Pre-filled syringes (PFSs)

Could hydrogen peroxide decontamination affect the results of a sterility test?
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.
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.
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.
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.


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