Air Velocity Test1.0 PURPOSE To describe a procedure for carrying out Air Velocity Test.2.0 SCOPE This Procedure includes guidelines for carrying out the Air Velocity Test.3.0 RESPONSIBILITY Validation Team and Engineering/Maintenance Department is responsible for carry out the Test.4.0 PRINCIPLE This test is performed to determine the average airflow velocity, volume and Uniformity in a clean room, as well as to determine air supply volume flow rate. Air velocity test will be performed and the results will be required to determine the air changes per hour for the clean room.5.0 DEFINITION 5.1 Air Changes per Hour The rate of air exchange in a particular room is expressed as Air Changes Per Hour and is calculated by dividing the total volume of air delivered in the time unit by the volume of the space. 5.2 Non-Unidirectional air flow Air distribution where the supply air entering the clean zone mixes with the internal air by means of induction. 5.3 Unidirectional Airflow Controlled airflow through the entire cross section of a clean zone with steady velocity approximately parallel streamlines.6.0 PROCEDURE 6.1 Airflow velocity measurement in unidirectional airflow 6.1.1 Before starting the work take the details of the whole area that to be validated. 6.1.2 Clean all the instruments with IPA before entering the clean area. 6.1.3 System should be kept ON before starting the measurements.
6.1.4 Hot wire Anemometer or Vane type Anemometer is used for measuring air velocity.6.1.5 Measure the filter size of the installation for which the test is to be carried out.6.1.6 Measuring point should be defined at a distance between 150mm from the filter face.6.1.7 For measuring the filter face velocity, the distance should be about 150mm, and for checking the uniformity, it should be more than 300mm.Measuring time at each position should be at least 10 second, and the average,maximum and minimum values should be recorded.6.1.8 Note down the readings.6.2 Airflow velocity measurement for non-unidirectional airflow6.2.1 Before starting the work take the details of the whole area that to be validated.6.2.2 Clean all the instruments with IPA before entering the clean area.6.2.3 System should be kept ON before starting the measurements.6.2.4 Hot wire Anemometer or Vane type Anemometer is used for measuring air velocity.6.2.5 Measure the filter size of the installation for which the test is to be carried out.6.2.6 Measuring point should be defined at a distance 150mm from the filter face.6.2.7 Measuring time at each position should be at least 10 second.6.2.8 Calculate the average velocity for each filter.6.2.9 Calculate the CFM of each filter by using following formula; CFM=Avg.Velocity (fpm) x Area of grill (ft2)6.2.10 Calculate the total CFM of room by adding each filter CFM.6.2.11 Find out the ACPH by using following formula: No. of Air Changes /Hr = Total CFM X 60 3 Room Volume (ft )6.2.12 Calculated the air changes should not less than the designed air changes.6.2.13 If the air changes are lesser than required, adjust the dampers to desired CFM.6.2.14 Note down the readings.
7.0 REFERENCE ISO 146448.0 ABBREVIATION SOP Standard Operating Procedure ISO International Standard Operating CFM Cubic Feet per Minute Ft Feet Avg Average Hr Hour ACPH Air Changes per Hour
DOP/PAO leak integrity test.1.0 PURPOSE To describe a procedure for carrying out DOP/PAO leak integrity test.2.0 SCOPE This Procedure includes guidelines for detection of defects or pinhole leaks of HEPA filter3.0 RESPONSIBILITY Validation Team and Engineers/ Maintenance Department is responsible for carryout the Test.4.0 PRINCIPLE This test is performed to confirm that the HEPA filter is properly installed by verifying the absence of bypass leakage in the installation and the filters are free of defects and leaks in the filter frame and gasket seals, leaks in the filter bank framework. The test is performed by injecting and aerosol challenge upstream of the filters and immediately scanning down stream of the filters and supporting frame.5.0 DEFINITION 5.1 DOP (Di octyl Phthalate) / PAO (Poly Alfa Olefin) A mono-dispersed test aerosol of sub-micron particles, generated to challenge (evaluateintegrity ) of HEPA filters for HVAC 5.2 Aerosol Challenge Challenging of filter or an installed filter system by test aerosol. 5.3 Aerosol Generator System wherein aerosol is mixed with particle –free dilution air in a known volumetric ratio to reduce concentration. 5.4 Installed Filter Leakage Test Test performed to confirm that the final filters are properly installed by verifying thatthere is absence of bypass leakage in the installation, and that the filters and the grid system are free of defects and leak. 5.4 Installed Filter Leakage Test Test performed to confirm that the final filters are properly installed by verifying thatthere is absence of bypass leakage in the installation, and that the filters and the grid system are free of defects and leak. 5.5 Aerosol A gaseous suspension of fine (100µm or smaller in size) solid or liquid particles.
5.6 Aerosol Photometer Light-scattering mass concentration indicating instrument which uses a forward Scattered optical chamber to make measurements. 5.7 Scanning Method for disclosing leaks in units, whereby the probe inlet of an aerosol photometer ismoved in overlapping strokes across the defined filter area.6.0 PROCEDURE 6.1 Before starting the work take the details of the whole area that to be validated. 6.2 Ask engineering / maintenance person to arrange single phase power supply as well as air connection with 20psi (1.5kg) pressure. 6.3 Clean all the instruments with IPA before entering the clean area 6.4 Ensure that the floor and area as well as Equipment is visually cleaned. 6.5 System should be kept ON before starting the measurements. 6.6 Connect the Spike Guard to Photometer before starting it. 6.7 Start the air to generate the aerosol particles at 20psi pressure. 6.8 Direct the generator face to the return air point or fresh air intake of the AHU. 6.9 Take a tube and connect on end to the filter face Upstream port and other to the photometer in Upstream mode. 6.10 Switch ON the photometer and set it to zero. 6.11 Put the photometer to upstream mode and note the reading, the reading should be in between 20mg/Ltr to 80mg/Ltr. 6.12 If it is between the above range then set the value to 100%, wait until the photometer displays 100% upstream concentration. 6.13 Put the photometer switch on clear mode and enter zero for machine to become zero. 6.14 Wait until photometer display ‘0’ (zero). 6.15 Now put the switch to down stream mode and scan the filter by holding the probe approximately one inch away from the filter face. 6.16 Scan the corners of HEPA filter for checking the installation leakages. 6.17 If the reading on the photometer is more than 0.01%, rectify the leakages by tightening the locking bolts. 6.18 Repair patches on filters should not exceed maximum of 5% of the total filter face area and the maximum width x length of each patch should not be more than 1.5 inches. Total number of patches should not exceed 5 numbers / filters. 6.19 Note down the final readings after rectification.
7.0 REFERENCE ISO 146448.0 ABBREVIATION SOP Standard Operating Procedure ISO International Standard Operating CFM Cubic Feet per Minute Psi Pascal per Square Inch HVAC Heating Ventilation and Air Conditioning AHU Air Handling Unit
Non- Viable Particle Count Test.1.0 PURPOSE To describe a procedure for carrying out Non- Viable Particle Count Test.4.0 SCOPE This Procedure includes guidelines for Carrying out Non-Viable Particle Count Test which includes the classification of air classification of air cleanliness in clean rooms and associated controlled environments in terms of Concentration of airborne particles.5.0 RESPONSIBILITY Validation Team and Engineers/ Maintenance Department is responsible for carryout the Test.4.0 PRINCIPLE This test is method specifies the measurement of air borne particle concentrations with size distributions having a threshold size between 0.5µm and 5.0µm. Measurements can be made in any of three defined occupancy states as-built, at-rest and operational. The measurements are made to certify the cleanliness classification.5.0 DEFINITION 5.1 AIRBORNE PARTICLES 5.1.1 Particle Solid or liquid object which, for purposes of classification of air cleanliness, falls with in a cumulative distribution that is based upon a threshold (lower limit) size in the range from 0.1µm to 5.0µm. 5.1.2 Particle Size Diameter of a sphere that produces a response, by a given particle-sizing instruments, that is equivalent to the response produced by the particle being measured. 5.1.3 Particle Concentration Number of individual particles per unit volume of air. 5.1.4 Particle Size Distribution Cumulative distribution of particle concentration as a function of particle size.5.2 OCCUPANCY STATES
5.2.1 As-Built Conditions where the installation is complete with all services connected and functioning but with no production equipment, materials, or personnel present. 4.2.1 At-Rest Condition where the installation is complete with equipment installed and operating, but with no personnel present.6.0 CLASSICATION 6.1 Classification for Cleanliness Classes for Clean Rooms and Clean ZonesISO Classification Number Particles / M3 0.5µm 5.0µm ISO CLASS 5 3520 29 ISO CLASS 6 35200 293 ISO CLASS 7 352000 2930 ISO CLASS 8 3520000 293007.0 SAMPLING 7.1 ESTABLISHMENT OF SAMPLING LOCATION 7.1.1 Calculation for No. of Locations To calculate the minimum number of sampling point locations: NL = √A Where, NL is the minimum number of sampling locations ( rounded up to a whole number A is the area of clean room or clean zone in square meters7.1.2 Sampling Point Ensure that the sampling locations are evenly distributed throughout the area of the clean room and positioned at a working level. 7.2. ESTABLISHMENT OF SINGLE SAMPLE VOLUME PERLOCATION
7.2.1 Sampling Volume At each sampling location, sampling a sufficient volume of air that a minimum of 20 particles would be detected if the particle concentration for the largest considered particles sized were at the class limit for the designed ISO Class. The single sample volume VS per locations is : Vs =20/Cnm x 1000 Where, Vs is the minimum single sample volume per location in liters Cnm is the class limit ( number of particles per cubic meter ) for the largest considered particles size specified for the relevant class. 20 is the defined number of particle that could be counted if the particle concentration were at the class limit.8.0 PROCEDURE 8.1 Before starting the work take the details of the whole are that to be validate. 8.2 Ask Engineering / maintenance person to arrange single phase power supply. 8.3 Clean all the instruments with IPA before entering the clean area. 8.4 Ensure that the floor and area as well as Equipment is visually cleaned. 8.5 System should be kept ON 2 hours before starting the measurements. 8.6 Connect the Spike Guard to particle counter before starting the counter. 8.7 Set the Particle counter as per the given details of rooms/LAFs. 8.8 The sampling probe shall be positioned vertically upward. 8.9 Switch ON the Air Borne Particle Counter.
8.10 Set the Particle Counter for 0 Purging before starting the measurement 8.11 Place the probe at working level height. 8.12 Start taking samples at different location as per the details and take print of the reading. 8.13 The Thermal paper reading should be pasted on a blank page and should be Xeroxed immediately.9.0 REFERENCE ISO 1464410.0 ABBREVIATION SOP Standard Operating Procedure ISO International Standard Operating LAF Laminar Air Flow Unit AHU Air Handling Unit