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Sunday , October , 22 2017

USP Pharmacy Cleanroom and PEC Testing

 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.

R. Kraft, Inc
129 Shorecliff Dr. 
Rochester, NY 14612
United States of America

Tel: (585) 621-6946
Email: info@cleanroomservices.com


Let our 40 yrs of cleanroom experience

(Certification, Troubleshooting, Performance Appraisals, Training Seminars, Design Assistance from a Service Provides viewpoint, Construction/Project Management)
assist you in achieving and operating a cost effective cleanroom facility.


ISO/IEC 17025 Accredited For The Testing/Certification of Clean rooms and Laminar Flow Devices.

NAISC CODES

    236210 - 238220 - 611430 

           

          Veteran Owned


See client recommendations at www.linkedin.com/in/rki129