Ensuring sterility in pharmaceuticals and medical devices is a non-negotiable aspect of patient safety. Sterility testing not only confirms compliance but safeguards the trust placed in life-saving products. However, the process is intricate, and several factors can impact success. What Can Lead to Sterility Test Failures? For Medical Devices Sterility testing for medical devices presents…
A Contract Manufacturing Organization is a third-party company that provides comprehensive services in the manufacturing of pharmaceutical and biotechnology products. CMOs are integral to the drug development process, as they allow companies to outsource various stages of production, enabling them to focus on other core areas like research, development, and marketing. Key Services Offered by…
Assuming that a production batch of oral powder sachets was prepared using a dry mixing method. Post-preparation, a uniformity test for API was conducted, and the results were Satisfactory. Subsequently, the product was filled into sachets using a sachet filling machine. A content uniformity test was then performed, yielding non-conforming results. The root cause was…
