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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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An innovative way to thermally sterilize Hyaluronic Acid Pre-filled Syringes

Several reports on degradation of Hyaluronic Acid (HA) involving microwaves, UV or γ-rays have been published. Rheological studies also show that Hyaluronic Acid (HA) solutions degrade at high temperature: viscosity of the solutions decreases in time as a function of temperature. Therefore, the thermal sterilization treatment of Hyaluronic Acid (HA) solutions represents a great challenge. […]
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Practical issues on PFS sterilization: an analysis of critical aspects

Introduction Prefilled syringes (PFS) 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 […]
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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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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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