Understanding USP 797 Standards

Published: 23rd June 2010
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The benchmark for sterile compounding is USP 797. The USP Chapter 797 was written by Mike Hurst, for pharmaceutical supplier Baxa Corp., and is the first promulgated standard for sterile compounding and became effective from January1, 2004. The concept of USP 797 is effective for safe compounding of sterile preparation considering patients safety.

The USP 797 standards are pertinent to all settings where sterile preparations are compounded, but few 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, correct and sterile dose; regardless of who makes 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 produced sterile drug or nutrient has to be evaluated and certified by FDA for protection and efficacy. These products are available in FDA approved labeling.

Any CSP that meets the requirements of the Sterility Test <71> is considered a high-risk level CSP. A product compounded or manufactured from this stock would remain a high-risk level product and should conform to the Beyond Use Date (BUD). The BUD for any CSP, whether low, medium or high risk that has conformed to the requirements of Sterility Test <71> may be based on the chemical constancy of the CSP, rather than microbial stability.

The preparation has to be made with proper protective gadgets. 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.

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