Penn Pharmaceutical’s Tredegar plant is located in the Tafarnaubach Industrial Estate in Gwent, South Wales, UK. Launched in 1986, the Tredegar facility has been in operation for more than 20 years, and is FDA inspected and licensed by the MHRA. The plant is undergoing a £12m expansion aimed at increasing capacity and improving the efficiency of the plant. Penn Pharmaceuticals plans to boost sales by 20% annually, having registered £23m in sales revenues in 2008.
The expansion was announced in March 2009 and will be carried out over a period of five years. Plans for the expansion will be finalised during the five years with Penn Pharmaceuticals completing the upgrades to support its growth. The expansion will be funded by the Welsh Assembly Government’s Single Investment Fund. It will result in the creation of 133 new jobs over the next five years besides safeguarding 111 existing jobs.
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Expansion
The first phase of the expansion was completed in November 2009. During the first phase, Penn Pharmaceuticals reorganised its infrastructure for transport and delivery to offer a smooth flow of process, materials and people. The phase resulted in extending the site by 2,400m².
During the expansion, the site externals, delivery and collection points were altered, which facilitated the creation of more efficient internal factory processes. The first phase has cost £315,000.
In March 2010, the company broke ground on the second phase of expansion that will oversee the construction of a cold storage facility. Scheduled for completion by the end of September 2010, the 2°C-8°C cold storage facility will be extended by 15,000ft², large enough to accommodate the secondary packaging and labelling processes of products that require this environment.
The facility, validated to operate on any two of the four refrigeration units available, will be powered by an essential services electricity supply that will ensure 100% power back up for the site. The second phase will be completed at an estimated cost of £200,000.
Additional phases of expansion will include the extension of the existing building to enhance and expand clinical and contract manufacturing services, laboratories renovation and relocation of the staff restaurant.
Facility
The Tredegar facility is spread over 60,000ft² and accommodates 16 class 100,000, cGMP-compliant manufacturing suites, six GMP-compliant secondary packaging suites and four containment suites. There is one high containment suite dedicated for the production and processing of high potent molecules. The high containment suite features double airlock, single-pass HVAC and safe-change EU 13 HEPA filters. It includes an isolator for dispensing of the highly potent active pharmaceutical ingredient (API) and chargepoint valves that allow contained transfer of API. The facility additionally houses a low humidity clean room.
The facility is fully equipped to support manufacturing of solids, liquids and semi-solids. Equipment for solid dose manufacturing includes high shear mixer / granulators, fluid-bed dryers and single-bowl mixer / granulator that can operate at capacities between 10kg and 150kg.
There are a range of blenders and mills installed. Tablet presses with between 4,000 and 175,000 hourly capacity, capsule filling machines that can operate at 3,000 to 60,000 per hour capacity, and tablet and capsule coaters with between 1kg and 150kg capacities are also installed within the facility.
The facility is additionally installed with mixing vessels and a range of bottle filling, tube filling, suppository filling and sealing equipment. The 5l to 150l mixing vessels are equipped with capabilities for heating and cooling.
To support blister packaging, additional equipment within the facility include Klockner and Noack-made blister packers, walleting, cartoning and labelling machines.
Production
The facility is equipped to provide a range of services including formulation development, analytical development and stability studies, packing and labelling for clinical trial supplies, and storage and distribution. It also conducts clinical trial manufacturing, specialised custom production for batch sizes ranging from pilot to commercial scale, production of specials and commercial product sourcing of clinical trials.
