Einfluss des Prionen-Sterilisationszyklus auf die bakterielle Barrierewirkung von Sterilisationsvlies im Endverpackungstest [Influence of prion sterilisation cycle on the bacterial barrier performance of sterilisation wrap according to the final pack test]
article
Kimguard One-Step sterilisation wrap has regulatory approval as a Class I medical device suitable for packaging terminally sterilised medical items. In this study, we evaluated the performance of five different grades of Kimguard One-Step sterilisation wrap after prion sterilisation cycle (134 °C for 18 minutes) using the final pack test method. Kimguard One-Step grades KC100, KC200, KC300, KC400 and KC500 were used to wrap a 1/1 DIN steel wire instrument tray (internal volume of 7.2 L) and each wrapped test pack was challenged with 100,000 1 μm latex particles delivered at an air flow rate of 250 mL/min during a 25-minute test period. For each grade of wrap, particle filtration efficiency measurements were carried out sixfold after sterilisation and repeated after test pack storage for three months. At both time points, particle counts within the wrapped test packs were negligible and yielded mean particle retention rates for all five grades of sterilisation wrap of ≥ 99.99%. From these results, we conclude that the microbial barrier effectiveness of Kimguard One-Step sterilisation wraps KC100, KC200, KC300, KC400 and KC500 remains unaffected by prevacuum steam sterilisation at 134 °C for 18 minutes, or by subsequent storage for three months with regular movement of packs during storage.
Topics
Barrier propertiesFinal packKimguard One-StepMicrobial barrierPrion steam sterilisation cycleSterilisation wrapEthylene oxideLatexPolypropyleneAirflowEnvironmental temperatureFlow rateHumidityInstrument sterilizationMedical deviceMicrobial contaminationNetherlandsPackagingPackaging materialPrionTemperature measurement
TNO Identifier
527748
ISSN
09426086
Source
Zentralsterilisation - Central Service, 21(4), pp. 277-284.
Pages
277-284
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