The microbial ecology of various natural environments has been an active area of research
since the earlier part of the twentieth century. Remote and sometimes extreme environments …

Background and Objectives Although most pathogen reduction systems for plasma primarily
target viruses, bacterial contamination may also occur. This study aimed to investigate the …

Considerations in Sterile Filtration. Part II: The Sterilizing Filter and Its Organism Challenge:
A Critique of Regulatory Standards | PDA Journal of Pharmaceutical Science and …

This three-volume set of Pharmaceutical Dosage Forms: Parenteral Medications is an
authoritative, comprehensive reference work on the formulation and manufacture of …

Microbial challenge testing is a common procedure to determine the retention efficiency,
performance, and validity of a sterilizing-grade filter. The ASTM 838-05 standard describes a …

Cleaning validation is demonstrated assurance that a cleaning procedure reliably and
reproducibly removes prior objectionable residue from a contaminated surface. Cleaning …

Very often, the concept of filtration is only considered in terms of sieve retention, which can
sometimes be misleading. In this review of the adsorptive particlecapture mechanism, the …

Until recently, the 0.2/0.22 µm-rated microporous membrane was considered the “sterilizing”
filter (1). The assumption was that on account of its resisting the passage of any of 1x107 cfu …

Sterile filtration is widely used in the biopharmaceutical industry to remove contaminants,
especially microorganisms from liquids, air, and gases (1). Microorganism removal is …