Understanding BI COA is one of the critical task for Non-Microbiology professional. I will be come up with number of sequel articles to understand the complete BI COA. In this article we majorly discussed about the survival time and killing time BI’s. ISO 11135-1 states that complete kill must be obtained in the half-cycle. Those […]
Monitoring of bioburden is one of the most important aspect of terminal sterilization. Before sterilization all samples to be collected based on the predetermined interval to cover the complete process/manufacturing time. Sample to be collected in the final container to represent to bioburden in the unsterile product bioburden at beginning, middle and end of the […]
Terminal sterilization is the reliable process to assure the sterility of the product. Regulators more relay on the Moist heat terminal sterilization process than aseptic processing. In terminal sterilization product sterilized in the final container. Terminal sterilization should be utilized when the product and container/closure system are able to withstand the terminal sterilization process. Note: Kindly […]
Introduction The COVID-19 pandemic presents an unprecedented challenge to healthcare, the pharmaceutical industry’s supply chain and personnel movement. Globally different support functions like API, excipient and packaging patterners to this industry are not able to respond with in pre-defined time frame. Apart from the third-party services like calibration and annual maintenance also impacted due to […]
Vaccines are a group of pharmaceuticals that include some of the oldest biologically-made compounds. The Smallpox vaccine was introduced by Edward Jenner as early as in 1796 and Louis Pasteur created the first live attenuated bacterial (Chicken Cholera) and viral (Rabies) vaccines at the end of the 19th century. A vaccine contains an antigen that […]
What is infection? The invasion and multiplication of microorganisms such as bacteria, viruses, and parasites that are not normally present within the body. An infection may cause no symptoms and be subclinical, or it may cause symptoms and be clinically apparent. An infection may remain localized, or it may spread through the blood or lymphatic […]
When the bioburden method is employed for sterilization process, the bioburden trend of materials and products should be routinely and frequently monitored and, if more heat-resistant microorganisms are identified, then method should re-validate and the potential effect of the microorganisms on pharmaceutical products already shipped from the plant need to be evaluated to ensure patient […]
Remdesivir is an experimental drug from drug maker Gilead that has shown to bring down the viral load on patients and hence help in faster discharge. The efficacy of the drug on severe patients is still under study. The drug, intravenously administered in hospitals, has already been approved for emergency use in severely-ill patients in […]
