Just-in-time operation for pharmaceuticals is running at Scotland’s new innovation centre

Sewtec says its modular line can offer a dramatic reduction in time-to-market while also meeting exacting standards of hygiene without the need for an entire ISO-class cleanroom. 

The Pharmacy Automation for Clinical Efficiency (PACE) system, which Sewtec calls “an innovative solution to drastically reduce time-to-market for new medicines”, was installed at the Medicines Manufacturing Innovation Centre (MMIC) in Scotland, earlier this year.

PACE allows the MMIC to fill containers with different drug types, in tablet or capsule form, says Sewtec, without the risk of cross-contamination, while ensuring full traceability throughout the process.

This multi-million-pound turnkey system consists of several individual modules, each designated for specific operations such as handling, filling, sealing, weighing, marking, labelling, and packing. A distinctive feature of this system is its ability to adhere to stringent pharmaceutical hygiene and cleanliness standards without requiring the entire system to be situated in an ISO-class cleanroom environment.

Sewtec business manager for PACE Lee Manning explains that multiple small runs can be delivered quickly and efficiently under cleanroom conditions.

“Crucially, while of course the whole packing line still needs to be in a cleanroom environment, only one cleanroom is now required to pack multiple drug types and formats,” he spells out. “For the clinical trials industry, PACE opens the door for more trials per year, as well as more diverse trials by having the ability to trial multiple doses and strengths simultaneously.”

As Sewtec makes clear, clinical trials need to be carefully controlled at every stage. “This inevitably makes them expensive and time-consuming to run,” says Manning. “One of the biggest issues facing pharmaceutical manufacturers is maintaining a cleanroom environment during packing - and this is exactly what our patented PACE technology does.”

PACE features include: modular filling, which can easily be removed for decontamination; inline, camera-verified label printing; scalable architecture; filling station design allowing multiple drugs to be handled in parallel, in one cleanroom; and a web-based quality process (QP) dashboard, for reviewing verified data and authorising batch release. 

In the future, says Sewtec, further drug types will be supported with the development of a filling station for liquids.

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www.sewtec.co.uk