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Current USP Perspectives on Sterilization & Sterility Assurance

Sterilization, Sterility Assurance & Sterility Testing. What’s on the Horizon? Who’s on the MSA Committee? James Akers, Ph.D., AK&A, Chairman  Scott Sutton, Ph.D., Vectech, Vice-Chair  James Agalloco, A&A Ivan Chin, Ph.D., J&J Anthony Cundell, Schering Plough J. Kirby Farrington, Ph.D., Eli Lilly Dennis Guilfoyle, Ph.D., FDA ORA David Hussong, Ph.D., FDA CDER Leonard Mestrandrea, Ph.D., […]
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Continued process verification methods in cleaning validation TOC

Abstract An increasing interest in continued process verification has brought to the spread of on-line assay methods in cleaning processes [1]. This paper deals with two different on-line applications: conductivity sampling and the Total Organic Carbon analysis for washing machines. Keywords: moist-heat sterilization, steam sterilization of aqueous solutions, sealed containers, headspace volume, internal pressure, autoclaving, […]
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Results after a chemical decontamination cycle performed with vaporized H2O2

Abstract This article discusses the challenge of the unexpected growth of a positive biological indicator in a chemical decontamination cycle. Specific features to be considered regarding biological indicators used for the validation of decontamination cycles are presented. Some practical solutions are suggested to avoid the risks related to false positives. Keywords: chemical bio-decontamination, hydrogen peroxide, […]
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Chemical Surface Bio- Decontamination Applied to Material Transfer into Sterile Enclosures

Presentation outline Material transfer to sterile suite issue and available technologies; Surface bio-decontamination drivers; QbD and risk assessment and mitigation overview; Surface chemical bio-decontamination cycle; Cycle validation approach; The material transfer issue… It is critical to adequately control material (e.g., in-processsupplies, equipment, utensils) as it transfers from lesser to higher classified clean areas to prevent […]
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ISO 14644 – Revision to Parts 1 and 2

Actions and implications of the changes in the International cleanroom standard. ISO 14644 ISO 14644 International cleanroom standard  Part 1 in 1999 12 part standard Electronics, healthcare, biotechnology, pharmaceuticals Replaced FS 209E in 2001 Accepted by EU GMP in 2003 for classification but not monitoring FDA aseptic filling guide in 2004. ISO 14644 – parts […]
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Aseptic Processing – Achieving Sterility by Design

Abstract Informal risk mitigation brought about the technology advances seen in aseptic processing. Confidence in aseptic processing is not derived from monitoring or testing; it is the result of attention to detail in aseptic processing design. With newer technologies the emphasis must shift even farther from monitoring & testing.   Aseptic Processing Definition “Handling sterile […]
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