Thursday, 7 October 2021

Applications of aseptic connectors


 

The application of single-use, sterile and disposable technology is encouraged by regulators, as the draft to EU GMP Annex 1 indicates. Such technology can increase the level of sterility assurance and reduce the environmental impact of processing at the pharmaceutical facility. Aseptic connectors (and disconnectors) are an important example of such technology, permitting the continuation of the fluid path by using devices designed to ensure no microbial contamination ingress. With aseptic processing, any connection undertaken post- sterilizing grade filter is of particular importance.

 

It is necessary for pharmaceutical manufacturers implementing aseptic connectors (or changing from one supplier to another) to evaluate the robustness of the connector and its ability to connect, plus aspects of the weld, and the sterilization method, as part of the Contamination Control Strategy. This article considers the microbial risk factors and the areas to examine, which can be used as the basis of questions to be directed at an aseptic connector supplier as part of the quality audit process. There are other considerations for aseptic connectors, which need to be considered as part of Quality by Design, such as product interactions through leachables and extractable testing, disinfectant compatibility, particulate release, and the design ergonomics. While important, these are not addressed in this article; the focus here is with microbial control.

 

On this topic, Tim Sandle has written an article:

 

Sandle, T. (2021) Microbial Considerations for the Selection of Aseptic Connectors, American Pharmaceutical Review, 24 (3): 16-20 At: https://www.americanpharmaceuticalreview.com/Featured-Articles/575211-Microbial-Considerations-for-the-Selection-of-Aseptic-Connectors/

 Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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