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208,861
2024-07-01 to 2026-02-28
Collaborative R&D
Contamination control is pivotal in safeguarding biomanufacturing processes to ensure product integrity, environmental protection and worker health and safety. Now with the new Annex 1 regulations being rolled out, Contamination control strategies (CCS) have been spearheaded back to the forefront, requiring biomanufacturing facilities to revisit their CCS and up their game. Combined with these new regulations, organisations are shifting their processes calling for quicker, more modular systems requiring handling of more potent and complex powder formulations which need to be aseptically (sterile) prepared. The current go-to solutions are high capital cost aseptic environments such as cleanrooms combined with expensive transfer equipment requiring significant training and maintenance to ensure that the appropriate levels of containment are achieved. These products are currently used upstream of the aseptic processes as they are unable to maintain sterility without the required infrastructure/processes around them. Due to these limitations these products only partially solve part of the process (dust containment) and are unable to be used as an end-to-end containment system required for the complete drug manufacturing process. Steriflow Express will be a single use device that will allow customers transfer pharmaceutical powders aseptically multiple times throughout a typical powder batch transfer required for API manufacture. Its inbuilt integrity will allow it to be used as an end-to-end containment system throughout the process. The device will: 1.Significantly reduce the environmental footprint for customers by facilitating a transition from time-consuming transfer processes, which currently demand substantial quantities of water and chemical cleaning for clean and contamination-free transfers. Our solution enables a swift shift to a readily available, off-the-shelf sterile product, eliminating the need for excessive resources and enhancing manufacturing efficiency through its 'Single Batch use' design rather than Single Use. 2: Be extremely simple and intuitive to use, thus reducing training requirements which will inevitably reduce product contamination/sterility assurance and health and safety risks due to the nature of the product being transferred. 3\. Improve productivity and reduced time to market by lowering the high capital investment required for space and equipment to perform the current processes as well as simplify the time consuming processes required to maintain the current process sterile and contamination free.