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Transient overheating in empty autoclave chambers

Abstract The transient overheat in empty autoclave chambers is a phenomenon that frequently occurs during validation studies. This article by Italian sterilization practitioner Vittorio Mascherpa investigates the main causes of it and suggests some methods to prevent it or to cope with it. The article also includes a useful table of superheating effects due to […]
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Highlights on F0

Abstract This paper summarizes the concept of F0 and its related parameters (D, z). Essential notions on sterilization kinetics are explained. The idea of physical and biological “equivalent time” is presented and its application in moist-heat sterilization processes is discussed.   Introduction It has been experimentally shown that the reaction of thermal degradation of microorganisms […]
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What is a sterilization autoclave?

ABSTRACT This short article is an introduction to the basic selection of sterilization autoclaves. It defines this type of equipment, summarizes the varieties available and discuss the preliminary problems to cope with in specification and design of sterilization autoclaves. GENERALS Both thermal and chemical actions are suitable for sterilization. Thermal sterilization of pharmaceutical products may […]
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Moist-heat sterilization of blood bags

Abstract This article provides basic information on the sterilization of blood bags systems by moist-heat. Problems of pressure compensation and steam penetration into the system parts without water inside, and the process choice between single and double autoclaving are discussed. Introduction In their complete configuration, Blood Bags (BBs) are sets of four bags; there are […]
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Risk and feasibility of aqueous solutions sterilization

Abstract This article is intended as a basic introduction on feasibility and risks of autoclaving aqueous solutions in sealed containers. Another article, Aqueous solutions in sealed containers: internal pressure under autoclaving, provides a technical approach to the matter. The feasibility and the level of risk of autoclaving sealed containers of liquid solutions under pure saturated […]
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F0 value – What it means, how to calculate it and how to use it in moist-heat sterilization

Introduction The purpose of this Fedegari Technical Note, firstly distributed in 1988 and perseveringly revised, is to clarify the nature of F0 and its related parameters (D, z, PNSU/SAL), and to explain their use and limits for the setting, adjustment, control and validation of moist-heat sterilization processes. The F0 algorithm was first introduced in 1968 […]
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Essentials of Steam Sterilization Kinetics

ABSTRACT Steam sterilization kinetics represent the base for a correct understanding of industrial practice of moist-heat sterilization, but is often a neglected topic. This article by the well-known Italian sterilization practitioner Dario Pistolesi and his former assistant Vittorio Mascherpa provides a simple but rigorous introduction to it and is preliminary and propaedeutic to any useful […]
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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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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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