A history of isolator and containment technology, Part 6: Development of the validation of isolators

Abstract This final section is devoted to the development of various validation methods conforming to GMP when applied to isolators and also a review of the methods in relation to validating the processes used in preparing for aseptic processing and sterility testing. There are brief comments on what the regulators expect. Early aspects Validation, as far […]

author: Thorogood Doug

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., […]

author: Agalloco James

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, […]

author: Ferretti Sara

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, […]

author: Bernuzzi Maria Luisa

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 […]

author: Mauri Sergio

ISO 14644 – Revision to Parts 1 and 2

Actions and implications of the changes in the International cleanroom standard.

author: Sandle Tim

Aseptic Processing Risk Assessment: The Simplified Akers-Agalloco Method

Abstract This method is an effort to assess risk in aseptic processing. We believe because we have broadened the perspective of risk relative to aseptic processing that if nothing else we have increased awareness that risk can vary substantially in what are perceived by many to be equivalent (and thus equally acceptable) practices and technologies. […]

author: Agalloco James and Akers James

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 […]

author: Mascherpa Vittorio

Risk Analysis for Aseptic Processing: The Akers-Agalloco Method

Abstract Aseptic processing is considered by many in this industry to be among the more difficult activities to execute properly. The number of variables that affect the safety of sterile products manufactured aseptically is substantial. In the design and operation of an aseptic production facility, it is essential that risk to the patient be minimized. […]

author: Akers James and Agalloco James

A history of isolator and containment technology, Part 6: Development of the validation of isolators

Current USP Perspectives on Sterilization & Sterility Assurance

Continued process verification methods in cleaning validation TOC

Results after a chemical decontamination cycle performed with vaporized H2O2

Chemical Surface Bio- Decontamination Applied to Material Transfer into Sterile Enclosures

ISO 14644 – Revision to Parts 1 and 2

Aseptic Processing Risk Assessment: The Simplified Akers-Agalloco Method

Aseptic Processing – Achieving Sterility by Design

Risk Analysis for Aseptic Processing: The Akers-Agalloco Method

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