How to Validate Your Cleanroom?

Cleanrooms are controlled environments that are designed to minimize the presence of airborne particles, microorganisms, and other contaminants that could compromise the quality and safety of products or processes.
Cleanrooms are essential for many industries, such as pharmaceuticals, biotechnology, medical devices, electronics, and aerospace; where products are manufactured or tested under strict conditions of cleanliness, temperature, humidity, pressure and airflow.

However, simply building a cleanroom is not enough to ensure its effectiveness. Cleanrooms need to be validated by qualified professionals before they can be used for their intended purposes. Validation is the process of verifying that a cleanroom meets the specified requirements and standards for its classification and application.

In this blog post, we will explain the steps of validating a cleanroom according to ISO 14644-1:2015, which is an international standard that specifies the requirements for the design, construction, testing, monitoring, and maintenance of cleanrooms and associated controlled environments.

HEPA filter leak test

Cleanroom validation consists of three main phases: installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). Each phase has different tests and procedures to evaluate the various aspects of the cleanroom performance. Here is a brief overview of each phase:

Installation Qualification (IQ)

The IQ phase verifies that all the critical components and equipment of the cleanroom are installed correctly and according to the design specifications. This includes checking the materials of construction, dimensions, layout, wiring, piping,

lighting, filters, HVAC units and other systems. The IQ phase also ensures that all the necessary documentation such as drawings, manuals, certificates and calibration records are available and complete.
The IQ phase typically involves visual inspection, measurement of utilities, verification and documentation of all the installation parameters.
Some examples of IQ tests are:

• Measurement of site utilities (voltage, amps, electrical protection switches, water supply specifications, compressed air pressure and its quality, steam supply and its quality if required…)

• Measurement of site environmental condition (Temperature, RH%, light intensity, sound level, magnetic fields,….)

• Verification of as-built drawings

• Verification of walls/ducts material specifications

• Verification of AHUs internal material certificates

• Verification of walls and door tightness certificates

• Verification of duct works tightness certificates

• Verification of availability of civil works load approvals before any machine installation

• Verification of training records and competence of personal

• Verification of availability of SOPs

• Verification of availability of operation and maintenance manuals

• Verification of availability of wiring diagrams for Building Management System (BMS)

• Verification of availability of wiring diagrams for Environmental Monitoring System (EMS)

• Verification of availability of software backup for EMS and BMS

• Verification of availability of protective maintenance procedure plans

• Verification of availability of spare parts list for various utilities

  The final step is to issue IQ summary report to assure that the Cleanroom is qualified for its intended use and allow the validation team to start the OQ Phase

Operational Qualification (OQ)

The OQ phase verifies that the cleanroom operates consistently and reliably within the specified limits under normal operating conditions.

This includes testing the functionality, performance, and control of all the systems, equipment, and instruments that affect the cleanroom environment.

The OQ phase also ensures that all the standard operating procedures (SOPs), work instructions, training programs, and maintenance schedules are established and applicable. Moreover, personnel is familiar with the SOPs through an active training program. The OQ phase typically involves testing, monitoring, recording, and analyzing all the operational parameters such as temperature, humidity, airflow, particle counts microbial counts, noise levels, lighting levels, etc.

Some examples of OQ tests are:

• Airborne particle count test:
  This test measures the number and size distribution of particles suspended in the air within each room or zone. A particle counter device is used to sample and count the particles at various locations within each room or zone. The particle counts should be below the maximum allowable limits for each class of cleanliness according to ISO 14644 standards.

• Microbial count test:
  This test measures the number and type of viable microorganisms present in the air within each room or zone. A microbial sampler device is used to collect air samples onto culture media plates at various locations within each room or zone. The plates are incubated for a specified time period at a suitable temperature depending on the type of microorganisms expected. The microbial counts should be below the maximum allowable limits for each class of cleanliness according to ISO 14698 standards.

  The final step is to issue OQ summary report to assure that the Cleanroom is qualified for its intended use and allow the validation team to start the PQ Phase.

Performance Qualification (PQ)

PQ is the phase where the actual performance of the cleanroom is tested and verified under normal operating conditions. PQ involves conducting various tests to measure the physical, chemical, and microbiological parameters of the cleanroom

environment, such as:

• HEPA filter leak test:
  This test checks for any leaks or defects in the high-efficiency particulate air (HEPA) filters that remove airborne particles from the cleanroom air. A special aerosol generator is used to introduce a challenge agent such as dioctyl phthalate (DOP) or poly-alpha-olefin (PAO) into the upstream side of each filter.
  A photometer or particle counter is used to measure the concentration of the challenge agent on both sides of each filter. The leakage rate is calculated as a percentage of penetration through each filter.

• Airflow velocity test:
  This test measures the speed and direction of air movement within the cleanroom. An anemometer or pitot tube is used to measure the airflow velocity at various locations within each room or zone. The airflow velocity should be uniform and within the specified range for each class of cleanliness.

• Differential pressure test:
  This test measures the difference in air pressure between adjacent rooms or zones within the cleanroom facility.
  A manometer or pressure gauge is used to measure the differential pressure at various points within each room or zone.
  The differential pressure should be positive for higher cleanliness rooms and negative for lower cleanliness rooms to prevent cross-contamination. The tests are performed according to a predefined protocol that specifies the test methods, acceptance criteria, sampling locations, frequency, and duration.
  The test results are documented and compared with the acceptance criteria to determine if the cleanroom meets the specifications.

The final step is to issue a validation summary report to assure that the Cleanroom is qualified for its intended use and that all the NCs or deviation found has been cleared to start using the Cleanroom for daily production activities