Chemical bio-decontamination

Chemical bio-decontamination
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.
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.
Decontamination with hydrogen peroxide: use and technical developments
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 of the hydrogen peroxide and its dosage control is presented.
Author: Mascherpa, Vittorio.
Could hydrogen peroxide decontamination affect the results of a sterility test?
A case study of hydrogen peroxide penetration through the load packaging: a customer required support for Ā«A Package Integrity VerificationĀ» which involved all the samples and consumables inside the Sterility Test Isolator.
Author: Bernuzzi, Maria Luisa.

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