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PubMedDate not supplied

A method for demonstrating appropriate environmental protection for capping aseptically filled and plugged vials.

Conventional aseptic filling of drug product into vials ultimately includes a step that requires time and travel from the stoppering stage to the capping/crimping stage. Lyophilized product necessarily includes a partial stoppering step and, therefore, Grade A conditions. The level of environmental control that is required to protect the contents of fully stoppered, but uncapped, vials of sterile product from microbial contamination hasn't been formally defined. There is considerable range of opinion regarding this topic. This is the result of the lack of data that indicates the level of protection afforded by vials that are closed with a stopper, but that have not yet been capped. In order to provide some insight into the level of environmental control that is appropriate for vials at this stage of production, studies were conducted that consisted of exposing stoppered, uncapped vials containing sterile microbiological media to an aerosolized microbial challenge. The test samples were selected and assembled in such a way that a range of container/closure presentations was simulated. Furthermore, a microbial challenge was selected that was in excess of the environmental conditions to which product vials would be exposed. The results of this testing indicated a high level of confidence that stoppered, uncapped vials exposed to microbiologically challenging conditions would be expected to maintain the sterility of their contents.

Drug Contamination↗
PubMed2000

Establishing the true costs and benefits of environmental protection and enhancement in the aquatic environment

In the aquatic environment, a number of techniques are available to evaluate environmental benefits arising from improvements in water quality. However, such techniques do not account for the environmental costs of implementing a given quality change, for example those associated with the construction and operation of necessary treatment processes. Life cycle assessment is a technique that enables the nature of environmental impacts arising from the construction and operation of processes to be established. Although comprehensive assessment of all options is likely to be uneconomic, focusing on a number of key system inputs and outputs offers the possibility to include such impacts cost effectively in investment appraisal.

Journal Article↗