Ensure your cleanroom meets ISO standards, passes audits, and supports approvals across medical devices, pharma, and high-tech industries.
We help you validate your cleanroom as per ISO 14644 so you can avoid audit failures, reduce rework, and move faster to market.
What is ISO 14644 Cleanroom Validation?
Cleanroom validation is the process of verifying that your controlled environment meets particle count, airflow, pressure, and environmental limits defined under ISO 14644.
It ensures your cleanroom consistently performs as required for contamination control and regulatory compliance.
For medical device manufacturers, clean room validation is essential for:
- Ensuring sterility and product safety
- Meeting regulatory requirements (FDA, EU MDR, CDSCO, etc.)
- Enabling ISO 13485 and GMP compliance
Looking For a Medical Device Regulatory Consultant?
Our ISO 14644 Cleanroom Validation Services
We provide comprehensive validation services in line with ISO 14644-1, ISO 14644-2, and ISO 14644-3.
Test #1: Airborne Particle Concentration
The first step in validating your clean room is measuring the airborne particle concentration.
- Purpose: Evaluate the air cleanliness classification in terms of airborne particles.
- Method: Perform the test according to ISO 14644-1.
- Particle Sizes: Measure particle sizes such as 0.5 μm and 5 μm.
- Limits: Comply with the limits specified in Table 1 of ISO 14644-1 for the at-rest state. For operational measurements, follow WHO guidelines or use the next class limits in Table 1.
Test #2: DOP Test or HEPA Filter Leakage Test
The DOP test, or HEPA filter leakage test, confirms the proper installation and integrity of the air filter system.
- Purpose: Verify the absence of bypass leakage and ensure filters are free of defects.
- Method: Introduce an aerosol challenge upstream of the filter and scan downstream according to ISO 14644-3.
- Acceptance Criteria: Detected leak should be no more than 0.01%.
Test #3: Air Pressure Difference Test
This test checks the cleanroom’s ability to maintain the specified pressure differential.
- Purpose: Verify the cleanroom air movement system’s capability.
- Method: Conduct the test according to ISO 14644-3.
- Pressure Differentials: According to ISO 14644-4, pressure differentials should typically range from 7.5 Pa to 15 Pa.
- Frequency: Perform during validation and daily routine monitoring.
Test #4: Air Change Rate (ACR)
The air change rate test measures the supply air volume flow rate in non-unidirectional cleanrooms.
- Purpose: Measure the air volume supplied to the cleanroom per unit of time.
- Method: Follow ISO 14644-3 guidelines.
- ACR: Should be 15-20 times per hour, or as per regulatory requirements.
Test #5: Temperature & Humidity
This test ensures that air temperature and relative humidity (RH) levels remain within control limits over time.
- Purpose: Verify temperature and RH levels.
- Method: Comply with ISO 14644-3.
- Criteria: Follow regulatory requirements, typically 18-22°C and RH not exceeding 65%.
Test #6: Recovery Test
The recovery test evaluates the time required for the cleanroom to return to target cleanliness levels after a disturbance.
- Purpose: Determine the recovery time to target cleanliness.
- Method: Conduct the test as per ISO 14644-3.
Why Cleanroom Validation is Critical for Your Facility
Cleanrooms are used in industries where even the smallest contamination can affect product quality, safety, and compliance.
Without proper validation, you risk:
- Failed audits and regulatory rejection
- Product contamination and recalls
- Delays in approvals and market entry
- Increased rework and operational costs
Cleanroom validation ensures your controlled environment performs as required and meets global compliance standards.
Read related blog: When Your Manufacturing Facility Becomes the Reason for Regulatory Rejection
Get Expert Consultation for Clean Room Validation
Why Choose Operon Strategist?
Operon Strategist plays a crucial role in helping medical device manufacturers navigate the complexities of clean room validation. With expertise in regulatory compliance and clean room validation, Operon Strategist provides comprehensive support, ensuring all tests are conducted correctly and standards are met.
By partnering with Operon Strategist, you can ensure your cleanroom validation process is thorough and compliant with ISO 14644 standards, paving the way for safe and sterile medical device production. As a medical device turnkey project management consultant, we also consult on establishing a medical device manufacturing plant as per compliance.
FAQs
It is the process of verifying that a cleanroom meets defined cleanliness, airflow, and environmental standards.
Cleanrooms are typically validated annually or after any major modification.
The duration depends on the size and complexity of the cleanroom and the number of tests required.
