Understanding USP 797 Standards
The benchmark for sterile compounding is USP 797. The USP Chapter 797 was prepared 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 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 biggest misconception was that USP 797 requires a sophisticated 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 done for patient safety, since every patient has the right to a safe, correct and sterile dose; regardless of who compounds it or where the dose is prepared.
As recommended by USP Chapter 797 low risk Compound Sterile Preparations (CSPs) can be formulated and compounded with sterile manipulations within ISO Class 5 standards. The compounding should be done using aseptic ingredients, products, components and devices. This is transfer, measure and mix utilizing three packages and confining to two entries into a container.
A mid level risk CSP can be compounded aseptically in low risk situation. CSP involves accumulating the said product for patients with multiple use or for many people to use. Any product to be defined as a commercially produced sterile drug or nutrient has to be evaluated and certified by FDA for security and efficacy. Such products are available with full prescribing information, commonly understood as the FDA approved manufacturer’s labeling or product package insert.
Any CSP that meets the stipulation of the Sterility Test 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 comply 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 consists of 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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