Cleanroom Certification Report

Transcription

1 2880 Bergey Road, Ste. K Hatfield, PA Presents: Cleanroom Certification Report Control ID #: Prepared for: SICBOY INDUSTRIES 1218 COMMERCE CT, UNIT B Attention: KEVIN KIRKPATRICK SICBOYIND@GMAIL.COM Date(s) Tested: 27 MARCH 2018 Field Service Technician(s): REGINALD RICHARD

2 TABLE OF CONTENTS SUMMARY REPORT 3 OVERVIEW 4 HEPA LEAK HEPA FILTER LEAK TEST 5 ROOM PRESSURIZATION ROOM PRESSURIZATION 6 ANTE ROOM AIR SUPPLY VOLUMES & AIR CHANGES PER HOUR 7 ANTE ROOM PARTICLE COUNTS 8 CLEANROOM 1 AIR SUPPLY VOLUMES & AIR CHANGES PER HOUR 9 CLEANROOM 1 PARTICLE COUNTS 10 CLEANROOM 2 AIR SUPPLY VOLUMES & AIR CHANGES PER HOUR 11 CLEANROOM 2 PARTICLE COUNTS 12 SECONDARY TEST 13 TEST EQUIPMENT 14

3 SUMMARY REPORT SICBOY INDUSTRIES LONGMONT, CO CLEANROOM All testing is performed by qualified personnel using instrumentation, procedures and methods which ensure measurements observed are reliable. When specified, testing is performed in accordance with current ISO-17025, ISO-14644, USP-<797> and ENV's Quality Manual. Specifications comply with applicable IEST recommended practices, CETA CAGS and/or customer determined specifications. Measurement instruments used are traceable to The National Institute of Standards and Technology (NIST). Results obtained apply to the specific room or equipment and are reflective of conditions at the time of this test. ANTE ROOM Test Specification Pass / Fail Comment Total Air Changes / Hr. 49 N/A For Reference Only ISO Class ISO 8 ISO 8 PASS CLEANROOM 1 Test Specification Pass / Fail Comment Total Air Changes / Hr. 38 N/A For Reference Only ISO Class ISO 7 ISO 7 PASS CLEANROOM 2 Test Specification Pass / Fail Comment Total Air Changes / Hr. 39 N/A For Reference Only ISO Class ISO 7 ISO 7 PASS HEPA LEAK Test Specification Pass / Fail Comment HEPA Leak 0.01% 0.01% PASS ROOM PRESSURIZATION Test Specification Pass / Fail Comment Pressure Ref: Cleanroom 2 to ante room: Positive N/A For Reference Only Pressure Ref: Cleanroom 1 to ante room: Negative N/A For Reference Only Pressure Ref: Cleanroom 1 out the conveyer belt Positive N/A For Reference Only window: Pressure Ref: Ante room to outside: Positive N/A For Reference Only 3 of 14 Control ID #:

4 OVERVIEW SICBOY INDUSTRIES LONGMONT, CO CLEANROOM 4 of 14 Control ID #:

5 HEPA FILTER LEAK TEST OPERATIONAL / DYNAMIC HEPA LEAK Aerosol challenge concentrations are 10ug/L. PASS = No Leakage Detected PASS 5 of 14 Control ID #:

6 ROOM PRESSURIZATION (UNITS IN INCHES WATER GAUGE) - OPERATIONAL / DYNAMIC ROOM PRESSURIZATION For Reference Only 6 of 14 Control ID #:

7 AIR SUPPLY VOLUMES & AIR CHANGES PER HOUR (UNITS IN CUBIC FEET PER MINUTE) - OPERATIONAL / DYNAMIC ANTE ROOM N/A 49 N/A Room Volume No. of Readings Total Air Supply Volume Room Air Changes/Hour Room ACH Specification Total Air Changes/Hour Total ACH Specification For Reference Only 7 of 14 Control ID #:

8 PARTICLE COUNTS OPERATIONAL / DYNAMIC ANTE ROOM The above referenced clean zone has successfully passed the minimum requirements to meet the ISO class listed below per ISO Standard :2015 for particle count testing of cleanrooms and associated controlled enviroments. Area(ft²) Area(m²) ISO Target Class Number of Locations AT 0.5 MICRONS AND LARGER Highest concentration Average concentration 95% UCL ISO Class Resulting ft³ m³ ft³ m³ ft³ m³ N/A N/A 8 * ISO Class 8 allows a maximun of particles 0.5 microns per cubic meter as an average count at any location as long as the entire clean area meets the required statistical tests. Sample Volume 1.00 ft³ Particulate Sampled AT 0.5 MICRONS AND LARGER PASS 8 of 14 Control ID #:

9 AIR SUPPLY VOLUMES & AIR CHANGES PER HOUR (UNITS IN CUBIC FEET PER MINUTE) - OPERATIONAL / DYNAMIC CLEANROOM N/A 38 N/A Room Volume No. of Readings Total Air Supply Volume Room Air Changes/Hour Room ACH Specification Total Air Changes/Hour Total ACH Specification For Reference Only 9 of 14 Control ID #:

10 PARTICLE COUNTS OPERATIONAL / DYNAMIC CLEANROOM 1 The above referenced clean zone has successfully passed the minimum requirements to meet the ISO class listed below per ISO Standard :2015 for particle count testing of cleanrooms and associated controlled enviroments. Area(ft²) Area(m²) ISO Target Class Number of Locations AT 0.5 MICRONS AND LARGER Highest concentration Average concentration 95% UCL ISO Class Resulting ft³ m³ ft³ m³ ft³ m³ N/A N/A 7 * ISO Class 7 allows a maximun of particles 0.5 microns per cubic meter as an average count at any location as long as the entire clean area meets the required statistical tests. Sample Volume 1.00 ft³ Particulate Sampled AT 0.5 MICRONS AND LARGER PASS 10 of 14 Control ID #:

11 AIR SUPPLY VOLUMES & AIR CHANGES PER HOUR (UNITS IN CUBIC FEET PER MINUTE) - OPERATIONAL / DYNAMIC CLEANROOM N/A 39 N/A Room Volume No. of Readings Total Air Supply Volume Room Air Changes/Hour Room ACH Specification Total Air Changes/Hour Total ACH Specification For Reference Only 11 of 14 Control ID #:

12 PARTICLE COUNTS OPERATIONAL / DYNAMIC CLEANROOM 2 The above referenced clean zone has successfully passed the minimum requirements to meet the ISO class listed below per ISO Standard :2015 for particle count testing of cleanrooms and associated controlled enviroments. Area(ft²) Area(m²) ISO Target Class Number of Locations AT 0.5 MICRONS AND LARGER Highest concentration Average concentration 95% UCL ISO Class Resulting ft³ m³ ft³ m³ ft³ m³ N/A N/A 7 * ISO Class 7 allows a maximun of particles 0.5 microns per cubic meter as an average count at any location as long as the entire clean area meets the required statistical tests. Sample Volume 1.00 ft³ Particulate Sampled AT 0.5 MICRONS AND LARGER PASS 12 of 14 Control ID #:

13 SECONDARY TEST OPERATIONAL / DYNAMIC *Temperature Unit: F For Reference Only 13 of 14 Control ID #:

14 TEST EQUIPMENT SICBOY INDUSTRIES LONGMONT, CO CLEANROOM Equipment Name Manufacturer Model Serial Calibration Due Date PHOTOMETER AIR TECHNIQUES TDA-2H SEP 18 PARTICLE COUNTER LIGHTHOUSE 3100E JAN 19 MULTIMETER FLUKE 77/AN OCT 18 TEMP & HUMID INDICATOR VAISALA HM40 M /M JUN 18 Test equipment calibration certificates available upon request. Company ID: CO Unique ID: of 14 Control ID #: