Understanding Usp 797 Standards

By Author: Jamie Hanson
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The benchmark for sterile compounding is USP 797. The USP Chapter 797 was codified by Mike Hurst, for pharmaceutical supplier Baxa Corp., and is the first implemented standard for sterile compounding and became effective from January1, 2004. The basic idea of USP 797 was to lay down procedures and practical requirements for safe compounding of sterile preparations, keeping in view patient safety concerns following professional guidelines and recommendations.

The USP 797 standards are valid to all settings where sterile preparations are compounded, but some raised concerns about the cost and ease of complying. The idea of USP 797 for sterile compounding is improving the standards. Similar to any change, USP 797 was misunderstood and certain misconceptions creeped in. The worst misinterpretation was requirement of clean room.

The application of USP 797 standards is not limited to any particular profession or any particular type or types of sterile compounding location. The standards apply to sterile compounding at any place without considering the profession of the compounding personnel. This is made for patient ...
... safety, since every patient has the right to a safe, precise and sterile dose; regardless of who prepares it or where the dose is prepared.

Low risk compound sterile preparations should follow the norm of ISO class 5 standards. The compounding should be made using aseptic ingredients, products, components and devices. This type of compounding pertains to transfer, measuring and mixing manipulations using at the most only three commercially manufactured packages of sterile products and limiting two entries into any one sterile container or package.

A mid level risk CSP can be compounded aseptically in low risk circumstances. However, these CSPs involve complex aseptic manipulations, accumulation of sterile products for administration to several patients or to a single patient several times, or the process of compounding requires a long duration. Any product to be defined as a commercially manufactured sterile drug or nutrient has to be evaluated and certified by FDA for safety and efficacy. These products are available in FDA approved labeling.

Any CSP that meets the necessity of the Sterility Test is considered a high-risk level CSP. This high-risk level product has to conform to BUD. The BUD for any CSP, whether low, medium or high risk that meet to the requirements of Sterility Test may be based on the chemical stability of the CSP, rather than microbial stability.

The personnel involved in preparing CSPs in the buffer area or clean room should be fully garbed with appropriate protective equipment. A typical clean room garb require shoe covers, gown, hair cover, mask and sterile gloves.

For more information on USP 797 and cleanroom supplies, visit Cleanroom Supply connection.