Waibel P J, Jornitz M, Meltzer T H
Sartorius Corporation, Edgewood, New Jersey, USA.
PDA J Pharm Sci Technol. 1996 Sep-Oct;50(5):311-6.
The more certain implications to retention based upon definition of the largest pores present in a filter may be had where bubble point testing is possible. Where diffusive airflows interfere with bubble point determinations, the diffusive airflow measurements themselves, correlated to organism retentions, serve as integrity tests. Diffusive airflow measurements have their advantage in addition to serving as indicators of filter integrity. They can more precisely reveal filter incompatibilities. They can be used to gauge the completeness of a filter's wettability, and they are more revealing of a filter's clean water flow properties. In almost all its applications, however, diffusive airflow integrity testing requires defining the diffusive airflow curve by way of multipoint measurements using the liquid product in question. This is especially true in filter validation contexts where product-specific testing is necessitated. Once the full diffusional airflow curve has been elucidated, single-point diffusional flow testing is warranted, as in production integrity testing settings. Single point diffusive flow testing can be used as a standard integrity test method for use in the pharmaceutical production environment.
在可能进行泡点测试的情况下，可以根据过滤器中存在的最大孔径的定义，得出与截留相关的更确定的含义。当扩散气流干扰泡点测定时，与生物体截留相关的扩散气流测量本身可作为完整性测试。扩散气流测量除了可作为过滤器完整性的指标外，还有其优势。它们可以更精确地揭示过滤器的不相容性。它们可用于衡量过滤器润湿性的完整性，并且更能揭示过滤器的清洁水流特性。然而，在几乎所有应用中，扩散气流完整性测试都需要通过使用相关液体产品进行多点测量来定义扩散气流曲线。在需要进行特定产品测试的过滤器验证环境中尤其如此。一旦完整的扩散气流曲线得以阐明，就像在生产完整性测试环境中一样，单点扩散流测试是可行的。单点扩散流测试可作为制药生产环境中使用的标准完整性测试方法。
