OBJECTIVE: To study sterility test after using Non-PVC bivalve soft-bag injection in PIVAS. METHODS: The test was divided into 3 groups according to the type of transfusion solution packaging and dispensing environment. Group 1 received Glucose solution using bivalve soft-bag, dispensed in PIVAS; group 2 received Glucose solution using bivalve soft-bag, dispensed in wards area; group 3 received Glucose solution using plastic bottle, dispensed in wards area. After puncturing 1, 3, 6, 9 times (n=80), finished products placed in ward for 0, 2, 4, 6 h (n=20), and then sterility test was conducted with membrane filtration method stated in second part of Chinese Pharmacopoeia (2010 edition). Infusion contamination of 3 groups was analyzed at 9th puncture. RESULTS: The growth of bacteria was not found in group 1; the positive detection rate of group 2 and 3 were 2.5% and 3.8% (n=320). The total positive detection rates after puncturing 1, 3, 6, 9 times were 0, 0.4%, 0.4%, 7.5% (n=240); the positive detection rates of group 1 were all 0, those of group 2 were 0,1.25%,0,8.75% and those of group 3 were 0,0,1.25%,13.75% (n=80). After 9 times of puncture, the positive detection rates of group 1 after placing 0, 2, 4, 6 h were all 0, those of group 2 were 25%,5%,0,5%; those of group 3 were 5%,15%,5%,30% (n=20). CONCLUSIONS: The use of the Non-PVC bivalve soft-bag injection in PIVAS can effectively prevent microbial contamination.
关键词
静脉药物集中调配中心非PVC双阀软袋包装输液无菌检查
Keywords
PIVASNon-PVC bivalve soft-bag injectionSterility test