaitant fournir un package extractibles standardisé. Les deux protocoles partagent des solvants d'extraction identiques et sont largement compatibles.
Pas nécessairement. Le rapport BPOG fourni par votre fournisseur couvre le niveau extractibles du composant, mais USP 665 exige que l'utilisateur final complète l'évaluation avec une étude de risque spécifique à son procédé (évaluation des PERLs dans les conditions réelles). FILAB vous aide à compléter ce maillon.
Pour obtenir un devis, vous pouvez contacter nos équipes via notre formulaire de contact, par téléphone ou par e-mail.
Il vous suffit de nous transmettre votre besoin (type de matériau, analyse souhaitée, norme éventuelle, urgence, quantité d’échantillons…). Nous vous envoyons ensuite une proposition technique et tarifaire personnalisée en 24-48H.
Les délais varient selon la nature de l’analyse et la complexité du projet d’expertise.
FILAB s’engage toutefois à fournir des délais rapides et adaptés à vos contraintes et urgences industrielles.
