ENVIRONMENTAL MONITORING
Environmental monitoring of the cleanroom for particles and microbes ensures compliance to applicable standards. CPC Laboratories can assist your company in the development of a cleanroom cleaning plan, performance of a cleaning validation and implementation of an effective environmental monitoring plan.
Air Sample
Contact Plate Surface Sample
Five Steps in the Implementation of an Effective Environmental Monitoring Program:
Step 1 Survey the Cleanroom
Diagram the cleanroom, identify the process that occurs in each area, study airflow patterns and inspect for dirt accumulation.
Step 2 Evaluate Disinfectant Effectiveness vs. Cleanroom Flora
Sample air and surfaces in the cleanroom for microbes, culture colonies and test each isolate for disinfectant effectiveness using Zone of Inhibition test. Rank disinfectants.
Step 3 Develop the Cleaning Plan
Specify chemicals, tools, consumables and cleaning methods.
Step 4 Develop the Environmental Monitoring Plan
Identify risk zones based on potential contamination of product, establish limits for air and surface samples, establish frequency of sampling in each risk zone.
Step 5 Validate the Cleaning Process
Clean each risk zone on three occasions, sample air and surfaces following each cleaning, test for microbial levels and compare results to specifications.