How to make tablets from potent APIs Containment Fundamentals
When talking today about solid dosage form production, often containment immediately becomes one of the issues. Why?
APIs are becoming more and more potent: meanwhile more than 50 percent of all NCE (New Chemical Entities) are classified potent (OEL <10 µg/m³). Furthermore, health and safety authorities all around the world are putting more focus on the protection of operators dealing with these substances. And, last not least, suppliers of various hardware components have developed a huge variety of containment solutions, making it difficult to decide which is best, even for experienced people. Before we look at the factors defining the required containment levels, and discussing the possible hardware solutions, some fundamental thoughts about containment need to be covered first.
“It is the first duty of the employer to protect (the health of) his employees.” Even though the regulatory situation differs from country to country, the above statement (taken from the UK COSHH rules) should be seen as general guidance when handling potent substances.
In fact, approximately 30 percent of all people in western societies will develop some form of cancer during their lifetime. If one of these had been exposed to a carcinogenic substance, whilst working for a pharmaceutical company, there is the potential for a legal claim against the company. This could result in high cost compensation and in very bad publicity, unless the company can prove that the employee had been protected using best available technology.