Acceptance Testing of Used Cascade Impactor Stages Based on Pressure Drop Measurements in a Flow System Managed with a Critical Flow Venturi: Part II-Quantification of the Test Uncertainty Ratio for Pass/Fail Decision-Making under Pharmacopeial Constraints.

IF 2 4区 医学 Q3 RESPIRATORY SYSTEM
Daryl L Roberts
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Abstract

Background: The pressure drop at any cascade impactor stage is related to the open area of nozzles at that stage. Pressure drop measurement therefore can potentially test whether the nozzles of a given stage are within the range specified for continued use for testing of inhalable drug products. Previous such efforts, however, have been hindered by the measurement precision required for making a pass/fail decision about these used impactors. In this study, we articulate the error analysis for a pressure drop measurement system managed with a critical flow venturi (CFV) and show that the resultant uncertainty in the effective diameter of used Next Generation Impactor (NGI) and Andersen-type impactor stages is generally small compared to the specification range. This result enables the user to make a pass/fail decision regarding suitability for continued use. Methods: We develop the equations governing the relationship between stage pressure drop and the effective diameter of each stage of a used impactor. These equations show that pressure drop measurements can indicate only the change (if any) in the effective diameter between a previous measurement and the current measurement. Propagation-of-error principles therefore show that the uncertainty of both measurements affects the resulting uncertainty. Results: The test uncertainty ratio (analytical power) of a CFV-managed pressure drop measurement system exceeds six for all but stage one of the NGI and for stages -1 and -2 of the Andersen-type impactor. The stage-one nozzle of the NGI is readily qualified with a Class X pin. Conclusions: The CFV-managed flow system described in Part I is sufficiently precise to enable a decision to be made about whether used impactor nozzles are suitable for continued use for testing of registered inhalable drug products. Examination of the industrial viability of the technology will require long-term testing in real-world settings with comparison to optical inspection methods.

用临界流文丘里管管理的流动系统中基于压降测量的已用级联冲击器级的验收测试:第二部分——药典约束下通过/不通过决策的测试不确定比的量化
背景:任何叶栅冲击器阶段的压降都与该阶段喷嘴的开口面积有关。因此,压降测量可以潜在地测试给定级的喷嘴是否在可吸入药品测试中规定的持续使用范围内。然而,之前的此类努力一直受到对这些使用的冲击器进行通过/失败决策所需的测量精度的阻碍。在这项研究中,我们阐述了用临界流量文丘里管(CFV)管理的压降测量系统的误差分析,并表明与规格范围相比,使用的下一代冲击器(NGI)和安德森型冲击器级的有效直径的不确定性通常很小。该结果使用户能够对是否适合继续使用做出合格/不合格的决定。方法:建立了用于冲击器各级压降与各级有效直径之间关系的方程。这些方程表明,压降测量只能表明以前测量和当前测量之间有效直径的变化(如果有的话)。因此,误差传播原理表明,两种测量的不确定度都会影响结果的不确定度。结果:cfv管理的压降测量系统的测试不确定度比(分析功率)超过6,除了NGI的第一级和安德森型冲击器的第一级和第二级。NGI的一级喷嘴很容易通过X级销的认证。结论:第一部分中描述的cfv管理的流量系统足够精确,可以决定使用的冲击器喷嘴是否适合继续用于已注册的可吸入药品的测试。要检验该技术的工业可行性,需要在现实环境中进行长期测试,并与光学检测方法进行比较。
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来源期刊
CiteScore
6.70
自引率
2.90%
发文量
34
审稿时长
>12 weeks
期刊介绍: Journal of Aerosol Medicine and Pulmonary Drug Delivery is the only peer-reviewed journal delivering innovative, authoritative coverage of the health effects of inhaled aerosols and delivery of drugs through the pulmonary system. The Journal is a forum for leading experts, addressing novel topics such as aerosolized chemotherapy, aerosolized vaccines, methods to determine toxicities, and delivery of aerosolized drugs in the intubated patient. Journal of Aerosol Medicine and Pulmonary Drug Delivery coverage includes: Pulmonary drug delivery Airway reactivity and asthma treatment Inhalation of particles and gases in the respiratory tract Toxic effects of inhaled agents Aerosols as tools for studying basic physiologic phenomena.
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