Test Optimisation

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:

1. 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.

2. 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.

3. 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.