Why:

This case study addresses the challenges faced by a supplier of raw materials dealing with three different (but similar) materials, each with five versions.

The client needed to develop a comprehensive testing strategy to perform chemical characterisation as per ISO 1099-18 as a first step and then define a complete biological evaluation according to ISO 10993-1 possibly optimised to achieve USP class VI classification.

The goal was to compile a detailed report with all the results, certificates, and statements necessary for marketing, customers, and regulatory authorities.

For whom:

The case study is intended for suppliers of raw materials in the pharmaceutical, medical device, or biotechnology industries.

How:

Material Variation Testing Strategy: A robust testing strategy was drafted by our team. The strategy focused on chemical characterisation as per ISO 10993-18 and cytotoxicity tests ISO 10993-5 to compare the chemical profiles of the different materials and identify a worst-case product or representative one.

Biological studies and USP Class VI testing: On the identified material, a series of biological studies in compliance with USP <88> and relevant ISO 10993 standards were performed. These studies were essential to evaluate the biocompatibility and safety of the materials, ensuring they met the necessary regulatory standards.

Comprehensive Report Generation: All the generated test results were gathered and a complete biological report was drafted. This report presented the results and discussion of the tests, highlighting the safety and compliance of the material series and their variations.

Outcomes:

The importance of a well-planned testing strategy.