USP<800> – Sterile Hazardous Compounding

This chapter takes effect December 2019. The facility will have until 12/31/2019 to comply with the new standard. Here is a summary as it pertains to the MIC line of products.

We have four main products:

  • MIC Single (negative pressure)
  • MIC Dual (both sides negative pressure)
  • MIC 800N (negative pressure)
  • MIC EDU (negative pressure)

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.

Option 3 – Place MIC-EDU in a ISO 8 negative pressure room with neutral pressure buffer area for entry. The beyond use date is 6 days 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.