Sampling Program
An exceeded one of these indicates that a process is outside of normal operating range
What is action level?
Location of the label on the air or surface sample
What is the perimeter of the base of the plate?
Provides a level of assurance that the media was not contaminated during handling and sampling
What is a negative control?
This is considered an excursion by USP <797>
What is an exceeded action level?
Non-selective medium that provides enough nutrients to allow a variety of microorganisms to grow
What is general growth medium?
Conditions under which viable samples must be collected
What are dynamic operating conditions?
The motion used to collect a surface sample
What is a rolling motion?
General order of sample collection
What cleanest to dirtiest?
The level to which a microorganism must be identified in the event of an exceeded action level
What is genus?
Viable samples are incubated at 30 to 35°C for this length of time
What is at least 48 hours?
The frequency that the sampling plan should be reviewed
What is annually?
The agent that must be used to wipe the surface after the collection of a surface sample
What is an EPA-registered one-step disinfectant cleaner?
Before exiting the compounding area, this should be done to avoid extra work
What verify that all samples were collected?
USP <797> specifies that this type of sample should be collected again in the event of an exceeded action level
What is the air sample?
Gram stain reaction, colony morphology, cell shape, and arrangement are used for this
What is microbial characterization?
The CAG that provides guidance on assigning action levels to pass-through air and surface samples
What is CAG-015?
Type of sampler that must be used for chapter compliance
What is volumetric, impaction air sampler?
Where a compromised plate or sample is discarded
What is outside of the compounding area?
Microorganisms that are typically found in water
What are gram negative bacteria?
This USP chapter defines growth promotion testing for TSA
What is USP <61>?
The trending tool that considers the total number of recoveries across all samples
What is contamination recovery rate?
Another name for the correction factor applied to impaction air sampler results
What is most probable number (MPN)?
Where air and surface samples are collected in the PEC
What is the direct compounding area (DCA)?
Two logs that are reviewed when investigating an excursion
What are cleaning, training, pressure, temperature, and humidity?
The single plate incubation parameters defined in CAG-009
What are 30 to 35 °C for 48 to 72 hours and 20 to 25 °C for 5 to 7 days?