Cleanroom qualification process: Achieving ISO 8 classification

Cleanrooms are essential in the production of products that require a controlled, contaminant-free environment. 

These facilities are essential in sectors such as pharmaceuticals, biotechnology and electronics where even the smallest particles can compromise product quality and safety. 

The ISO 8 classification is one of the internationally recognised standards that defines the permissible limits of airborne particles and other critical parameters within a Cleanroom. 

Obtaining this classification guarantees a suitable working environment, enhances customer confidence and ensures regulatory compliance.

Cleanroom qualification

Cleanroom qualification is a systematic and documented process that ensures that facilities, equipment and operating procedures meet the requirements established for use in controlled environments. 

This process is essential to ensure that the environment within the cleanroom is suitable for the production and handling of contamination-sensitive products such as drugs, medical devices and electronic components.

Cleanroom qualification process

The Cleanroom qualification process is a methodical and structured procedure that ensures that all facilities and equipment meet the required standards. These are some of the key stages of the process:

• Planning: In this initial phase, qualification objectives are established and specific protocols are developed. It is important to identify the regulatory requirements and technical specifications to be met.

In addition, responsibilities are assigned to the team involved in the process.

Measurements are performed following the established methodology and standards, including ISO 14644-1, which regulates the cleanliness of air by particle concentration in cleanrooms and controlled environments, ISO 14644-3, applicable to these same environments, as well as the Work Instructions of Tecnoprocesos Control y Sistemas.

• Documentary review: Before starting the physical tests, a review of existing documentation, including drawings, design specifications, operation and maintenance manuals, is carried out. 

This ensures that all relevant aspects are taken into account during qualification.

• Calibration Testing: Instruments used to measure critical parameters (such as temperature, humidity and pressure) must be calibrated and verified to ensure their accuracy. 

This may include comparison with traceable standards.

• System Verification: A visual and functional inspection of all critical Cleanroom systems such as HVAC, HEPA filters, lighting and access control is carried out. 

In this way, the initial verification ensures that all components are installed correctly and in good condition.

• Scope of qualification: Different points have been taken from the following areas of the Clean Room facility, injection area, personnel SAS, material SAS and external enclosure to the room of a machine.
• Performance Testing: At this stage, specific tests are carried out to assess how the Cleanroom performs under operational conditions. This includes:
  • Air quality: Measurement of the number of airborne particles in the air and comparison with the limits set by the ISO 8 classification.
  • Temperature and humidity: Verification that these parameters are maintained within the specified ranges.
  • Differential pressure: Check to ensure that the pressure inside the cleanroom is higher than adjacent areas to prevent contaminants from entering.
  • Leakage detection: Leakage testing of absolute filters installed on supply air. 
  • Supply air flow: Air flow tests. Measurement of supply air flow rates. 

• Validation: All results obtained during the tests must be documented. This includes the collection of quantitative data and any relevant observations on the performance of the system.

Once the data has been collected, an analysis is performed to determine whether the Clean Room meets the ISO 8 classification. 

If deviations or non-conformities are found, they must be documented and addressed through corrective actions.

Cleanroon maintenance

The Cleanroom requires a regular maintenance plan to ensure that conditions are maintained over time. 

This includes regular monitoring, preventive maintenance and periodic revalidations to detect any deviations or failures in the systems and to continue to meet standards over time.

For qualification, we have relied on Tecnoprocesos, following the standards established for cleanrooms and controlled environments. 

And, in addition, the tests have been carried out under ENAC accreditation (National Accreditation Entity in Spain), guaranteeing compliance with the requirements of quality and reliability in the measurements.

For more information, please contact us.