This FDA requirement, thus, in itself recognizes that a membrane that sterilizes under one set of circumstances may not so perform under another even when the same organism isinvolved. As stated, the model organism is the
grown under stipulated conditions(Leahy and Sullivan 1978, Fennington and Howard 1997). The present definition of “sterilizingfilter” is, then, referenced in terms of this organism
s size and its adsorptive proclivities.
Pore Size Distribution 0.2 micron
Different Filter Manufacturers
min. averagemax.00,20,40,60,8Pore Size (µm)F1F2F3F4F5F6
Figure 1.: Pore size distribution measured with Coulter Porometer of 0.2 µm rated filter membranes
Bubble Point Correlations and Retention Ratings
Efforts have been made to match the
size to the 0.2 µm-rated pore size; arelationship expressive of the sieve retention mechanism. The results are clouded if only because pore-size ratings are innocent of any measurement standards. However, correlations have beendeveloped between organism retention levels and bubble point integrity test values that areindicative of a filter
s largest pores (Johnston and Meltzer 1979) (See Figure 2).