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).
A negative pressure regime is maintained within the internal volume of the isolator. Turbulent airflow is generally adopted.
The operator accesses to the inside of the isolator via glove ports or half-suit.
Containment level from 10 ug/m3 down to the low nanogram level are guaranteed with adequate designs and configurations.
FPS is the trusted containment partner of many leading OEMs. This requires a long collaboration and gives FPS a complete understanding of the process. The result for the customer is a bundle solution where both the process equipment and the isolator work seamlessly as one unit.
FPS combine a proven design with devices and components specifically manufactured for isolator applications to create unique solutions that fit any specific requirement.
The system can therefore designed and built around new or existing equipment, with excellent ergonomic operations and performances.
Isolators for HPAPI Production are available for many applications:
The project definition always starts from on-site supervision to check installation area and discuss with end user about specific needs.…
When handling HPAPI or intermediates, all operations in chemical reactors, filters, centrifuges, and dryers must be carried out under absolute…