Study on Sterility Test after Using Non-PVC Bivalve Soft-bag Injection in PIVAS / 中国药房

ABSTRACT

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 filtra-tion 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 bi-valve soft-bag injection in PIVAS can effectively prevent microbial contamination.