Cleanroom Compliance Testing and Room Validation

Cleanroom Validation

There is more to cleanroom validation than just counting particles, there are various design and test criteria depending on intended usage. Below you will find many different measurements that may or may not pertain to your particular application. All of these tests are designed for one reason, and that is to ensure final product quality along side of worker safety. As with many regulatory agencies, GMP/FDA regulated medical and pharmaceutical companies are obligated to rigid testing cycles and guidelines in order to provide critical process assurances.

Enviro currently provides testing and certification for the following types of cleanrooms and controlled environments:

Pharmacy Compounding Suites
Research / Biotechnology Facilities
OR Surgery Suites / Healthcare Facilities
Medical Device Facilities
Hospital Isolation Patient Suite (Positive / Negative)
Animal Holding Rooms

Quality with Integrity

Cleanroom / Controlled Environment Testing Services

Airflow Volume Measurements
Testing verifies that turbulent (non-unidirectional) cleanrooms are operating optimally and achieving an adequate air exchange rate
Air Velocity Profile
Verifies non-turbulent (unidirectional) Cleanrooms and Work Stations are operating optimally and maintaining unidirectional flow patterns
Room Air Exchange Rates
Verifies your cleanroom is meeting design specification and/or acceptance criteria for airflow
Room Pressure Measurement
Ensures the room is properly balanced and meeting its design criteria in relation to adjacent spaces
Non-Viable Particle Counting
Testing provided to verify Cleanroom is in compliance with designed air cleanliness classification level per ISO 14644 specifications
Viable / Microbial Air Testing
Assures Bioburden levels for bacteria and/or fungi are within acceptable parameters per the Cleanroom design or client specifications
Viable / Microbial Surface Testing
Assures Bioburden levels for bacteria and/or fungi are within acceptable parameters per the Cleanroom design or client specifications
Viable / Microbial Surface Testing
Assures Bioburden levels for bacteria and/or fungi are within acceptable parameters per the Cleanroom design or client specifications
In-Place Leak Testing of HEPA Filters
Integrity testing verifies that all HEPA filters are free of leaks and are sealed properly assuring that your environment is as clean as it was designed for safety and quality
Temperature, Relative Humidity Measurements
Verifies the Cleanroom is operating within its design specifications
Lighting Measurement
Verifies that lighting levels are in compliance with design level
Sound Level Measurement
Verifies the sound level is not exceeding cleanroom design or worker comfort level

ADDITIONAL INFORMATION:

A cleanroom or clean room is an environment, typically used in manufacturing, including of pharmaceutical products or scientific research, as well as aerospace semiconductor engineering applications with a low level of environmental pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors.

Source: https://en.wikipedia.org/wiki/Cleanroom

Cleanroom Compliance Testing and Room Validation

Cleanroom Validation

Pharmacy Compounding Suites

Research / Biotechnology Facilities

OR Surgery Suites / Healthcare Facilities

Medical Device Facilities

Hospital Isolation Patient Suite (Positive / Negative)

Animal Holding Rooms

Quality with Integrity

Cleanroom / Controlled Environment Testing Services

Airflow Volume Measurements

Air Velocity Profile

Room Air Exchange Rates

Room Pressure Measurement

Non-Viable Particle Counting

Viable / Microbial Air Testing

Viable / Microbial Surface Testing

Viable / Microbial Surface Testing

In-Place Leak Testing of HEPA Filters

Temperature, Relative Humidity Measurements

Lighting Measurement

Sound Level Measurement

Location

Contact Information

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