Controlled environments are essential for applications like research and manufacturing, where environmental factors like humidity, temperature and particle levels can impact safety or accuracy. Cleanrooms allow teams to control these elements and complete tasks in specific conditions.
The International Organization for Standardization (ISO) created cleanroom standards to ensure consistency, accuracy and process repeatability in industries such as pharmaceuticals, medical device manufacturing, biotech and life sciences. Here, you can learn more about ISO 8 cleanrooms, including standard specifics, common applications and different types.
ISO classifications indicate the allowable size and number of particles per volume of air over specific time frames. There are nine ISO classes. Class 1 has the most stringent requirements, and Class 9 has the least stringent requirements.
3,520,000 particles or less for 0.5 micrometers or larger.
832,000 particles or less for 1 micrometer or larger.
29,300 particles or less for sizes 5 micrometers and above.
ISO Class 8 Cleanroom Standards
Although ISO Class 8 cleanrooms have less strict requirements compared to other classes, teams completing tasks in these zones must adhere to specific standards and regulations for safety and accuracy. ISO 8 cleanroom requirements to note include:
Airflow: Unlike Classes 5 and higher, ISO 8 cleanrooms don’t require unidirectional airflow. These zones can operate with standard airflow systems, often making cleanroom implementation and management more affordable. ISO 8 cleanrooms can also be softwall or hardwall. Softwall rooms allow a single pass-through of air, making them more affordable but unable to support HVAC systems. Comparatively, higher classes require recirculating air, which is only achievable through hardwall usage.
Air changes per hour (ACH): ACH refers to the number of times indoor space air is replaced within one hour. This metric depicts the efficiency of a ventilation system and how “dirty” or “clean” a zone is relative to another environment. Higher ACH rates indicate efficiency at replacing and removing air, helping spaces maintain particle limits. ISO 8 cleanrooms must have at least 20 ACH to be sufficient. These requirements are much less than those for Classes 5 and higher but still demand a high degree of fresh air compared to residential or standard office environments.
Ceiling coverage: Ceiling coverage for ISO cleanrooms refers to the portion of the ceiling that must be equipped with filtration tools and systems to circulate clean air. ISO Class 8 cleanrooms have fewer ceiling coverage demands than higher classes. Generally, Class 8 cleanrooms should have ceiling coverage between 15% and 25% to meet standards.
Filtration: A final consideration for ISO 8 cleanrooms is filtration. Teams must use high-efficiency particulate air (HEPA) filters to trap particles. HEPA filters can trap particle sizes 0.3 micrometers or larger with high efficiency. However, teams must be aware of industry and application-specific requirements for filtration to determine whether certain HEPA filters are suitable.
Common Applications for an ISO 8 Cleanroom
The less demanding standards of ISO 8 cleanrooms make these environments suitable for less critical applications. Examples include:
Food processing
3D printing
Nutraceuticals repackaging
Aerospace composites manufacturing
Medical device subcomponents plastic injection molding
Mask manufacturing
Sterile packaging
Industrial product lamination
Precision manufacturing
Different Types of Class 8 Cleanrooms
When preparing to implement a cleanroom, it’s beneficial to consider the various types available. Unlike some higher classes, Class 8 cleanrooms offer three room types. These types include:
Modular cleanrooms: A modular cleanroom uses prefabricated roof decks, walls and HEPA filter units. The process to complete a modular cleanroom is generally simple, as teams assemble them on-site and cause few disruptions to your daily operations while completing installation. Reliable modular cleanroom providers like Starrco also offer customization options for elements like lighting, air filtration units, wall systems and flooring.
Softwall cleanrooms: Softwall cleanrooms are unique to ISO Class 8. These environments typically use aluminum or steel frames and clear vinyl curtains to create a cleanroom zone. In many cases, the cleanroom is installed on casters, allowing you to move the zone as necessary. These structures are generally best for teams with short-term cleanroom needs.
Stick-built cleanrooms: A traditional approach for construction cleanrooms, stick-built models involve on-site construction with individual components. You can tailor each component to meet unique needs, allowing you to adapt or expand as necessary. However, the on-site construction can disrupt your regular activities. Additionally, completion time is generally much longer for stick-built models than the other options, and the labor-intensive nature of these cleanrooms can raise project prices significantly.
Filtration and Gowning Considerations for ISO 8
Those using ISO 8 cleanrooms must follow filtration and gowning considerations to maintain the cleanliness and integrity of the environment. Primary considerations for filtration include:
Filters: ISO 8 cleanrooms generally require HEPA filters. However, specific requirements can vary depending on the industry and application.
Pressure: Positive pressure in cleanrooms prevents outside contaminants from entering the zone. ISO 8 cleanrooms should maintain a positive pressure relative to adjacent areas to meet this standard.
Monitoring and maintenance: Like every cleanroom, Class 8 requires regular testing and continuous monitoring. Teams must have accurate ways to measure and control particle levels and ensure filtration system efficiency.
Gowning refers to the process of wearing the proper attire and equipment to operate the cleanroom. Specific gowning considerations for Class 8 include:
Proper protocol: It’s crucial to implement proper gowning protocols before entering and operating in your cleanroom. Administer training to all cleanroom personnel and implement best practices with updates to reflect industry changes when necessary.
Materials: Material type and quality are important gowning considerations. Low-particulate, nonlinting materials are best for cleanroom operations. Synthetic fibers like polyester don’t shed, preventing the spread of contaminants. Additionally, cleanroom operators should inspect gowning materials for tears or defects before entering the zone.
Personal hygiene: Personal hygiene is crucial during pregowning processes and while using the cleanroom. Employees should wash their hands thoroughly before changing into cleanroom attire. Additionally, the use of sanitizers can minimize microbial contamination.
Exposed skin: Minimize microbial and particle contamination by minimizing exposed skin. Operators should wear latex gloves and similar coverings inside the cleanroom. If you notice a hold or other defect, remove and dispose of the attire and find a replacement.
Meet ISO 8 Standards With Starrco Modular Cleanrooms
At Starrco, you can find user-friendly modular cleanrooms to meet your industry and application demands. We manufacture precision-made modular systems to suit your budget and needs. Our expert team of engineers, manufacturers and designers makes it easy to implement a cleanroom with minimal disruptions to your regular activities.
Request a free quote today to discover how we can aid you in completing your project.
