Hecker W, Meier R, Thevenin J P, Hartberger K
Zentralbl Bakteriol Mikrobiol Hyg B. 1983 Jun;177(5):375-93.
Filtration is one of the classical methods for the determination of the microbial content of the air or the number of microbe-bearing particles in the ambient air. Hereby, the opinion prevails that gelatin foam filters yield better results than filters made of cellulose esters. Since gelatin filters are themselves by no means free from disadvantages, several tests were carried out under the conditions encounted in practice in two packaging rooms used for pharmaceutical preparations. The objective was to ascertain whether the customary cellulose ester filters really are less suitable for determination of the microbial content of the air than the filters made of soluble gelatin. Based on the results of various preliminary experiments, gamma-irradiated filters of cellulose nitrate, with a pore size of 0,45 micron, were selected from a range of tested membrane filters (Tables 1,2,4-6 and Fig. 1) and compared directly with the gelatin filters. The statistical evaluation of these tests showed that, under the chosen experimental conditions, both filters yielded the same count of organisms (Tables 3, 9 and 10, Figs. 2 and 3). Moreover, by means of further tests, it could be proved that neither cellulose nitrate filters with a pore size of 0,8 micron, which had undergone gamma-radiations, nor filters made of the mixed esters of cellulose, which had been treated with ethylene oxide or autoclaved, differed significantly from the selected type (Tables 5-8). This study therefore clearly demonstrates that - in addition to gelatin filters - a whole range of membrane filters made of cellulose esters yield equally good results and may be used for supervision of the microbial content of the air in closed rooms.
过滤是测定空气中微生物含量或环境空气中带微生物颗粒数量的经典方法之一。据此,普遍认为明胶泡沫过滤器比纤维素酯制成的过滤器能产生更好的结果。由于明胶过滤器本身也并非没有缺点,因此在用于药物制剂的两个包装车间的实际条件下进行了多项测试。目的是确定常规的纤维素酯过滤器在测定空气中微生物含量方面是否真的不如可溶性明胶制成的过滤器合适。根据各种初步实验的结果,从一系列测试的膜过滤器(表1、2、4 - 6和图1)中选择孔径为0.45微米的γ辐照硝酸纤维素过滤器,并直接与明胶过滤器进行比较。这些测试的统计评估表明,在所选的实验条件下,两种过滤器产生的生物体计数相同(表3、9和10,图2和3)。此外,通过进一步测试可以证明,经过γ辐照的孔径为0.8微米的硝酸纤维素过滤器,以及经过环氧乙烷处理或高压灭菌的纤维素混合酯制成的过滤器,与所选类型相比均无显著差异(表5 - 8)。因此,这项研究清楚地表明,除了明胶过滤器外,一系列纤维素酯制成的膜过滤器也能产生同样好的结果,可用于监测封闭房间内空气中的微生物含量。