Based on PIC/S Annex 1 “Manufacture of Sterile Medicinal Products”, it is particularly important to ensure the quality and safety of sterile medicinal products throughout their manufacturing process. QC has played an essential role in the control and reduction of contamination by microorganisms, particulates and endotoxins/pyrogens.
1. QC monitors the number of microparticles in the daily monitoring environment to ensure that the correct environment is provided for the use of aseptic filling technology
2. Bioburden testing provides critical data on microbial contamination levels prior to filtration, helping manufacturers assess the effectiveness of their aseptic filling processes.
3. When releasing the final product, endotoxin testing is conducted for safety quality control. We can perform Kinetic Chromogenic method or the kinetic turbidity method according to customers’ needs.
4. Sterility is a critical quality attribute of aseptic products, ensuring that the products are safe and free from viable microorganisms. The operating environment of the sterility test has a profound impact on the test results; Amaran QC operates the sterility test in an isolator (under background C-level area) that enhances the reliability and safety of the testing process.
With the support of QC team, Amaran has successfully delivered high quality drug products to our clients. In addition to the above-mentioned activities, the QC team is involved in front-end analysis method development, method verification, and method suitability testing. Amaran’s QC remains dedicated to providing clients with dependable services. .