June 6, 2012 -- GEA Pharma Systems has secured a high value order for processing equipment with Penn Pharma based in Tredegar in South Wales. The new equipment will significantly increase the pharmaceutical contract manufacturer’s production capacity and allow it to provide a single source for high containment development and manufacture of highly potent drugs for its international customers.
Penn Pharma believes that the new production plant will give it a leading position in Europe as the contract manufacturer best able to provide high containment manufacturing for the development, clinical trial supply and commercial production of tablets and capsules containing highly potent APIs (such as cancer drugs, hormones and steroids).
The GEA equipment includes highly contained materials handling from Buck® Systems based on Buck® MC valves and Hicoflex®; a PharmaConnect® line for product formulation and for production high shear granulation and blending; FlexStream™ fluid bed technology; and the MODUL™ P tablet press with the unique Exchangeable Compression Module that keeps all the product contact parts within a sealed unit. The entire production facility is being designed for maximum containment to ensure a safe working environment for the operators without the need for isolation suits. This meets the demands of the pharmaceutical industry and health and safety organisations to provide contained engineering as the primary means of protecting operators and the wider environment.
Penn Pharma has many years’ experience of manufacturing potent products and already has a dedicated containment facility. Mark Dean Netscher, the company’s COO, explained that last year they decided to expand manufacturing capacity to provide pharmaceutical companies with a unique partner. “Large pharmaceutical companies often have their own R&D facilities but choose to outsource larger volume production,” he explained. “There are few companies around the world that are capable of providing the quality and range of capacities required, while ensuring the high levels of containment without resorting to cumbersome isolation suits. Today, those old ways are just not acceptable.”
Jerome Detreille, Senior Director New Business Development said that those companies are looking to consolidate the number of suppliers. “We felt it was essential to provide high quality production facilities under one roof to allow us to handle a much broader range of potent APIs with less reliance on protective equipment.”
Penn Pharma chose GEA equipment after a comprehensive, competitive tender. “We believe GEA gave us the best balance of productivity and compliance to be able to produce a good quality product in a safe, contained and compliant manner,” said Mark. “Also many large pharmaceutical companies use GEA equipment themselves therefore there can be no question in our customers’ minds that our technology is of the highest level.”
The company believes that its new facility will be leading edge and a vitally important resource for the world’s leading pharmaceutical companies. “Not only will we have increased capacity, we will also be able to provide scale-up capability from small-scale development batches, through clinical trials requirements, right up to commercial production in one facility using the same equipment as many of our customers and using the latest engineering controls to maintain a clean environment that does not expose people to harm,” explained Jerome. “Not having to worry about the environmental impact is a key concern of big pharmaceutical companies and an essential component in their ability to maintain their increasingly stringent corporate ethical responsibilities.”
The new production facility is expected to be validated and running by end Q1 2013.
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Photo: The Penn Project team, left to right; Kate Smith, Project Validation Leader; Rory Jones, New Manufacturing Facility Start-Up Manager; Mark Dean-Netscher, Chief Operating Officer; Silvia Andrei, Project QP/Regulatory Leader; Jerome Detreille, Business Development Director; Agata Jankowska, Business Development Marketing Associate; Dilwyn Patterson , GEA.