GEA used its expertise to eliminate the use of isolation suits
Representatives from GEA Pharma Systems were present when Penn Pharma officially opened its new, £14m purpose-built state-of-the-art facility for the development and manufacture of high quality oncology drugs in Tredegar, South Wales at the end of September.
Penn Pharma now operates a high-containment manufacturing plant for the production of multiple active pharmaceutical ingredients (APIs) in batches of 1–120kg.
The firm identified an increase in the number of potent molecules in the market and, therefore, the opportunity to provide an outsourcing solution for the development and production of potent solid dosage products. In response, it required a totally new concept in plant design, incorporating leading technology, the latest techniques and the ability to upscale operations from R&D, through pilot-scale testing, up to full production.
The high-containment production suite at Penn Pharma
Penn Pharma partnered with GEA Pharma Systems from the outset to develop an initial concept and select the technologies required, then co-operated with the engineering consultants to ensure that the plant was optimally designed for containment using a design-for-manufacture approach.
GEA’s approach was to use its containment expertise to eliminate the use of isolation suits in favour of containment interfaces (Buck MC high-containment valves and Hicoflex couplings). These would interface with GEA’s advanced granulation (FlexStream, PMA 150, PharmaConnect), containment and compression (Courtoy MODUL) technologies — all of which were incorporated into the new plant.
Compliant with the highest international standards of cGMP production, the new purpose-built 15,000ft2, three-storey site now offers a geometrically scalable dispensing, granulation and blending process from powder to capsule and has almost completely eliminated the need for isolation suits. Highly contained equipment trains were designed to minimise the need for personal protective equipment (PPE) and reduce the use of isolators to an absolute minimum.
Penn and GEA worked together to deliver an end-result on budget against a demanding timescale: the first product batch of coated tablets was delivered within 12 months of GEA receiving the initial order.
Presenting a commemorative plaque to Richard Yarwood to mark the occasion, Frans Maas, Vice President, Sales and Marketing for GEA Pharma Systems, said: 'We’re delighted to have been the partner of choice for Penn in this project. In recent years, we have supplied solid dosage processing lines globally, where containment expertise and process knowledge were the differentiating factors for our customer base to choose GEA Pharma Systems. This expertise and experience gives us confidence to be a leading technology partner for future projects in the constantly growing field of high potency drug manufacturing.'