--- type: "WebPage" title: "BPOG analysis laboratory" description: "Do you want to carry out an analysis of your plastic materials used in your pharmaceutical products according to BPOG? The BPOG protocol: context, status, and relationship with USP 665 The BioPhorum Operations Group (renamed BioPhorum in 2019) published the..." resource: "https://filab.fr/en/sectors-of-activity/analysis-industry-pharmaceuticals/bpog-analysis/" tags: ["EN", "pll_65fd7c14c9a93", "Anaïs DECAUX"] timestamp: "2026-05-18T07:08:04Z" published: "2024-03-25T15:52:09Z" language: "en" author: "Laure Durieux" --- # BPOG analysis laboratory ## Do you want to carry out an analysis of your plastic materials used in your pharmaceutical products according to BPOG? ### The BPOG protocol: context, status, and relationship with USP 665 ![BPOG](https://filab.fr/wp-content/uploads/2024/03/bpog.png) The [BioPhorum Operations Group](https://www.biophorum.com/) (renamed BioPhorum in 2019) published the “Standardized extractables testing protocol for Single-Use Systems in Biomanufacturing.” This document has become the de facto industry reference for extractables studies of single-use bioprocess equipment (SUS), used by suppliers to provide their customers with comparable extractables packages. Although it has an important regulatory status, the BPOG protocol is not an official regulatory document. It is an industry best-practice guide. Since May 2026, **USP 665 has been the binding reference standard for SUS**, but its extraction protocols are largely aligned with BPOG, with both being compatible and complementary. ### What analysis are recommended by BPOG? The analyses recommended by the BioPhorum Operations Group (BPOG) for the evaluation of extractables and leachables in the context of using single-use plastic systems (SUS) in biopharmaceutical manufacturing focus on a comprehensive risk-based approach. Here are the main techniques and methodologies recommended by BPOG: Analyse des composés volatils et non volatils Le BPOG recommande l'utilisation de diverses techniques analytiques pour détecter et quantifier les [composés volatils](https://filab.fr/en/our-services/our-analysis-services/voc-analysis-laboratory.md), semi-volatils, non volatils et inorganiques. Analyse du seuil d'évaluation analytique (AET) L'[AET](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/medical-devices-calculation-aet.md) est une valeur importante dans l'évaluation des extractibles et des lixiviables, représentant la concentration minimale à laquelle un composé doit être quantifié pour satisfaire aux exigences de sécurité. Les méthodes d'analyse sont conçues pour atteindre ou dépasser cette sensibilité. ## FILAB supports you in analyzing your products according to BPOG ### Our technical resources for a BPOG study To provide you with reliable analyses and interpretations, FILAB has a comprehensive analytical platform suited to analysis. This includes in particular: [### HS-GC-MS headspace COV, résidus solvants de fabrication, monomères résiduels](https://filab.fr/en/our-technical-resources/hs-gc-ms-analysis-in-the-laboratory.md) [### ICP-MS Ni, Cr, Ti, Zn, Al, Fe, Ba, As, Sb, Pb — catalyseurs polymérisation, pigments](https://filab.fr/en/our-technical-resources/laboratory-analysis-icp-icp-ms-icp-aes.md) [### GC-MS direct injection full scan SVOCs, antioxydants, plastifiants, agents de glissement, oligomères](https://filab.fr/en/our-technical-resources/laboratory-analysis-gcms.md) [### LC-PDA-MS/MS et PLC-HRMS NVOCs, composés polaires non volatils, surfactants (PS20, PS80), oligomères](https://filab.fr/en/our-technical-resources/high-resolution-mass-spectrometry-hrms-analysis.md) ### TOC sur extraits aqueux contrôle de cohérence et d'épuisement de l'extraction BPOG reporting threshold: 0.1 µg/cm² of exposed component surface. This threshold is compared with the AET calculation based on USP 665/1665, which takes into account the volume of biological product in contact, the daily administered dose, and the applicable SCT ### Why choose FILAB for BPOG analysis? - **COFRAC ISO 17025 accreditation and GMP environment** Guarantees technical competence, traceability of our measurements, and the enforceability of our analytical results before French, European, and U.S. FDA regulatory authorities. - **Comprehensive multi-technique analytical platform** - **Mastery of regulatory thresholds (AET, SCT, etc.)** - **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. [Learn more](https://filab.fr/en/about-us.md) ## Our other pharmaceutical E&L analysis services For the pharmaceutical sector, the FILAB laboratory follows [the ICH Q3E guideline](https://filab.fr/en/our-services/our-expertise-services/laboratory-extractable-leachable-testing/ich-q3e-analysis.md). - [Identification of extractables according to USP <1663>](https://filab.fr/en/our-services/our-expertise-services/laboratory-extractable-leachable-testing/leaching-analysis-laboratory-according-to-usp-1663-and-usp-1664.md) - [Identification of leachables according to USP <1664>](https://filab.fr/en/our-services/our-expertise-services/laboratory-extractable-leachable-testing/extractables-leachables-testing-according-usp-1664.md) - [Plastic packaging analysis according to USP <665>](https://filab.fr/en/sectors-of-activity/analysis-industry-pharmaceuticals/usp-665-analysis.md) and [USP <1665>](https://filab.fr/en/our-services/our-expertise-services/laboratory-extractable-leachable-testing/extractables-analysis-laboratory-according-to-usp-1665.md) - [Analysis of plastic material components according to USP <661.1>](https://filab.fr/en/our-services/our-expertise-services/laboratory-extractable-leachable-testing/usp-661-laboratory-analysis.md) - [Analysis and verification of packaging: interactions with the drug according to ](https://filab.fr/en/our-services/our-expertise-services/laboratory-extractable-leachable-testing/testing-laboratory-usp-661-2.md) ## What is the purpose of the guidelines issued by the BPOG? Single-use technologies and components, such as bags, tubing, valves, and other bioprocessing equipment, play an increasingly important role in the industry because of their efficiency and the benefits they bring. However, it is crucial to demonstrate their regulatory compliance and compatibility with production processes in order to ensure the safety and efficacy of final biological pharmaceutical products. Extractables testing is therefore an essential part of the design of this equipment. The guidelines issued by the BPOG aim to provide guidance for the [characterization of plastic materials](https://filab.fr/en/our-services/our-analysis-services/laboratory-material-testing.md) and systems used in the production, processing, and [packaging of pharmaceutical products](https://filab.fr/en/sectors-of-activity/health-pharmaceutical-cosmetics/packaging-analysis-laboratory-for-the-pharmaceutical-industry.md). ## Our FAQ Quelles sont les conditions d'extraction édictées par le BPOG ? Le protocole BPOG définit 4 temps d'extraction par solvant, permettant d'établir la cinétique d'extraction et de couvrir différents scénarios d'utilisation : - T1 : 24 heures à 40°C ± 2°C — simulation contact intermédiaire accéléré - T2 : 7 jours à 40°C ± 2°C — simulation contact intermédiaire accéléré - T3 : 21 jours à 40°C ± 2°C — simulation contact long terme / stockage - T4 : 70 jours à 40°C ± 2°C — simulation contact très long terme / worst case Ces 4 temps × 4 solvants génèrent jusqu'à 16 conditions d'extraction par composant. FILAB propose une approche de réduction basée sur l'évaluation du risque permettant de rationaliser le programme tout en maintenant la robustesse scientifique. Les 4 solvants du protocole BPOG et leur justification | **Solvant BPOG** | **Fluide de procédé simulé** | **Justification** | | --- | --- | --- | | WFI (eau pour injection, pH naturel) | Solutions protéiques aqueuses neutres, milieux de culture | Extraction des composés polaires et ioniques — représente la majorité des fluides biologiques aqueux. Spécifique BPOG vs USP 665 (qui ne l'inclut pas systématiquement) | | H₃PO₄ 0,1 M (pH acide ~3) | Tampons d'élution acides (ex. élution IEX, purification de protéines) | Extraction des composés polaires libérés à pH bas | | NaOH 0,5 N (pH alcalin ~13) | Solutions de nettoyage CIP alcalin, tampons alcalins | Extraction des composés libérés à pH très basique — simulation CIP NaOH | | EtOH/H₂O 50% (semi-polaire) | Solutions d'excipients alcooliques, nettoyage EtOH | Extraction des composés peu polaires — additifs apolaires des polymères non captés par les solvants aqueux | Un rapport extractibles BPOG est-il directement acceptable par la FDA et l'EMA pour les dossiers BLA ? Le rapport BPOG constitue une pièce essentielle acceptée par FDA et EMA comme démonstration d'une évaluation extractibles rigoureuse. Cependant, il doit être complété par l'évaluation du risque leachables spécifique au procédé de l'utilisateur final, conformément aux attentes des BLA (FDA) et dossiers CTD/IMPD (EMA). Comment obtenir un devis avec FILAB ? 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. Quelle est la durée typique des analyses ? 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.