By Martin C. Easter
This assortment offers newly constructed replacement and speedy tools that provide more suitable functions for detecting microbial infection in pharmaceutical items. The 14 papers describe labor-saving units, automation of conventional equipment, adenosine triphosphate (ATP) bioluminescence, electric impedance, species id and typing, sterility checking out, DNA-based applied sciences for detecting particular organisms, and the limulus endotoxin attempt. The participants assessment the recommendations and platforms to be had from particular businesses, occasionally even directory their fee, observe their capability and verified functions for checking out pharmaceutical articles, and tackle the problems of validation and regulatory recognition.
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Extra info for Rapid Microbiological Methods in the Pharmaceutical Industry
However, a more fundamental problem has been the failure of the technology suppliers to understand the specific technical and regulatory requirements of the pharmaceutical sector. These requirements are very different from those of the food and beverage industries. Initially it was hoped that methods from one industry could be easily transferred into the pharmaceutical sector. There was little, if any, communication between the manufacturers of these techniques and the potential users in pharmaceutical microbiology.
Use of a modified MacConkey Agar medium for the selective growth and enumeration of all Enterobacteriaceae. Journal of Bacteriology 84:381. Cornelissen. 1963. The examination of foods for Enterobacteriaceae using a test of the type generally adopted for the detection of Salmonellae. Journal of Applied Bacteriology 24:444–452. Morita. 1978. Possible strategy for the survival of marine bacteria under starvation conditions. Marine Biology 48: 289–295. Kjelleberg. 1992. Survival, stress resistance, and alterations in protein expression in the marine Vibrio sp.
An alternative method relying on a different set of conditions might detect a different subset of all possible organisms. Under such circumstances, equivalence of the methods would be very difficult to define. 1% (Doorne et al. 1998), and the number of tests done per year in a typical sterility testing laboratory is between 500 and 5,000. Several years of parallel testing (including the risk of introduction of false positives in each of the test series) would be needed to obtain statistically significant figures demonstrating method equivalence.