Category: Steam Sterilizer

Cycles for steam sterilisation and post-aseptic processing terminal heat treatment

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| Steam Sterilizer, Sterility Assurance, Validation

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 […]

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UNDERSTANDING Fphy OR EQUIVALENT EXPOSURE TIME AT 121°C

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| Steam Sterilizer, Sterility Assurance, Technology, Validation

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                                                                               […]

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Mystery of Bio-burden over moist heat terminal sterilization process journey

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| Steam Sterilizer, Sterility Assurance

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 […]

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Growth in BI at Moist Heat Terminal Sterilization

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| Drug regulatory and guidelines, Steam Sterilizer, Technology

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 […]

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Trouble with Equilibration Time

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| Steam Sterilizer, Technology

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 reduction of the equilibration time. Based on the all demonstrated study in the […]

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Analyzing HPHV cycle in steam sterilizer

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| Steam Sterilizer
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This article is based on the practice experience gained by performing hundreds of validation test conducted on the dozen of steam sterilizer of various manufacturer. It is primarily intended that personnel who performed validation testing on steam sterilizer may benefit from these experience, and that it will assist in ensuring a high level of compliance […]

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Global Challenges for Indian Pharmaceutical Industry

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| Interview & Placement, News Updates, Quality Assurance, Steam Sterilizer, Validation

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 improved healthcare financing are driving growth in the domestic market. Pharma companies are […]

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Basic Check Points Of Autoclave Validation

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| Quality Assurance, Steam Sterilizer

The success of sterilization is dependent upon the performance reliability of the autoclave. Validation of effectiveness includes monitoring temperature, pressure and cycle duration time for each cycle and providing periodic sterilization/decontamination challenges (quality assurance), i.e. use of biological indicators. A logbook should be maintained to record autoclave use and be available for inspection. Temperature: This […]

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