Permeability and release of decontaminating agent used in cytotoxic reconstitution units: diffusion of hydrogen peroxide in IV solution container

Introduction

Oxidant agents used to top-decontamination, in cytotoxic reconstitution units may spread into IV solution containers. Amount of hydrogen peroxide passing through the bags and it release have been evaluated, using wrapped or unwrapped infusion bags made of three layers of polyolefin (Freeflex®, Fresenius).

Method

3 measurement series were carried out, each one was made of 2 packages of 30 bags in polyolefin, with (package A) or without (package B) overwrapping. Each series went through a 43 minutes decontamination cycle, with H₂O₂ 30%. Quantitative analysis was made by spectrophotometry at 562 nm, measuring a colored adduct formed by ferric iron and xylenol orange. To evaluate the release of H₂O₂, samples were taken att₀, t₁, t₂, t₇, t₂₁ days. Limit of detection is around 0.08 ppm.

Results

Calibration, made prior each analysis, was linear from 0 to 3 ppm. Concentration of H₂O₂ in over wrapped containers (A) was non-significantly different than 0 (p>0.05 Wilcoxon test) until 21 days. At t0 there was no significant difference between package A and B, but from day 2, H₂O₂ was detected in non-overwrapped bags (B) (First series, at t2 p=4, 5.10^-12 Wilcoxon test). The higher concentration was reached after 21 days (0.16 ppm).

Conclusion/Discussion

Theses results allow removing overwrapping for a lean production system, with an extemporaneous used. However, the graduate release of H₂O₂ and the absence of any toxicity threshold, make it impossible to remove the overwrapping for a pre-empted production.