USP 797 & 825 Overview QUESTIONS WITH ANSWERS RATED
A+
Media-Fill Testing - Annual testing for personnel compounding low or medium-risk products to
simulate challenging conditions
Fingertip Sampling - Quality control mechanism to ensure cleanroom environments remain in a
state of control by assessing sterile hand hygiene
Colony Forming Units (CFUs) - Units used to measure the number of viable bacteria or fungal
cells in a sample
ISO 5 Environment Testing - Testing conducted in an environment meeting specific air
cleanliness standards
Microbial Contamination Action Levels - Threshold levels of microbial contamination that
trigger corrective actions
Garbing - The process of donning personal protective equipment (PPE) before entering a sterile
compounding area
PPE - Personal protective equipment such as gowns, gloves, masks, and shoe covers worn to
maintain sterility
Laminar Flow Hood - A device used to direct a continuous flow of HEPA-filtered air over a
work area to maintain sterility
Immediate Use Exceptions - Exemptions from standard sterile preparation requirements for
specific situations
BUD - Beyond Use Date, the date after which a compounded preparation should not be used
Hotlab - A specialized laboratory for handling and compounding radioactive materials in nuclear
medicine
HEPA Filter - High Efficiency Particulate Air filter used to trap airborne particles
Ante Room - A room adjacent to a cleanroom or buffer area where garbing and hand hygiene
procedures are performed
Buffer Room - An area where compounding of sterile preparations takes place within a
cleanroom
A+
Media-Fill Testing - Annual testing for personnel compounding low or medium-risk products to
simulate challenging conditions
Fingertip Sampling - Quality control mechanism to ensure cleanroom environments remain in a
state of control by assessing sterile hand hygiene
Colony Forming Units (CFUs) - Units used to measure the number of viable bacteria or fungal
cells in a sample
ISO 5 Environment Testing - Testing conducted in an environment meeting specific air
cleanliness standards
Microbial Contamination Action Levels - Threshold levels of microbial contamination that
trigger corrective actions
Garbing - The process of donning personal protective equipment (PPE) before entering a sterile
compounding area
PPE - Personal protective equipment such as gowns, gloves, masks, and shoe covers worn to
maintain sterility
Laminar Flow Hood - A device used to direct a continuous flow of HEPA-filtered air over a
work area to maintain sterility
Immediate Use Exceptions - Exemptions from standard sterile preparation requirements for
specific situations
BUD - Beyond Use Date, the date after which a compounded preparation should not be used
Hotlab - A specialized laboratory for handling and compounding radioactive materials in nuclear
medicine
HEPA Filter - High Efficiency Particulate Air filter used to trap airborne particles
Ante Room - A room adjacent to a cleanroom or buffer area where garbing and hand hygiene
procedures are performed
Buffer Room - An area where compounding of sterile preparations takes place within a
cleanroom
