HealthJune 30, 2016

USP on the road: mobile pharmacy considerations

Mobile pharmacies are designed to maintain sterility and safety standards for the sake of pharmacists responsible for compounding drugs. Before introducing a mobile compounding facility, several factors need to be considered, which comply with USP <797> and USP <800> standards.

Establishing an offsite compounding environment

In some instances, a temporary USP 797-compliant cleanroom needs to be established to conduct compounding outside of a permanent facility.1 Natural disasters and structural renovations may force a pharmacy to create a mobile cleanroom until it can create a more permanent compounding area.

In these cases, a few factors need to be considered. Most importantly, the volume of work must be taken into account prior to utilizing a mobile compounding facility. A cleanroom should be developed according to a projected workload to ensure that time, money and materials are not wasted.

Additionally, location needs to be taken into account when considering the use of a mobile cleanroom. These types of temporary facilities should be located where they can be accessed by existing employees and customers, reducing the risk of an interruption in business.

Finally, mobile cleanrooms need to contain the same materials that would otherwise be found in a permanent compounding location. For example, they must have a minimum work area of 72 square feet, a laminar flow hood, and continuous positive pressure, unless the hood is self-venting.2

A look at the first use of a certified USP mobile cleanroom

Duke Raleigh Hospital made news in September 2015 when it announced that it had become the first healthcare facility to use a USP 797-certified mobile cleanroom.3 The unit allowed the hospital to maintain separate, on-site sterile compounding operations during a facility renovation.

The goal was to create a mobile pharmacy that would be immediately operational, beginning with the renovation project. The structure housed distinct, controlled work zones with ISO 7 environments, as well as a hazardous drug preparation room.

Today, there are several manufacturers of USP 797-compliant mobile cleanrooms for compounding purposes. However, it is up to the pharmacy to ensure that there is no interruption in service and proper compounding standards are upheld when a mobile facility is introduced.

References

1. Three Case Studies in Cleanroom Renovation. Pharmacy Purchasing and Products. Published July 2015: http://www.pppmag.com/article/1716

2. USP 797 Clean Rooms & Sterile Compounding Labs. Portafab. Retrieved March 29, 2016: http://www.portafab.com/compounding-labs.html

3. US Hospital Pioneers Use of First Mobile Compounding Cleanroom. Germfree Labs. Published September 24, 2015: http://www.prnewswire.com/news-releases/us-hospital-pioneers-use-of-first-mobile-compounding-cleanroom-300148333.html

Solutions
Simplifi 797®

Take the guesswork out of USP medication compounding compliance with a customizable, mobile, evidence-based solution.

 

Simplifi 797 provides the latest evidence-based guidance and helps navigate the complex USP Chapters 795, 797 and 800 processes to ensure inspection confidence and keep patients and staff safe.