Slogans or Quotes of the day
1. Earning is the by-product of learning.
Cycles for steam sterilisation and post-aseptic processing terminal heat treatment
Sterilization Process Advisor – Tool Overview and Instructions The Sterilization Process Advisor is a simple and interactive tool designed to help users evaluate sterilization cycles, process hold temperatures, and understand the required information for quality dossier submissions. The tool provides tailored recommendations based on selected sterilization cycles and entered temperature values. <<<<Link for using the […]
How can AI use to assure Sterility Assurance?
AI can play a crucial role in assuring sterility for sterile products manufacturing by improving various aspects of the process. Here are some ways AI can be utilized to enhance sterility assurance: By integrating AI into the sterile products manufacturing process, companies can improve the overall sterility assurance, minimize contamination risks, and enhance the quality […]
Calculate Spore Log Reduction (SLR) for VHP (vaporized hydrogen peroxide) qualification studies in a pharmaceutical aseptic processing Isolator
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 (N0/Nt) Where: N0 = The initial number of spores of the test organism […]
Q&A On Sterility Assurance
#1. Why sterility assurance need to be ensure for sterile pharmaceutical preparations ? Sterility assurance is a crucial aspect in the production of sterile pharmaceutical products. It is the assurance that the final product is free of any viable microorganisms, which can cause harm to the patients. Ensuring the sterility of pharmaceutical products is important […]
Protected: Biological indicator failure during process validation is one of the critical events
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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.