Demystifying USP Chapter 797 Definitions for Safe Sterile Compounding

Navigating sterile compounding can be daunting, especially when encountering various technical terms. In this article, we'll unravel the key definitions from USP Chapter 797, shedding light on essential concepts that play a crucial role in ensuring the safety and efficacy of compounded medications. Let's explore these definitions in an easy-to-understand manner:

1. Ante Area

The Ante Area is a designated space where personnel don required garb, such as gowns and gloves, before entering the buffer area or clean room.

It serves as a transition zone, preventing external contaminants from entering the critical compounding areas.

2. Buffer Area

The Buffer Area, also known as the Anteroom, is a space adjacent to the clean room where personnel prepare and stage components used in compounding sterile preparations.

It helps maintain a controlled environment by reducing the risk of contamination during the compounding process.

3. Clean Room

A Clean Room is a controlled environment where sterile compounding occurs.

It has strict air quality and cleanliness standards to prevent the presence of harmful microorganisms during drug preparation.

4. Classification of Clean Room

Clean rooms are classified based on the number of particles allowed per cubic meter of air at specified particle sizes.

The classifications range from ISO Class 5 (the most stringent) to ISO Class 8 (the least stringent), with ISO Class 7 and 8 commonly used for compounding non-hazardous drugs.

5. Direct Compounding Area (DCA)

The Direct Compounding Area (DCA) is a specific area within the clean room where sterile drug compounding takes place.

It must meet stringent cleanliness and environmental requirements to minimize the risk of contamination.

6. Primary Engineering Control (PEC)

The Primary Engineering Control (PEC) refers to the device or equipment used to maintain an aseptic environment during drug compounding.

Examples include biological safety cabinets or compounding aseptic isolators.

7. Critical Area

The Critical Area encompasses the DCA and its immediate surroundings.

It is an area within which any contact or exposure to non-sterile surfaces poses a risk of contamination to sterile preparations.

8. Critical Site

The Critical Site refers to any area or point in the sterile preparation where contact with non-sterile surfaces could introduce contaminants.

It is essential to maintain the integrity of critical sites during compounding.

9. First Air

First Air refers to the HEPA-filtered air exiting the PEC, which creates a zone of protection for sterile compounding.

It prevents airborne contaminants from entering the critical areas.

10. Hazardous Drugs

Hazardous Drugs are medications that pose a risk of adverse health effects, such as toxicity or carcinogenicity, to individuals handling them.

USP Chapter 797 provides guidelines for safe handling and compounding of hazardous drugs.

11. Media-Fill Test

The Media-Fill Test is a process used to assess the capability of personnel and procedures in maintaining aseptic conditions during compounding.

It involves filling sterile media into containers and observing for any signs of contamination.

12. Multiple-Dose Container

A Multiple-Dose Container is a vial or other container that holds more than one dose of a drug.

It requires specific procedures for handling and storage to prevent contamination and ensure stability.

Conclusion

Understanding the definitions from USP Chapter 797 is vital for anyone involved in sterile compounding. By familiarizing ourselves with these terms, we can ensure safe practices and uphold the highest standards of patient care. These definitions, coupled with strict adherence to guidelines, enable healthcare professionals to provide patients with sterile medications of the utmost quality and safety.