Overview:
Sterility Testing is a critical quality control procedure used to verify that pharmaceutical products, especially sterile injectables and implantables, are free from viable contaminating microorganisms. This test is mandatory for parenteral preparations and other products labeled as “sterile”.

Test Description:
Product samples are aseptically transferred into sterile culture media and incubated under controlled conditions to promote the growth of any contaminating microorganisms. The test is performed in isolators or cleanroom environments to avoid false positives and ensure regulatory compliance.

Purpose & Benefits:

• Confirm that parenteral, ophthalmic, and surgical products are sterile
• Support regulatory submissions and GMP compliance
• Prevent risk of sepsis, infection, and patient harm
• Required for batch release, stability studies, and validation protocols

Industries Served:

• Pharmaceuticals & Biotech
• Medical Devices & IV Solutions
• Tissue & Cell-Based Therapies
• Ophthalmics & Injectable Drug Products