skanfog® pure is the first isolator to be DIN 12980 certified.
This standard sets out the requirements for safety workbenches and isolators in applications involving cytostatics and other CMR pharmaceuticals. It covers aspects that are essential to the safe handling of these products, for example ease of cleaning, low-contamination filter changes and the connection of the equipment to the building’s exhaust air system.
skanfog® pure is also a practical solution for aseptic small-scale GMP manufacturing. This means that the isolator can be used as a small A zone in a D zone cleanroom.
skanfog® pure offers a solution to common problems
It is becoming increasingly common to work with active or pathogenic substances that require a closed work space to protect the user.
In addition, when a new containment solution is integrated there is usually limited space available and the building infrastructure – often not new – offers little flexibility or opportunity for conversion. Thanks to its compact design, this is no problem for skanfog® pure during either installation or operation.
The isolator can be assembled in a modular fashion from airlocks and working chamber to tailor it to your individual requirements.
The skanfog® decontamination process is based on a unique method. The decontamination agent hydrogen peroxide ( H2O2 ) is sprayed directly into the isolator’s working chamber. At the touch of a button, either the airlocks or the working chamber can be decontaminated. H2O2 is sprayed directly into the working area through a pressure nozzle. This has a number of advantages compared with the conventional method of using vaporised H2O2 . It uses less hydrogen peroxide, which makes the decontamination process much shorter. Unlike vaporisation, in which the H2O2 is forced through the filters, spraying the decontaminant directly into the chamber is more gentle on the filters. The H2O2 is decomposed by a catalyst. This is integrated in the isolator itself, allowing autonomous operation in the laboratory, independent of on-site connections.
During development, the focus was on keeping the decontamination cycle as short as possible to maximise productivity and efficiency. Decontamination of an airlock, for example, takes less than 30 minutes.
Discover skanfog® pure live
To learn more about skanfog® pure or try it out for yourself, you are welcome to visit our headquarters in Allschwil, Switzerland. Please get in touch with us.