Sterility Testing

Quality-control analytical methods: the quality of sterility testing.

Microbiology, like compounding, is a science that must be demonstrated to show that it is reliable, reproducible, and scientifically sound. Aseptic technique must become second nature to the microbiologist and the compounding pharmacist. With each new drug tested by a quality-control laboratory, there is a responsibility that everything possible is done to ensure that the test result reported i...

Sterility testing: the control of efficiency of sterilization techniques.

During the course of an investigation of cotton for use as air filters on the needles of bleeding units, a heat-resistant, spore-forming organism was isolated. Because of its unusual degree of heat resistance, the organism appeared to be more suitable as a control of the efficiency of sterilization than species of Clostridium usually employed for this purpose. Experiments were undertaken to det...

Bioluminescence for USP sterility testing of pharmaceutical suspension products.

Bioluminescence measurement significantly improved the accuracy, sensitivity, precision, and reliability of the current visual endpoint determination for the USP sterility test and eliminated the day 7 transfer/dilution step required for testing suspension products. Thirteen strains of bacteria and fungi (representing potential contaminants in sterile products), three pharmaceutical suspension ...

Sterility

Sterility in Wheat Hybrids. I. Sterility Relationships and Endosperm Development.

Partial or complete sterility is of frequent occurrence in species crosses. Within the same genus certain species are sterile when crossed while ather combinations are completely fertile. Partial sterility may cause the elimination of certain classes of gametes and prevent desired recombinations of characters in the second generation. Sterility may also cause an abnormal vegetative development....