HD Facilities

December 2020 : USP <800> - Vol.17 No. 12 - Page #4
Category: Cleanrooms/Modular Cleanrooms

With the flurry of cleanroom construction over the past few years, compliance to USP facility requirements is on the rise. External venting of sterile compounding CPECs and the installation of pressure indicators has surpassed the 90% mark. Additional progress has occurred in HD storage segregation and the installation of dedicated refrigerators.


HD unpacking is typically conducted in a neutral- or negative-pressure area. This year for the first time, those unpacking HDs in a positive pressure area or in a storeroom where they have not ascertained the pressure has dropped below 20%.


Most facilities (80%) have committed to separating and segregating HDs from non-HDs in storage. There was a drop this year (from 18% to 11%) in the number of facilities that are waiting to implement storage segregation until USP <800> becomes officially required.


A growing number of facilities have designated their HD compounding areas as authorized access only. Because this requirement is simple to accomplish, it should be undertaken immediately.


The number of facilities with a dedicated refrigerator for antineoplastic HDs located in a negative pressure area with at least 12 ACPH (such as the storage room, buffer room, or C-SCA) increased by 24% this year. A solid majority (81%) have now made this investment. Those without a dedicated HD refrigerator are typically smaller facilities.


It is quite rare for liquid or antineoplastic HDs to be delivered to the units in pneumatic tubes. Just 3% of facilities utilize this practice.

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