validation-qualification-astrotechworld

Validation / Qualification

TESTING, VALIDATION, QUALIFICATION

ventilation

Testing of Ventilation Systems

  • Review of Air Handling Units (AHU) for all sections
  • Review of regulation elements (regulation dampers, volume dampers, manual dampers, constant pressure dampers)
  • Duct traverse testing of total air flow from Air Handling Units (AHU) with internal and external static pressure testing
  • Defining working set points of supply and return air fans from Air Handling Units (AHU)
  • Supply and return air volumes testing on all diffusers and grills with air changes calculations
  • Supply and return air volume balancing (balancing of air distribution)
  • Air Handling Unit (AHU) and duct air leakage (defining the class of leakage) with additional air flow smoke visualization
  • Air Handling Unit (AHU) tightness test (defining tightness class) in defining leak points
  • Air Handling Unit (AHU) vibration test

Differential Pressure Testing and Regulation (dP)

  • Cascade or reference point regulation and testing
differential-pressure


room-temperature

Room Temperature and Relative Humidity Test

  • Testing temperatures and humidity inside rooms and clean rooms


Air Flow Visualization Test

  • Inside clean rooms in ‘AT Rest’ condition, using air flow smoke tubes from DRAGER
  • Inside clean rooms in ‘AT Rest’ condition, using purified water fogger (recommended for GMP class A & B rooms)
  • Inside GMP class A laminar flow cabinets or isolators in ‘At Rest’ condition
  • Inside GMP class A laminar flow cabinets or isolators in ‘Operational’ condition
air-flow

Microbiological / Biological Safety Cabinets

  • Downflow velocity and uniformity test
  • Inflow face velocity test
  • Filter integrity test- DOP in-situ scan test of HEPA filters
  • Particle count test
  • Air flow visualization test at state ‘At Rest’
  • Light and electrical safety testing
  • KI discus contamination test- Defining operator safety factor

Temperature or Temperature and Relative Humidity Mapping (Warehouses, Cold Rooms, Incubators, Chambers, Transport Vehicles)

  • Prepare Risk Assessment prior to mapping in order to determine mapping positions
  • Prepare drawings with position of air conditioning units, permanent probe positions, racks
  • Determination of minimum, maximum, average and Mean Kinetic Temperatures for each position
  • Determination of spatial homogeneity and temporal instability
  • Determination of COLD and HOT spots
  • Conclusion with expert opinion about permanent probe position opposite to RA and COLD and HOT

Filter Test Integrity DOP In-Situ Test

  • Terminal HEPA filter scan tests
    HEPA filter Volumetric tests

Particle Count Test Room Classification

  • Particle count

Laminar Flow Cabins or Cabinets

  • Velocity and uniformity test
  • Filter integrity test- DOP in-situ scan test
  • Particle count test
  • Air flow visualization test at state ‘At Rest’
  • Light and electrical safety tests

Fume Cupboard Testing

  • Review of mechanical installation including duct and room positioning
  • Inflow face velocity test
  • Duct traverse test
  • Air flow visualization test at state ‘At Rest’
  • Light and electrical safety test
  • KI discus contamination test- defining operator safety factor
  • SF6 inner plane contamination 
  • SF6 inner plane contamination test- defining operator safety factor
  • SF6 outer plane contamination test- defining operator safety factor
  • SF6 robustness contamination test

Room Recovery Test

  • Room recovery test for all classes

documentation

Preparing Complete Documentation

Note: All Testing Templates are Prepared and Validated as Accredited by ISO 17025 Testing Laboratory

  • Installation Qualification Protocol (IQ)
  • Performance Qualification Protocol (PQ)
  • Operational Qualification Protocol (OQ)
  • Validation Report or Requalification protocol (RQ)
compresed-nitorgen

Compressed Nitrogen Validation

  • Dew point test (humidity test)
  • Oil mist or aerosol test
  • CO2, CO, O2, H2S, SOx,…
  • Microbiological sampling test

Compressed Air Validation

  • Dew point test
  • Oil mist or aerosol test
  • Particle count test
  • Microbiological air sampling test
  • CO2, CO, O2, H2S, NOx, SOx

Qualifications and Certifications

  • Qualified and certified clean room and equipment validator by Clean Room and Certification Board from (February 2007, Level: Professional)
  • Certificate for particle counting- Classification, by Irish Cleanroom Society
  • Certificates and training for particle counting
  • Certificates for filter integrity testing
  • Certificates for Microbiological Safety Cabinet testing and validation
  • ECA Certification -Introduction to Risk Management – Barcelona 2015 (ICH Q9, GAMP5, Risk Assessment/Management in Validation, Ranking, Periodic Review Priorities)
  • ECA Certification- Computer Validation- Barcelona 2015 (Electronic records/signatures, EU

The Following Procedures are ISO 17025 Approved/Accredited

  • Duct traverse air flow test
  • Velocity testing
  • Differential pressured test
  • Temperature and relative humidity testing of monitoring (mapping)
  • Electrical safety tests 
calibration

CALIBRATION

  • Temperature probe calibration, with MU down to 0,15°C
  • Temperature probe calibration (by Resistance), with MU down to 0,1°C
  • Temperature probe calibration (by Resistance + Triple Point of Water) with MU down to 0,02°C
  • Relative humidity probe calibration, with MU down to 1,5%RH
  • Differential pressure sensor or transducer, range from 100 to 100 Pa, with MU down to 0,6 Pa
  • Differential pressure sensor or transducer, range from 5000 to 5000 Pa, with MU down to 1,5 Pa
  • Differential pressure sensor or transducer, range from 0.87 to 20 bar, with MU down to 20 mbar
  • Differential pressure sensor or transducer, range from 1500 to 1500 Pa, with MU down to 0,6 Pa
  • Thermostat chamber: 9-point calibration (freezers, refrigerators, incubators, …), with MU down to 0,1°C (Determination of temperature spatial homogeneity, temporal stability, radiation and loading effect, indicator precision)
  • Climatic chamber: 9-point calibration, with MU down to 0,1°C and 3%RH (Determination of T/RH spatial homogeneity, temporal stability, radiation and loading effect, indicator accuracy)
  • Dry block calibration, with MU down to 0,15°C (determination of axial and radial inhomogeneity, stability, loading and accuracy of temperature indicator
tests

OTHER TESTS

Testing of Electrical Installations

  • Conduction test by small resistance
  • Conduction test by 500 V or 1000 V
  • Indirect voltage test
  • Monitoring of all electrical parameters (voltage, current, frequency, high harmonics, etc…)

Atomic Shelter Testing

  • Review of all installations
  • Ventilation test (air volumes, duct traverse)
  • Pressure tests

Blower Door Test

  • Air tightness inside rooms

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