ISO 14644 Class 7 Cleanroom Certification Renewed

Waternation Scientific has successfully completed the renewal of its ISO 14644-1 Class 7 cleanroom certification, following independent third-party audit and particle count verification of our primary manufacturing environment.

The ISO 14644 standard defines the classification of air cleanliness in cleanrooms and associated controlled environments by particle concentration. Class 7 certification — equivalent to the former Federal Standard 209E Class 10,000 — specifies a maximum of 352,000 particles per cubic metre at 0.5 microns, making it a recognised benchmark for pharmaceutical, biotech, and high-purity manufacturing operations.

Why It Matters

For customers in regulated industries such as pharmaceuticals, medical devices, and life sciences, the environmental conditions under which reagent water is produced directly impact product quality and regulatory compliance. Our certified cleanroom provides the controlled conditions necessary to prevent contamination during the filling and packaging stages of production.

• Third-party certified by an accredited inspection body
• Annual particle count testing and environmental monitoring
• Positive pressure gowning protocols maintained
• HEPA-filtered air supply with continuous monitoring
• Temperature and humidity controlled to defined limits

Our Commitment

This renewal reflects our ongoing investment in the infrastructure and quality systems required to manufacture water products that meet the most demanding purity and compliance standards. Copies of the current certification are available on request for customers requiring documentation for their own regulatory submissions.