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USP 797 & 800 Cleanroom Compliance Standards

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In 2005, guideline USP-797 was introduced to ensure a cleaner environment for healthcare institutions, pharmacies, physician's practice facilities, and other areas where compounded sterile preparations are prepared, stored, and dispensed. In 2019, USP-800 was introduced to replace USP-797, providing a more thorough overview of the required compounding standards for safely handling hazardous drugs.

NCI can assist you by providing the components, equipment, and cleanrooms to assure compliance with these regulations. Contact us to learn more, or download our catalog today.

How Are USP 797 & 800 Related?

USP 797 was designed to protect hazardous and non-hazardous drugs from contamination. USP 800 was intended to provide guidance on protecting individuals who may have been exposed to hazardous drugs.

USP 800 Standards Regarding Hazardous Drugs (HD) and Cleanrooms

USP-800 compliance regulations affect the following standards regarding hazardous drugs and cleanroom environments:

Require negative pressure rooms and BSC
Signs and demarcation lines warning of hazard
Labeling requirements
Storage requirements
Pass thru requirements

Compounding Within USP 797 & 800 Cleanroom Standards

USP 797 and 800 standards require compounding to be done entirely with ISO Class 5 (Class 100) or better air quality. Facilities currently doing such compounding have such equipment; however, if you do not have a unit, please see our CAP 301 Horizontal Flow Clean Bench listed below. NCI will gladly give you the expert information needed to provide your facility with the right equipment. However, this is not all required under the new USP 797 regulation. A cleaner environment is necessary. Two avenues can be taken to accomplish this.

USP 800 Optimal Designs for HD Compounding Areas

According to USP-800, HD drugs cannot be stored with non-HD drugs, so additional square footage and storage space must be allotted to be in full compliance with the USP-800 standards. Designated areas include:

Receipt and unpacking of HD
Storage of HDs
Nonsterile HD compounding
Sterile HD compounding (+ ante-room)

NCI can work with you to ensure your cleanroom design complies with USP-797 and USP-800 requirements. Contact us for more information, or email us at info@nciclean.com to speak with a representative.

USP 797 & 800 CLASS ISO 5 BARRIER ISOLATION STANDARDS

The first option is a Class ISO 5 (Class 100) laminar flow barrier isolator. This is an enclosed laminar flow glove box with attached gloves, where the operator stands outside the viewscreen. The operator puts their hands into the attached gloves and manipulates the compounding products within that enclosure.

Barrier Advantages

The advantage of such a unit is that it does not require a cleanroom and may take less space. The unit also applies to low-, Medium, and High risk conditions. For facilities that work with potential carcinogenic, mutagenic, and/or teratogenic agents, a Chemo Hood (a more protective unit) is required. This type of hood also protects the operator from aerosols generated from the preparation of chemotherapeutics.

Barrier Disadvantages

One of the main disadvantages of an enclosure is that it can be cumbersome to work in. The gloves attached to the box are generally heavy since they are semi-permanent, and the movement is somewhat restricted. The unit is also restricted to one or two operators. Additional usage requires additional equipment, which can be costlier than additional horizontal flow units. If your facility currently uses a non-enclosed Class ISO 5 (Class 100) unit, there is the cost of equipment replacement instead of a possible lower cost to construct a cleanroom.