Global contract development and manufacturing firm PCI Pharma Services (PCI) has announced a significant expansion of its facility in Tredegar, Wales designed to help keep pace with the market growth of powerful, targeted oncology therapies.
The expansion includes two new facilities dedicated to the manufacturing and packing of solid oral-dose tablets and capsules.
A second contained manufacturing building (CMF2), capitalising on the success of the original CMF1 which opened in 2013, will double large-scale processing capacity including dispensing and fluid bed granulation of high-potency solid-dose products at the commercial scale.
A new High Potent Pack Facility expansion at PCI Tredegar will deliver a 8,300 square foot, multi-product, three-storey facility delivering packaging capabilities from small-scale clinical through to large-scale commercial packaging of solid dose products containing highly potent drug substances.
The facility will include primary and secondary packaging capabilities and Serialization for commercial products with the primary and secondary packaging lines fully integrated to deliver one end-to-end line.
The primary bottling packaging line consists of a bottle unscrambling unit, desiccant inserter, tablet counter, and capping technology.
The secondary bottling packaging line consists of induction sealer, re-torque unit, bottle labeler, cartoner, check weigher, and Serialization carton aggregation.
The primary blistering line consists of a blister packer and online HAPA printer. The digital HAPA printer allows single colour, full artwork to be printed in one operation onto plain lidding foil.
The secondary blistering line consists of a cartoner and check weigher with the capability to add serialization carton aggregation.
Rebecca Coutts, general manager at the Tredegar site, told TCP&F “The SMEPAC target for both suites was set at 0.1µg/m3 over an eight hour Time Weighted Average (TWA) for coated tablets and 1μg/m³ over an eight hour Time Weighted Average (TWA) for uncoated tablets.
“This expansion complements the existing and newly expanded contained manufacturing capabilities located at the same site, providing a truly integrated, end-to-end solution for the manufacturing and packaging of highly potent drug substances for our global client base.”
Rodney Steel, BCMPA chief executive, added: “I was delighted to be invited to the opening ceremony and to see first hand this impressive new facility.”
PCI Tredegar, a BCMPA member, currently employs almost 500 people and is a major employer in the area. The expansion is expected to create up to 40 new jobs in the first year and add more as the facilities scale up.
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