Microbiological Assay For Pharmaceutical Analysis

A user-friendly guide for the evaluation of microbiological assays, this book provides a lucid explanation of the sources of error in microbiological assay and helps analysts choose efficient assay designs that will minimize those sources of error. The author discusses microbiological assay as a branch of pharmaceutical analysis and distinguishes it from biological assay in general. He draws attention to the microbiological aspects that may not be so obvious to the chemical analyst and to the analytical aspects that may not be so obvious to the microbiologist. The book expands on the guidance given in pharmacopoeias and helps readers choose the assay design most appropriate for the purpose of their assay.

Theory and Application of Microbiological Assay first presents an overview of microbiological assay, including general principles, basic techniques, capabilities, and limitations. This book also explains when to use a certain microbiological assay for specific analysis, citing examples to further clarify the matter. Some chapters discuss the test organisms and solutions, wherein test solutions are the final dilutions at a series of two or more concentrations that have been prepared from reference standard and unknown for application to the test system. Other chapters explore the various aspects of agar diffusion assays, tube assays, and diffusion assays. The book further looks into the quality control procedures, assay design and evaluation, and assay replication. This book will serve as an introduction to newcomers to the field and as a reference source for established workers in microbiological assay.

Analytical Microbiology focuses on the processes, methodologies, developments, and approaches involved in analytical microbiology, including microbiological, antibiotic, and amino acid assays and dilution methods. The selection first offers information on the theory of antibiotic inhibition zones, microbiological assay using large plate methods, and dilution methods of antibiotic assays. Discussions focus on serial dilution assay, requirements for accurate assay, microbiological assay of riboflavin, laws of adsorption and partition, mechanisms of antibiotic action, and biological considerations affecting the use of statistical methods. The text then ponders on the elements of photometric assaying and automation of microbiological assays. The manuscript elaborates on antibiotic substances, vitamins, and amino acids. Topics include assay organisms, validity, specificity, reliability, and calculation of results of amino acid assays, bacitracin, chloramphenicol, dihydrostreptomycin, erythromycin, neomycin, and streptomycin. The selection is a dependable reference for researchers interested in analytical microbiology.

Annotation Provides basic information about microbiology for analytical chemists in industry who have no background in it but are occasionally required, for example, to test for bacteria in food or water. Establishing whether a sample is contaminated, counting and identifying micro-organisms, determining their effect on the sample, and procedures for disinfecting and preservative testing are among the topics. Describes both traditional laboratory methods and the new rapid techniques. Annotation c. by Book News, Inc., Portland, Or.

Semi-automated method for microbiological vitamin and vitamin and antibiotic assays; An automatic dilution apparatus for use in vitamin and antibiotic assay; Application of automated assay of asparaginase and other ammonia-releasing enzymes to the identification of bacteria; An automatic plating-out machine for microbiological assay employing an 8 X 8 design; Virus concentration by means of soluble ultrafilters; The assay of thermally induced inhibitors derived from nitrite; The assay of nisin in foods; Serological methods for the assay of staphylococcal enterotoxins; Assay of myo-inositol using the yeast Kloeckera apiculata (K. brevis); Notes on the preservation and checking of vitamin assay bacteria; A simple, rapid assay for the measurement of antibiotic concentrations in human serum; Bio-assay of agricultural and horticultural fungicides; Testing biocidal paints; Microbiological assay of chemicals for the protection of wood; Techniques for the assay of effects of herbicides on the soil microflora; The effect of herbicides on cellulose decomposition; Use of micro-algae for the assay of herbicides.

Microbiological Assay: An Introduction to Quantitative Principles and Evaluation aims to provide an introduction to the principles of microbiological assay, assay design, and calculation procedures. Organized into nine chapters, this book begins with the philosophy of biological assay, as well as the method’s basic techniques, principles, mechanization, automation, purpose, reference standards, specifications, and reports. It also looks into the preparation of test solutions of standard and sample. Some chapters follow explaining the specific methods, such as agar diffusion assay and tube assay; others explore the statistical evaluation of these assays. Features of assay design, such as replication, number of dose levels, and spacing of dose levels, are also described. This book will serve as an elementary introduction to this field of interest to help encourage a less empirical approach to the subject.

Microbiologists working in both the pharmaceutical and medical device industries, face considerable challenges in keeping abreast of the myriad microbiological references available to them, and the continuously evolving regulatory requirements. The Handbook of Microbiological Quality Control provides a unique distillation of such material, by provi

In recent years there has been increased interest in the possibility of rapid microbiological methods offering enhanced potential error detection capabilities. However, these methods raise a number of questions, such as how to validate new methods, will they be accepted by the pharmacopoeias, and, most importantly, how will the regulators respond?