Pharma - Liquids

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.
What is a sterilization autoclave?
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.
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.
Current USP Perspectives on Sterilization & Sterility Assurance
Sterilization, Sterility Assurance & Sterility Testing. What’s on the Horizon?
Author: Agalloco, James.
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.
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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