USP 797 - What Directors Need To Look For

  Subscribe to FREE newsletter  Sep 12, 2009

The buzz in the pharmacy industry is, “What do we need?”; “What is a clean room?”; “What do we need to consider?” A lot of the pharmacists we have an open dialogue with have voiced these concerns. Stating that even after reading the mandate, confusion surrounds the What To Do’s of the mandate.

HWI has been on the forefront of this mandate and knows the clean room industry inside and out. We have been here to educate and assist hospitals around the nation. From the top ten hospitals in the nation to the small 100 bed facilities, HWI has designed and built USP797 pharmacies.

The 5 main points pharmacists need to track and be aware of are:

  1. Ergonomic Flow of the Design. Be sure to have input in the design of your clean room. Pharmacists understand their processes and flow of work better than the architects. HWI hears a lot of design flow complaints from pharmacists that have had architects design their rooms. HWI has the ability to assist and advise in what the ergonomic flow should be.
  2. Temperature, Humidity, and Pressure: Know these gauges, and know how to read them. These three components must be logged on a daily basis. Pharmacists are responsible for knowing the ranges for temperature, humidity, and pressure differentials between the rooms.
  3. Particle Counts and Microbial Contaminant Screening: Particle counts must be monitored and certified at least every 6 months. An optional continuous particle monitoring system is an ideal option to install. Data can be accessible from any connected computer. Swabbing of surfaces and personnel attire all need to be monitored as part of the mandate. Many times a variation in readings can be traced back to a technician not following gowning procedures. These testing processes can be done in house or sent to a third party for validation.
  4. Gowning Protocols: This protocol is a must and one of the biggest contentions for pharmacists and their staff. The staff is not used to washing hands, gloving, covering hair and face, and gowning. But, proper gowning protects the end product from the biggest contamination-humans. And ladies, sorry but skip your daily make-up routines when you work in a clean room!
  5. Cleaning Protocols: A constant cleaning protocol must be followed to ensure particle and microbial contaminants are at a non-existent level. Cleaning schedules are preformed daily, weekly, bi-weekly, monthly, bi-monthly, quarterly, and bi-yearly as described in the mandate.

By Heather Wylie, President of HWI

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