Tablet Manufacturing How To Make Tablets From Potent APIs
The overall materials handling concept for potent APIs is the controlling factor in determining the containment performance of the entire installation. There are two basic choices: stainless steel or disposable systems.
Part 1 of this article (“Containment fundamentals”, PROCESS India 3–2011) explained that more than half of all new APIs are classified as potent (OEL <10 μg/m3), and that health and safety authorities around the world are strengthening protection for operators who work with these substances.
The article showed why effective containment is always better than personal protective equipment or systems, which rely on human behaviour, and showed how to calculate the degree of containment required based on Occupational Exposure Limits (OELs), Acceptable Daily Intakes (ADIs) and cross-contamination limits. In this second article, we look at how to choose containment solutions from the huge variety on the market.
A typical tablet process has the following steps:
- dispensing of API and excipients
- milling of raw materials to destroy lumps
- (wet) granulation with subsequent drying
- dry milling
- addition of lubricants
- tablet compression
- primary and secondary packing
IBCs (Intermediate Bulk Containers) with split butterfly valves are the material handling systems most commonly used for potent APIs. Split butterfly valves offer a proven solution for make-and-break connections. They are available in different performance levels.