The CIP (Cleaning-In-Place) process is crucial in pharmaceutical, food, and chemical industries for cleaning equipment without disassembly. Using cleaning agents and water, it reduces time and ensures product safety. Key Stages of the CIP Process: Common Challenges: Key Considerations: Performance Monitoring: Read also:
Sterile filtration is a vital step in the production of eye drops in the pharmaceutical industry, ensuring that products are safe for use and compliant with regulatory standards. Proper techniques and rigorous testing are essential for maintaining the quality and integrity of the final product. Importance of Sterile Filtration Microbial Contamination Prevention: Eye drops are…
This is a natural polysaccharide extracted from red seaweeds (mainly Gelidium and Gracilaria species). Properties of Agar: Agar is essential in microbiology due to its stability, clarity, and inert nature, making it the preferred medium for microbial cultivation: Because of these properties, agar is the most widely used solidifying agent in microbiological culture media. Uses…
When the specifications for the drug substances or drug product are being prepared, The following concepts as per ICH Q6A are important in the development and setting of harmonized specifications. such as, but limited to: 1) Periodic or Skip Testing: Periodic or skip testing is the performance of specified tests at release on pre-selected batches…
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…
