Bacterial monitoring in vials using a spectrophotometric assimilation method.
Aseptic-filling processes are often used with fragile parenteral products that might be destroyed by terminal autoclaving. However, aseptic filling is not as effective as autoclaving in reducing contamination. As a result, time-consuming microbiological methods and turbidimetry are employed currently as product inspection techniques, but these processes can destroy the product and might not detect low levels of contamination. Thus, near-infrared (IR) light scattering was evaluated in this study as a new method for determining low levels of contamination noninvasively and nondestructively. A new parallel mathematical technique was used in conjunction with near-IR spectrophotometry to detect successfully contamination by several species of bacteria through intact glass vials. Using the near-IR method, products can be evaluated without introducing contamination, preserving the sample vial for dispensing or evaluation by another method.
Galante
L J
LJ
Glaxo, Inc., Research Triangle Park, North Carolina 27709.
Brinkley
M A
MA
Lodder
R A
RA
D000465:Algorithms; D001419:Bacteria; D001431:Bacteriological Techniques; D004866:Equipment Contamination