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 — to adequately protect personnel and the environment, including the facility.

With this in mind, ACP has built segregated ISO 7 and ISO 8 clean room suites with dedicated air handling for potent compounds. Flexibility has been engineered into the suites, equipment and systems in order to meet our clients current and future needs. The room sizes and equipment capabilities have been chosen to enable ACP to scale your project from clinical through commercialization.

New APIs are placed into Alliance’s robust evaluation procedures to determine classification levels. This is used to determine safe handling procedures and clearance limits. ACP also performs 100% verification on the equipment and the facility upon cleaning to further ensure the safety of the employees and to protect future products.

Our 30,000 square foot facility features a 10,000 square foot warehouse, a 5,300 square foot manufacturing area, including segregated and dedicated potent handling capabilities and a 3,000 square foot analytical lab. Give us your challenging APIs and we will make you successful!

 

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