Consulting Services
Analysis in Products
These services include Bacterial endotoxin testing (LAL or pyrogen test), Bioburden Test and Biological indicators (BIs) sterility testing. LAL qualitative method (gel-clot) and quantitative method using photometric technique (turbidimetric or chromogenic) for determination of endotoxin on product, raw material or water samples. Validation and testing technique in accordance with ANSI/AAMI ST72 and USP [85]. Enumeration of bio-contamination present on samples (finished product, component or raw material) as per ISO 11737 standard. Four testing categories available on request: aerobic and anaerobic bacteria, bacterial spores and fungi. Sterilization´s routine monitoring and performance qualification. Sterility verification on biological indicators (BIs) for dry heat, steam, ETO processes as per ISO 11138 and USP [1229.5]. Population verification on BIs, inoculation of products and PCDs preparation are available upon customer´s request.
Microbiología y Calidad Industrial, MCI