Test Report. Room: Production Room. Serial Number Air Particle Counter Aerosol Generator Sound Level Meter + Calibrator Termohygrometer

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Reynold Cox
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1 Report Number: 37AR17 Report Date: Amadora - Portugal Department: Phone: Room: Production Room Room Conditions: Resting Number of people: 1 Room Area (m²): 10.4 Equipment Tested: CLEANROOM Customer Identification: Institute IlhaPlast - Soc. Transformadora de Plásticos Direction Contact Person: Engº Jorge Jesus Adress: ilhaplast@ilhaplast.com Installation Adress: Zona Industrial de Vagos, Lote 87, Vagos, Portugal Equipments used in the tests: Test Equipments Serial Number Air Particle Counter Thermoanemometer Luximeter Micromanometer Photometer 1137 Aerosol Generator Sound Level Meter + Calibrator Termohygrometer / Others: Supports, tapes leaflets, tape and smoke ampoules Applicable Standards: ISO :2015 ISO 1498:2003 IEST- RP-CC00.3:2004 Cleanrooms and associated controlled environments Cleanrooms - Biocontamination control Testing Cleanrooms Equipment calibration na Validation Procedures HEPA and ULPA Filter Leak Tests Testing date: Responsible for the Technical Tests João Fonseca Technical and Quality Director Elsa Rodrigues EN/7/R11 The results presented in this report refer only to the tested items. Test report page 1/

2 Report Number: 37AR17 Report Date: SLZOQ.02 IEST-RP-CC00.3 Air velocity report test IEST-RP-CC00.3- Uniform flow measurement Total insuflation area with HEPA filters (m 2 ): 1.44 Number of tests: Medium of velocity* in insuflation by HEPA filters (m/s): 0.50 Numberenovations of the air in the cleanroom by hour: Amadora - Portugal Phone: *Speed above 1,0 m/s is outside the scope of accreditation. Test code SLZOQ.03 IEST-RP-CC00.3 Test of the Pressure diference There is not a defined value by the norm, this value is defined by the customer. Pressure inside the room compared with exterior pressure: Pressure in the antechamber compared with exterior pressure: Pressure in the room compared with room : (Pa) - 4,2 4 Filtration System Integrity Test - Leak Test SLZOQ.04 Method IEST-RP-CC00.3 IEST-RP-CC00.3-The aerosol penetration can not exceed 0,01% at any point of the filter HEPA filter test Lighting intensity test SLZOQ.05 Method IEST-RP-CC00.3 There is no defined value by the norm, this value is defined by the customer specifications. Procedure by the normative IEST-RP-CC00.3 Light medium intensity (lux): 70 EN/7/R11 The results presented in this report refer only to the tested items. Test report page 2/

3 Report Number 37AR17 Report Date Noise Level Test SLZOQ.0 There is no defined value by the norm, this value is defined by Method the customer specifications. IEST-RP-CC00.3 Procedure by the normative: IEST-RP-CC00.3 Maximum Value obtained by the Frequency Tested: 3 Hz Amadora - Portugal 125 Hz Hz 59.7 Phone: Hz 3.4 1K 3.8 2K 5.1 4K K 51.4 NC Value of the room (db(a)): < 70 Humidity and Temperature Test Test code SLZOQ.07 Expected Report There is no defined value by the norm, this value is defined by Method the customer specifications. IEST-RP-CC00.3 Procedure by the normative: IEST-RP-CC00.3 Measuring sites: Same as the particle counts. Medium value of the temperature obtained in the room (ºC): 22.2 Maximum value ( C): 22.5 Minimum value (ºC): 22.0 Number of measurements: Medium value of the humidity obtained in the room(%): 55.1 Maximum value ( C): 5.2 Minimum value (ºC): 54.1 Number of measurements: SLZOQ.07 Method IEST-RP-CC00.3 Flow Direction Test IEST-RP-CC00.3 Insuflation - Perpendicular air with velocity enough to reach the work area. Air extration must follow the flow direction. In the working area the air must circulate from top to bottom and with considerable speed. Air direction in the insuflation area: Air direction the extraction area: Air direction in the working zone: s EN/7/R11 The results presented in this report refer only to the tested items. Test report page 3/

Report Number: 37AR17 Report Date: 14-11-2017 Room classification - Particle Counting Test code SLZOQ.

4 Report Number: 37AR17 Report Date: Room classification - Particle Counting Test code SLZOQ.01 ISO :2015 normative (see attached table) Amadora - Portugal Phone: Number of Particle Counting proceeded: Sample flow: 28 l/min Medium values of the countings (particles/m 3 ): 0,3 µm 0,5 µm 1,0 µm 5,0 µm Trust Limit at 95%: 0,3 µm 0,5 µm 1,0 µm 5,0 µm Note: When the number of counting points is greater than 9 the value of trust limit at 95% is equal to the medium value of the counting (particles / m³) because the factor UCL (t) is equal to zero. Particle Count Bead Printed Legend - Particle counting points made according to the attached plan. ISO classification of the room : ISO EN/7/R11 The results presented in this report refer only to the tested items. Test report page 4/

5 Report Number: 37AR17 Report Date: Corrective Actions Check the differential pressure meter of the production and contiguous rooms Amadora - Portugal Phone: Conclusions The differential pressure meter in the personnel room is always measuring.2 Pa. The equipment measuring from the personnel room to the outside is also very slow. The Clean Room tested has an ISO rating, so it can be used while a lower rating is not required. Note: The corrective actions, observations and conclusions presented are not supported by the accreditted evaluation criterium. NA: Not applicable EN/7/R11 The results presented in this report refer only to the tested items. Test report page 5/

6 Report Number: Report Date: Attachment: Room plant tested Amadora - Portugal Phone: Legend - Places where the particle counts were made. EN/7/R11 The results presented in this report refer only to the tested items. Test report page /

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Joint Committee Issue Paper NSF Standard(s) Impacted: Background: Provide a brief background statement indicating the cause and nature of concern, the impacts identified relevant to public health, public understanding, etc, and any