NEBB Certified Cleanroom Testing Services

Triangle Certification performs a full array of NEBB Certified cleanroom tests in accordance with all current industry criteria:

  • IEST-RP-CC006.3
  • IEST-RP-CC034.1
  • ISO 14644
  • NEBB Procedural Standards
  • Current Good Manufacturing Practice for Sterile Drug Products Produced by Aseptic Processing (Sept. 2004 Pharmaceutical CGMP'S)
  • EC Guide to Good Manufacturing Practice
  • Triangle Certification Standard Operating Procedures
  • USP 797 Pharmaceutical Compounding - Sterile Preparations
  • Installed HEPA Filter Leakage Test
  • Airflow Velocity and Uniformity
  • Airflow Volume and Uniformity
  • Airflow Turbulence Intensity
  • Room Air Exchange Rate Measurement and Calculation
  • Airborne Particle Counts (viable and non-viable)
  • Room Pressurization Differential
  • Noise Level Intensity (decibels or NC Curve)
  • Lighting Intensity and Uniformity
  • Temperature and Relative Humidity
  • Airflow Pattern Visualization (non-contaminating highly visible, written report supported by video in VHS and DVD formats)
  • Environmental(EM) Sampling and Analysis (airborne and surface)
  • Clean Compressed Dry Air (pressure, microbial content, hydrocarbons, particle counts and dew points)
  • Barrier Isolator Testing
  • Extract Technologies Weigh Booth Test Experts

At Triangle Certification, we understand the importance of documentation retention. We have all of our documentation, including customer records, stored in a 21CFR Part 11 compliant database, that is backed up daily on a secure server.

Contact Triangle Certification for more information or to schedule services.
 
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