First SafeBridge certification awarded in Europe
potent compound safety certification by SafeBridge, confirming that
Almac is capable of handling potent compounds safely and is able to
limit exposure using closed laboratory systems.
SafeBridge Consultants is an occupational health and safety consulting firm that offers an objective and scientifically supportable assessment of a company's ability to safely handle and manufacture potent compounds to industry standards. Almac is the first company outside of the US to receive the industry-respected benchmark, and fourth on a worldwide scale. The driver behind the certification is that companies are interested in demonstrating that they can handle potent active pharmaceutical ingredients (APIs) in a safe manner as verified by an independent company, explained Justin Mason, managing director of the European division of SafeBridge. The Northern Ireland site at Craigavon has facilities such as cytotoxic manufacturing suites with barrier isolators (glove box technology), good manufaccturing practice suites for both cytotoxic and potent compounds that operate at 0.1 microgram per cubic meter occupational exposure limits (OEL). SafeBridge carried out a 60-point review of programs, procedures and containment of APIs at the site and also checked set criteria in management, evaluation, containment, control and communication parts of potent API production operations. This included on-site assessment of the potent API manufacturing and laboratory areas and equipment, training, toxicology and industrial hygiene. "This is a further enhancement of our package of supply chain solutions in all-scale production of cytotoxics and potent compounds," said David Moody, vice president of commercial operations at Almac. "Safebridge certification is the gold standard in this rapidly-growing sector of pharma services and sends a highly positive message to the customer and prospective customer communities." "Almac Sciences have 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," said John Farris, president and CEO of SafeBridge. The three other companies that have received SafeBridge certificates are SAFC, Ferro Pfanstiehl, and BI Chemicals.
