Aseptic manufacturing is subject to increasingly safe standards, regulations and recommendations. To meet these regulatory requirements, STERIGENE offers process equipment that enables the reduction of qualification constraints: pharmaceutical isolators.s
The advantages of pharmaceutical isolators
Among the different process devices and equipment that enable sterility testing and aseptic filling, pharmaceutical isolators have become an effective manufacturing solution. The aseptic process has the unique capacity of avoiding containment rupture of manufactured products, and so protecting them from microbiological contamination during production or from human environments.
Pharmaceutical isolators are also currently the most economical kind of aseptic process for the medium and long term. In effect, this process equipment ensures a much higher level of sterility than in traditional environments, and provides a durability when confronted with increasingly stringent pharmaceutical regulations.
System sterility tests under isolator
STERIGENE offers a range of pharmaceutical isolators that allow you to perform sterility testing in a contained environment; this avoids microbiological and particulate contamination of your injectables. This range includes a H2O2 decontamination and quick transfer airlock for going to and from the isolator without aseptic rupture.
Our design tem enables you to create your own “turnkey” contained production line consisting of an isolator coupled to an online washer, a freeze dryer, a H2O2 decontamination and quick transfer airlock, a pharmaceutical autoclave, a pharmaceutical washer or other process equipment for your aseptic filling or sterility tests.
If you would like more information about our pharmaceutical isolators, contact our sales engineers by email at sterigene@sterigene.com or by phone at +33 (0) 1 34 44 23 23.