Svensson Mårten, Pettersson Gunilla, Asking Lars
Analytical Development, AstraZeneca R&D Lund, SE-221 87 Lund, Sweden.
Pharm Res. 2005 Jan;22(1):161-5. doi: 10.1007/s11095-004-9022-2.
Fifty-three Andersen Cascade Impactors (404 stages) have been investigated using an automated visual stage mensuration technique. A cleaning method was suggested for stages with jets smaller than nominal diameters. The impact of nonapproved jet diameters on result parameters from particle size analysis was evaluated theoretically.
The jet diameters were measured using the Andersen Visual Inspection Device. A stepwise cleaning procedure was performed to recover the jets of noncompliant stages, and after each step a new stage mensuration was performed.
The result of this extensive investigation, including measurements of each jet, is compared to other studies, to tolerance limits applied at AstraZeneca Lund and also to limits used by the manufacturer. Sixteen of the investigated stages were outside applied tolerance limits due to too small average diameters. Insertion of a go gauge into every jet of the stages was the only technique of those tested that increased the jet diameters toward nominal dimensions. Moreover, the relative standard deviation of the jet diameters decreased considerably after use of go gauges.
Stage mensuration is a valuable technique for detection of improper jet dimensions of the Andersen Cascade Impactor, and use of go gauges is an effective cleaning method especially for jets with small diameters. However, use of stop/go gauges as a periodical quality control test on a small number of randomly selected jets was a poorly discriminating test, as both compliant and noncompliant stages would most probably pass such a test.
采用自动视觉级测量技术对53个安德森级联撞击器(404个级)进行了研究。针对射流直径小于标称直径的级,提出了一种清洁方法。从理论上评估了未批准的射流直径对粒度分析结果参数的影响。
使用安德森视觉检测装置测量射流直径。执行逐步清洁程序以恢复不符合要求的级的射流,并且在每个步骤之后进行新的级测量。
将包括对每个射流测量在内的广泛研究结果与其他研究、阿斯利康隆德应用的公差极限以及制造商使用的极限进行了比较。由于平均直径过小,所研究的级中有16个超出了应用的公差极限。在所测试的技术中,将通规插入级的每个射流是唯一能使射流直径向标称尺寸增大的技术。此外,使用通规后,射流直径的相对标准偏差大幅降低。
级测量是检测安德森级联撞击器射流尺寸不当的一种有价值的技术,使用通规是一种有效的清洁方法,特别是对于小直径射流。然而,将止通规作为对少量随机选择的射流的定期质量控制测试,是一种区分性较差的测试,因为合规和不合规的级很可能都会通过这样的测试。