Ferro Pfanstiehl can bring your proprietary potent compound to market in record time. Whether it's an Anti-cancer, Anti-viral, CNS-active, Cytotoxic or other API or intermediate material requiring containment chemistry, our new state-of-the-art potent compound manufacturing facility houses the equipment to match your synthesis, purification, and packaging needs.
Ferro Pfanstiehl is the first multi-purpose potent compound manufacturer to be certified by the pharmaceuticals industries leading experts, Safebridge Consultants, Inc.
Containment Safeguards Guarantee Purity and Productivity
Your production schedule is guaranteed because we leave no room for errors. To prevent environmental and product-to-product cross-contamination and to protect personnel, product finishing takes place within a Class 100,000 containment area. The containment facility features single-pass, in-and-out HEPA-filtered air; multiple pressure-differential airlocks at entry/exit and between critical processing areas; facility engineering plus Physical and Administrative human controls prevent particulate migration.
Operators protect themselves with Primary and Secondary Barrier Protection, then add Supplied Air Respirators (SARs), air-line hoods, or Level A containment suits originally developed for NASA.
Through certified processing, product, environment and operators are assured to be protected from contamination.
Fully contained synthesis isolators are used for development scale-up and small commercial volume production items.
Process Safeguards Ensure Product Quality
Primary reactor vessels in our potent manufacturing facility are interfaced with a central control/data acquisition system for continuous monitoring.
To maintain optimal processing temperatures, reactors, stills, and dryers are individually temperature-controlled.
Process water meets USP standards for purified water and meets Water for Injection (WFI) endotoxin limits. The USP Purified Water system is validated and has been approved for further manufacture into injectable formulation grade products by the US FDA.
Critical utilities in the containment manufacturing facility have emergency back-up systems.
Contact Us
If you want a strategic partner to develop and scale-up your high potency pharmaceutical substance from early development into commercial scale manufacturing, Ferro Pfanstiehl can meet your needs. Take a look at our certified multi-purpose potent compound manufacturing facility. For more information, contact us or call 1-800-383-0126