OSD
The pharmaceutical industry is moving towards the development of innovative medicines containing highly potent active pharmaceutical ingredients (HPAPIs). Used as treatments across a variety of fields, including oncology, chronic indications, and severe pain, the promise of these materials lies in their ability to elicit a pharmacological response at low concentrations.
However, their potency makes development and manufacture inherently difficult, with strict regulations surrounding proper handling and containment. To assure operator safety when working with these materials, HPAPIs must be contained at the source throughout production and consider occupational exposure limit (OEL) assessments to ensure appropriate processes are in place.
To meet these regulatory requirements, specialised equipment, facility, and process design are essential. In addition, all personnel must undergo extensive training in HPAPI management in line with safety, health and environmental (SHE) considerations.
Manufacturing of pharmaceuticals like HPAPIs not only carries the risk of harm to operators if handled incorrectly but can also negatively impact the environment. Implementing strategies in line with ISO 14001 assures that an effective environmental management system is in place. By identifying risks, assuring compliance and having strategies to handle incident management, environmental risks are minimised.
In a recent Q&A with PHARMAnetwork, our Senior Commercial Manager, OSD cluster lead, Ana Clement Gaspar Lopez, discusses the drive towards HPAPIs, and the steps taken to ensure the safety of operators and the environment when working with these potent materials.