Chapter USP <1665> “Characterization and Qualification of Plastic Components Used in the Manufacturing of Pharmaceutical Drug Substances and Biopharmaceutical Drug Products” is the USP’s informative reference framework for evaluating production systems. It defines the scientific principles and best practices validated by regulatory authorities to ensure the safety of plastic manufacturing equipment (single-use systems, tubing, filters) and their compatibility with biopharmaceutical manufacturing processes.
As a pharmaceutical manufacturer, you want to carry out an extractables analysis according to USP 1665
What does USP 1665 say?
USP 1665 is a guideline from the United States Pharmacopeia (USP) focused on assessing the risk of migration from plastic components used in the manufacture of pharmaceutical substances and products.
This section focuses on the identification and quantification of extractable compounds that may be released by plastic components of manufacturing systems into the pharmaceutical substance or product. This includes establishing standardized protocols for the extraction and analysis of chemical substances (PERLs) that could migrate from process equipment (such as bioprocess bags, tubing, or filters) into the production stream. The goal is to characterize the extractables profile in order to assess potential risks to process quality, active ingredient stability and, ultimately, patient safety.
FILAB supports pharmaceutical manufacturers in the analysis of extractables and leachables according to USP 1665
Our analytical characterization solutions
We support device manufacturers and pharmaceutical laboratories at every stage of the product lifecycle.
We help you classify your components according to the USP <1665> criteria:
Temperature and contact duration.
Chemical reactivity of the solvent/product.
Proximity to the final filling step.
Implementation of the rigorous extraction conditions required by the standard:
Extraction at acidic pH (pH 3), basic pH (pH 10) and water/ethanol mixture (50/50).
Analyses on new components and post-sterilization (Gamma, Autoclave).
FILAB provides its clients with state-of-the-art analytical equipment to identify organic and inorganic compounds.
Our technical resources for analysis according to USP 1665
| Compound Category | Techniques Used | Analysis Objective |
| VOC / SVOC (Volatile Organic Compounds and Semi-Volatile) | GC-MS (Headspace or direct injection) | Identification and quantification of residual solvents and light additives. |
| NVOC (Non-Volatile Organic Compounds) | LC-HRMS (Orbitrap / Q-TOF) | Non-targeted identification of complex molecules and degradation products. |
| Trace Elements (Inorganic) | ICP-MS | Detection of heavy metals and catalysts originating from plastic materials. |
| Global Parameters | TOC (Total Organic Carbon) and Conductivity | Monitoring of total organic load and ionic purity of extracts. |
Why choose FILAB for your analyses according to USP 1665?
- COFRAC ISO 17025 accreditation and GMP environment
Guarantees technical competence, traceability of our measurements and the enforceability of our analytical results before French and European regulatory authorities, as well as the US FDA. - Comprehensive multi-technique analytical platform
- Mastery of regulatory thresholds (AET, SCT…).
- Structured reports for your regulatory submissions
Each FILAB report is structured for direct integration into your files: 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.
For the pharmaceutical sector, FILAB follows the ICH Q3E guideline.
- Identification of leachables according to USP <1664>
- Identification of extractables according to USP <1663>
- Extractables & Leachables analysis according to BPOG (Best Practice Operating Guidelines)
- Analysis of plastic material components according to USP <661.1>
- Analysis and verification of packaging: interactions with the drug according to USP <661.2>
- Analysis of leachables from process materials according to USP <665>
Our related services
Heavy Metal Analysis and ICH Q3D Elemental Impurities
Analytical Validation According to USP 233 for the Analysis of Elemental Impurities
Did you know?
The FILAB laboratory has been COFRAC ISO 17025 accredited for the following scope since 2015: Analysis and quantification of elemental impurities and minerals, including heavy metals, by ICP-AES and ICP-MS in cosmetic and pharmaceutical products according to European Pharmacopoeia 2.4.20 and USP 233
Our FAQ
The USP <665> is the “mandatory” chapter that defines the standards and acceptance criteria for plastic components. USP <1665>, on the other hand, is the “informative” chapter that provides guidance, scientific rationale, and detailed protocols for carrying out the tests. In short, <1665> explains how to properly apply <665>.
USP <1665> applies to all plastic components that come into contact with fluids during the manufacture of pharmaceutical substances or products. This includes:
Single-Use Systems (Single-Use Systems): storage and culture bags.
Tubing, connectors, and valves.
Filter cartridges.
Sensors and various polymer components.
We use the risk assessment matrix recommended by USP <1665>. It cross-references several factors:
Chemical severity (nature of the solvent).
Contact conditions (duration and temperature).
Proximity to the finished product (the risk is considered higher toward the end of the production chain). This risk score determines the scope of analyses to be carried out.
The AET (Analytical Evaluation Threshold) is the concentration limit above which an extractable must be formally identified and quantified for toxicological assessment. Our experts calculate the AET specifically for each project based on the drug dose and process parameters.
To get a quote, you can contact our teams via our contact form, by phone, or by email.
Simply send us your requirements (material type, desired analysis, applicable standard, urgency, number of samples, etc.). We will then send you a tailored technical and pricing proposal within 24-48 hours.
Lead times vary depending on the nature of the analysis and the complexity of the expert assessment project.
FILAB is nevertheless committed to providing fast turnaround times adapted to your constraints and industrial urgencies.
