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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

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 […]
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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.
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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 […]
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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. The F0 algorithm was first introduced in 1968 in […]
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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 […]
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How does moist heat inactivate microorganisms?

Book chapter – Steam Sterilization: A Practitioner’s Guide (Ch.01) Chapter summary WHAT DO WE MEAN BY MOIST HEAT STERILIZATION? COMPARISON OF MICROBIAL SENSITIVITY MECHANISMS OF INACTIVATION – Vegetative Cells – Bacterial Spores -Bacterial Spores Defined -Spore Characteristics – Spore Formation – Mineralization – The Transition from Spore to Vegetative Cell – Thermal Injury to Spores […]
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