Pharmacists can be in control of their cleanroom environment by understanding the critical elements.

Although the USP 797 mandate had a January 1, 2008 deadline, the buzz in the pharmacy industry is still, “What do we need?”; “What is a cleanroom?”; “What do we need to consider?” A lot of the pharmacists we have spoken to have voiced these concerns. Stating that they have read the mandate but are still confused has been a constant complaint. Those in the pharmacy industry are well versed in compounding medications, but are unsure as to what an ISO 7 ante room, an ISO 7 buffer zone, and an ISO 5 compounding zone are. What does the ISO mean? This has been a constant question throughout this industry.

The main points pharmacists need to track and be aware of are ergonomic flow of the design, environmental controls of the room (temperature, humidity, pressure, and particle counts), and gowning and cleaning protocols. Knowing these elements will enable pharmacists to be empowered about their cleanroom needs for this mandate.

ERGONOMIC FLOW
The ergonomic flow of the design is the first crucial step in creating a cleanroom environment to fit pharmacists’ needs. Pharmacists’ input to the architect/cleanroom contractor about their day to day operations is vital to the design of their cleanroom environment. Because pharmacists understand their processes and workflow better than the architects or cleanroom contractors, they need to play a major role in the design of the room. An open dialogue is a must to ensure that you receive the best cleanroom to meet your pharmacists’ needs.

There have been a lot of design flow complaints from pharmacists that have had cleanrooms built without their design input. From having a sink in the farthest location from the ante room entrance door to chemo-compounding BSCs being placed in ante rooms, there have been many disappointments in the industry.