The Athlone-based plant of a multi-national pharmaceutical firm has been accredited for microbiology testing by the Irish Medicines Board this week.
Intertek Bioclin, which is based in the IDA Business Park in Garrycastle, will now be able to offer a greater range of testing facilities to help manufacturers meet regulatory quality standards required for raw material testing, and release testing of oral medicines (liquid, tablet, and capsule ), topical (creams and ointments ), as well as injectables, transdermal, ophthalmic products, and purified water.
The firm began as Bioclin, an offshoot of Elan nine years ago, before being sold to the multinational Intertek in 2008, and moving to Garrycastle in 2010 to a premises three times the size of the one it was vacating.
The firm started with five people, and now employs a highly educated 26 staff.
“Certainly this will secure our client base, but we are also recruiting at the moment,” said the firm’s founder, and director of special projects, Mary Burke.
“We’re looking to expand our research and development section, and hope to take on at least three more people before year’s end,” she added.
The firm received this award from the IMB after satisfying the rigorous demands of a two-day audit of its microbiology services, which has been in use for the last year and a half.
The scope of services now extends to the testing and validation ofmicrobial limits, preservative efficacy; endotoxin testing, validation of water systems, and incubation of environmental monitoring.
Intertek Bioclin has broad experience using internationally recognised methods of testing; however, the transfer of client-specific methods or bespoke method development are also offered.
“As Intertek Pharmaceutical's regional centre for microbiology services, this accreditation further strengthens our ability to help our pharmaceutical and healthcare clients not just in Ireland but across all of the EU with a much more comprehensive and essential QC support service for their production and R&D needs,” said Ms Burke.
“Connected into Intertek's worldwide pharmaceutical services network it enables Athlone to be a more effective portal for an unrivalled range of expert support services for our Irish customers,” said Dr Ben Cliff, lab manager at the plant.