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EMA Annex 1 Draft Revision Comments from Industry Experts

Submission of comments on Revision of  ‘Annex 1: Manufacture of Sterile Medicinal Products’ Jim Agalloco, Russ Madsen and Jim Akers developed a comprehensive set of comments to the draft revision of Annex 1. The authors believe it is essential that the EMA receive comments that outline the difficulties that the draft presents. Their more than […]
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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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Moist-heat sterilization of blood bags

Abstract 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. Introduction In their complete configuration, Blood Bags (BBs) are sets of four bags; there are […]
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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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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 Material perspective Sterilizing processes should be a compromise between the degradation effect on the materials and destruction of […]
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