Clean Room Standard

Green Excel is committed to encouraging a healthier and cleaner environment through our cutting-edge technologies and expertise of the Clean Room Standard. We are dedicated to offering top-notch solutions that not only fulfil the stringent standards but also support our vision of a cleaner planet as the need for contamination-free places grows across numerous industries.

 

What is Clean Room Standard?

The level of cleanliness required in controlled environments is specified by a set of rules and procedures known as the “Clean Room Standard.” Industries, including pharmaceuticals, biotechnology, electronics, aircraft, and more, depend on these environments. The main goal is to maintain a controlled atmosphere that reduces the presence of particulate matter and germs to assure product quality, research integrity, and worker safety.

 

What are the ISO Clean Room Standards?

The International Organization for Standardization (ISO) established a set of standards known as ISO Clean Room standards. They focus on cleanroom design, building, and management across a range of sectors, including pharma, biotech, electronics, and medical devices. These standards are meant to make sure that cleanrooms comply with strict guidelines for hygiene, air quality, and environmental controls.

Below, we are mentioning different ISO clean room standards:

• ISO 14644-1: Air cleanliness classification

This standard specifies the general requirements for clean rooms, including cleanliness categories, air quality standards, and monitoring requirements based on the amount and size of particles per cubic meter of air.

• ISO 14644-2: Monitoring to show proof of cleanroom performance

This standard offers guidelines for microbial monitoring, particle concentration, sample techniques, and clean room testing and monitoring.

• 14644-3: Test procedures

This standard offers methods for measuring and testing cleanroom performance, including air pressure, particle count, and air velocity.

• ISO 14644-4; Design, construction, and startup

This standard covers clean room design, building, and installation, as well as the necessary airlocks, filters, and ventilation setups. It also covers the commissioning of clean rooms, which includes choosing the right supplies, tools, and employees.

• ISO 14644-5: Operation 

This standard offers instructions for the use and maintenance of clean rooms, covering cleaning practices, gowning standards, and paperwork.

 

Components of Clean Room Standard

• Classifications for Clean Rooms: The maximum number of airborne particles per cubic meter is used to categorize cleanrooms. These classifications are made from ISO Class 1 (more stringent) to ISO Class 9 (the least strict).
• Airflow and Filtration Systems: Particles in the air are removed using HEPA (High-Efficiency Particulate Air), and ULPA (Ultra-Low Penetration Air) filters to maintain a controlled atmosphere.
• Cleaning and disinfection: Regular and thorough cleaning and disinfection procedures are essential to maintain a suitable level of cleanliness.
• Personnel Training: Personnel must receive the proper training on cleanroom protocols, gowning techniques, and hygiene practices to prevent contamination.
• Controlled Access: Access to cleanrooms is restricted and controlled to reduce the input of contaminants from the outside.