Active pharmaceutical ingredient containment isolator

steriledispensingdrying

API (active pharmaceutical ingredients) is the active pharmaceutical ingredient, that is, the biologically active component of a pharmaceutical product (tablet, capsule, cream, injectable) that produces the desired effects. While HPAPIs (high potency active pharmaceutical ingredients) are the highly potent active pharmaceutical ingredients, then pharmacologically active substances that exhibit biological activity at extremely low concentrations, such as a therapeutic daily dose <10 mg or an occupational exposure limit (OEL) of <10 μg/m3 over an eight-hour time-weighted average. In recent years, the advent of highly potent active pharmaceutical intermediates (or HPAPIs) has required a rethinking of pharmaceutical manufacturing operations. This trend has been especially evident in the research, development, and production of anticancer drugs and has therefore required specialized equipment for manufacturing, handling, and packaging. Production and handling of HPAPI or toxic products (in gas, liquid or powder form) need complete product separation from the environment to protect the operators. Isolator technology assures the possibility to execute contained operations with a total product protection (sterile application) or operator and environment protection (toxic application). Isolators for HPAPI Production are available for many applications: •Laboratory •Synthesis •Filtration & Drying •Production Reactor Charging •Process vessel discharging •Pilot Milling & Micronization •Production Milling & Micronization •Dispensing…