INTRODUCTION

The tests described hereafter will allow for quantitative enumeration of mesophilic bacteria and fungi that may grow under aerobic conditions. The tests are designed to determine whether a sample complies with an established limit for bioburden (see Bioburden Monitoring 〈1119〉). The term sample refers to the item subject to testing, which might be a unit item (e.g., vial stopper) or a quantity (e.g., weight or volume). Justified changes to the instructions below may be used, as described in 〈1119〉.