We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we'll assume that you are OK with this.     OK  No, I would like to know more...
Mastering all aspects of EHS

Mastering all aspects of EHS

Tame the beast Pharma CDMO banner

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.

 Novasep EHS 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.

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!

  • A full range of CDMO services for APIs
    A full range of CDMO services for APIs
    Novasep provides flexible development and manufacturing solutions for small molecules APIs and advan...
    Download +
  • Highly effective services for highly potent APIs
    Highly effective services for highly potent APIs
    Our manufacturing expertise in highly potent APIs and cytotoxic compounds covers process development...
    Download +
You can stay on this page and select more documents or you can directly download the brochure(s) you selected
Give us your feedback!