Single use systems, now widely used in pharmaceutical production, are for the most part made from plastic materials, and can be used to replace many of the fixed stainless steel components that previously predominated process equipment. The transition has facilitated a more flexible way of manufacturing pharmaceuticals and led to the current hot topic of continuous manufacturing. It allows rapid switching between different products in the same manufacturing suite, simply by exchanging one module for another once a run is complete.
The materials used for the disposable equipment must be fit for purpose and carefully qualified. It is usually wise to have at least two qualified vendors for all consumables, including single-use manufacturing equipment and components. The purchasing strategy must ensure that suppliers deliver equipment that has the same functionality and safety profile each time.
A safety assessment must be made to ensure that all the polymeric materials that come into contact with the drug product cannot contribute impurities that might migrate out of the material in the process stream. The result of the presence of such leachables might be toxicological effects in patients, or the substances might impact the drug’s efficacy. They could even cause production problems; if an antioxidant material leaches out into a bioreactor during a cell culture process, it could impact cell growth, thus having a major economic impact.
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