2 VALIDATION OF HVAC SYSTEMS Validation test is carried out at Rest and also under dynamic conditionsValidation of a clean room involves the following:Air flow velocity, air changes calculationUni directional flowAirborne particle countHEPA Filter installation leak testTotal viable count (settle plate and air sampling)
3 VALIDATION OF HVAC SYSTEMS AIR FLOW VELOCITYAIMThis test is performed to determine the average airflow velocity and the velocity uniformity within a laminar flow work zone. APPARATUSHot wire or Vane type anemometer which within ± 3% of scale reading over the velocity of interest.The anemometer should be in a state of calibration and should have traceability certificate.
4 VALIDATION OF HVAC SYSTEMS AIR FLOW VELOCITYPROCEDUREDivide the work zone entrance plane into grids of equal area.The area of the individual grids should not be greater than 4 sq ft Measure and record the velocity of each grid point under an air producing areaTake measurement for a minimum of 5 seconds using the average during that period as the measurement.
5 VALIDATION OF HVAC SYSTEMS AIR FLOW VELOCITYPROCEDUREGet average velocity and thereby calculate the air changes per hour in the rooms. Report the average air flow velocity in fpm or mps.Under laminar, calculate the air flow uniformly range equal to the average airflow velocity ± 20%Calculate and Identify all readings which are outside this airflow uniformity range and calculate the percentage of readings which are within the airflow uniformity range.
6 VALIDATION OF HVAC SYSTEMS AIR FLOW VELOCITYACCEPTANCEThe max. and mini average velocity should be agreed to between buyer and seller. The minimum percentage of airflow reading within the ± 20% is acceptable limit.S.NoClassMin. Changes1100,000 (ISO 8)20210,000 (ISO 7)40 to 453100 (ISO 5)Up to 80
7 VALIDATION OF HVAC SYSTEMS HEPA FILTER INSTALLATION LEAK TESTAT REST FACILITYAt rest facility room which is complete and has the production equipment installed and operating, but has no personnel or material movement within the facility.HEPAA throw-away extended-media dry type filter in a rigid frame having a minimum particle collection efficiency of 99.97% for 0.3 micrometer with PAO (Poly Alpha olefins)
8 VALIDATION OF HVAC SYSTEMS HEPA FILTER INSTALLATION LEAK TESTPROBING OR SCANNING A method for disclosing leaks in filters and in which the probe nozzle of an aerosol photometer is held approx. 1” from the filter face and moved at a rate of not more than 10ft/min. across the test areaAEROSOL GENERATORAn aerosol generated by blowing air through the PAO When generated with a Laskking type nozzle the approximate light scattering mean droplet size distribution is 40% less than 1 micrometers 50% less than 0.7 micrometer and 10% less than 0.4 micrometers
9 VALIDATION OF HVAC SYSTEMS HEPA FILTER INSTALLATION LEAK TESTOPTICAL PARTICLE COUNTERA Light scattering instrument with display or recording means to count and size discrete particles in airAEROSOL PHOTOMETERA light scattering mass conc. Indicator Instruments of this type with a threshold sensitivity of at least 102 mg per liter for 0.3 micrometer diameter DOP particles.
10 VALIDATION OF HVAC SYSTEMS HEPA FILTER INSTALLATION LEAK TESTCLEAN ROOMA room in which the air supply, air distribution filtration supply, materials of constructions and operating procedures are regulated to control airborne particle concentrations to meet the appropriate cleanliness levels as defined by ISO requirements .CALIBRATED EQUIPMENTTest equipment which has been calibrated in accordance with the equipment manufacturer, recommendations and or accepted industry practices.
11 VALIDATION OF HVAC SYSTEMS HEPA FILTER INTEGRITY TEST (DOP TEST)This test is performed to confirm that the HEPA filter system is properly installed by verifying the absence of bypass leakage in the installation and that the HEPA filters are free of defects and pinhole leaks. It is particularly important for LAF units and mixed airflow clean room where a ISO 8,7,6,5 cleanliness specification is imposed.
12 VALIDATION OF HVAC SYSTEMS HEPA FILTER INTEGRITY TEST (DOP TEST)The test is made by introducing an aerosol challenge upstream of HEPA filters and scanning immediately downstream of the HEPA filters and support frame.This procedure detects small pinholes or other damage in the filter medium and frame seal by-pass leaks in the filter frame and gasket seal and leaks in the filter bank framework.
13 VALIDATION OF HVAC SYSTEMS HEPA FILTER INTEGRITY TEST (DOP TEST)AIMTo check leaks above 0.01% in The HEPA and installation by DOPAPPARATUSAerosol generator, Air pressure, Photometer, scanning probe, DOP
14 VALIDATION OF HVAC SYSTEMS HEPA FILTER INTEGRITY TEST (DOP TEST)PROCEDUREThis Test is performed by introducing the DOP or specified upstream of the HEPA filters and searching the leaks by scanning the downstream side of the filters with the photometer probe. The design airflow velocity should be set prior to performing the filter installation leak test.Introduce the aerosol in the air supplied to the HEPA filters in a manner which will produce a uniform challenge conc. at each of the HEPA filters being exposed at the same timeWhere construction permits, introduce the aerosol and measure the upstream concentration immediately upstream of the filter in question.
15 VALIDATION OF HVAC SYSTEMS HEPA FILTER INTEGRITY TEST (DOP TEST)PROCEDURESet the aerosol generator air supply pressure at 20 psig minimum. Operate one or more laskin nozzle and or generators as necessary to produce the upstream concentration required for the leak detection 10 mg per liter is recommended. Photometer to be used.Measure the upstream aerosol challenge concentration, using it a linear photometer scale. 10 mg per liter of air on the upstream cont, is adjusted to read 100%.
16 VALIDATION OF HVAC SYSTEMS HEPA FILTER INTEGRITY TEST (DOP TEST)REPORTING Block, If the leakage is minor by silicon sealant and re do the procedure of DOP, leak not more than 0.01% is acceptable.
17 VALIDATION OF HVAC SYSTEMS AIRBORNE PARTICLE COUNTAIMThis test is performed to determine that the completed facility AT REST facility can achieve the air cleanliness level desired by the user. This test is not intended for routine monitoring.APPARATUSOptical laser based particle counter having a particle size determination capability to detect particles of 0.3, 0.5, 1, 5 micrometers.
18 VALIDATION OF HVAC SYSTEMS AIRBORNE PARTICLE COUNTPROCEDUREIts very important that one looks minutely towards particle counter. The particle counter by which particle count is carried out must be of 1 CFMVerify that all aspects of the clean room system which contribute to its operational integrity (air handling, filtration systems, walls, ceilings, floors etc ) are complete and functioning nominally in accordance with the requirement of the type clean room and the operational mode under test.
19 VALIDATION OF HVAC SYSTEMS AIRBORNE PARTICLE COUNTPROCEDUREEstablish a test point grid pattern at the working level or at the ground level which satisfies user requirement and compatible with the type of clean room and the operational mode being tested. Determination of the number, location and grid size of sampling points should be based on the specified cleanliness level and number of critical locations in order to obtain the desired confidence level.
20 VALIDATION OF HVAC SYSTEMS AIRBORNE PARTICLE COUNTPROCEDURETest point should not directly sample contamination released from operating equipment and or people. i.e the air should be sampled as it approaches the work activity area. This will generally be immediately above the work activity level or immediately upstream in laminar air flow rooms.The number of test points and their locations must satisfy the statistical requirement of the user.
21 VALIDATION OF HVAC SYSTEMS AIRBORNE PARTICLE COUNTREPORTINGRecord the mean particle count at each grid location and note all measurements exceeding the specified air cleanliness level S.NoClassMax. particles of 0.5µMax. particles of 5µ1ISO 8100,0007002ISO 710,000703ISO 5300 of 0.3 µ and 100 of 0.5 µNil
22 VALIDATION OF HVAC SYSTEMS AIRBORNE PARTICLE COUNTACCEPTANCETo Classify the complete clean room as meeting the specified air cleanliness level, particle counts shown on the sample point plan should not exceed the specified level.Clean work zone areas within the clean room may also be specified and classified by the maximum allowable particle count. In addition the room or work area may be classified differently in the “At Rest” operating facility modes.
23 VALIDATION OF HVAC SYSTEMS TOTAL VIABLE COUNTSettle plate method – Expose Agar plates Soya bean Casein digest Agar as well as Saboraud Dextrose Agar for a definite period– depends on the activities and the sensitivity of the products manufacturedSettle plates measure exactly that phenomenon for which they are intended—the random settling of biologically active particles
24 VALIDATION OF HVAC SYSTEMS TOTAL VIABLE COUNTAnother approach to sampling is to collect micro-organisms on a membrane filter in a filter cassette connected to a low-volume rechargeable pump. The whole assembly can be clipped to a belt and used to collect a personal sample over a normal working day. After sampling, small portions of washings from the filter and dilutions of the washings can then be spread out on a range of agar media, incubated and counts of viable micro-organisms made. An alternative to the filter sampler is the liquid impinger, in which particles in air drawn in through capillary jets impinge on and collect in liquid. Portions of the collection liquid and dilutions prepared from it are treated in the same way as those from filter samplers