External and internal differences in pressure of prefilled syringes can cause plunger
movement during sterilization, which might cause drug product contamination …

INTRODUCTION A sterile medical product is one that is free of viable microorganisms. Most
medical products produced under standard manufacturing conditions according to the FDA …

The use of steam as a sterilizing media for rigid, fixed volume containers is routine. When
applied to less rigorous packages this process can cause package failure and product …

Sterilization Validation of disposable syringe components presents unique process
requirements due to component design and required mechanical attributes. These include …

Sterile products have several unique dosage form properties, such as freedom from micro-
organisms, freedom from pyrogens, freedom from particulates, and extremely high standards …

Purpose. The direct influence of environmental cleanliness and risk manipulations on
prepared syringes was evaluated. Methods. Media-fill testing was used to estimate potential …

A sterile active ingredient plant and a sterile finished dosage filling plant both comprise very
complex production processes and systems. The sterility of the final product cannot be …

This chapter discusses methods and equipment for the sterilisation of medicinal products,
medical devices, and utensils. Sterilisation is an active, validated process to kill …

Some microbiological validation procedures for sterile drug production are described. There
concern the environmental microbial and particle" self-decontamination" time specified in …

This chapter discusses sterilisation methods and equipment for the sterilisation of medicinal
products, medical devices and utensils. Sterilisation is an active, validated process in order …