High containment gloveboxes (HCG) have been used in the pharmaceutical industry for containment of potent compounds, along with providing specific environmental conditions, for years. These types of glovebox design fit well into the Class III Bio Safety Cabinet classifications but provide even better environmental attributes than the standard BSC designs.
Once you have decided on the best system and design, testing needs to completed. Testing methods are standard and can be applied to the HCGs. Testing of the HCGs would conform to the industry standard and include the following:
Air quality/flow and microbiologic testing.
1. Testing should only be done by a third party.
2. Testing needs to be relevant to the biohazardous substance.
3. Testing of the HEPA filters by DOP with particle analysis a ROYCO counter.
4. Tests using a micro nebulizer.
5. Bacterial or BI are placed in the glovebox and a decontamination cycle is run and submitted for results.
6. Air changes per hour need to be verified.
Containment/ cleaning validation:
1. Third party containment testing can be completed using the ISPE Guidelines.
2. Riboflavin testing for verification of CIP (clean in place systems).
3. Drainability.
Testing should be robust and conform to industry standards for both types of systems.
This cleanroom tip was taken from “Cross Over from Class III BSC to High Containment Gloveboxes” by Michelle Frisch. The article originally appeared in the November/December 2015 issue of Controlled Environments.
