Eskenazi S, Bychkowski O E, Smith M, MacMillan J D
J Assoc Off Anal Chem. 1982 Sep;65(5):1155-61.
External surfaces of packaging materials used for sterile medical devices may introduce contaminants into working areas used for sterility testing. Light wiping with tissues moistened with alkaline 2% glutaraldehyde (Cidex) or 3% hydrogen peroxide effectively reduced counts on 5 X 8 cm strips of packaging material (Tyvek) inoculated with 10(7) spores of Bacillus subtilis. The ability of antimicrobial agents to penetrate packaging material and kill contaminants on the medical device was tested by inoculating filter membranes with ca 100 cells of Pseudomonas aeruginosa or Staphylococcus aureus or ca 100 spores of Bacillus subtilis. A sterile square of test packaging material placed over the inoculated membrane (direct method) or 0.5 cm above the membrane (indirect method) was wiped with the antimicrobial agent. Except for polyethylene film (3 mil), all materials tested, including glassine and several types of coated and uncoated Tyvek, were penetrated by the agents, killing cells on the inoculated membranes. Death rates varied, depending on the organism, packaging material, and testing method. It is suggested that penetration tests be performed before using antimicrobial agents for sanitizing packaging materials during sterility tests.
用于无菌医疗器械的包装材料外表面可能会将污染物引入用于无菌测试的工作区域。用含2%碱性戊二醛（Cidex）或3%过氧化氢的湿纸巾轻轻擦拭，能有效减少接种了10⁷个枯草芽孢杆菌孢子的5×8厘米包装材料条（特卫强）上的菌数。通过在滤膜上接种约100个铜绿假单胞菌或金黄色葡萄球菌细胞或约100个枯草芽孢杆菌孢子，测试了抗菌剂穿透包装材料并杀死医疗器械上污染物的能力。用抗菌剂擦拭覆盖在接种膜上的无菌测试包装材料方块（直接法）或距膜0.5厘米上方的材料方块（间接法）。除了聚乙烯薄膜（3密耳）外，所有测试材料，包括玻璃纸和几种涂覆和未涂覆的特卫强，都能被抗菌剂穿透，杀死接种膜上的细胞。死亡率因微生物、包装材料和测试方法而异。建议在无菌测试期间使用抗菌剂对包装材料进行消毒之前进行穿透测试。
