A pharmaceutical contract manufacturer that handles a wide variety of early stage active pharmaceutical ingredients needed to have their engineering controls and administrative practices validated. Working with Company personnel, Affygility Solutions conducted surrogate monitoring and defined the level of control offered by current systems.
A successful pharmaceutical contract manufacturer that handles a wide variety of early stage active pharmaceutical ingredients with limited toxicological data.
Company needed to gain a better understanding of its capabilities to handle more potent compounds.
Working with the client, Affygility Solutions developed a containment validation and surrogate monitoring protocol. Using naproxen sodium as a surrogate compound, Affygility Solutions collected a variety of personal and area samples during the execution of the protocol. Samples were analyzed by an American Board of Industrial Hygiene accredited laboratory, a report was prepared that provided detailed information on potent compound containment capabilities based on current engineering controls and work practices.
Client benefited from having a detailed understanding of their ability to handle potent compounds. Based on the results of the containment validation report, the client has seen an increase in business opportunities from biotechnology and pharmaceutical clients inquiring about their contract manufacturing services.
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