As single-use, or disposable, technology becomes established in labs and manufacturing facilities, it's beginning to have an impact on manufacturing practices. Sterilization provides a case in point, according to Pharmaceutical Processing magazine.
For one, most single-use components arrive pre-sterilized, saving manufacturers a step while also minimizing the validation effort and reducing the time required for post-sterilization holding, according to the article.
Use of pre-sterilized components, in turn, is driving greater use of rapid surface sterilization for packaging materials, the article says. And that's being accompanied by use of pre-sterilized packaging.
The upshot for manufacturers is that sterilization is becoming less of a burden for them as it becomes a responsibility for single-use component suppliers. Of course, manufacturing quality is always the responsibility of the manufacturer, regardless of which products and services it uses. But components and packaging that arrive pre-sterilized, even though they have to be checked, allow for time- and process-cost savings.
The transfer of sterilization responsibility to suppliers may also bring with it changes in sterilization methods, the article says. "A disposable product supply line is likely to be gamma irradiated or sterilized with ethylene oxide by the supplier, whereas the end user would have processed it through a steam autoclave," says Paul Stewart of Telstar Life Sciences, in the article.
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