MDTL performs qualification measurements and validation of clean rooms, laboratories, operating theaters, and other premises with controlled air cleanliness, as well as laminar airflow cabinets, biological safety cabinets, hoods, sterilizers, thermostats, incubators, refrigerators, HVAC systems, biological isolators, and other equipment. MDTL is Qualified for testing and measuring of cleanrooms and premises and equipment with controlled air cleanliness, air conditioning systems and components, microclimate, working environment, thermal processes, air filtration and laboratory equipment.

Cleanroom validation is a critical process used to ensure that cleanrooms, which are controlled environments with low levels of airborne particles, meet the required standards for cleanliness. Cleanrooms are commonly used in industries such as pharmaceuticals, biotechnology, electronics manufacturing, and healthcare. The validation process involves a series of tests and assessments to confirm that the cleanroom complies with specified cleanliness and environmental control standards. Here are key elements of cleanroom validation:

MDTL COVER ALL THE PARTS OF FULL QUALIFICATION AND VALIDATION:

ISO 14644 is a standard that provides guidelines for cleanroom environments used in various industries, including pharmaceuticals, biotechnology, healthcare, and electronics. Cleanroom validation is a crucial aspect of ensuring that a cleanroom facility meets the specified cleanliness requirements. Here is a general overview of the cleanroom validation process as per ISO 14644:

Define Cleanroom Classification:

Determine the required cleanliness level based on the ISO 14644-1 classification.

ISO 14644-1 specifies the maximum allowable particle counts for different particle size ranges in the cleanroom air.

Design Qualification (DQ):

Develop a Design Qualification document that outlines the cleanroom design, specifications, and intended use.

Verify that the cleanroom design meets the requirements specified in ISO 14644.

Installation Qualification (IQ):

Verify that the cleanroom is constructed and installed according to the design specifications.

Ensure that all equipment, systems, and utilities are installed correctly and meet the required standards.

Operational Qualification (OQ):

Verify that the cleanroom operates according to the defined specifications.

Conduct tests and inspections on equipment and systems to ensure they function within specified limits.

Performance Qualification (PQ):

Demonstrate and document that the cleanroom consistently performs within the defined operational limits during actual use.

Conduct tests under dynamic conditions to simulate real-world scenarios.

Particle Monitoring:

Implement a continuous monitoring system for airborne particles based on ISO 14644 requirements.

Regularly perform particle counts at specified locations and intervals.

Microbiological Monitoring:

If applicable, implement a microbiological monitoring program to ensure the absence of viable microorganisms.

Perform regular microbial air and surface monitoring.

Validation Protocol and Reports:

Develop a validation protocol that outlines the procedures, acceptance criteria, and responsibilities for each qualification stage.

Generate comprehensive validation reports documenting the results of each qualification stage.

Change Control:

Establish a change control system to manage any modifications to the cleanroom or its processes.

Ensure that changes are assessed and validated to maintain the cleanroom's validated state.

Periodic Requalification:

Regularly requalify the cleanroom to ensure continued compliance with ISO 14644 standards.

Implement a periodic review of procedures, equipment, and documentation.

It's important to note that the specific requirements for cleanroom validation may vary depending on the industry and the nature of the processes conducted in the cleanroom. Always refer to the latest version of ISO 14644 and any relevant industry-specific guidelines for detailed and updated information.