Development of Instrumentation to Detect Bacterial or Fungal Growth in Intact Final Containers of 25% Normal Serum Albumin (Human).

摘要

A prototype instrument was developed for the detection of bacterial contamination in 25% normal serum albumin (human) at levels of at least 10,000,000colony forming units (CFU) per ml in sealed final containers of 50and 100ml capacity. This investigation was undertaken due to the properties of 25% Human Serum Albumin which provide an excellent growth media for contaminants but allow the fluid to remain visually clear even when high levels of contamination are present. The approach was based on laser light scattering and selective measurement of the amount of light scattered in the forward direction. The scattering characteristics of serum bottles containing uncontaminated albumin were investigated,and baseline scattering levels were established for different lots of albumin. Eight contaminating bacterial or fungal organisms were analyzed. In all cases,the optical signal increased significantly over the background level by the time the CFU count had reached 10,000,000organisms. The prototype instrument is capable of a go/no go screening of up to 3,000bottles per day. The ability of the unit to detect contamination below the threshold of 10,000,000 CFU was confirmed with coded contaminated samples.