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
The BioPhorum Operations Group (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:
BPOG recommends using various analytical techniques to detect and quantify volatile compounds, semi-volatile, non-volatile and inorganic compounds.
The AET is an important value in the evaluation of extractables and leachables, representing the minimum concentration at which a compound must be quantified to meet safety requirements. Analytical methods are designed to achieve or exceed this sensitivity.
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
VOCs, residual manufacturing solvents, residual monomers
ICP-MS
Ni, Cr, Ti, Zn, Al, Fe, Ba, As, Sb, Pb — polymerization catalysts, pigments
GC-MS direct injection full scan
SVOCs, antioxidants, plasticizers, slip agents, oligomers
LC-PDA-MS\/MS and PLC-HRMS
NVOCs, non-volatile polar compounds, surfactants (PS20, PS80), oligomers
TOC on aqueous extracts
extraction consistency and exhaustion control
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.
Our other pharmaceutical E&L analysis services
For the pharmaceutical sector, the FILAB laboratory follows the ICH Q3E guideline.
- Identification of extractables according to USP <1663>
- Identification of leachables according to USP <1664>
- Plastic packaging analysis according to USP <665> and USP <1665>
- Analysis of plastic material components according to USP <661.1>
- Analysis and verification of packaging: interactions with the drug according to <USP 661.2>
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 and systems used in the production, processing, and packaging of pharmaceutical products.
Our FAQ
The BPOG protocol defines 4 extraction time points per solvent, making it possible to establish extraction kinetics and cover different use scenarios:
- T1: 24 hours at 40°C ± 2°C — accelerated intermediate-contact simulation
- T2: 7 days at 40°C ± 2°C — accelerated intermediate-contact simulation
- T3: 21 days at 40°C ± 2°C — long-term contact\/storage simulation
- T4: 70 days at 40°C ± 2°C — very long-term contact\/worst-case simulation
These 4 time points × 4 solvents generate up to 16 extraction conditions per component. FILAB offers a risk-based reduction approach to rationalize the program while maintaining scientific robustness.
BPOG solvent | Simulated process fluid | Rationale |
WFI (water for injection, natural pH) | Neutral aqueous protein solutions, cell culture media | Extraction of polar and ionic compounds — represents the majority of aqueous biological fluids. Specific to BPOG versus USP 665 (which does not systematically include it) |
H₃PO₄ 0.1 M (acidic pH ~3) | Acidic elution buffers (e.g., IEX elution, protein purification) | Extraction of polar compounds released at low pH |
NaOH 0.5 N (alkaline pH ~13) | Alkaline CIP cleaning solutions, alkaline buffers | Extraction of compounds released at very basic pH — NaOH CIP simulation |
EtOH\/H₂O 50% (semi-polar) | Alcoholic excipient solutions, EtOH cleaning | Extraction of low-polarity compounds — non-polar polymer additives not captured by aqueous solvents |
The BPOG report is an essential document accepted by the FDA and EMA as evidence of a rigorous extractables assessment. However, it must be supplemented by a leachables risk assessment specific to the end user's process, in accordance with the expectations for BLAs (FDA) and CTD\/IMPD dossiers (EMA).
To obtain a quote, you can contact our teams via our contact form, by telephone or by email.
Simply send us your requirements (type of material, requested analysis, applicable standard, urgency, quantity of samples, etc.). We will then send you a personalized technical and price 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 tailored to your industrial constraints and urgent requirements.
