Compass Pharma has completed a capital investment project to upgrade its production capabilities to include ISO Class 8 (ISO 14644) specifications, so as to provide packaging services for certain high-potency pharmaceutical products.
Reportedly, the capital improvements for ISO-Class 8 certification include a fully-integrated production suite, where the primary packaging area has negative differential air pressure relative to surrounding gowning and secondary packaging areas. High-Efficiency Particulate Air (HEPA) filters are deployed in the primary packaging area.
Tony Fenno, chief operating officer, Compass Pharma, said: “These capital improvements now allow us to provide cGMP contract packaging services for select potent pharmaceutical compounds such as enzymes, antibiotics, antifolates, antimetabolites and some hormones.”