Moist-heat sterilization

Moist-heat sterilization
Essentials of Steam Sterilization Kinetics
Steam sterilization kinetics is the base for a correct understanding of industrial practice of moist heat sterilization, but is a too often 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.
Author: Mascherpa, Vittorio.
Moist Heat Terminal Sterilization for Controlled Release Materials
Presentation Overview - Terminal Sterilization Fundamentals ■ Steam ■ Radiation ■ Current Best Practices ■ TS processes and approaches that everyone, including regulators can agree on ■ Current processes with a modest twist. Those may that create will likely create some angst ■ Expected Future Developments ■ Thinking outside the current box that might be a part of our future.
Author: Agalloco, James.
How does moist heat inactivate microorganisms?
Book chapter - Steam Sterilization: A Practitioner’s Guide (Ch.01)
Author: Moldenhauer, Jeanne.
Non-heat terminal sterilization of controlled released material
Presentation overview - A balance must be achieved between the need to maintain a safe, stable and efficacious product while providing sufficient lethality to attain a minimum level of sterility assurance •No sterilization method should be considered exempt •Sterilizing processes should be a compromise between the degradation effect on the materials and destruction of microorganisms •A sterilization process that destroys all microorganisms, but renders the item being sterilized unfit for use is of no value •The sterilization process and the specific product, formulation and container must all be suited to each other • There are few universal answers, and some of those that appear to be broadly applicable may be wrong.
Author: Agalloco, James.
F0 value - What it means, how to calculate it and how to use it in moist-heat sterilization
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.
Author: Mascherpa, Vittorio. Pistolesi, Dario.
Risk and feasibility of aqueous solutions sterilization
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 steam conditions (e.g. in “classical” steam autoclaves, without “counterpressure”) depends on a large amount of factors. The knowledge of the mechanical resistance of the material, of which the containers are made, is very important to ascertain whether the differential pressure shall be compensated for (and to which extent), or may not be compensated for.
Author: Mascherpa, Vittorio.
Sterilization of blood bags
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.
Author: Mascherpa, Vittorio.
Aqueous solutions in sealed containers: internal pressure under autoclaving
This article is a technical support to the practice of autoclaving aqueous solutions in sealed containers. Two “classical” scientific contributions on the matter are due to Beck and to M. A. Joyce & J. W. Lorenz which are referred in the article. In this article, metric units (abs bar or abs mbar) are used for the pressure. KEYWORDS: moist-heat sterilization, steam sterilization of aqueous solutions, sealed containers, headspace volume, internal pressure, autoclaving, autoclave, superheated water sterilizers, steam/ air mixture sterilizers
Author: Mascherpa, Vittorio.
Practical issues on PFS sterilization: an analysis of critical aspects
Prefilled syringes offer several advantages over traditional packaging in vials. For example, microbial contamination is minimized due to less manipulation.This presentation discusses a method for sterilizing PFSs through a moist heat process, the most common and approved method used by pharmaceutical facilities for this type of products. The main issues to consider while sterilizing PFSs with a moist heat process are described.
Author: Bernuzzi, Maria Luisa.
An innovative way to thermally sterilize Hyaluronic Acid Pre-filled Syringes
Several reports on degradation of HA involving microwaves, UV or γ-rays have been published. Rheological studies also show that HA solutions degrade at high temperature: viscosity of the solutions decreases in time as a function of temperature. Therefore, the thermal sterilization treatment of HA solutions represents a great challenge. An optimized moist-heat sterilization cycle can minimize product degradation (and change of molecular weight) maintaining the required viscosity for the specific application.
Author: Bernuzzi, Maria Luisa. Gori, Andrea.

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