As market demand for advanced biopharmaceuticals continues to grow so do the demands placed upon modern aseptic processing, and primarily of parenterals such as vaccines. Quality of the final product remains of upmost importance, putting the techniques involved in ensuring sterility during manufacture under the spotlight. The current techniques adopted to ensure this fundamental requirement is met primarily consist of high classification cleanroom areas and barrier/isolator technology, coupled with validated sterilisation or decontamination processes to ensure both product and components within the critical areas can be maintained at the required sterility assurance level (SAL).
Arguably the most challenging aspect of handling components (such as vial stoppers) and powder-form product lies in the transfer of these materials from process to process. Personnel contaminants and operator error are among the greatest sources of microbial contamination, driving the need for the transfer method not only to be enclosed but also to ensure minimal operator intervention. Specific techniques are also required to achieve optimum results.
A current method for such batch transfer processes utilises alpha beta port technology, which offers a common transfer interface between processes. With any transfer device of this nature the decisive detail lies in how the device can eliminate or minimise the volume and frequency of interfacing surfaces that are first exposed outside the critical area and subsequently exposed inside the process, thus decreasing the risk of bioburden. The device must be adapted to allow steam sterilisation or decontamination in place while ensuring a sealed environment before, during and after the transfer.
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