INTRODUCTION

Proper microbiological sampling of microbiologically susceptible nonsterile products can be difficult because these products are often filled into unique primary containers that are designed to protect the product from inadvertent contamination during storage and use. These unique designs may increase the difficulty of taking an aseptic sample of sufficient size or volume for microbiological testing. Unless special approaches are used, products such as inhaled, nasal liquid, or powder dosage forms can be difficult to sample without potential exposure to extraneous microbial contamination. This general test chapter provides these special approaches for sampling either low- or high-content inhaled or nasal dosage forms. Alternative sampling approaches may provide better ways to sample containers in an aseptic manner. Any alternative methodology should employ aseptic techniques and should be conducted under environmental and other conditions that are appropriate for aseptic sampling.