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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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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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Results after a chemical decontamination cycle performed with vaporized H2O2

Abstract 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. Keywords: chemical bio-decontamination, hydrogen peroxide, […]
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