USP <797> Sterile Compounding

These flashcards cover essential vocabulary related to USP <797> sterile compounding, including definitions of key terms and concepts.

Aseptic Technique

A procedure to prevent contamination by pathogens during the preparation of sterile products.

Garb Procedure

A systematic method for putting on protective clothing in a specific order to minimize contamination.

Beyond Use Date (BUD)

The date after which a compounded sterile product should not be used, determined by specific factors like sterility.

Primary Engineering Control (PEC)

A device or environment that provides a sterile field for compounding sterile products, like a Laminar Air Flow Workbench.

ISO Classification

A standard for classifying the cleanliness of air based on the number of particles present.

Cleaning Steps

Procedures for maintaining cleanliness in compounding areas, including disinfection and removal of contaminants.

Compounded Sterile Products (CSP)

Pharmaceutical preparations that are compounded and are intended to be sterile when administered to patients.

HEPA Filter

High-Efficiency Particulate Air filter used to trap harmful particles in sterile environments.

Training Requirements

Standards outlining the knowledge and skills personnel must have to perform compounding under USP regulations.

Dynamic Airflow Testing

A procedure to evaluate the airflow within a compounding space to ensure it meets safety standards.

Immediate Use Compounds

Low-risk sterile preparations intended for immediate administration to a patient, with specific guidelines.

Sporicidal Disinfectants

Agents that are capable of destroying bacterial and fungal spores, used in compounding environments.

Compounding Record

A document that tracks all relevant details regarding the preparation of compounded sterile products.

Labeling Requirements

Standards for what must be included on the labels of compounded sterile products to ensure safety and compliance.

Garb Order

The specific sequence in which personal protective equipment should be donned to maximize sterility.

Surface Contamination

Presence of unwanted substances on surfaces that can lead to compromise in sterility.