With 40 years of experience of troubleshooting and servicing cleanroom facilities, we understand what needs to be accomplished for a successfully designed and constructed cleanroom facility and Sterile Compounding Suite(s) in conjunction with understanding how to operate and maintain them properly.
We provide 3rd party:
Consulting for those considering a Sterile Compounding Suite (s).
Gap Analysis Visit
An action plan report will be submitted to outline actions required to meet compliance with CETA-CAG-003-2006.
Design Assistance to minimize upfront frustration and maximize dollars invested
Work as "Owners Representative" overseeing your construction team and incorporate our "Build Clean" Construction Methodology program
Final certification in accordance with CETA-CAG-003-2006, per USP <797>.
1. Air Flow Testing – Turbulent
2. Air Changes per Hour
3. Airflow Smoke Pattern Test with video documentation
4. Room Segregation
5. Room Pressurization
6. HEPA Filter Installation Test
7. Airborne Non-Viable Particle Count Test
8. Light Uniformity
9. Noise Uniformity
10. Temperature Uniformity
11. Humidity Uniformity
Biological Safety Cabinet Tests
1. Exhaust Velocity and CFM Calculations
2. In-Flow and Down-Flow Airflow Velocities
3. HEPA Filter Integrity Test
4. Cabinet Integrity Test
5. Airflow & Smoke Pattern Test
6. Light Level
7. Noise Level
Laminar Flow Bench Certification:
1. Air Velocity and Uniformity Test
2. HEPA Filter Integrity Test
3. Cabinet Integrity Test
4. Light Level
5. Noise Level
6. Non Viable Particle Count
Prior to us leaving your site, we will have an exit meeting with all parties concerned to go over the test results and provide you with recommendations (that will also be in the report) to better optimize your operations immediately.