Containment performance of semi-continuous tablet coating equipment
Potent and highly potent active pharmaceutical ingredients have the potential to cause adverse health effects in workers at very low airborne concentrations.
The use of containment equipment during manufacture of oral solid dose pharmaceutical products, as part of a systematic approach to potent compound safety, is advised to control worker exposure. Containment performance for a “new generation” tablet film coating device, capable of continuous and batch film coating, has been assessed during three phases of operation: film coating, disassembly and cleaning. The results of these assessments provide data for emissions of airborne material, associated with each of these three phases, to allow potential users of this equipment to determine suitability for their application.
SAFE HANDLING OF POTENT ACTIVE PHARMACEUTICALS
The manufacture and production of pharmaceutical products containing potent and highly potent active pharmaceutical ingredients (APIs) is becoming commonplace in the pharmaceutical and biopharmaceutical industries. Safe handling systems to protect a healthy workforce against the adverse effects of these materials are routinely applied by many of the large multi-national (bio)pharmaceutical manufacturing companies and are increasingly being taken up by smaller companies and contract manufacturing organizations.
Based on toxicological evaluations, APIs can be placed into control bands depending on their hazards and potency. This is the first step in a systematic approach to ensure worker safety when handling potent and highly potent APIs. Each control band should be associated with a safe handling guideline (2) which describes in detail how a material of that potency should be handled according to the environment (research, development, or commercial-scale production) encountered in the workplace. In general, most parties define a potent API as one with an occupational exposure limit (OE ...