In the manufacturing process, pollutants like dust, airborne organisms, aerosol particles, and chemical vapors can compromise production and testing. To meet regulatory standards, some devices need to be produced in a separated space where airborne particles are regulated. Learn how a cleanroom can provide the ideal controlled environment for your medical device.
What is a controlled environment?
A controlled environment is an area set apart for a specific function that must have certain parameters, such as regulated pressure and temperature.
What is a cleanroom?
A cleanroom is an enclosed space where air particles, temperature, pressure, airflow, and humidity are carefully regulated to ensure an optimal environment for assembly, packaging, or quality control testing of a product.
What’s the difference?
Unlike cleanrooms, a controlled environment doesn’t typically have to meet standards for airborne particle contamination. A cleanroom requires more energy, air, and advanced technology than a controlled environment, and is often enclosed or in a separate facility.
Why is a cleanroom necessary?
A cleanroom offers the following benefits:
- A germ- and bacteria-free environment, while not necessarily sterile, ensures consistency and quality.
- Temperature can be regulated to affect the hardness of plastic or rubber parts.
- Maintaining positive pressure in a room keeps contaminated air from flowing inside.
- Controlled airflow directs clean, filtered air to sweep pollutants away from critical components.
- Humidity control protects moisture-sensitive materials (like metals and electronics) from damage.
How does a cleanroom work?
All air going into a cleanroom passes through a high efficiency particulate air (HEPA) filter or an ultra-low particulate air (ULPA) filter. Cleanroom air is regulated by the air-change rate (ACR). ACR is the number of times per hour that filtered air from outside replaces the volume of air inside the cleanroom. In a normal home, an air conditioner replaces indoor air up to two times per hour. In a cleanroom, air volume is changed anywhere from 10 to 600 times per hour.
What are cleanroom airflow principles?
A cleanroom may have a laminar airflow or turbulent airflow system.
- A laminar flow cleanroom intakes air through high efficiency filters across the whole ceiling. The air flows downward in one direction and sweeps contaminates toward vents near the floor.
- In a turbulent flow cleanroom, air passes through one filter in the ceiling, flows in multiple directions as it mixes with the room air, and removes contamination through air extracts at the bottom of the walls.
What types of cleanroom classifications are there?
Cleanrooms are regulated by the International Standards Organization. ISO 14644-1 measures controlled levels of contamination. This classification system distinguishes nine cleanroom standards based on airborne particles per cubic meter, at a certain particle size. An ISO 1 cleanroom has the lowest contamination, while an ISO 9 holds the highest number of airborne particles.
The U.S. General Service Administration’s standards (FS209E) distinguish six cleanrooms. The cleanest FS209E is Class 1, while the dirtiest is Class 100,000. In the U.S. and Canada, both these regulations are used interchangeably.
What does Via Biomedical offer?
Via Biomedical, an ISO 13485:2016 certified medical device company, occupies an 18,000 square foot facility that includes a 2,968 square foot controlled environment. Within the clean environment, there is also a 477 square foot ISO Class 7 clean room.
Contact us to learn more about our quality management system and cleanroom capabilities.