The sterility test is generally recognized as a flawed test for its stated purpose. Since the
original description in 1932. this test has generated controversy as to its role in product quality …

In recent years there have been significant advances in microbiology, achieved through the
sister sciences of chemistry, molecular biology, and computer aided imaging. These have …

Environmental monitoring methodology for recovering fungal organisms often dictates the
use of a selective medium incubated at ambient temperatures (20–25C) for as many as seven …

This book describes various methods of decontamination and how the methods work. There
is a discussion of the various cleaning and disinfection methods utilized, along with details …

In recent years the Parenteral Drug Association has issued several technical reports that had
a significant impact on the validation of steam sterilization. They provide more formalized …

The topic of “objectionable organisms” is frequently found in regulatory observations and
publications. While there is a good understanding that companies need to know the …

The FDA has issued proposed regulations to require that manufacturer's evaluate the “steam
sterilizability” of parenteral products. There are many different ways to assess sterilizability.…

The methods used in most microbiological test laboratories originated in the laboratories of
Koch, Lister, and Pasteur. As such, they are very old, typically over a hundred years. While …

Bacillus stearothermophilus spores (liquid suspension) were inoculated onto rubber
stoppers and exposed to sublethal steam sterilization cycles at 120C. The D-values were …

Microbiological testing is foundational to the operation of pharmaceutical facilities. This
testing is used to assess the microbiological quality and attributes of the product, components, …