Sterility Test (Usp , Ip 2.6.1, Ep 2.6.1)
Sterility Test (Usp , Ip 2.6.1, Ep 2.6.1)
Sterility testing verifies that sterile products such as injectables, ophthalmics, and implantables remain free from viable microorganisms. In line with USP <71>, EP 2.6.1, and IP 2.2.1, the test is performed using membrane filtration or direct inoculation methods within Grade A cleanroom environments. Method suitability, growth promotion testing, and the use of positive and negative controls are incorporated to ensure reliability. As one of the most critical quality control assays, sterility testing is a regulatory requirement before batch release of sterile products.
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BiomatiQ Scientific Pvt. Ltd:
#1386, Satyavathi’s Park Avenue, Pragathi Nagar, Hyderabad, Telangana 500090 - INDIA
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BiomatiQ Private Ltd:
#Plot No. 167,168, TGIIC Industrial Park, Thuniki Bollaram, Mulugu (M), Siddipet (DIST), Telangana 502279 - INDIA - + 1800 571 9696
- contact@biomatiq.com
