October 16, 2013

On 26 September, representatives from GEA Pharma Systems were present when CDMO Penn Pharma, in Tredegar, Wales, officially opened its new, purpose-built state-of-the-art facility for the development and manufacture of high quality oncology drugs. Representing an investment of £14 million, the company now offers a world-class, market leading, high-containment manufacturing plant for the production of multiple APIs in batches of 1–120 kg. An official representative of the Queen, Simon Boyle, the Lord Lieutenant of Gwent, was in attendance to mark the economic importance of the occasion.

Penn Pharma identified an increase in the number of potent molecules in the market and, therefore, the opportunity to provide an outsourcing solution for its customers regarding the development and production of potent solid dosage products. In response, the company 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.

Because of its proven track record in containment technology and process expertise in creating fully integrated production lines, 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 — using a design-for-manufacture approach — for containment.

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 not only 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 1,394 m2, 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 cumbersome isolation suits, thereby freeing up the staff and processes to enable enhanced production. 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. The entire production facility has been designed for maximum containment to ensure a safe working environment for the operators without the need for isolation suits.

Penn Pharma Chief Executive Officer Richard Yarwood commented: “The investment shows our commitment to this area and to our customers, who trust us to provide timely solutions for their needs. With this new facility, we will continue to build our reputation and be able to meet both the current and evolving needs of our clients.”

Penn Pharma Chief Operating Officer Mark Dean-Netscher added: “The new facility is key to bringing in greater efficiency and capacity to our operations. It’s another important step in our ongoing expansion. Our new facility ensures we are positioned to become a trusted partner to our customers who required contained services. Our strength lies in the fact that we can take highly potent compounds from molecule to market under one roof.”

Presenting a commemorative plaque to Richard Yarwood to mark the occasion, Frans Maas, Vice President, Sales and Marketing for GEA Pharma Systems, commented: “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.”

GEA Pharma Systems, +32 3 350 1293, pharma@gea.com, www.gea-ps.com.

October 16, 2013

Comments (2)

Comment Feed

containment tests

this manfacturing facility unit has obey the containment performance target (CPT) ande factory
acceptance test (FAT)

A.RAVITEJA REDDY 179 days ago

lay out and cost

this equipment or process approved by us FDA and how much space and money is need to construct this set up in india

ravi teja reddy 179 days ago

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