Regis Technologies, a contract provider of custom synthesis and separation services, has started up a new potent compound suite (PCS) at its 36,000 square foot, cGMP facility in Morton Grove, Illinois. The PCS addition provides for small-molecule cGMP manufacturing of potent compounds up to about one kilogram per batch.

Regis' new PCS includes isolators, laminar flow hoods, and local exhaust ventilation appropriate for potent compound handling. In 2014, Regis worked with high containment industry consultants to choose the best laboratory and personal protective equipment for potent compound handling and conducted employee training. Regis also completed validations and cGMP qualifications for the suite. In 2015, the PCS passed the commissioning process. Safebridge Consultants, Inc. evaluated the containment performance of the facility via industrial hygiene monitoring. Based on the occupational exposure limits of the future active pharmaceutical ingredients to be handled, a containment performance target was set to 50 ng per cubic meter. The surrogate monitoring involved handling of surrogate material (naproxen sodium) in PCS by Regis' employees while performing the air and surface sampling by certified industrial hygienist in order to find out how much of material could escape from the containment.

Source: Regis Technologies