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 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 moreTerminal 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
India always stand in the first row whenever there is a chance to serve for humanities and social welfare. Pharmaceutical sectors in India is one of the highest contributing segments, firms are not only generating revenue and also serving patients across the…
read moreThe 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 moreVaccines 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…
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
Understanding and analysis of Equilibration Time will tell, how your cycle is consistent. Recently an article in PDA journal (1) was published to understand the impact of the following autoclave variables on the consistent measurement of the equilibration time and on the…
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