POTENT HANDLING CAPABILITIES
The safe manufacturing of products containing potent active pharmaceutical ingredients (APIs) requires both hardware (facility features, equipment, and engineering controls) and software (practices and procedures) that adequately protect personnel and the environment, including the facility.
With this in mind, we built segregated Grade C clean room suites with dedicated air handling for potent compounds. Flexibility is engineered into the suites, equipment, and systems in order to meet your current and future needs. The room sizes and equipment capabilities were chosen to enable us to scale your project from clinical through commercialization.
New APIs are placed into our robust evaluation procedures to determine classification levels for safe handling procedures and clearance limits. We also perform 100% verification on the equipment and facility upon cleaning, to further ensure the safety of the employees and to protect future products.