Environmental Monitoring Program Design
What is the current environmental status of your cleanroom? When was the last time the air or surfaces of critical areas were tested for the presence of contaminants? How were the site locations or number of test sites decided upon in the first place? Since the purpose of an environmental monitoring program is to demonstrate that a facility performs within control and is protecting the compound, it is important to properly design, implement, and perform environmental monitoring at a practice site. Let us design or update your EM program so you can demonstrate that the facility performs within control, protects individuals, the environment, the process, and the product.
What’s Included
Design & Flow Review | Risk Assessment | EMPQ | Custom SOPs
Assess the Facility Design, Airflow Visualization, Process/Personnel/Material Flow, and Historical Contamination Risks (if available)
Provide an Initial Risk Assessment for Proposed Sample Site Locations, Frequencies, and Limits
Conduct an Environmental Baseline Study (e.g.; EMPQ)
Adjust Sampling Site Map, Frequencies, and Limits Based on EMPQ Findings
Customize SOPs for the EM Program, Air Sampling Equipment, Sampling Methods and Reading Results