Clean Room Validation
The validation of the cleanroom shall demonstrate that the production area (in which your products and components shall be exposed to the environment during its manufacturing process) is suitable and appropriate under acceptable conditions and parameters of the design in compliance with the international organization ISO under standard ISO14644.
Technical Qualifications
Clean room validation involves a series of tests and inspections to verify that the clean room facility complies with specified cleanliness standards and regulatory requirements. The validation process typically includes the following steps out of which Usha Filters only provide Operational Qualifications.
Design Qualification (DQ) -
This step involves reviewing and verifying the design documentation of the clean room facility to ensure that it meets the intended purpose, operational requirements, and relevant guidelines or standards.
Installation Qualification (IQ) -
It focuses on verifying the proper installation of clean room systems, equipment, and components according to the design specifications. This includes checking the adequacy of utilities, HVAC (heating, ventilation, and air conditioning) systems, filters, lighting, and other infrastructure elements.
Operational Qualification (OQ)-
This step involves testing and documenting the performance of clean room equipment and systems under normal operating conditions. It includes verifying temperature and humidity control, airflow patterns, pressure differentials, particle counts, and other critical parameters.
Performance Qualification (PQ) -
The PQ phase evaluates the ability of the clean room to consistently meet the specified cleanliness and environmental control requirements. It includes rigorous testing over an extended period to assess the clean room’s performance under various operating conditions and loads.
Monitoring and Maintenance -
Once the clean room is validated, ongoing monitoring and maintenance activities are essential to ensure continued compliance. Regular inspections, calibration of monitoring equipment, cleaning and disinfection protocols, and staff training are crucial to maintaining the integrity of the controlled environment.
The validation process aims to provide documented evidence that the clean room meets the required standards, mitigates contamination risks, and ensures product quality, safety, and efficacy. It helps organizations comply with regulatory guidelines, such as Good Manufacturing Practices (GMP) and ISO standards and demonstrates their commitment to maintaining a controlled environment.
The cleanroom validation protocol includes the following (14) challenges and testing activities which is done by us in validation.Â
Challenges And Test Activities
- Room Temperature
- % Relative Humidity
- Viable Particulate – Surface
- Viable Particulate Air
- Non-Viable Particulate
- Pressure Differential
- HEPA Filter Integrity
- HEPA Filters Velocities
- Room Air Changes
- Room Air Balance CFMs
- Smoke Test – Airflow Pattern
- Particle Decontamination Test
- Recovery Test – AHU shut down
- Sound and Lighting Test
Note -
 Not all Usha Filters products are washable, as due to washing filter media fibers get weak and damaged which may later affect the filter’s poor performance. Please consult the manufacturer for the same. We provide a detailed cleaning manual.
 Filters can be made in various tailor-made sizes and types per customer requirements concerning their application, fitment, Usage, desired flow, particulate matter concentration load, and filtration class required.
