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)
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.USP 797 & 800 CLEANROOM ADDITION STANDARDS
The second option is the addition of a cleanroom. A cleanroom is a contained area with a laminar flow of HEPA filtered air with enough positive pressure to attain a pre-determined level of cleanliness. In the case of USP 797, the level that needs to surround the Class ISO 5 (Class 100) laminar flow unit is Class ISO 8 (Class 100,000).Cleanroom Advantages
The advantages of a cleanroom are that it gives the operator more freedom of movement. The cleanroom can be large enough to accommodate a large staff and more equipment and supplies. The cost to build a cleanroom, especially a Class ISO 8 (Class 100,000), is relatively low. Below are a variety of options NCI can provide, from enclosing the corner of a room to a large-scale, hard wall cleanroom. (See "A Primer on Cleanrooms ")Cleanroom Disadvantages
One of the main disadvantages of a cleanroom is that it may take more space than a laminar flow glovebox. Suppose your facility has no compound preparation taking place currently. In that case, the cost for a cleanroom and a laminar flow Class ISO 5 (Class 100) may be more than a laminar flow glovebox, but that is not necessarily true in all cases. Finally, a cleanroom takes additional cleaning care since it requires supplies and solutions that are low in particulants. Those low-particulate items are also needed to clean Isolation Barriers (see A Primer on Equipment and Supplies).Why Choose NCI for Your ISO Class 5 Cleanroom Equipment Needs?
NCI is a direct supplier and distributor of premium ISO Class 5 Cleanrooms, Laminar Flow Hoods, and Horizontal Flow Cleanbenches. Whether your industry is aerospace, electronics, medical devices, pharmaceuticals, semiconductors, biotech, food processing, injection molding, or another high-tech field, we stock the cleanroom products and equipment you need. Some of the benefits of choosing NCI include:- Electronic order placement
- Visa/MasterCard/American Express payments
- Net 30 Terms (contact us to be set up with terms)
- Contracts with fixed pricing
- Quick, economical delivery
- Cleanroom consultation
- Latex-free product options
- EDI order service
