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read moreThe 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…
read moreHeating, 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….
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#483#and air conditioning (HVAC) system consumed huge energy. Especially chillers#biotech#FDA#GMP#Handling Planned Shutdown of Clean Room Air Handling Unit?; Palash Chandra Das#Heating#hot water generation#Injectable#MHRA#Palash#Palash chandra Das#Palash Das#Parenteral#Pharma#PRES#Steam sterilizer#sterilisation#sterility#sterility assurance#sterilization#sterilizer#USCGMP#USFDA#ventilation#warning letter#WHO
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.
read moreUnderstanding 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….
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#483#autoclave#Bacillus stearothermophilus#Bacillus subtilis#Bio burden#biotech#cGMP#COVID#COVID-19#Favipiravir#FDA#Geobacillus#Geobacillus stearothermophilus#GMP#INDIA#Injectable#MHRA#Palash#Palash chandra Das#Palash Das#Parenteral#Pharma#PRES#Steam sterilizer#stearothermophilus#sterile#sterilisation#sterility#sterility assurance#sterilization#sterilizer#USCGMP#USFDA#warning letter#WHO
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…
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#483#autoclave#Bacillus stearothermophilus#Bacillus subtilis#Bio burden#biotech#cGMP#COVID#COVID-19#Favipiravir#FDA#Geobacillus#Geobacillus stearothermophilus#GMP#INDIA#Injectable#MHRA#Palash#Palash chandra Das#Palash Das#Parenteral#Pharma#PRES#Steam sterilizer#stearothermophilus#sterile#sterilisation#sterility#sterility assurance#sterilization#sterilizer#USCGMP#USFDA#warning letter#WHO
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…
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#483#autoclave#Bio burden#biotech#cGMP#COVID#COVID-19#Favipiravir#FDA#GMP#INDIA#Indian Pharmaceutical Industry to support a pandemic crisis with hydroxychloroquine#Injectable#MHRA#Palash#Palash chandra Das#Palash Das#Parenteral#Pharma#PRES#Steam sterilizer#sterile#sterilisation#sterility#sterility assurance#sterilization#sterilizer#USCGMP#USFDA#warning letter#WHO
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…
read moreInvesting 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….
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