Almac Sciences' cytotoxics plant gains SafeBridge certification
Almac Sciences, a division of the Almac Group, has been granted SafeBridge certification in the safe handling of potent pharmaceutical compounds for its cytotoxic and potent compound manufacturing operations.
Certification covers facilities, containment equipment, procedures and personnel training at the division's facility in Craigavon, Northern Ireland.
SafeBridge Certification is a respected benchmark in highly demanding pharma HPS operations that are focused on a handful of international players, including Almac Sciences. SafeBridge Consultants is recognised for its high level safety, health and environment consultancy support to the pharma, biotech and chemical industries, with the potent compound Certification programme as a noted speciality.
Certification at Craigavon specifically embraces competency in the safe handling of materials in pre-clinical, clinical and commercial scale operations for the production of cytotoxic and potent APIs as well as radiolabelled syntheses. Included are the facilities for cytotoxic manufacture where barrier isolators contained within dedicated suites are used for the safe handling of these compounds at the 80,000ft2 production complex. These state-of-the-art facilities were expanded in 2003.
Development, kilo-lab and cGMP manufacturing suites have been designed to operate at 0.1µg/m3 OEL for cytotoxic compounds enabling manufacture of cytotoxic products at commercial scale. For potent compound manufacture, the cGMP manufacturing plant, (also operated at 0.1µg/m3 OEL) allows production at ~ ten fold higher levels.
'This is a further enhancement of our package of supply chain solutions in all-scale production of cytotoxics and potent compounds,' said Almac Sciences' commercial operations vp Dr David Moody. 'SafeBridge certification is the gold standard in this rapidly growing sector of pharma services.'
SafeBridge's potent compound safety certification programme verifies performance with set criteria in management, evaluation, containment, control and communication elements of potent compound production operations. Elements of the programme include on-site assessment of production plant and equipment, training, toxicology, occupational hygiene and environmental control.
'Almac Sciences has met our criteria for Certification through the application of engineering controls for the containment of powder handling operations, construction of modern contained facilities in the GMP Labs for kilo scale operations and implementing a comprehensive system of Standard Operating Procedures - including potent compound safety elements,' confirmed John Farris, certified industrial hygienist and president and ceo of SafeBridge, who was part of the Certification and evaluation team.
Along with Almac, SafeBridge Certification was also awarded to Boehringer Ingelheim Chemicals (BI Chemicals), of Petersburg, Virginia, US.
BI Chemicals and Almac become the third and fourth contract manufacturing organisations respectively to achieve Potent Compound Safety Certification by SafeBridge. Other companies previously achieving this Certification include Sigma Aldrich Fine Chemicals Inc. (SAFC), Madison, WI and Ferro Pfanstiehl Inc., Waukegan, IL.
