In healthcare, medication compounding plays a critical role in patient care. However, the process of compounding injectable medications carries a certain degree of risk, which is why the United States Pharmacopeia (USP) has set forth guidelines and standards for safe and effective compounding practices. One such standard is USP 797, which outlines the IV room requirements for compounding sterile preparations.
What is USP 797?
USP 797 is a set of guidelines for the compounding of sterile preparations, including injectable medications, in healthcare facilities. The purpose of USP 797 is to ensure that sterile preparations are prepared in a manner that minimizes the risk of contamination and infection to patients, healthcare workers, and others who may come in contact with these medications. The guidelines cover a variety of topics, including the design and operation of the compounding area, personnel training and qualifications, environmental monitoring, and testing and quality control.
IV Room Requirements under USP 797
One of the key requirements of USP 797 is that all sterile compounding must be performed in a designated cleanroom or IV room that meets specific standards for cleanliness and air quality. The IV room must be physically separate from other areas of the pharmacy or healthcare facility to minimize the risk of contamination. It must also be designed to facilitate proper air circulation and filtration, and to minimize the introduction of particulates and microorganisms.
Some of the specific USP 797 IV Room Requirements include:
- The IV room must have a minimum of ISO Class 7 air quality, which means that there are no more than 10,000 particles larger than 0.5 microns per cubic meter of air.
- The IV room must have a positive air pressure differential of at least 0.01 inch water column (WC) relative to adjacent areas to prevent the entry of contaminants.
- The IV room must have a HEPA (high-efficiency particulate air) filtration system that can capture particles as small as 0.3 microns.
- The IV room must be constructed with smooth, non-porous surfaces that are easy to clean and disinfect.
- The IV room must have a sink for hand hygiene and cleaning equipment, with a touch-free faucet and disposable towels.
- The IV room must have appropriate storage areas for compounding equipment and supplies, with separate areas for sterile and non-sterile supplies.
Maintaining a Compliant IV Room
To ensure that the IV room remains compliant with USP 797 requirements, it is essential to establish a comprehensive quality control program. This program should include regular environmental monitoring and testing to verify the air quality and cleanliness of the IV room, as well as regular testing of compounded preparations to ensure their sterility and potency.
In addition to quality control measures, personnel training and education are also critical components of maintaining a compliant IV room. All personnel who work in the IV room must receive specialized training in aseptic technique and compounding procedures, as well as ongoing education to stay up-to-date with the latest guidelines and best practices.
USP 797 IV room requirements are essential to ensure the safety and efficacy of sterile medication compounding. By following these guidelines, healthcare facilities can minimize the risk of contamination and infection, protect the health of patients and healthcare workers, and maintain the highest standards of quality and safety in medication preparation.
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Does the drain from sink in IV prep room serve as a source of air borne bacteria? I was told that water source should not be in the same room as IV prep/
I was also told that we should not have a sink with water because if bacteria. Will hand sanitizer be sufficient?
What about a portable sink if we have to get one?
The water from the drain can certainly serve as a airborne contamination source. Though the USP797 market has been slow to grasp the idea of no water in the ante, it is a good idea NOT to have a sink in the cleanroom. Have it outside and close and touchfree doors after handwashing to avoid touch contamination.
Hey, thankyou for sharing it. I got clear understanding about it.
Yeah, for USP797 the temp and rh are “shoulds” not “shalls” There are free standing AC/HEPA units that may be able to help.
Does anyone know is 797 buffer room is allowed to be 70 degrees. We are dying in there and have a boss who is saying that 70 is a soft number meaning it’s okay. And she does not care that we are about to pass out in there with all the garb on etc. Thank you so much
if you are sweating you are shedding skin particles therefore contaminating the room.
What about a saltwater fish tank with a lid in an IV room?
It depends on the type of fish 🙂 Seriously, not in an IV room, PLEASE.
Great post about USP 797 IV Room.
Thank you!
Sure! We can help 🙂
Thank you for stopping by!
Sure, we have procedure templates that can help. We also have data collecting air quality, temp and RH monitors
I am not aware of any such program. It can be quite a lot for a small pharmacy to take on. Study, Train, network with peers and lean on suppliers for assistance.
Do you have examples of home IV compounding stations? I am trying to get an idea of what to do in my house to accommodate the USP 797 IV room requirements.
Thank you,
Desiree Shewell
IV by Design
Thanks for the great question. According to the current version of USP, here’s how to prepare your “Segregated Compounding Area” (SCA):
A Primary Engineering Control (PEC) can be placed in an unclassified area without an anteroom or buffer room. This setup is called an SCA. Only Category 1 Compounded Sterile Preparations (CSPs) can be made in an SCA.
The SCA must be situated away from unsealed windows, doors leading outside, and high-traffic areas, as these can negatively impact the air quality in the PEC. The SCA should also not be near places with environmental control issues, such as restrooms, warehouses, or food preparation areas, which could affect the air quality in the PEC.
When designing an SCA, consider the impact of activities around or near it, such as patient care activities. The area within 1 meter of the PEC should be reserved exclusively for sterile compounding. This means it shouldn’t be used for storage, hand hygiene, putting on and removing garb, or other activities that generate a lot of particles, like patient care.
Many of our equipment designs significantly reduce the potential adverse impact of the SCA’s placement location. Please don’t hesitate to reach out if there is anything else we can do to help!