Protected: Biological indicator failure during process validation is one of the critical events
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Tag: cGMP
Chance of Positive BI during Sterilization
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 […]
Mystery of Bio-burden over moist heat terminal sterilization process journey
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 […]
Growth in BI at Moist Heat Terminal Sterilization
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 […]
Vaccine manufacturing process
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 […]
A Tale of Infection
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 […]
Defining log reduction based on Product specific bio-burden approach
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 […]
Contributions Indian Pharma Industry to fight against COVID-19
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 […]
What? And How in Pharmaceuticals ?
The most important word in the pharmaceutical industry. Usually number of audit concluded based on the “What” and How? Few important examples are quoted below, What is the equipment requalification frequency? What is the HEPA replace frequency? What is the calibration frequency? Once you provide the reply of their next question will be, how you […]