In accordance with the ISO 14644 standards, ISO Class 7 cleanrooms represent a highly controlled environment that is engineered to maintain specific cleanliness values. The enclosed system encompasses ceiling-mounted fan filter units (FFUs) that generate a continuous supply of HEPA or ULPA-filtered air. In this article, we'll cover top-level considerations and standards for ISO 7 cleanroom design and construction. Additionally, we'll explore general principles for ISO 7 standards including particulate levels, ACH requirements, and equipment-based considerations among several unique applications.
Under ISO 14644-1, an ISO 6 cleanroom is a controlled environment that must maintain specific levels of air quality. Adherence to these limits is typically assessed using multi-channel particle counters, which measure the number of particles in the air at many different sampling points across the cleanroom.
The first consideration for ISO 5 cleanroom design is determining whether your application requires a positive or negative pressure design. The choice between positive and negative pressure cleanrooms is dictated by the broader goals of contamination prevention or containment. Each configuration serves distinct operational objectives.
ISO 5 rated cleanroom air is widely adopted as a minimum requirement for air quality when processing, packaging, or manufacturing products that are sensitive to microbes and ultra-fine particulates. In ISO 5 environments, airborne particulates are closely measured and monitored to ensure appropriate cleanliness for ISO 5 certification under ISO-14644-1.
Particulate and contamination arise from many different hosts including operators, clothing, processes, equipment, cleaning procedures, raw materials, and the introduction of outside air.
Subpar air quality detrimentally influences throughput, reproducibility, and shelf life across a multitude of life science applications, encompassing but not limited to in vitro fertilization, cell culturing, genomics, and proteomics.
Softwall cleanroom systems are an economical solution for controlling airborne particulates in addition to fume and aerosol management, ESD static control, or explosion-proof compliance. Designed with structural integrity in mind, Terra's frames accommodate multiple fan filter units without structural compromise. When integrated with mobile casters, these systems maximize versatility by permitting easy relocation.
Terra's prefabricated softwall cleanrooms are common for ISO 8 / ISO 7 cleanroom applications that moderate particulate control. Terra softwall rooms are rated for air quality classifications as low as ISO 6, however, efficiency trade-offs arise due to air leakage beneath the curtains. The trade off being, that any increase air leakage must be counteracted with additional make up air, which incurs additional operating costs to maintain positive pressure.
Terra provides five unique cleanroom construction solutions including pre-fabricated, stick-built, hybrid, modular, and custom-built. Each system has inherent benefits and advantages depending on the size, complexity, and cleanliness requirements of the build. Terra specialists will work with you to determine which system meets your needs for your specific budget, floor plan, cleanliness, or room-to-room requirements.
ISO 8 cleanroom design requires the understanding of several methodologies and procedures that evaluate airborne contamination levels including ISO 14644-1 to ISO 14644-8, ISO 14698-1, and ISO 14698-2.
Cleanroom garments are an essential component of any controlled environment, as they help to protect both the product and the individual wearing them from contamination. ISO-rated cleanroom garments are a specific type of protective clothing that meet the standards set forth by the International Organization for Standardization (ISO).
Laminar flow air and positive pressure cleanroom design are ideal for non-hazardous, ultra-clean applications. Positive pressure mitigates dirt from entering the cleanroom when opening doors or pass-through chambers. Laminar airflow design ensures that air maintains a singular, uniform direction and velocity from intake to exhaust port. Terra's positive pressure cleanrooms include HEPA filtration systems capable of ISO Class 3 - ISO Class 8 air quality conditions. ULPA filtration units are available for the most sensitive ISO 3 - ISO 5 product applications including pharmaceutical compounding, semiconductor wafer processing, sterile packaging, and micro-nanofabrication.
Most cleanroom professionals understand that Fan/Filter Units (FFUs) capture contaminants that degrade particle-sensitive samples. But they also remove bacteria, viruses and mold spores that contribute to a host of infections.
With the threat of superbugs on the rise in medical facilities, sterilization has never been more crucial. Superbugs, or drug-resistant bacteria that cannot be killed by standard antibiotics, have the potential to cause infections that are increasingly difficult to cure. The number of deaths related to these bacteria is decreasing. But the bugs, and the danger, remain present.
Until new cures are developed to battle bacteria, the solution to preventing the spread of germs is to update cleanliness procedures in hospitals, pharmaceutical manufacturing facilities and other places where drugs are regularly developed or used. Hand-washing can push back against the threat, but it’s important to implement protective measures against any potential breach,