Brecon Pharmaceuticals Ltd has begun 2004 with the launch of its new purpose-built analytical laboratory, which offers customers access to the highest quality clinical trials, commercially packed product or stand-alone analytical services.
The 95 sq m state-of-the-art facility provides a wide range of services to match the needs of multi-national clients, virtual organisations and global pharmaceutical companies. Brecon’s customers can benefit from an extensive range of clinical trial services including simple identification testing and analytical method transfers through to complete finished product and ICH stability testing.
The new lab aims to be compliant with current European Good Manufacturing Practice (GMP), ICH and FDA requirements, which will enable Brecon to provide stability testing and studies to full ICH standard. Method validation or the further development and updating of methods can also be offered, together with extra validation to GMP standards as required.
To maximise the versatility of the lab, additional facilities have been incorporated including a dark room for light sensitive products, a large fume cupboard and a containment room for cytotoxic drugs. The containment room has a dedicated, negative pressure HEPA filtered air-handling system for the preparation and analysis of less well characterised development drugs.
The lab equipment has been specified to the highest standards and features: flexible HPLCs for method development, semi micro analytical balance equipment, Coulometric Karl Fischer apparatus, dissolution baths, disintegration apparatus, hardness testers, a friabulator and colour meter together with equipment to carry out a wide range of pharmacopaeial analysis.
The air-conditioned facility can house up to eight analysts with the capacity to expand to 16 analysts when required. The analyst team can provide customers with an extensive report writing service covering protocol generation, certificates of analysis, method transfer, validation and ICH stability reports.
Manager of Quality Services, Dr Karl Fry QP heads up the new analytical team. He believes the new lab positions Brecon at the forefront of the industry. He said, “This is an exciting development for Brecon and one that I believe will prove popular with existing and future clients”.