PP-005 Improving safe preparation of injectable medicines: the effects of introducing a sporicidal agent

BackgroundDue to recent fatalities from the use of aseptically prepared injectable medicines, the EU Good Manufacturing Practice (EU GMP) regulator recommended the introduction of a sporicidal agent (by January 2016) in the first stage of a two step decontamination process. Our licensed aseptics unit produces chemotherapy, intravenous additives, parenteral nutrition and radiopharmacy batches, using non-gassing isolator (grade A) technology in a grade C room environment. Traditional GMP environmental monitoring methods are employed, and historical monthly trending revealed a microbial recovery rate of 1.6% across grade A.PurposeThis project outlines our strategy for and results since the introduction of a sporicidal agent to enhance the sanitisation process for aseptic preparation, as recommended by the EU GMP regulator.Material and methodsOur sanitisation process was reviewed, in order to identify opportunities for improvement, and criteria for assessing an ideal sporicidal agent were developed. Our old sanitisation practice involved spraying products and consumables with sterile 70% alcohol in the grade D preparation room and transferring into the isolator room (grade C), where any extra packaging (if double wrapped) was removed, and the materials sprayed again with alcohol, and wiped with alcohol impregnated wipes, before being transferred into the isolator. Using the assessment criteria, a chlorine based sporicidal agent was selected, and introduced, after staff training and a pilot phase, in combination with a change in the sanitisation process to wipe then spray (with sporicide, and 2 min contact time) in the preparation room, followed by spray (with alcohol) then wipe in the isolator room. Traditional environmental monitoring was carried out.Results7 months after introduction, the microbiology results consistently showed a 20% reduction in overall contamination (recoveries) and 100% elimination of mould recoveries in grade A isolators (representing a 3% reduction in the ratio of spore formers to vegetative organisms). The microbial air quality improved by 70% in the preparation rooms, and by 50% in the isolator rooms.ConclusionA simple change in the sanitisation practice to a more robust wipe–spray–spray–wipe process, using a chlorine based sporicidal agent for the first ‘spray’ step, significantly improved the background environmental conditions, reducing the risk of contamination, and ensuring that injectable medicines are prepared safely for the b