Proposed USP <797>

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:

  • MIC Single positive pressure(RABS)
  • MIC Dual (both sides positive pressure) (RABS)
  • MIC 797P (RABS)
  • MIC EDU Positive (Isolator)

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:

  • Category 1 – With this scenario basically you are faced with minimal restrictions as if it were a CAI in the current chapter of <797>. The units are defined as RABS and you would place the RABS in a segregated area (IE – demarcation compounding zone). However, your BUD (beyond use dating)cannot exceed 12 hours at room temp or 24 hours in refrigerator.
  • Category 2 – Place the above defined RABS in an ISO 7 clean room and increase the BUD to 6 days (room temp) and 12 days (fridge). A clean room adds significant expense to build and to maintain, the clean room must have at least 30 air changes per hour plus added garbing, cleaning, and certification expenses.

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) with decontamination procedures, unidirectional airflow, and must maintain continuous positive pressure.

  • An Isolator falls into category 2 but only needs to be placed in an Environment 8 room with 15 ACH′s. An environment 8 room is very easy to achieve and far less expensive than an ISO 7 clean room
  • Going the Isolator route in an environment 8 room is much less expensive, faster to implement, and provides a much higher level of sterility assurance (6 log kill rate) versus the RABS solution in an ISO Class 7 clean room