The Effect of the Vaporized Hydrogen Peroxide Residues in a Trypticase Soy Agar Plates for a New Barrier Isolated Syringe Filling Machine

Abstract

This study has been performed to evaluate the feasibility and adequacy of the Trypticase Soy Agar (TSA) plates in promoting growth after being exposed to Vapor Phase Hydrogen Peroxide (VPHP) decontamination cycle. This project has been successfully completed in two phases. Data obtained from Phase 1 demonstrated that the growth promotion properties of the Becton & Dickinson Sterile Triple bagged of TSA plates were not impacted after being exposed to up to three consecutive decontamination cycles in the new syringe filling line isolator at the established decontamination cycle parameters. The results obtained from Phase 2 as well demonstrates no impact in the growth promotion properties after being exposed to a decontamination cycle, unpacked and the individual plates exposed to 1 ppm VPHP residues up to two (2) hours in a simulated manufacturing process when using the Quality Control Work Center isolator. Key Terms - isolator decontamination cycles, Trypticase Soy Agar plates, vapour phase hydrogen peroxide.