Evaluation of setup for Intego PET Infusion System in ambient air environment.

Background: The Medrad® Intego PET Infusion System (Bayer HealthCare LLC, Whippany, NJ) allows an easy and safe way for automated injecting PET patients through a multi-dose vial of ¹⁸F-FDG. The setup of using this infusion system, a fully shielded mobile unit, consists of needle-puncturing the shielded multi-dose vial. However, there is no specific direction for the setup environment in the Intego manual. The proposed USP General Chapter <825> indicates the setup attachment or needle-puncture can be performed in an ambient air environment. The purpose of this study was to evaluate if ¹⁸F-FDG product remains sterile and pyrogen free after puncturing a multi-dose vial per the proposed < 825> instructions.

Methods: Two Intego PET Infusion Systems involved in this study were aseptically setup and used in our uptake rooms. Air supplied to this room is filtered at the air handling unit (pre-filter efficiency: MERV [minimum efficiency reporting value] 7, final filter efficiency: MERV 14) with ACPH (air change per hour) 7.3-7.7. All vials tested were taken from these infusion systems over a 22-day period. The vials were used for one clinical day and stored until microbiological assessments were made the next day. Thirty ¹⁸F-FDG vials had sterility testing performed in the clean room using remaining volume of the vial. Sterility testing was performed by incubating 1 mL of ¹⁸F-FDG solution in Trypticase Soy Broth and 1 mL of ¹⁸F-FDG solution in Fluid Thigolycollate. Results were read on days 3, 7, and 14 after incubation. Endotoxin tests were also run on each vial with Endosafe PTS Endotoxin Testing System involving ¹⁸F-FDG solution dilution of 1:100. A small sample was placed on a cartridge and results were read same day. All results were expressed either pass or fail.

Results: Sterility passed at each check point for all 30 vials. Endotoxin passed for each of all 30 vials.

Conclusions: Based upon our limited evaluation, we found no evidence against the current setup practice of ¹⁸F-FDG multi-dose vials in the Intego PET Infusion Systems in our facility. However, the tested sample size (n=30) might not be sufficient to justify this setup environment. Additionally, these results may not be applicable to other facilities as the ambient air quality of the area/room where they setup the Intego PET Infusion System(s) might be different from ours.