Validation

ISO 14644 - Revision to Parts 1 and 2
Actions and implications of the changes in the International cleanroom standard.
Author: Sandle, Tim.
Risk Analysis for Aseptic Processing: The Akers-Agalloco Method
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. This article presents a new approach to risk assessment for aseptic processing that emphasizes the contributions of personnel.
Author: Akers, James. Agalloco, James.
Aseptic Processing Risk Assessment:The Simplified Akers-Agalloco Method
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. Akers, James.
Aseptic Processing – Achieving Sterility by Design
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.
Author: Agalloco, James.
Current USP Perspectives on Sterilization & Sterility Assurance
Sterilization, Sterility Assurance & Sterility Testing. What’s on the Horizon?
Author: Agalloco, James.
Chemical Surface Bio- Decontamination Applied to Material Transfer into Sterile Enclosures
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;
Author: Mauri, Sergio.
Continued process verification methods in cleaning validation TOC
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.
Author: Ferretti, Sara.
Results interpretation after a chemical decontamination cycle performed with vaporized H2O2
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.
Author: Bernuzzi, Maria Luisa.

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