Proposed USP797

Proposed USP<797> -- Sterile Non-hazardous Compounding (proposed chapter)

This proposed chapter is still in the comment phase. No definite date on final revision or implementation. Here is a summary as it pertains to the MIC line of products.

We have 4 main products:
The MIC Single, Dual, and 797P will no longer be referred to as CAI′s under the proposed version of USP<797>. These units will now be defined as RABS (restricted access barrier systems). RABS will fall into two categories:
The MIC EDU will now be defined as an Isolator. An isolator is generally defined as a RABS with automated decontamination of the compounding chamber (VHP), dynamic airlock with decontamination procedures, unidirectional airflow, and must maintain continuous positive pressure.
MIC Single Isolator (Model A1000R) MIC Single
MIC Dual Isolator MIC Dual Chamber
MIC 797P MIC 797P
MIC EDU Isolator MIC EDU Systems