INTRODUCTION

This chapter is intended to be used as a risk-based test for the detection of microbial contamination in short-life products and encompasses short shelf-life products and/or short manufacturing times where the product must be administered as soon as possible. (See Rapid Microbiological Methods for the Detection of Contamination in Short-Life Products—A Risk-Based Approach 〈1071〉 for more details.) It may also be used as an in-process control for the testing of product intermediates, cell culture media, or process solutions. Growth-based methods that use detection signals other than visible signs of microbial growth or precipitation within the culture media (i.e., turbidity, pellicle formulation, or floccular growth) have been used to test a variety of products. Instrumentation for respiration-based methods is based on blood culture systems used in the clinical setting that utilize colorimetric or fluorometric sensors to detect an exponential increase in carbon dioxide as an indicator of microbial growth. The application of respiration-based methods for the detection of contamination in a variety of short-life products, such as cell therapy products, has been published in peer-reviewed literature.