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Wednesday , August , 23 2017

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 and E-Cig Manufacturing, E- Vapor, E-Vapor Manufacturing, 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 programs to assure conformance with current industry guidelines for:

1. Cleanroom Facilities

2. Laminar Airflow Benches

3. Metrology Labs

4. Fume/ Exhaust Hoods

5. <797> Sterile Compounding Facilities

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. In-Place Hepa Filter Integrity Test

4. Airflow Parallelism

5. HEPA Filter Leak Testing (Bench Testing)

6. Viable Particle Counting (Witness Plate)

7. Visual Airflow Characterization (Smoke Test)

8. Differential Pressure Gage Calibration.

9. Re-Balancing of the supply/return air system(s).

10. Air Pressure Re-Balancing of Critical Areas.

11. IAQ Testing and Monitoring of Industrial/Commercial Spaces

12. Minitab Analysis of Cleanroom Data

Why Us?

Our only business is the certification of cleanrooms and laminar flow benches, consulting services, training seminars. 

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 17025:2005 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.

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

1. Square Footage of room with ceiling height.

2. Number of Hepa Filters.

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
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