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.