BD PhaSeal™ and particulate contamination

Abstract

Background: The closed system transfer device, BD PhaSeal™, is used to compound individual doses of cytotoxic medication in the Aseptic Production Unit (APU) of the Lady Cilento Children's Hospital (LCCH) Brisbane, Queensland, Australia. The APU noted a large number of cytotoxic medications compounded using BD PhaSeal™ required remaking of the product due to visible particulate contamination. The small gray particulate contaminate was assumed to be rubber bung produced by ‘coring’ the rubber stopper of the drug vial when using the BD PhaSeal™ Protector P50 as part of the compounding process. Aim: The aim of this study was to determine if substituting the BD PhaSeal™ Protector P50 with the BD PhaSeal™ Protector P55 reduced the level of particulate contamination in cytotoxic compounded products. Method: Phase 1 – baseline collection of contamination over 4 months. Phase 2 – substitute the Protector P50 with the P55 into the compounding process to compound a single medicine product, vincristine in sodium chloride 0.9% 50 mL bags for 2 weeks. Phase 3 – substitute the Protector P50 with the P55 into the compounding process of all cytotoxic medicines for 4 months. Results: Phase 1 – 134 products were contaminated out of 2501 compounded products (5.3%). Phase 2 – one out of 75 vincristine products had particulate contamination (1.3%) using P55. Phase 3 – 28 contaminated products out of 3877 (0.72%) using P55. Conclusion: This study demonstrated that substituting BD PhaSeal™ Protector P50 with the Protector P55 reduced the incidence of particulate contamination of cytotoxic medicines from 5.3–0.72% of products. This provides significant resource and financial benefits.L6217270322018-04-24 <br />2018-04-26 <br />