SAFC Pharma completed expansion at Irish API manufacturing facility
A new reactor at SAFC Pharma's manufacturing site in Arklow, Ireland, has begun operation, expanding the facility's capacity for large-scale API manufacturing by approximately 15%.
A new reactor at SAFC Pharma's manufacturing site in Arklow, Ireland, has begun operation, expanding the facility's capacity for large-scale API manufacturing by approximately 15%.
The new reactor is the latest in a series of investments designed to enhance production capacity and expand capabilities at the Arklow site, which is the company's global centre for the production of commercial and late-stage APIs and advanced intermediates.
The US$4m (Euro 2.9m) project involved the installation and start-up of a 6,000-litre Hastalloy reactor, increasing the total capacity at the site to 96,000 litres, with a reactor range from 250 to 8,000 litres.
This latest investment complements two additional expansion projects at the Arklow site: the building of a $2.25m (â"šÂ¬1.63m), 15kg capacity pilot-scale filter dryer designed to double the facility's current capacity for small-scale (10-150kg) manufacturing of APIs, due for commission in third-quarter of 2009; and a $1.8m (â"šÂ¬1.3m) expansion of the site's cGMP warehouse capacity, also scheduled for completion in 2009.
"Enhancements to our Ireland site help us strengthen our position as the leading pipeline partner for the pharmaceutical industry, offering complete support for the development, manufacturing and testing of APIs - from preclinical to commercialisation stages," said SAFC Pharma vice president Europe, Dr. Michael Harris.
The 64,000m3 Arklow complex is cGMP, FDA and IMB inspected and fully validated. It supports customers with expertise in new process evaluation, process development validation and technology transfer. The site's special process technologies include carbon coupling reactions, polyamino acids, Suzuki coupling reagents, distillations, salt formations, Grignard chemistry and powder handling, and it is one of the industry's few sites to offer large-scale simulated moving bed (SMB) chromatography for chiral separations.
The site is a recognised leader in setting environmental standards and received the PharmaChem Ireland's Responsible Care 2006 Award in the Environment category for development of an imaginative approach to reduce and recycle its solvent waste from API processing. As well as adding capacity for both large- and small-scale manufacturing, this latest investment will improve upon the site's award-winning environmental performance, the company says.