Exam 1 USP 797 Flashcards
What are the purposes of USP 797 and USP 800?
To ensure safety in sterile compounding and handling hazardous drugs.
Who do USP 797 and USP 800 apply to?
Healthcare personnel involved in compounding sterile preparations.
What is a Primary Engineering Control (PEC)?
The IV hood where sterile compounding takes place.
What is the ISO classification of air in a PEC?
ISO 5 air.
What type of airflow is usually used for non-hazardous compounding in a PEC?
Horizontal air flow.
What type of airflow is required for hazardous compounding in a PEC?
Vertical air flow.
What must a PEC be vented to?
Exterior of the building.
What is a Secondary Engineering Control (SEC)?
The IV clean room.
What is the ISO classification of air in a SEC?
ISO 7 air.
What is the required air change rate for a SEC?
30 air changes per hour.
What pressure must a SEC maintain if used for hazardous drugs?
Negative pressure.
What pressure must a SEC maintain if used for non-hazardous drugs?
Positive pressure.
What is an anteroom?
A transition area attached to a clean room.
What is the ISO classification of air in an anteroom for non-hazardous drug rooms?
ISO 8.
What is the ISO classification of air in an anteroom for hazardous drug rooms?
ISO 7.
What occurs in the anteroom?
Gowning and garbing.
What is the required air change rate for an ISO 8 anteroom?
20 air changes per hour.
What is the required air change rate for an ISO 7 anteroom?
30 air changes per hour.
What are the differences between Category 1, 2, and 3 CSPs?
They differ based on risk levels and compounding conditions.
What is the difference between Stability and Sterility?
Stability refers to the drug’s physical and chemical integrity; sterility refers to the absence of viable microorganisms.
What is the significance of beyond-use dating?
It indicates the time period after which a compounded preparation should not be used.
Define Designated Person.
A qualified individual responsible for ensuring compliance with compounding standards.
What is First Air?
The first air that comes from the HEPA filter in a PEC.
What is an Immediate-use product?
A preparation that is used within a short timeframe after compounding.
What is a Ready-to-use system?
Pre-prepared sterile products that require no further manipulation.
What is a Media-fill test?
A test to ensure aseptic technique during compounding.
What is a gloved fingertip test?
A test to assess the effectiveness of hand hygiene and glove usage.
What does the NIOSH list of hazardous drugs indicate?
A list of drugs deemed hazardous for handling.
Who publishes the NIOSH list of hazardous drugs?
The National Institute for Occupational Safety and Health (NIOSH).
True or False: Gowning and garbing are the same for hazardous and non-hazardous sterile compounding.
False.
