Monitoring of microbiological quality in the pharmaceutical industry is an important criterion
that is required to justify safe product release to the drug market. Good manufacturing …

Bacterial contamination control in pharmaceutical products is a critical aspect in the field of
drug manufacturing industry due to the encountered risk to the patients' health and possibly …

This paper describes the fundamental mechanisms of microbial contamination during
manufacture of pharmaceutical products. Models are derived that describe air and surface …

The microbial risk to patients from aseptically manufactured pharmaceuticals is dependent
on the chance that a product contains sufficient microbes to initiate an infection. This …

The release of quality, safe, and effective non-sterile drugs needs to exclude the presence of
objectionable microorganisms, which include microorganisms potentially involved in product …

In the present work we compared different calculation approaches for their ability to
accurately define microbiological control levels based on historical data. To that end, real …

Microbial quality control of non-sterile drug products has been a concern to regulatory
agencies and the pharmaceutical industry since the 1960s. Despite being an old challenge …

Purpose Contamination of pharmaceuticals with microorganisms irrespective whether they
are harmful or nonpathogenic can bring about changes in physicochemical characteristics of …

Due to the increasing number of immuno-compromised patients, increased attention is paid
to the quantitation and identification of microorganisms in oral pharmaceutical products; …

Relying on practical examples from the authors' experience, this book provides a thorough
and modern approach to controlling and monitoring microbial contaminations during the …