Most HAPI processing—during research, development, production, packaging and analysis—is done in isolators. In these systems, operator protection is defined in terms of Operator Exposure Limit (OEL) or Operator Exposure Band (OEB) levels. MBRAUN isolators achieve an OEL level of 5 nanograms per cubic meter over 8 hours.
For product protection, defined filter systems are the first defense. They may have defined atmospheric conditions (e.g., nitrogen) to exclude environmental oxygen and humidity. Systems that provide aseptic environments also are available.
In addition to these operator- and product-protection measures, the handling of some drug ingredients requires additional safety measures. MBRAUN explosion-proof isolator systems conform to the norms of the European ATEX explosive atmosphere directives, while measures against electrostatic charges, solvent vapors and waste also are available.
MBRAUN isolators meet requirements for all steps on the way to final API and HAPI manufacturing. We follow the norms of international regulatory requirements in all API isolators, easing the full qualification and validation processes.
One of the key steps in the production of active and highly active pharmaceutical ingredients (API and HAPI) is the charging of active raw materials to reactors and tanks for further production. Raw materials come in a variety of packaging types, including plastic bags, aluminium bags, drums, large bags, and bottles.
Challenge areas to watch with reactor and tank charging:
- Raw material transfer to isolator (known processes may have to be changed)
- Interface of isolator to reactor or tank (charge point)
- Environmental conditions (e.g., explosion-proof areas, heat, pressure differences)
- Operator safety around the reactor (e.g., moving parts, heat, vapors)
At MBRAUN, we follow international and regulatory norms from our first contact with you to final product, including qualification and validation.
We produce isolators that achieve an Operator Exposure Level of 5 nanograms per cubic meter over 8 hours.
Please contact us if you have questions choosing the right API isolator system for your specification needs.