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Methods of evaluation and measurements for Testing & Validation

Table of Contents

Methods of evaluation and measurements for Testing & Validation

Testing & validation

AXENIC SYSTEMS (established in 1995), lead the way in installing and designing an extensive range of customised cleanrooms, including modular cleanrooms, LEED Cleanroom, Medical Device Cleanrooms and USP797 USP800 Cleanroom that meet the utmost international installation and validation qualification standards across several industries. ISO 14644 is one of the installation and cleanroom validation testing qualifications AXENIC SYSTEMS adhere to.

Testing & Validation is an important procedure for any cleanroom. It helps to ensure that the cleanroom is appropriately installed and designed for its intended ISO classification and all the components (facility, environment, equipment) meet supervisory requirements and other defined standards.

Testing & Validation of cleanroom has different phases, starting with design qualification, and ending in final certification. Some of the tests implemented in these phases include airflow volume and velocity tests, HEPA/ULPA filter leak testing, air movement visualization (smoke testing), room pressurization, room recovery, airborne particle counts tests, relative humidity, temperature, and other testing conditions.

Cleanrooms are authorized and then certified to a chosen class of ISO 14644-1. Each class of ISO14544-1 has its unique requirements that must be made for a facility to be categorized in the specified classification.


Testing & Validation of a new cleanroom follows a detailed lifecycle. The life cycle includes different phases each of which undertakes particular tasks to control variation in the modular environment.


Cleanroom testing & validation begins with Design Qualification (DQ). The purpose of this phase is to verify through objective evidence that the design is fit for its anticipated purpose. Design Qualification is a verification exercise against requests defined in the acceptance criteria of the DQ protocol.

The protocol should address the following:

  • User Requirement Specifications(URS).
  • Vendor documents and specifications.
  • Facility blueprint
  • Purchase orders
  • Design documentation
  • Factory Acceptance Tests(FATs)
  • As built drawings
  • Data sheets

The output of the Design Qualification stage is a phase report and a Standard Documentation List (SDL) folder that documents the following:

  • Design requirements
  • Bidding requirements
  • Purchasing and order documentation
  • Vendor supplied documents list
  • As built drawings
  • Component lists
  • Inspection lists
  • Factory Acceptance Tests

The authorization of the Design Qualification, DQ phase is a pre-requisite for the initiation of the Installation Qualification, IQ phase.


The purpose of this Installation Qualification (IQ) stage is to confirm through verification that equipment— as installed—authorized user requirements and design requirements. Verification is focused on the following things that should be called for in your IQ protocol:

  • P&ID loop verification
  • HVAC calibration
  • Site Acceptance Tests(SATs)
  • HEPA filter integrity test data review
  • Utility verification
  • Critical equipment calibration status
  • Installation Qualification tests
  • Piping and welding documentation
  • System standard operating procedures and work instructions

The output of this stage should be an IQ report addressing all the above elements, and an SDL folder that documents the following elements:

  • IQ tests performed
  • Project changes
  • Calibration
  • Supplier supplied documents
  • Equipment certificate
  • Installation deviations
  • Site Acceptance Tests (SAT)
  • Consumable list
  • Spare part list
  • Environmental review report
  • List of Operational and Instructional documents

IQ approval is a prerequisite for the initiation of Operational Qualification (OQ) phase.


The main aim for this Operational Qualification (OQ) stage is to show through objective evidence that the cleanroom functions in conformance with design requirements and user defined requirements, and that it constantly operates within a defined range of conditions.

The OQ protocol should address the following:

  • Testing HVAC (Heating-Ventilation-Air Conditioner) system operation against definite functional requirements
  • Interlock Alarms
  • Critical Alarms
  • Critical operating parameters defined on the room data sheet
  • Filter integrity tests
  • Standard operation for the cleanroom
  • Air speed and air flow
  • Air flow patterns
  • Pressure differential

The OQ phase should also address worst case scenarios. To design the worst case scenario for the operation of the cleanroom, serious operating parameters are identified from the cleanroom data sheet. Operation ranges and extreme ranges, are set for each critical parameter and a worst case designed and documented. It should include the following:

  • Maximum and minimum humidity
  • Maximum and minimum temperatures
  • Personnel contamination
  • Maintenance schedules

The worst case scenario is commonly carried out at a specified High and specified Low parameters.

The output of this phase is an OQ report addressing alarms and operative requirements of the cleanroom specified in the user requirement specifications.


The purpose of Performance Qualification (PQ) of the cleanroom is to demonstrate with objective evidence that the cleanroom steadily operates within distinct parameters to produce the defined, desired environmental outcome. Cleanroom performance qualification includes testing and monitoring of the following:

  • Surface particulate levels
  • Airborne particulate levels
  • Practical microbial particulates
  • Relative humidity
  • Differential pressure
  • Temperature

The output of the PQ phase is a PQ report that examines the performance of the cleanroom using specified equipment parameters. PQ is a prerequisite for certification.


Validated cleanrooms are authorized to a necessary class of cleanliness. The level of cleanliness chosen is driven by user requirements. Cleanroom classes are described in ISO 1464-1:

Methods for evaluation and measurements for Certification are specified in ISO 14644-3. It calls out for the following ten tests.

  • Airborne particle count test
  • Airflow test
  • Air pressure differential test
  • Filter leakage test
  • Flow visualization test
  • Airflow direction test
  • Temperature test
  • Humidity test
  • Recovery test
  • Containment leak test

Once certified to a specific class the cleanroom factors are monitored to make sure that parameters have not drifted or altered and that the environment is under control.


A continuous monitoring program is essential after certification. Requirements for compliance are found in ISO 14644-2.

Statistical analysis for cleanroom parameters is encouraged as an instrument for monitoring the cleanroom after certification to ensure compliance. The instrument of choice is statistical process control, SPC.

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