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Clean Room Qualification (HVAC System Validation)

Clean Room Testing

EESS experience in cleanroom systems helps ensure these critical area are performing in accordance with international standards and customer quality specifications.

EESS cleanroom testing and certification services are executed in accordance with EESS standard operating procedures (SOPs) which are updated to remain compliant with current Good Manufacturing Practices (cGMPs) and International Organization for Standardization  (ISO).

All cleanroom service results are thoroughly documented and quality-reviewed in accordance with the rigors of cGMP.

Cleanroom test protocols and report documentation can be customized to customer specifications.

Clean room tests include:

  • Airflow velocity test
  • Air flow volume and Room air change rates
  • HEPA filter integrity testing
  • Non-viable particulate Counting
  • Air Pressure Difference between rooms
  • Temperature and humidity measurements
  • Airflow visualization testing
  • Recovery time test

Our technical knowledge and experience in cleanroom testing coupled with our steadfast commitment to quality and the highest standards of customer service, provide our clients with reliable, accurate and thoroughly documented clean room testing results, ensuring optimal cleanroom performance, documented regulatory and quality compliance, and minimized facility down time.

Standards

  • ISO 14644 Clean room and associated environment
  • Federal standard FED-STD 209E
  • USP 797 ,Pharmaceutical Compounding – Sterile preparation
  • EU GMP
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