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EMA Annex 1 Draft Revision Comments from Industry Experts

Submission of comments on Revision of  ‘Annex 1: Manufacture of Sterile Medicinal Products’ Jim Agalloco, Russ Madsen and Jim Akers developed a comprehensive set of comments to the draft revision of Annex 1. The authors believe it is essential that the EMA receive comments that outline the difficulties that the draft presents. Their more than […]
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Could hydrogen peroxide decontamination affect the results of a sterility test?

A case study of hydrogen peroxide penetration through the load packaging A case study of hydrogen peroxide penetration through the load packaging: a customer required support for «A Package Integrity Verification» which involved all the samples and consumables inside the Sterility Test Isolator. USP 39, General Chapter 1208 Sterility testing – Isolators Systems Package Integrity […]
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Decontamination with hydrogen peroxide: use and technical developments

ABSTRACT This article compares the concepts of sterilization, disinfection and decontamination with reference to the different scopes thereof. Decontamination by hydrogen peroxide vapor and its use for conditioning the Sterility Test Isolators are discussed. A technologically new method for the vaporization ofthe hydrogen peroxide and its dosage control is presented. Keywords: Sterilization, sterile, disinfection, chemical […]
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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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