30 Jul USP 797 IV Room Requirements: A Quick Guide
In the healthcare industry, even minor contamination of intravenous (IV) medications can lead to disastrous consequences, including severe infections and prolonged hospital stays. Since the contamination of compounded medications poses such a big risk to the safety of patients, the United States Pharmacopeia (USP) has established strict guidelines under USP 797 to make sure that IV medications and other compounded drugs (compounded sterile preparations [CSPs]) are safe. In this article, we will cover some of the most important USP 797 IV room requirements.
Requirements for USP 797 IV Rooms
To keep CSPs safe and sterile, USP 797 outlines specific requirements for the design, maintenance, and operation of IV rooms. Below are the key requirements for these spaces.
Cleanroom Classifications
USP 797 requires certain areas in IV rooms to comply with cleanroom classifications set by the International Organization for Standardization (ISO).
- ISO Class 5: The primary engineering controls (PECs), such as laminar airflow workbenches and biological safety cabinets, must comply with ISO Class 5 standards.
- ISO Class 7: The buffer area, where the PECs are located, must meet ISO Class 7 standards.
- ISO Class 8: The ante-room, which serves as a transition space between the uncontrolled environment and the buffer area, should meet ISO Class 8 standards (at the very least).
It goes without saying that in each of the controlled spaces, air quality must remain pristine. This often involves the use of HEPA filtration, unidirectional (laminar) airflow, and other controls to reduce contamination as much as possible.
Environmental Monitoring
Regular environmental monitoring is also important for ongoing USP 797 compliance. In fact, anytime equipment is rearranged or any other changes are made to the space, tests should be run again. Here are a few important types of environmental monitoring:
- Air Sampling: Regular air sampling to detect airborne microbial contaminants. USP 797 recommends this at least every 6 months.
- Surface Sampling: Routine surface sampling to identify microbial contamination on work surfaces and equipment. USP 797 recommends this monthly.
- Pressure Differential Monitoring: Continuous positive pressure differentials are needed to prevent airflow from lower to higher air-quality areas. There must be at least a 0.020-inch water column pressure difference between each ISO-classified area, such as between the buffer room and the ante-room. Pressure monitoring must be continuous, and the numbers should be reviewed and documented daily (when compounding is occurring).
Personnel Training, Garbing, and Cleaning
Additionally, all personnel involved in the compounding of CSPs in IV rooms must be thoroughly trained and qualified. A designated individual should oversee the training process, which must be refreshed every 12 months.
Further, each facility must develop a written training program detailing the required training, frequency, and performance evaluation process. Training and evaluation must be documented, including training records and performance results.
Personnel must also demonstrate competency regarding hand hygiene, garbing, cleaning and disinfection, aseptic techniques, and equipment use. Regular hygiene training for all staff who handle CSPs is essential in IV rooms.
Similarly, proper garbing, including sterile gloves, gowns, masks, hair covers, and shoe covers, is important to reduce the possibility of contamination as much as possible. Garbing procedures should be evaluated every six months.
The Bottom Line
There are many USP 797 IV room requirements that are important to follow when compounding CSPs. While it is impossible to cover all the guidelines in one article, we have provided an overview of many of the requirements needed to run a USP 797-compliant space. These guidelines are meant to keep medications safe and sterile, and above all, protect patient safety.
Still confused about what’s required for a USP 797 IV room? Talk to the experts at Allied Cleanrooms and get a free quote on a cleanroom today.