Methods Development and Validation Services

Description

Ensuring sterility is critical for pharmaceutical, biotechnology, and medical device products. Our Method Development and Validation Services are designed to help manufacturers comply with global pharmacopeial standards (IP/ USP/ EP/ BP/ JP) and regulatory guidelines.

Our Services Include Method Development:

Selection of appropriate sterility testing method (Membrane Filtration or Direct Inoculation).
Optimization of neutralizers to counteract antimicrobial properties of the product.
Simulation studies using product-contact materials to assess method suitability.

Method Validation:

Validation of sterility testing method in line with pharmacopeial harmonized requirements.
Growth promotion testing to confirm the ability of media to support microbial growth.
Suitability testing (Bacteriostasis/Fungistasis test) to demonstrate that the product does not inhibit microbial recovery.
Documentation and reporting as per GMP and regulatory expectations.