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首页> 外文期刊>PDA journal of pharmaceutical science and technology >Method for qualifying microbial removal performance of 0.1 micron rated filters. Part III: bacterial challenge tests on 0.2/0.22 and 0.1 micron rated filter cartridges with Hydrogenophaga (formerly Pseudomonas) pseudoflava.
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Method for qualifying microbial removal performance of 0.1 micron rated filters. Part III: bacterial challenge tests on 0.2/0.22 and 0.1 micron rated filter cartridges with Hydrogenophaga (formerly Pseudomonas) pseudoflava.

机译：鉴定0.1微米额定过滤器的微生物去除性能的方法。第三部分：在0.2 / 0.22和0.1微米级滤芯上用Hydrogenophaga（以前的假单胞菌）假黄精进行细菌攻击试验。

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We have previously reported on the preliminary characterization of Hydrogenophaga (formerly Pseudomonas) pseudoflava for potential use as a standard challenge organism to qualify 0.1 microm rated filters. This article reports on the retention efficiencies of a large panel of 0.2/0.22 microm and 0.1 microm rated filter cartridges for H. pseudoflava (ATCC 700892) versus the retention capabilities of the same filters for Brevundimonas diminuta (ATCC 19146). A total of thirty-two 0.2/0.22 microm rated filter cartridges, spanning nine different "sterilizing grade" filter types from four different filter manufacturers, were challenged with H. pseudoflava at challenge levels exceeding 10(7) cfu/cm2. H. pseudoflava was shown to penetrate every 0.2/0.22 microm rated filter tested, with log titer reduction (LTR) values ranging from 3.5 to 7.7 logs. H. pseudoflava was shown to be more penetrative than B. diminuta under the same challenge conditions. B. diminuta was fully retained by nineteen of the twenty 0.2/0.22 microm rated filters that were challenged with both organisms. In the case of 0.1 microm rated filters, eighteen filter cartridges, spanning five different filter types from three manufacturers were tested. H. pseudoflava was consistently retained by four out of the five filter types tested, with LTR values in excess of 11.5 to 12.2 logs. The 0.1 microm rated filter type that was penetrated by H. pseudoflava has been previously demonstrated to be not fully retentive for naturally occurring bacteria. The data show that H. pseudoflava penetrates 0.2/0.22 microm rated filters just as readily as B. diminuta penetrates 0.45 microm rated filters. In addition, titer reductions provided by 0.2/0.22 microm rated filters for H. pseudoflava are comparable to those reported for A. laidlawii mycoplasma, albeit under different conditions. This study demonstrates that H. pseudoflava meets all criteria for use as a standard organism for qualifying the microbial removal performance of 0.1 microm rated filters for enhanced sterility assurance.
机译：我们之前曾报道过拟氢假单胞菌（以前称为假单胞菌）的初步表征，有可能用作鉴定0.1微米级滤膜的标准攻击生物。本文报告了一个大型面板，其假单胞菌（ATCC 700892）的额定滤池为0.2 / 0.22微米和0.1微米的保留效率，与相同的滤膜对短小Brevundimonas diminuta（ATCC 19146）的保留能力相比。用伪弗氏杆菌以超过10（7）cfu / cm2的挑战水平挑战了总共32个0.2 / 0.22微米额定值的滤芯，这些滤芯跨越了来自四个不同过滤器制造商的九种不同的“灭菌级”过滤器类型。假单孢菌被证明每经过0.2 / 0.22微米额定过滤器渗透一次，对数滴度降低（LTR）值在3.5至7.7个对数之间。在相同的攻击条件下，拟杆菌H. pseudoflava被证明比B. diminuta更具穿透性。在受到两种生物攻击的二十个0.2 / 0.22微米级滤膜中，有十九个完全保留了B. diminuta。对于额定值为0.1微米的过滤器，测试了18个滤芯，这些滤芯跨越了三个制造商的五种不同的过滤器类型。在测试的5种过滤器类型中，有4种始终保持拟假丝酵母的LTR值超过11.5至12.2 log。以前已经证明，假丝酵母​​穿透的0.1微米额定过滤器类型不能完全保留天然细菌。数据表明，假黄杆菌穿透0.2 / 0.22微米等级的过滤器就像B. diminuta穿透0.45微米等级的过滤器一样容易。另外，尽管在不同条件下，通过假丝酵母的0.2 / 0.22微米级过滤器的滴度降低与报告的支原体支原体的滴度降低相当。这项研究表明，假黄花假丝酵母符合用作标准有机体的所有标准，以限定0.1微米级过滤器的微生物去除性能，以增强无菌性。

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