Abstract
1160
Objectives USP 797 requires that any person who compounds radiopharmaceutical (RA) must pass an initial and annual media fill test for bacterial growth. Media fill test consists of aseptically transferring of Triptic Soy broth (TSB) incubating for 14 days at 30-35 for any bacterial growth that simulated compounding techniques of RA.
Methods Our media fill techniques consisted of a 100 ml TSB vial, donning and disinfection the gloves with 70% Isoprophyl alcohol (IPA), followed by drawing 3 ml of TSB with a 5cc syringe and a shield, followed by placing the syringe in a dose calibrator (DC) and adding into empty vial. This process was repeated 2 additional time with the same syringe. This step simulated kit preparation technique. The dose drawing technique simulation was performed using a 3cc syringe with a shield and withdrawing 1.5 ml of the TSB from the first vial, placing in DC and transferring to second vila for a total of three times with the same syringe. Second vial was incubated at 30 -35 degree Celsius for 14 days. At the end of each simulation, gloved fingertip test was performed by pressing finger tips on TSA (Triptic Soy Agar) plate to create a slight depression. Plates were incubated for 3 days at 30-35 degree Celsius, TSB vials and TSA plates were observed for growth. This is simulation performed three time.
Results We tested 18 technologist in media fill challenge who compounds radiopharmaceuticals in our NM department. 89% of our personnel passed the media fill challenge one their first attempted. The remainder passed on the second attempted after retraining. If any cloudiness in TSB or any growth on TSA plates indicated a failed test.
Conclusions Personnel who compounds RA must pass the media fill test before being allowed to compounds RA as per USP 797 compliance. This media fill test may be modified to simulate most intrusive compounding technique.