What is a Clean Room Used For?
Electronics
- Computer component and package assembly
- Circuit board manufacturing
- Wafer and chip manufacturing
- Displays, optics, and thin film manufacturing
- Hard drive manufacturing and data recovery
- PCB/SMT manufacturing
- Satellite and spacecraft assemblies
- Precision lasers and optics
Hospitals, Biotech, Lifesciences
- Hospital, laboratory, and veterinary pharmacies
- Pharmaceutical packaging and preparation
- Sterile and non-sterile compounding
- RNA / MRNA research
- Gene and T-cell
- Hazardous and non-hazardous containment
- Isolation wards
- Medical devices and tooling
Food and Agriculture
- Food, beverage, and spirits manufacturing
- Agriculture, cultivation, germination, and micropropagation
- Genetics research
- Mycology
Manufacturing Cleanroom-Ready Products
- Sterile packaged items
- Cleanroom rated garments and PPE
- Cleanroom gloves and wipes
- Single-use cleanroom items
What is a Cleanroom Rating?
ISO ratings are developed by the International Standards Organization. As a worldwide federation of national standards, the organization works alongside internal organizations, governmental, and non-governmental agencies to create technical performance standards and suggested practices.
What is an ISO 14644-1 Cleanroom?
ISO 14644-1:2015 is deemed a golden standard for constructing particle-controlled environments. ISO documentation provides a blueprint for structural design, testing, and calibration imperative to achieving an ISO-rated cleanroom environment. Based on the cleanroom rating and task at hand, a cleanroom may require additional features and enhanced enclosures that can provide isolation, containment, or safe exfiltration of potential hazards, chemicals, aerosols, and viable or non-viable particulates.
ISO requirements address a wide range of contamination control and risk-mitigating strategies that may include:
Health and safety requirements;
- Compatibility with cleaning agents and techniques
- Cleanability
- Biocontamination
- Specific requirements of equipment and materials for processes and products
- Design details of equipment
Why are ISO Cleanroom Ratings Important?
Repeatability, consistency, benchmarking, and application-specific compliance are the most common reasons for seeking ISO-rated cleanrooms and enclosures. While ISO standards are non-binding suggestions, enforcement organizations such as the FDA lean on these standards as indicators of compliance.
In most cases, achieving an ISO-rated environment is a method of quality assurance and protection. Maintaining a strict ISO rating ensures that if new contamination sources arise and air quality declines, a facility can more easily detect rising contamination levels after comparing them to baseline levels. Additionally, ISO standards provide organizations with standard performance benchmarks when designing and constructing a room appropriate for their application.
In more sophisticated systems with active monitoring and automated alarms, cleanroom operators can be automatically notified of increased particulate levels or changes in humidity or temperature.
Most cleanroom enclosures are not hermetically sealed, meaning the walls and ceilings do not form an airtight structure. However, in some pharmaceutical and research applications, the entire structure is sealed to prevent the escape of hazardous, noxious, biohazardous, or carcinogenic compounds.
What Are the Different ISO Cleanroom Classes?
Cleanrooms are classified by stringent requirements that define a cleanroom "rating". Depending on the number of particles per cubic meter of air, a cleanroom is assigned a rating between ISO Class 1 through ISO Class 9. In the US, cleanrooms are ordinarily rated between ISO Class 3 - ISO Class 8. The lower the cleanroom class, the cleaner the environment.
Uncontrolled environments may contain millions, if not billions, of particles per cubic meter. In comparison to a typical office environment, an ISO 8 cleanroom reduces airborne particulate by a factor of 10, thus each cubic meter of air sampled must contain fewer than 100,000 particles. For each jump in ISO class, air quality increases by an additional factor of 10.
What are the standard cleanroom classes defined by ISO cleanroom ratings?
- ISO Class 3
- ISO Class 4
- ISO Class 5
- ISO Class 6
- ISO Class 7
- ISO Class 8