Biocompatibility testing for pharmaceutical packaging, medical devices, and materials of construction requires more than selecting a test panel. It requires a clear understanding of how materials interact with biological systems and how those interactions are evaluated under different regulatory frameworks. Programs often become fragmented, with USP and ISO requirements treated independently and without a cohesive strategy.
We approach biocompatibility as a program design problem, not just a testing exercise. The goal is to build a testing strategy that is aligned with the product, the patient risk, and the regulatory pathway from the outset.
What We Support
We support biocompatibility programs for medical devices, pharmaceutical packaging systems, and combination products where material contact with drug product or patient pathways must be evaluated. This includes elastomeric components, polymeric materials, container closure systems, and fluid path materials used in both drug and device applications.
Our role spans early program definition through execution and coordination of required studies.
USP and ISO Frameworks
Biocompatibility programs are typically structured around USP <87> cytotoxicity, USP <88> biological reactivity, and the ISO 10993 series. While these frameworks overlap, they are not interchangeable, and misalignment between them is a common source of regulatory friction.
Test selection depends on the nature and duration of contact, route of administration, and intended use of the material. We work with clients to determine when USP testing is sufficient, when ISO risk-based evaluation is required, and how to integrate the two into a single defensible program.
Program Design
Biocompatibility does not exist in isolation from other testing. Extraction conditions, material preparation, and sample handling all influence both microbiological and chemical outcomes. We support program design that integrates biocompatibility with endotoxin, microbiology, and material characterization to ensure consistency across datasets.
Where required, we coordinate specialized or in vivo testing through qualified partners, maintaining a single, coherent program structure and documentation set.
Standards and Regulatory Framework
Our biocompatibility programs are aligned with:
- USP <87> Biological Reactivity Tests, In Vitro
- USP <88> Biological Reactivity Tests, In Vivo
- ISO 10993 series for biological evaluation of medical devices
- FDA expectations for material safety and combination products
Start the Conversation
If you are building a new biocompatibility program or reassessing an existing one, we can help structure it correctly before testing begins.
