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ISO 14644 is a standard that provides guidelines for cleanrooms and associated controlled environments. While ISO 14644 does not specifically address filter integrity testing, it does provide specifications for cleanroom air cleanliness, which can indirectly influence the testing requirements for filters used in cleanrooms.

Filter integrity testing is typically performed to ensure that the filters in a cleanroom or controlled environment are functioning effectively and are free from leaks or damage. The specific testing procedures may vary depending on the type of filter and the application. Here are some general guidelines for filter integrity testing that align with the principles of ISO 14644:

HEPA and ULPA Filters:

  • Integrity testing for high-efficiency particulate air (HEPA) filters and ultra-low penetration air (ULPA) filters should be performed regularly to ensure their effectiveness.
  • Common test methods include the aerosol photometric method (e.g., using a photometer or laser particle counter) or the Poly Alpha Olephine (PAO) method.
  • The testing should be performed in accordance with recognized standards such as EN 1822 or IEST-RP-CC034.

Filter Leak Testing:

  • Leak testing should be performed on all filters, including pre-filters and intermediate filters.
  • Common methods for leak testing include the use of a non-hazardous smoke generator, bubble emission test, or pressure decay test.
  • The specific test procedure may depend on the filter type and manufacturer’s recommendations.

Testing Frequency:

  • The frequency of filter integrity testing should be defined in the facility’s standard operating procedures (SOPs) based on factors such as filter type, criticality of the cleanroom, and regulatory requirements.
  • Typically, filter integrity testing is performed during the initial installation and qualification of the filters and then on a regular basis as part of the cleanroom monitoring program.
  • Monthly or quarterly testing is common for HEPA/ULPA filters, while pre-filters may be tested more frequently.

Record Keeping:

  • It is essential to maintain accurate records of all filter integrity tests performed, including test results, dates, and any corrective actions taken.
  • These records can demonstrate compliance with ISO 14644 requirements and serve as evidence of a robust quality control program.

Remember that while the information provided aligns with the principles of ISO 14644, it’s important to consult the standard itself, as well as any relevant local regulations and guidelines, to ensure full compliance with specific requirements for filter integrity testing in your cleanroom or controlled environment.

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