Particle Counters for Cleanroom Monitoring

A recent TGA inspection identified opportunities for enhancement in EMHS contamination prevention strategy, specifically highlighting the need for more robust particulate monitoring in critical manufacturing areas. As cell and gene therapy products are sensitive to particulate contamination, implementing state-of-the-art continuous particle counting systems is essential to ensure product quality and compliance with Good Manufacturing Procedures requirements. Through a successful grant application to Therapeutic Innovation of Australia (TIA), CTTWA has secured funding for Fifteen ISoPro counters in total and facility pro processor and software, which offer unique advantages critical to CTTWA operation. This configuration was specifically chosen to meet CTTWA’s requirements: Integrated vacuum pump system, eliminating the need for external vacuum sourcesCompact footprint, crucial for our space-constrained cleanroom environment In response to the TGA audit, CTTWA has committed to implementing enhanced particulate monitoring within a TGA-specified timeframe of August 2025 for EMHS.