For the production of tablets and capsules containing highly potent APIs
GEA Pharma Systems has secured an order for processing equipment from Penn Pharma based in Tredegar, South Wales.
The equipment is expected to significantly increase Penn Pharma’s production capacity and allow it to provide a single source for high containment development and manufacture of highly potent drugs for international customers.
Penn Pharma says the new production plant will give it a leading position in Europe 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 materials handling from Buck Systems based on Buck MC valves and Hicoflex; a PharmaConnect line for product formulation and high shear granulation and blending; FlexStream fluid bed technology; and the Modul P tablet press with an 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.
Penn Pharma has many years’ experience of manufacturing potent products and already has a dedicated containment facility. Mark Dean Netscher, chief operating officer, explained that last year the firm decided to expand manufacturing capacity.
‘Large pharmaceutical companies often have their own r&d facilities but choose to outsource larger volume production,’ he said. ‘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.’
Penn Pharma chose GEA equipment after a 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 Netscher.
‘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 new production facility is expected to be validated and running by the end of Q1 2013.