PDA TR23 Industry Survey on Current Sterile Filtration Practices 1998英文原版资料.pdfVIP

COMMENTARY An Interpretation of the Pharmaceutical Industry Survey of Current Sterile Filtration Practices RUSSELL E. MADSEN, JR.* and THEODORE H. MELTZER PDA, Bethesda, Maryland and Capitola Consulting Company, Bethesda, Maryland Introduction quantities of air diffused at the selected pressure level and the required retention of B. diminuta challenges. An impor- The PDA Sterile Filtration Committee in July 1995 tant body of opinion believes, however, that multipoint conducted a survey of 242 filter-user companies to deter- diffusive air measurements through the bubble point are mine the several aspects of filter performance and filtration essential to the establishment of the necessary bacterial practices currently prevailing in the pharmaceutical industry. retention correlation. The differences between these two Some 38 replies were received. The proportion of respon- points of view are important to the filter integrity picture; dents was about 17 percent; not an unusual figure for surveys however, the respondents’ answers regarding diffusive flow/ of this type, but an amount insufficient to be a statistically forward flow testing do not indicate whether single-point or meaningful representation of the industry. Nevertheless, multipoint testing is u