The United States Food and Drug Administration (US FDA) Guideline for Aseptic Processing states, “The suitability, efficacy, and limitations of disinfecting agents and procedures should be assessed. The effectiveness of these disinfectants and procedures should be measured by their ability to ensure that potential contaminants are adequately removed from surfaces.” Planning is an important part of the disinfectant qualification process. With proper planning, half the battle is won.
Microrite facilitates planning of comprehensive yet cost effective disinfectant qualification studies. We start by helping our clients answer the important questions below, which are building blocks of a defendable qualification study.
- Which chemical agents to use?
- Which and how many microorganisms to use for the challenge test? Reference cultures? Environmental Isolates? Or both?
- Which and how many hard surfaces to test?
- What test method to use for maximum recovery?
Microrite develops the optimal method for qualification of your disinfectants considering the best recovery rate for the surviving organisms and the optimal method for neutralization. Additionally, we develop the qualification protocol, review data and generate a report.
Microrite’s consultants also help with:
- Troubleshooting disinfectant qualification study failures
- Establishing scientifically sound cleaning and disinfection programs
- Disinfectant qualification data analysis
- Resolving microbial contamination issues in cleanrooms
- Hands on training of microbiology laboratory staff on executing disinfectant qualification studies