What is Media Fill Testing?
What is the purpose of media fill testing?
To simulate a drug in a microbial growth medium
What should you first do when you sit down to start the Media Fill testing process?
Sterilize the work area and materials
A media fill test with even one positive unit is considered this, requiring a full investigation.
Failure
What is contamination?
The biggest risk is if you touch sterile items or critical sites during a media file
What is Media Fill testing?
A simulation used in aseptic processing to prevent contamination in sterile pharmaceutical manufacturing
What angle should your syringe be when inserting the needle into a vial?
45 or 90 degrees
The visual results in a media fill unit that indicates a test failure
Cloudiness/Turbidity
What happens if you don't disinfect the injection port or rubber stopper?
Increases the risk of microbial growth during a media test
How often are Media Fill Tests performed?
3 tests when hired, and after it must be performed quarterly
7 to 14 days
What if you don't get out all of the air out of the vile what will happen to that dose
The incorrect Dose
What is the decreased effectiveness of disinfection/contamination risk?
Not letting alcohol fully dry after wiping surfaces
What indicates a failed media fill test?
Visible (cloudiness) or "strings" or "clumps"
How often should you check the containers in the incubation period?
Daily
A separate sample that shows growth to prove that the test medium itself is effective at detecting microorganisms
Positive control
What is producing a false result that can threaten patient safety?
If you don't follow the exact steps of the media fill procedure
How do you go about media fill testing?
Use a sterile liquid growth medium instead of a drug to simulate compounding, then perform all the usual aseptic steps and incubate the final containers to check for microbial growth
20-25 C and 30-35 C
After implementing corrective and preventive actions, personnel must do this again before resuming actual sterile compounding
Revalide
What is blocking the first air and contaminating the product?
Reaching over sterile supplies in the hood increases the risk of the media test