USP<800> - Sterile Hazardous Compounding

This chapter takes effect 2/1/2016. The facility will have until 7/1/2018 to comply with the new standard. Here is a summary as it pertains to the MIC line of products.

We have three main products

There are two main options with this chapter in regards to placement of the MIC Family of Products.

Option 1 – Place the units in an unclassified negative pressure room.The BUD (beyond use date) is 12 hours room temp or 24 hours refrigerated.

Option 2 – Place the units in an ISO Class 7 negative pressure cleanroom, with an ISO Class 7 positive pressure buffer room for entry. This option gives you a BUD (beyond use date) of 6 days at room temp and 12 days refrigerated.

The MIC′s should be externally vented with both options and the MIC Dual solution must be a negative / negative pressure combination.

MIC Single Isolator (Model A1000R) MIC Single
MIC Dual Isolator MIC Dual Chamber
MIC 800N MIC 800N