Introduction

Microbiology can arguably be considered as the original of the classical sciences. Although our ability to visualize, enumerate, and isolate most microorganisms is relatively modern, i.e., over the last 300 to 400 years, their impact was surely known to the earliest inhabitants of Earth. Putrefaction of meat and vegetable matter, while caused by a virtual microcosm of different genera, owes much to the activity of bacteria and fungi. Similarly, although the actual agents associated with specific diseases were not identified until the mid-1800s, it did not stop thoughtful men from musing on the agents of disease. Lucretius (95-55 B.C.) recognized the existence of "seeds" of disease.

While the other sciences have seen a veritable explosion of techniques and associated instrumentation over the last 200 years, microbiology techniques are often still based on work done in the late 1700s to mid 1800s, the vast majority of microbial enumeration is still carried out by the pour plate method developed in 1870 by Robert Koch.

Our guidance provides a review of techniques available to microbiologists to considerably improve both the accuracy and speed of their determinations. Unfortunately the take-up of some of these techniques has been slow for multifarious reasons that include regulatory attitudes in this arena, and the sensitivity of the areas impacted by microbiology in the pharmaceutical industry, such as the manufacture of aseptic sterile products.

Our purpose is to present a rapid overview of the most commonly available commercial rapid microbiological test methods. Our coverage includes a description of each method, with a proposal for where it can be used. Where appropriate, suggested "validation" provides guidance whereby users can achieve regulatory approval for use of their chosen method. It is not intended to be a treatise on microbiology. Refer to more detailed standard reference works for this purpose, at the end of this chapter.

This section discusses the principles of several rapid microbiological methods and their application within the pharmaceutical and medical-device industries. The food industry has already embraced many of these techniques.

The regulatory acceptance of these methods from a European and U.S. perspective is based on experience, and on public comments made with respect to the methods, by both the Medicines Control Agency (MCA) (now Medicines and Health Care Products Regulatory Agency (MHRA)) in the U.K., and the Food and Drug Administration (FDA) in the U.S.

The text is based on the authors' joint experience of utilizing the methods to deal with common pharmaceutical dosage forms, i.e., tablets, capsules, liquids, ointments, creams, and suppositories. Sterile products are only touched upon, as the authors do not have personal knowledge of the use of rapid methods in this arena.

Although a number of methods are examined, we concentrate on those suited to the hurly-burly daily activities conducted in a pharmaceutical or medical devices control laboratory.

While the nomenclature "rapid" is used to describe the methods evaluated in this text, it is perhaps better to consider them as "modern" as a more apt counterpoint to "traditional" or "conventional" methods.

The suppliers of media, reagents, etc., have made considerable strides associated with traditional methods, helping to improve their discriminatory ability, and the rapidity at which results are produced.

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