ABSTRACT

Microorganisms such as Staphylococcus epider midis or Micrococcus luteus are also useful test organisms, since these are potential bioburden organisms originating from a human source. In order to determine if viable microorganism growth is being inhibited or the microorganisms are being killed in the eluent, a modification of the screening procedure can be performed. The testing described is modeled after the bacteriostasis/fungistasis (B/F) test used for the validation of sterility test procedures. If the results of the B/F test are acceptable, then there is bacteriocidal activity occurring in the eluent prior to the culturing portion of the bioburden test in the screening procedure. Permanent specifications for bioburden testing of each device should be prepared to ensure that the test parameters found to be acceptable are followed each time the device is tested for bioburden enumeration. For a bioburden method where an eluent is employed, the screening procedure simulates the preparation of the device in the eluent.