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The South Wales, UK contained-manufacturing operation was built in less than a year using design-to-manufacture and modular approaches.
Penn Pharma started up a new, contained-manufacturing facility for highly potent tablets and capsules at its South Wales, United Kingdom base, the company announced in a press release. The 15,000-sq ft facility was designed and built on a tight timeframe of less than one year.
“Our market assessment found a need for contained manufacturing of highly potent compounds to allow scale-up from small-scale to clinical and commercial batch sizes,” said Penn Pharma COO Mark Dean-Netscher in an interview with Pharmaceutical Technology. The new facility was can produce both small scale (1–10 kg) and larger scale (10–100 kg) batches.
Equipment was designed to be flexible. Intermediate bulk containers (IBCs), for example, for example, were designed for manufacture using geometric scale-up and ensuring that both small and large IBCs use the same size containment valves. The bulk containers can all be easily interchanged between small and large-scale processing. Equipment was also designed to reduce dependence on personal protective equipment by keeping all equipment under negative pressure and designing the equipment to be either disposable or cleaned or washed in place.
Penn Pharma used a design-to-manufacture approach that allowed the facility to be built in under a year. This approach included a focus on regulatory compliance, and the company took the initiative to obtain regulatory support and direction from the start of the project. “We engaged MHRA (Medicines and Healthcare Products Regulatory Agency) and met with them at each phase-concept, design, final layout, and selection of equipment-so that we were prepared for final approval,” explained Dean-Netscher. The design approach also included modular building concepts for cleanrooms and for heating-ventilation-air conditioning (HVAC) systems.