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3rd Party Cleanroom Certification Periodic Monitoring Programs

In Accordance with current Industry Guidelines and Recommended Practices for Aerospace, Automotive,Electronics, Semiconductor, Optical, Precision Assembly, Pharmaceutical, Medical Device, <797> Sterile Compounding, We have the time proven expertise to assist you with the Design and Construction phases and are ISO/IEC 17025 Accredited for the Testing/Certification of Cleanrooms and Laminar Flow Devices.

(A) Development and documentation of regularly scheduled certification and/or routine monitoring and testing programs to assure conformance with current industry guidelines for:

1. Cleanroom Facilities

2. Laminar Airflow Devices

3. Metrology Labs

4. Fume/ Exhaust Hoods

5.. Biological Safety Cabinets (BSC'S)

6. Precision Assembly/Mfg.

Minimal Cleanroom Certification to include:

1. Air Flow, Volume, Velocity, Uniformity Test

2. Room Pressure

3. Non Viable Particle Count

4. Temperature and Relative Humidity Test
 

Optional Tests/Services Available:

1. Light Level Test

2. Noise Level Test

3. Airflow Parallelism

4. HEPA Filter Leak Testing (In-Place & Bench Testing)

5. Non Viable Particle Counting (Settling Plate with Surfscan results and report)

6. Airflow Visualization Studies (Smoke Test)

7. Differential Pressure Gage Calibration.

8. Air Pressure Re-Balancing of Critical Areas.

9. Negative Room Pressure Monitoring and Rebalancing


 

Why Us?

Our only business is the certification of cleanrooms, laminar flow devices, cleanroom consulting services, cleanroom training seminars and the testing of HVAC HEPA filter systems

Our certification visit to your site is more of a consultancy visit to better enhance your on-going cleanroom endeavors.

 

 

1. Having successfully completed the ISO 9001-2008 Lead Auditors Course and the ISO/IEC 17025:2005 Internal Auditors Course in addition to being ISO 17025:2017 Accredited for the certification of cleanrooms, we approach your cleanroom  from an Auditors perspective.

2. During the certification process, we will be critiquing your room, observing personnel disciplines, housekeeping procedures and other items that may produce Airborne Molecular Contamination (AMC).

3. At the completion of this certification/consultancy visit and prior to leaving your site, we ask for an exit meeting with all concerned parties to go over the certification findings and the finding of our observations, so that you can implement any applicable enhancements and/or recommendations, immediately.

4. You will receive (electronically) the certification report within one week of our visit or it can be  done on-site prior to us leaving your site, should you request this prior to our visit.

Some of the industries we have serviced over the years has been: Aerospace, Automotive, Electronics, Data Recovery, Ceramics, Semiconductor, Thin Film, Optics, Medical Device, Precision Assembly, Contract Packaging, Sterile <797> Compounding, Pharmaceutical, Food, Cosmetics, PCB, SMT, Nanotechnology, E-Vapor, E-Cig

For a FREE 24 hour turn around quote, contact us with the following information:

1. Square Footage of each room you want tested with ceiling height.

2. Number of Hepa Filters. per room you want tested

3. Do the Hepa filters have a removable perforated protective grille?___________

4. What tests do you want performed (make selection from above list)? If unsure, contact us to discuss your needs.

R. Kraft, Inc
478 Manse Lane 
Rochester, NY 14625
United States of America

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


Let our 45 + yrs of cleanroom experience

assist you in achieving and operating a cost effective cleanroom facility.

( 3rd Party Certification, Troubleshooting, Performance Appraisals, Training Seminars, Design Assistance from a Service Provides viewpoint, Construction/Project Management)


ISO/IEC 17025 Accredited For The  3rd Party Testing/Certification of Clean rooms and Laminar Flow Devices.



NAISC CODES

236210 - 238220 - 325412 - 326111 - 326112 - 541380 - 541611 - 541614 - 541620 - 541910 - 541990 -561210 - 611430 

             Cage: 3EVT1

         


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

ISNetworld Member Contractor

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