• Air Velocity Test
    • The purpose of this test is to measure the velocity and to confirm the uniformity through the whole filter area. It can also be used for calculating the air flow (m3/h), by multiplying the average air velocity (m/s) with the surface area (m2) of that filter.
    • This test is used for qualification of Unidirectional Cleanrooms, Laminar Air Flows, Down Flow Booths, Isolators, Bio Safety Cabinets, Filling Machines… wherever it is required.
  • Air Visualization Test
    • The objective of this test is to confirm good mixing in turbulently ventilated cleanrooms and that there is no entrainment of air from areas outside of the critical area. This test can be confirmed between cleanrooms and their adjusted areas.
    • This test is used for qualification of Unidirectional Cleanrooms as well as Turbulently Ventilated Cleanrooms, Laminar Air Flows, Down Flow Booths, Isolators, Bio Safety Cabinets, Filling Machines…
  • Airflow and Air changes
    • Some of the most important tests conducted in cleanrooms are the examination of airflows and air change rates. The purpose of these tests is to measure the supply airflow rate in the cleanrooms and clean zones and to confirm the design specification for the air changes per hour. Air changes are provided in order to dilute any particles present to an acceptable concentration.
    • This test is used for qualification of Turbulently Ventilated Cleanrooms.
  • Commissioning
    • This test is typical for the period of commissioning after system is balanced. The purpose of this test is to give identity to the installed fan section of the air handling unit (motor, fan, pulleys, belt, power, etc.). This test also has target to confirm the spare capacity of the motor/fan.
    • This test is used for all types of cleanrooms and equipment which have supply, or extract fan installed.
  • Component Installation Checks
    • This test is part of commissioning and/or IQ process. Here "as built” drawings have to be challenged with the installation. Components have to be checked for any visible damage and any visible impurities. It has to be verified that the “Components” in the selected section of the distribution ductwork and installed cleanroom elements are correct (suitably located, installed securely and free from damage).
    • Components are defined as:
      • Constant Volume Control Boxes
      • Ductwork
      • Terminal diffusers, grilles
      • Volume Control Dampers & Motorized Dampers
      • Panels, doors
      • Sensors (Pressure sensors, Pressure switches, Temperature and Humidity Sensors etc.)
      • Air handling units, coils, humidifiers, dehumidifiers, inverters
      • Diffusers and Grilles
      • Pumps, valves, pipes, instruments
      • Filters
      • Sockets, switches, lights etc.
    • This test is used for all types of cleanrooms and equipment.
  • Containment Leak - Photometer Method
    • Containment leak test is performed to determine if there is intrusion of contaminated air into the clean zones from surrounding non-controlled areas.
    • This test is used for biosafety laboratories, where environment/surroundings must remain protected.
  • Differential Pressure
    • Differential pressure test is one of the main tests that part of every cleanroom qualification and its’ goal is maintain air quality in a cleanroom and to avoid cross-contamination between cleanrooms. This is to ensure that air does not pass from “dirtier” adjacent areas into the higher grade cleanroom. Thus the differential pressure is one of the main characteristics to be considered in every cleanroom.
    • Usually cleanrooms are exposed to a higher pressure than the pressure of their surroundings. Very often a differential pressure is required between different cleanrooms (a cascade of differential pressures). This will depend upon the different cleanliness levels required.
    • This test is conducted in order to prove that the air system is capable of maintaining differential pressures between cleanrooms and their surroundings in a given period of time. During the measurements of the differential pressure, all doors which belong to the inspected area must be closed.
    • This test is used for all types of cleanrooms.
  • Drawing Documentation
    • “As Built” drawings of ductwork and components, finishes, fixtures and fittings, ceiling, wall partition, P&ID have to be challenged with the installation. Ductwork and all the components have to be checked for any visible damage and any visible impurities.
    • Using a copy of the drawings, verify that the ductwork and components, finishes, fixtures and fittings, ceiling, wall partition, P&ID in the selected section of the HVAC System and installed cleanroom elements are correct (suitably located, installed securely and free from damage).
    • This test is used for all types of cleanrooms.
  • Filter Integrity Scan - Photometer Method
    • This test is conducted in order to confirm that the filter system is properly installed and that leaks have not developed during use. The test verifies the absence of leakage, relevant to the cleanliness performance of the installation.
    • The test is performed by introducing an aerosol and scanning immediately downstream of the filters and support frame. The test is a leak test of the complete filter installation comprising the filter media, frame, and gasket.
    • This test is used for all types of cleanrooms and equipment which have HEPA or ULPA filters installed.
  • Filter Integrity Volumetric - Photometer Method
    • The Volumetric Filter Integrity test is used in many configurations for HEPA filters, notably in air-handling units where it is difficult to apply a uniform upstream challenge, or to carry out a full downstream scan-test. For ducted systems, it is generally accepted that that in order to ensure homogeneous mixing of the challenge aerosol, the aerosol should be injected into an upstream duct at a distance that is at least 15 duct diameters from the upstream face of the filter.
    • The challenge aerosol presented to the upstream side of the filter should be stable, homogeneous and have a concentration of between 20 µg/l and 50 µg/l.
    • It should be noted that volumetric leak test methods, where the downstream samples give the overall penetration rather than the local penetration, are greatly inferior to scan methods.
  • Manufacturer Documentation
    • This test is for comparing the installed equipment and enclosed manufacturer documentation. The checker on Site will also have right to use available “As built” P&IDs and “As built” drawings comparing with the installed equipment. Checkers with the reviewers and approvers of this section may add initialed and dated comments or notes if necessary.
    • This test is used for all types of cleanrooms and equipment.
  • Particle Counting
    • It is the most important of all tests, being used to prove that cleanroom functions are in conformity with the requirements and that it fulfills the set of standards in terms of meeting its required classification.
    • This test is performed to determine the Air Cleanliness and the Classification of the Cleanroom, as specified in EU GMP and ISO 14644-1:1999.
    • A prerequisite for starting the Particle Counting Test is:
      • The air system must be balanced and meet the required number of air changes per hour;
      • The differential pressures between the cleanrooms and their surroundings must be confirmed;
      • The filter integrity test must have been completed finished;
      • The room being tested must be clean and ready for use.
    • The test frequency is:
      • ≤ISO 5 on every 6 months
      • >ISO 5 on every 12 months
    • This test is used for all types of cleanrooms and equipment.
  • Recovery Time
    • This test should confirm that the ventilation system has the capacity to maintain the cleanliness level in the cleanroom in question. The objective is to calculate the time needed for a cleanroom to recover after a contamination event has occurred. That is, to determine if an elevated number of particles can be reduced to a level within the cleanroom class within a given period of time.
    • The room recovery test is conducted in ‘at as built’ or ‘at rest’ occupancy states. According to ISO 14644-3, 100:1 room recovery time for classes such as ISO classes 8 and 9 is not recommended. This is because generating a sufficiently high level of particles is very difficult.
    • This test is beneficial only for non-unidirectional cleanrooms.
  • Rectangular Duct Traverse
    • For Duct airflow, Pitot traverse test velocity measurement locations are determined by using Log-Tchebycheff rule, creating matrices of measuring points. The air velocities within the rectangular duct are measured using a Pitot tube and using the measuring points to obtain an average velocity which is converted to the air volume from a knowledge of the cross sectional area of the duct.
    • It is essential for measuring the velocity using Pitot tube or any other probe within the rectangular ducts that the measuring location must be at the place where the air will be less turbulent, i.e. on the straight part of the duct where it can be proved that the minimum requirement for the location is to be 1-2 lengths beyond the measurement site and at least 5-6 lengths after any disturbance of the ductwork such as elbows, t-parts, damper, etc.
    • Also, measuring within the ductwork is only satisfactory as long as reasonably high numbers of measurements are taken.
  • Round Duct Traverse
    • If the duct is round, then the measuring is performing by establishing areas of equal volume across the duct, and if possible, but not always practical, where all points are taken on 3 diameters by dividing the area into 6 parts of 60°.
    • It is essential for measuring the velocity using Pitot tube or any other probe within the round ducts that the measuring location must be at the place where the air will be less turbulent, i.e. on the straight part of the duct where it can be proved that the minimum requirement for the location is to be 1-2 diameters beyond the measurement site and at least 5-6 diameters after any disturbance of the ductwork such as elbows, t-parts, damper, etc.
    • Also, measuring within the ductwork is only satisfactory as long as reasonably high numbers of measurements are taken.
  • Temperature and Relative Humidity
    • The purpose of this test is to demonstrate the capability of the installation's air-handling system to maintain the air temperature and humidity level within the control limits and over the time period specified in the user requirement specification.
    • This test is used for all types of cleanrooms.