3 Key Metrics for Monitoring Cleanroom Hygiene During CQV

Maintaining cleanroom hygiene is essential for product safety in the pharmaceutical industry. During the CQV (Commissioning, Qualification, and Validation) process, monitoring hygiene becomes crucial to meeting regulatory standards and ensuring cleanroom performance. Below are three key metrics for cleanroom hygiene:

1. Airborne Particulate Levels (NVPC)

Airborne particulate levels must be closely monitored during the CQV process to ensure that cleanrooms maintain required cleanliness standards. Particle counters can measure the concentration of airborne particles in critical zones, testing both at-rest and operational states to validate system performance. If particulate levels exceed limits, investigate air filtration systems, HVAC performance, and personnel movement patterns.

2. Microbial Contamination Levels (VPC)

Monitoring microbial contamination is essential to protect sterile manufacturing processes. Active air sampling and surface testing help ensure aseptic conditions during CQV. If microbial counts are elevated, review cleaning protocols, gowning procedures, and air filtration systems to prevent contamination risks.

3. Contact Plate Surface Cleanliness

Surface cleanliness is vital to minimize both particulate and microbial contamination. ATP testing and swabbing critical surfaces can detect organic residues and contamination hotspots. If residues are found, revise cleaning procedures and assess the effectiveness of cleaning agents.

Tracking these key metrics is critical for maintaining cleanroom hygiene and ensuring that the CQV process runs smoothly. By taking proactive measures, companies can maintain regulatory compliance and safeguard product integrity.

To learn more about CQV, visit Incepbio.