PT120
How often must handwashing and garbing requirements of personnel preparing category 1 and category 2 CSPs be visually inspected? pg 54
Quarterly
What is the most common type of disinfectant used when cleaning compounding surface areas? pg 57
70% Isopropyl Alcohol
How often must the measurements of air quality and presence of microbials in the PEC must be certified by an approved outside organization? pg 53
Every 6 months
What should a technician do if there is an indication that the CSP has been compromised? pg 64
The CSP should not be administered, it should be discarded, and an investigation should be performed on how it occurred
What does Release testing ensure? pg 51
It ensures a product meets required quality characteristics
How long must the Growth Media for surface sampling be placed in the incubator, and at what temperatures? pg 53
7 days at 20° to 25° C followed by additional 2 to 3 at 30° to 35° C
What is a media fill test? pg 51
A process simulating compounding processes or products to ensure microbial growth is not present
What is the timeframe that an Urgent Use CSP must be prepared and administered? pg 57
1 hour
What is a technician looking for when doing a visual inspection of the CSP? pg 64
Cloudiness, particulate matter, leakage, or container compromise
How often must gloved fingertip and thumb sampling inside the ISO Class 5 PEC performed for personnel preparing Category 1 and 2 CSP's? pg 54
Quarterly
What is a Preservative? pg 51
A substance used to prevent microbial growth
How often is the Airflow Adequacy of the ISO classified areas required? pg 56
Every 6 months
How often is surface sampling of the interior of a PEC in a SCA is performed? pg 53
Monthly
How many times must gloved fingertip and thumb sampling tests be performed before a technician can perform initial compounding? pg 53
3 separate tests
Name the types or preparations that require sterile compounding. pg 52
Injectables, water-based aqueous bronchial inhalations, live organ baths and soaks, ophthalmic medications, and internal body cavity irrigations
Which ISO Class environment must have a minimum ACPH of 30? pg 55 - 56
ISO Class 7
How often is the temperature of the refrigerator used to store CSP's checked to ensure the stability of the CSP? pg 64
Once daily
What Beyond Use Date (BUD) gets assigned to a Categoty 1 CSP? pg 64
12 hours or less at room temperature and less than 24 hours if kept in refrigerator
What must be done if the surface sampling of the PEC in a SCA exceeds recommendations? pg 53
Additional cleaning, retraining of personnel, or verification of storage or expiration dates of testing materials used
When a Category 2 is prepared with only sterile products and sterility testing is not performed, what are the Beyond Use Dates? Talks about Category 2 on pg 53 and 64 but I did not find the answer
10 days refrigerated or 4 days at room temperature can be assigned to a category 2 CSP when no sterility testing was performed