ABSTRACT
This chapter offers general guidelines for validating and documenting microbial methods for the personal care product industry. Validation of microbiological procedures within the personal care product industry simply establishes their efficacy, accuracy, and reproducibility. Validation without documentation, however, is useless; the results of validations should be documented in organized and permanent records. Documentation of an environmental control program involves tracking trends in contamination levels in the environment using process control charts. Laboratories require the use of sterilizers to provide sterile media and materials for assaying the microbial contents of products. The most expedient way to validate a sterilizing cycle in a microbiology laboratory is the use of a biological indicator (BI). Biological indicators come in a variety of forms, including inoculated products with sterilant-resistant spores, spore paper strips, and disks and commercially available self-contained BI systems.
