Environment, Health & Safety: a critical competency for producing HPAPIs
Mastering the safe handling of highly potent APIs comes through our long experience of commercial HPAPI and cytotoxic manufacture.
The identification and the management of the risks result from the combination of four elements: the unique product considered, its production process, the equipment and facility used and the people. The safe handling of HPAPIs results from this holistic approach, where all four elements are cautiously evaluated to guarantee the safety of the patients, our employees and the cGMP production of HPAPIs.
The potency of the product is assessed in close collaboration between our client and Novasep toxic substances committee. The production process will be tailored to match the requirements associated with the product’s potency. The appropriate production suite will be defined and assembled from our range of portable and fixed equipment. An appropriate strategy will be established for containment, personal and collective protection, as well as Standard Operating Procedures (SOPs). The efficiency of all the measures implemented is regularly tested by occupational hygiene monitoring. Containment is assessed with surrogates and actual compounds when possible throughout the premises including R&D labs, QC labs, pilot and industrial production workshops. All employees undergo a regular training and medical surveillance.
The good practices established over the years at Novasep have been recognized by the Safebridge® certification since 2009.
Each project requires a tailor-made solution. With our flexible capabilities and the know-how of our experienced and passionate employees, we work closely with each of our customers to deliver the best solution for their product. Contact us to discuss your specific needs!