Cleanroom Certification & Testing

 ISO 14644-1

Federal Standard 209E

Conversion Table

AVERAGE, MEAN, STANDARD DEVIATION, STANDARD ERROR AND UPPER CONFIDENCE LIMITS (UCL):

FOR ROOMS WHERE NUMBER OF SAMPLING LOCATIONS IS MORE THAN ONE AND LESS THAN NINE

AVERAGE PARTICLE CONCENTRATION:

A= Where C₁, C₂,”¦”¦, C_N = Individual particle counts

N = Number of particle counts taken at each location.

MEAN OF AVERAGES:

M = Where A₁, A₂, “¦”¦, A_N = Average particle concentrations at each location.

L = Number of locations.

STANDARD DEVIATION:

SD = Where A₁ , A₂ , “¦.. A_N = Average particle concentrations at particular locations

M = Mean of Averages

L = Number of Locations

STANDARD ERROR:

SE =  SD

            L

Where SD = Standard Deviation and L = Number of Locations

UPPER CONFIDENCE LIMIT (UCL):

UCL = M + (SE) (UCL Factor)

Where M = Mean of Averages

SE = Standard Error

UCL factor shown on table:

* When the number of locations is less than 2 or greater than 9, the calculation of a UCL is not required.

The HEPA Filter Leak Test is a critical process to ensure that all HEPA filters, their housings, and mounting frames within the cleanroom are free from leakage when operating at the manufacturer’s recommended airflow velocities.

Purpose

To verify that HEPA filters and their components maintain integrity and are functioning properly, ensuring no leaks that could compromise the cleanroom’s controlled environment.

Instrumentation

• Particle Counter:
  • Used to detect and measure particle concentration downstream of the HEPA filter.
  • Calibration:
    • Calibration documents for the particle counter are included in the certification report to ensure the accuracy of the test.

Procedures

1. Scanning the HEPA Filter System:

   • Use the particle counter probe to scan the entire downstream side of:
     • HEPA filters.
     • Mounting frames.
     • Filter housings.

2. Traverse Technique:

   • The probe is moved at a traverse rate of no more than two (2) inches per second in slightly overlapping strokes.
   • This ensures complete coverage and detection of potential leaks.

3. Probe Specifications:

   • The probe used shall have an area of at least one (1) inch to ensure effective scanning of the filter surface.

4. Data Collection and Reporting:

   • Record and report all results in the test report, including particle concentrations and any detected anomalies.

Acceptance Criteria

• Leakage Threshold:

  • Ambient air particle concentration downstream should not exceed 0.01 percent of the upstream concentration at any point.

• Upstream Considerations:

  • If the upstream ambient air is too clean to perform a leak test in a reasonable amount of time, alternate methods or agreements may be required.

• Custom Agreements:

  • Filter integrity requirements and acceptance criteria should be clearly defined between the buyer and seller to accommodate specific cleanroom needs.

Why Perform a HEPA Filter Leak Test?

• Regulatory Compliance:

  • Verifies that filters meet ISO, GMP, and FDA standards for cleanroom certification.

• Operational Assurance:

  • Confirms that the HEPA filters are functioning properly, ensuring the cleanroom maintains a particle-free environment.

• Preventative Maintenance:

  • Identifies potential leaks early, reducing the risk of contamination and operational disruptions.

Partner with ACM for HEPA Filter Leak Testing

ACM’s certified technicians provide meticulous HEPA filter leak testing, following rigorous protocols to ensure your cleanroom meets and exceeds all regulatory standards. Our comprehensive reports and calibration documentation ensure full transparency and audit readiness.

Contact ACM today to schedule your HEPA filter leak test and safeguard your cleanroom’s performance and compliance.

The HEPA Filter Leak Test using PAO (Polyalphaolefin) or Dry Test Spheres is a critical process for verifying the integrity of HEPA filters, their housings, and mounting frames in cleanrooms. This test ensures that all filters operate without leakage at the manufacturer’s recommended airflow velocities.

Purpose

To verify the leak-tight performance of HEPA filters, ensuring proper containment and particle filtration as per cleanroom operational and regulatory requirements.

Instrumentation

• ATI Photometer:
  • Used to measure aerosol penetration downstream of the HEPA filter.
• ATI Aerosol Generator:
  • Used to introduce a controlled aerosol challenge (PAO or Dry Test Spheres) into the upstream side of the HEPA filter.
• Calibration:
  • Calibration documents for both instruments are included in the certification report to ensure test accuracy.

Procedures

1. Aerosol Challenge Generation:

   • Use an ATI Aerosol Generator to introduce PAO (or Dry Test Spheres) into the upstream airflow of the HEPA filter.

2. Scanning Process:

   • Using the ATI Photometer, scan the entire downstream side of:
     • HEPA filters.
     • Mounting frames.
     • Filter housing.

3. Traverse Technique:

   • Position the probe 1 inch (2.5 cm) downstream from the filter surface, whenever possible.
   • Move the probe at a traverse rate of no more than two (2) inches per second in slightly overlapping strokes.

4. Probe Specifications:

   • The probe should:
     • Be no more than 1 inch in diameter.
     • Have a sample rate of at least 1 cubic foot per minute (CFM) for accurate particle detection.

5. Reporting Results:

   • Record and report aerosol penetration data at each scan location in the test report.
   • Include all calibration and reference documentation for full traceability.

6. Reference Standards:

   • Procedures adhere to IES-RP-006.2 and ACM-9000-PAO.01 for standardized testing protocols.

Acceptance Criteria

• Aerosol Penetration Threshold:

  • PAO or DOP aerosol penetration should not exceed 0.010 percent of the upstream concentration at any point.

• Buyer-Seller Agreements:

  • Filter integrity requirements, including specific thresholds, can be customized based on agreements between the buyer and seller.

Why Use PAO or Dry Test Spheres for HEPA Leak Testing?

• Precise Leak Detection:

  • The test identifies even the smallest leaks in filters, frames, and housings.

• Regulatory Compliance:

  • Ensures adherence to ISO, GMP, FDA, and IES standards for cleanroom operations.

• Operational Assurance:

  • Validates that HEPA filters maintain containment and proper airflow, minimizing contamination risks.

Partner with ACM for HEPA Filter Leak Testing

ACM provides comprehensive HEPA filter leak testing using PAO or Dry Test Spheres, ensuring your cleanroom meets all regulatory standards and operational requirements. With certified technicians, state-of-the-art equipment, and detailed reporting, ACM delivers reliable results and peace of mind.

Contact ACM today to schedule your HEPA filter leak test and maintain the integrity of your cleanroom environment.

HEPA Filter Air Flow Velocity testing is critical for assessing the performance of HEPA filters, ensuring proper air delivery, uniform airflow, and compliance with cleanroom standards. This test calculates the average airflow velocity, uniformity range, and room air exchange rate within the cleanroom environment.

Purpose

To determine the volume of air delivered through each HEPA filter and ensure the airflow meets the cleanroom’s design specifications for both unidirectional and non-unidirectional airflow systems.

Instrumentation

• Shortridge Air Data Multimeter:
  • Used for measuring linear airflow velocity and volume.
• Calibration:
  • Calibration documents for all testing equipment are included in the certification report, ensuring accuracy and traceability.

Procedures

1. Unidirectional Air Flow Test:
   • Divide the work zone entrance into a grid of 2 x 2 sections.
   • Position the anemometer or Shortridge instrument at a distance of 12 inches below the HEPA filter, ensuring uniform measurement.
2. Non-Unidirectional Air Flow Test:
   • Divide the filter area into a grid of 2 x 2 sections.
   • Orient the anemometer perpendicular to the velocity flow vector being measured.
   • Position the probe at a distance of no more than 6 inches (15 cm) from the filter face for accurate readings.
3. Airflow Volume Test Using an Anemometer/Shortridge:
   • Measure and record the linear airflow velocity at multiple points.
   • Calculate the average airflow velocity by averaging all recorded data points.
   • Multiply the average velocity by the effective filter area to determine the total airflow volume.
4. Airflow Volume Test Using a Balometer:
   • Place the flow hood completely over the filter or diffuser, ensuring the hood face is seated against a flat surface to prevent air bypass.
   • Measure and record the flow rate in cubic feet per minute (CFM) for each filter or diffuser.

Acceptance Criteria

• Airflow Velocity and Volume Tolerances:
  • The average airflow velocity or the total airflow volume for the cleanroom or clean zone must fall within ± of the specified design value.
• Buyer-Seller Agreement:
  • Tolerances may be customized based on the agreement between the buyer and seller, allowing flexibility for specific cleanroom applications.

Why Perform HEPA Air Flow Velocity Testing?

• Regulatory Compliance:
  • Verifies that cleanroom airflow meets ISO 14644 and GMP standards.
• Performance Validation:
  • Ensures filters provide consistent and uniform airflow, minimizing contamination risks.
• Operational Assurance:
  • Confirms the cleanroom’s air exchange rate supports proper environmental control for sensitive processes.

Partner with ACM for Air Flow Velocity Testing

ACM’s certified technicians provide precise and reliable airflow velocity testing using industry-standard instruments like Shortridge Air Data Multimeters and Balometers. With detailed reporting and calibration documentation, ACM ensures your cleanroom meets its design and compliance requirements.

Contact ACM today to schedule your HEPA filter airflow velocity test and ensure your cleanroom operates at peak performance.

The temperature testing process evaluates the ability of cleanroom air handling systems to maintain temperature levels within specified design requirements. This ensures that the cleanroom provides a stable environment for personnel comfort and process or equipment needs.

Purpose

To verify the capability of the cleanroom’s air handling equipment to maintain temperature within the agreed-upon design specifications.

Instrumentation

• Extech Hygro-Thermometer:
  • Used to measure and monitor temperature levels within the cleanroom.
• Calibration:
  • Calibration documents for the Extech Hygro-Thermometer are included in the certification report to ensure accuracy and compliance.

Procedures

1. Preparation:

   • Allow the cleanroom to operate continuously for 24 hours before testing to stabilize environmental conditions.

2. Measurement Locations:

   • Measure temperature at a minimum of one location per temperature control zone.
   • Position sensors at work-level height in each designated area.

3. Data Collection:

   • Record the time and temperature readings at each location.
   • Ensure consistency across all measured zones for accurate comparison.

4. Application Notes:

   • For areas where temperature and moisture are controlled primarily for worker comfort, this standard testing procedure is recommended.
   • When strict temperature control is required for processes or equipment, a more comprehensive test should be performed.

Acceptance Criteria

• Buyer-Seller Agreement:
  • Temperature uniformity and requirements are customized and agreed upon between the buyer and seller, allowing flexibility to meet specific needs.

Why Perform Temperature Testing?

• Worker Comfort:

  • Ensures the cleanroom provides a safe and comfortable working environment.

• Process Compliance:

  • Confirms that temperature levels meet operational requirements for sensitive processes or equipment.

• Regulatory Adherence:

  • Supports compliance with ISO standards and other applicable guidelines for environmental control.

Partner with ACM for Temperature Testing

ACM provides precise and reliable temperature testing to ensure your cleanroom maintains optimal conditions. With certified technicians, advanced instrumentation, and comprehensive reporting, ACM helps you achieve environmental stability and regulatory compliance.

Contact ACM today to schedule your cleanroom temperature testing and maintain the performance and reliability of your controlled environment.

Humidity control is a critical aspect of cleanroom management, ensuring the environment remains within optimal conditions for both personnel comfort and product integrity. Proper humidity control also helps prevent damage to equipment, reduces contamination risks, and ensures compliance with industry standards.

Purpose

To verify that the cleanroom’s humidity control system is functioning effectively and maintaining humidity levels within the specified acceptance range. Proper humidity control is essential to:

• Prevent Corrosion and Oxidation:
  • Protects sensitive equipment and materials from environmental damage.
• Prevent Condensation on Work Surfaces:
  • Ensures that moisture does not accumulate on critical surfaces, avoiding contamination and damage.
• Reduce Static Electricity:
  • Minimizes static buildup, which can interfere with sensitive electronics and processes.
• Provide Personnel Comfort:
  • Creates a comfortable working environment for cleanroom operators.
• Prevent Product Contamination:
  • Maintains ideal conditions for product safety and quality.
• Compensate for Hygroscopic Materials:
  • Controls moisture levels to prevent material degradation or damage.
• Control Microbial Growth:
  • Helps mitigate conditions conducive to microbial proliferation.

Instrumentation

• Extech Hygro-Thermometer:
  • A reliable instrument used for measuring and monitoring relative humidity.
• Calibration:
  • Calibration documents for the Extech Hygro-Thermometer are included in the certification report to ensure accurate and reliable results.

Procedures

1. Room Grid Mapping:

   • Divide the cleanroom work zone into grids of equal proportion to ensure consistent and representative testing.

2. Probe Placement:

   • After air and hydronic balancing are completed, position the humidity probe in the center of each test grid to capture accurate readings.

3. Data Recording:

   • Record the humidity levels for each grid point, ensuring the measurements reflect the uniformity and effectiveness of the system.

Acceptance Criteria

• Buyer-Seller Agreement:
  • The humidity levels and uniformity requirements should be agreed upon between the buyer and seller to ensure the cleanroom’s specific needs are met.

Why Perform Humidity Testing?

• Environmental Control:

  • Verifies that the cleanroom maintains the correct moisture levels to avoid contamination, corrosion, and other operational issues.

• Product and Process Integrity:

  • Ensures that the cleanroom environment remains conducive to high-quality product manufacturing and reliable process outcomes.

• Regulatory Compliance:

  • Supports adherence to ISO, GMP, and other industry regulations for environmental controls.

Partner with ACM for Humidity Testing

ACM’s certified technicians ensure that your cleanroom maintains optimal humidity levels, providing accurate testing and detailed reporting to guarantee compliance and operational efficiency.

Contact ACM today to schedule your humidity testing and ensure your cleanroom is operating at its best.

Maintaining proper room pressurization is crucial for ensuring the flow of air from the cleanest areas to less clean areas, particularly during normal operations and when there are temporary upsets in air balance. This helps prevent contamination from entering clean spaces, safeguarding both personnel and products.

Purpose

To verify that a differential pressure is maintained between the cleanroom and surrounding areas, ensuring that airflow moves outward progressively from the cleanest spaces to the least clean. This is important during both normal operation and periods of temporary upsets (e.g., when a door connecting two rooms is suddenly opened).

Instrumentation

• Shortridge Differential Pressure Measurement Equipment:
  • Used to measure the differential pressure between the cleanroom and surrounding areas.
• Calibration:
  • Calibration documents for the Shortridge equipment are included in the certification report to ensure accuracy and reliability of the measurements.

Procedures

1. System Preparation:

   • Ensure all doors are closed and the air handling systems are operating at their design capacity to maintain standard conditions for pressure measurement.

2. Pressure Measurement:

   • Measure the differential pressure (in inches of water gauge) between the cleanroom and the surrounding areas.

3. Data Recording:

   • Record the following data:
     • Direction of Pressurization (whether the cleanroom is positive or negative in relation to surrounding spaces).
     • Differential Pressure in inches water gauge.
   • Ensure all results are documented and reported in the test report for future reference and regulatory compliance.

Acceptance Criteria

• Buyer-Seller Agreement:
  • Pressurization and uniformity requirements should be agreed upon between the buyer and seller, ensuring that the cleanroom’s specific operational and regulatory needs are met.

Why Perform Room Pressurization Testing?

• Contamination Prevention:

  • Proper pressurization ensures that air flows outward from cleaner areas to less clean areas, reducing the risk of contaminants migrating into controlled spaces.

• Environmental Control:

  • Verifies that the cleanroom is maintaining consistent air balance during normal operations and temporary disturbances, such as door openings.

• Regulatory Compliance:

  • Ensures that your facility meets ISO, GMP, and other regulatory requirements for cleanroom operations.

Partner with ACM for Room Pressurization Testing

ACM’s certified technicians ensure that your cleanroom maintains optimal pressurization for both operational efficiency and regulatory compliance. We offer precise measurements, comprehensive reporting, and ongoing support for all your cleanroom needs.

Contact ACM today to schedule your room pressurization testing and ensure that your facility operates at peak performance.