Clean It Like You Mean It
This ISO class is required inside the Primary Engineering Control (PEC).
What is ISO Class 5?
True or False: Garb should be donned from dirtiest to cleanest.
False – from cleanest to dirtiest.
Category 1 CSPs can be compounded in this type of area.
What is a Segregated Compounding Area (SCA)?
Every CSP must undergo this check before release.
What is a visual inspection?
The label on a CSP must include this key safety date.
What is the Beyond-Use Date (BUD)?
This type of airflow keeps contamination away from sterile areas.
What is unidirectional (laminar) airflow?
These gloves must be worn for sterile compounding.
What are sterile, powder-free gloves?
True or False: Category 2 CSPs require a cleanroom suite with an ISO Class 5 PEC.
True
True or False: All CSPs require sterility testing.
False
True or False: The BUD is the same as the manufacturer’s expiration date.
False
True or False: Air in a cleanroom should flow from dirtier to cleaner areas.
False – it should flow from clean to dirty.
Hand hygiene is required at these times.
What is before gloving, after contamination, and before each compounding session?
The main difference between Category 1 and Category 2 CSPs.
What is the BUD and environmental requirements?
Endotoxin testing applies to this type of preparation.
What are parenteral CSPs?
Documentation must be these three things.
What are contemporaneous, legible, and complete?
The minimum frequency for air and surface sampling.
What is semi-annually?
This test checks for microbial contamination on gloved fingertips.
What is the gloved fingertip test?
Aseptic technique prevents these two types of contamination.
What are microbial and particulate contamination?
Deviations from SOPs must be handled this way.
What is documented and investigated?
True or False: Electronic records must meet 21 CFR Part 11 standards.
True
This filter must be leak-tested during every cleanroom certification.
What is a HEPA filter?
Personnel must requalify their garbing technique at least this often.
What is annually?
All compounding must be documented to include these details.
What are personnel, date/time, ingredients, and lot numbers?
Continuous monitoring of this ensures air cleanliness and pressure integrity.
What is pressure differential and environmental control?
The frequency for reviewing temperature and humidity logs.
What is daily?