American Pharmaceutical Review: A Russell Publishing Publication

Perfex Corporation
BiomerieuxLonza

A Rapid Microbiological Assay to Monitor the Effectiveness of a Vaccine Injector Sanitization Following a Microbial Challenge Procedure

Microbiology

Claudio Denoya, Ph.D.1, Edwin Dawson2, Darwin Sessoms2, Michael Baumstein3 & John Shabushnig, Ph.D.3 (1) Pfizer Global R&D (2) Pfizer Poultry Health (PPH), Animal Health, (3) Pfizer Global Manufacturing

Introduction

Classical microbiology techniques used in the quality control (QC) of food, cosmetics and pharmaceutical products as well as those used to monitor manufacturing environments are based on the growth of the potential microbial contaminants in liquid or solid nutrient media. These classic techniques usually require lengthy incubation times, typically on the order of days. Currently, there are a variety of rapid microbiological technologies commercially available that promise to significantly reduce these testing times and the associated delays in the release of manufactured products. Reduced testing times also offer increased capacity within existing manufacturing facilities, minimize required in-process inventory and faster monitoring and better control and understanding of the manufacturing process.
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