Protected: Biological indicator failure during process validation is one of the critical events
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Tag: USCGMP
UNDERSTANDING Fphy OR EQUIVALENT EXPOSURE TIME AT 121°C
The F0 value of a saturated steam sterilisation process is the lethality expressed in terms of the equivalent time in minutes at a temperature of 121 °C delivered by the process to the load in its container with reference to micro-organisms possessing a theoretical Z-value of 10. ——- Equation 1.0 Lethality rate (L) = 10(T-Tref)/z […]
How to Plan a Shutdown for Clean Room Air Handling Unit?
Heating, ventilation, and air conditioning (HVAC) system consumed huge energy. Especially chillers, hot water generation, boiler operation consumed lots of energy. We can understand the qualification requirement from the table 1. Loosing microbial controls is very high due to unplanned shut down. An efficient design and qualification approach can help firm for long run. […]
With Pen and Paper
I always try to bring few important information or available information in a simplified way. After a long time I started work with Pen and paper and try to sketch and introduced few interesting topic.
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 […]
HOSTING REMOTE INSPECTION AT PHARMACEUTICAL FACILITIES
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 […]
Use TIMWOOD to overcome Challenges at Pharmaceutical Industries due to COVID-19
Investing time for Planning and give best effort to execution, is the best way to get success. Ensure doing correct in first time only, don’t waste time in duplication. Here I will explain TIMWOOD, it a took to eliminate or reduce wastes. We know different explanation available for TIMWOOD, but I will emphasize on the […]