Calculation of Spore Log reduction (SLR) from VHP (vaporized hydrogen peroxide) qualification in a pharmaceutical aseptic processing isolator The formula to calculate Spore Log Reduction (SLR) from VHP (vaporized hydrogen peroxide) qualification in a pharmaceutical aseptic processing isolator is: SLR = Log10…
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 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
The words “plant shutdown” — even if referring to a temporary one — can be associated with a long litany of negatives. Stopping production, no matter the duration, results in decreased revenue. The additional resources and other costs associated with the shutdown…
read moreOne of the key advantages of using an isolator for an aseptic processing application is that it makes a physical barrier between the operator and the core aseptic processing area. Additional main benefit is that an isolator can be totally sealed before…
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#483#biotech#FDA#Injectable#MHRA#Palash#Palash chandra Das#Palash Das#Parenteral#Pharma#PRES#Rationale for using triplicate biological indicators during VHP decontamination in Isolator#Steam sterilizer#sterilisation#sterility#sterility assurance#sterilization#sterilizer#USCGMP#USFDA#warning letter#WHO
The Indian pharma industry is on a good growth path and is likely to be in the top 10 global markets by value by 2020. High burden of disease, good economic growth leading to higher disposable incomes, improvements in healthcare infrastructure and…
read moreSoftware Classification Categories Comparison of software categories in GAMP 4 and GAMP 5 As I mentioned earlier, the software categories in GAMP 5 have been revised. To appreciate the scope of these changes fully we need to look at the classification of…
read moreSmoke study or air flow visualization is the important factor in clean room qualification. My query to some experts were as following 1. What will be the requalification frequency for Smoke study?2. If there is no significant changes in the clean room…
read moreRecommendation Airflow velocity measurements should be taken at locations where meaningful and reproducible results can be obtained. This typically at a distance of 15-30 cm from the filter face. Rationale for Recommendation The primary reason for airflow velocity measurements in unidirectional airflow areas (e.g, area where products , product contact packaging components,…
read moreHow to calculate conveyor speed in Tunnel? Dry heat is used for sterilization instead of the much more efficient moist heat because some materials are sensitive to moisture. Dry heat is often used to ensure that glass and other laboratory equipment is…
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