Compass Pharma Services has upgraded its production facility to include ISO Class 8 (ISO 14644) specifications in order to provide packaging services for certain high-potency pharmaceutical products.
The 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 used in the primary packaging area.
The company said that these capital improvements provide cGMP contract packaging services for select potent pharmaceutical compounds such as enzymes, antibiotics, antifolates, antimetabolites and some hormones.
The company said that the New Jersey-based Manufacturing Automation is assisted with the engineering/design and validation of the new ISO Class 8 area.
The company claims that the Whitehouse Analytical Laboratories has been retained to provide the company with ongoing analytical services.
Tony Fenno, chief operating officer of Compass Pharma Services, said: “Compass Pharma investments continue to position the company as a responsive contract pharmaceutical packaging partner for sophisticated, high-demand contract packaging services for the pharmaceutical industry.”