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.
For ISO Class 6 cleanroom certification, particle counts must maintain the following particulate counts for each per cubic meter of air:
According to industry standards, the air change rate (ACH) for ISO 6 cleanrooms generally ranges between 150-240 air changes per hour. Frequent air changes ensure rapid dilution and removal of airborne particles, thus minimizing the likelihood of contamination. It is pertinent to note that the optimal ACH rate is contingent upon several factors including room size, environmental conditions, and operational processes.
ISO 6 ACH requirements are not specifically described in ISO 14644 guidelines. However, the chart below describes the typical air change rate specified by the respective cleanroom class.
|FS209E Class||ISO Class Equivalent||Suggested ACR|
The application spectrum of ISO 6 Cleanrooms is diverse, encompassing sectors such as pharmaceuticals, biotechnology, and semiconductor manufacturing.
ISO 6 cleanrooms support several unique manufacturing sectors including semiconductors, biopharmaceuticals, aerospace, and other processes that require low particulate environments for testing and calibration of precision equipment. Generally, ISO 6 cleanrooms are specified for operations that demand low levels of particulate but do not necessarily require sterile outcomes.
Hardwall cleanrooms can maintain pressure differentials, which may be required to meet certain standards for cleanliness (ISO 5 or 6). Hardwall construction also allows temperature and humidity control, which is enhanced in a recirculating clean room design using vertical air returns in conjunction with A/C units.
In the semiconductor industry, ISO 6 Cleanrooms are often utilized for tasks like photolithography and wafer processing. Given that even sub-micron particles can create defects in semiconductor wafers, the specific allowable particle counts for ISO 6 cleanrooms offer a controlled environment conducive to lower defect and failure rates. These conditions contribute to increased yield and product quality for crucial components that are integrated into a broad array of electronics.
In addition to particulate contamination, semiconductor components are highly susceptible to trace amounts of moisture. These environments typically need to maintain anywhere from 20 - 35% humidity, with respect to their ideal ambient operating temperature. As temperature increases, air can hold a greater amount of water vapor, leading to a decrease in relative humidity (assuming no change in absolute humidity). Conversely, a reduction in temperature diminishes the capacity of air to hold moisture, thus resulting in a relative increase in humidity levels. Maintaining precise temperate controls with heating and cooling systems helps to alleviate the associated impacts of climatic drift.
Terra's Insulated Hardwall Cleanrooms use double-wall insulated panels that lend themselves to temperature set points with remarkably tight tolerances. This design flexibility enables more efficient and reliable control over ambient conditions, reduces heating/cooling expenditures, and stabilizes humidity and temperature for critical processes. Notably, the system is conducive for applications requiring stringent environmental control, including long-term sample storage and high-volume process equipment.
For ANSI/ESD S20.20 compliance, Terra offers static-dissipative PVC cleanroom panels for protection against electrostatic discharge. For additional measures, Terra also offers ceiling-mount ionizing bars that neutralize charges on workstations. These systems are beneficial for eliminating surface charge build-ups, preventing discharge events, and reducing “static cling” that tends to attract airborne particles.
Terra's Modular Hardwall Cleanrooms are configurable for ISO 6 / Class 1000 ratings in many different multi-suite layouts.
Pictured below, this free-standing modular cleanroom is designed to reach ISO-6, class 1,000 classification for a data server center, and features raised flooring with wide, double-swing opaque polypropylene doors.
In the biopharmaceutical sector, ISO 6 Cleanrooms are predominantly used for the formulation and filling of non-sterile, yet highly sensitive biological products. Tasks may include the handling and packaging of protein-based therapies and monoclonal antibodies. Here, contamination control is critical not necessarily for sterility but to prevent any particulate or molecular-level contamination that could compromise the therapeutic efficacy of these complex molecules.
As shown above, BioSafe® Hardwall Modular Cleanrooms are suitable for hazardous and non-hazardous compounding pharmacy purposes. This room is customized with a class 1,000/ISO 6 positive-pressure room and a class 100/ISO 5 negative-pressure room, all with class C FRP wall panels.
BioSafe Modular Hybrid Cleanrooms provide a turnkey solution for achieving ISO 6-level controlled environments. With adherence to multiple compliance standards including ISO-14644, cGMP, GLP, ASTM, and IEST, the design flexibility of this system is notable, unhindered by variables such as overhead clearance or existing infrastructure at the installation site. Utilizing prefabricated, pre-engineered components expedites the time-to-completion metric significantly. Material selection is tailored to the specifics of cleanroom applications, encompassing epoxy-coated uPVC and painted polyester wall panels.
Terra's BioSafe® cleanroom systems are available in several materials including stainless steel, FRP/CPVC, and uPVC. BioSafe cleanrooms are designed to be moisture and humidity-resistant, ensuring an airtight seal that precludes the ingress of contaminants. Utility connections are seamlessly integrated into the design, offering end-users a streamlined approach to service integration, including compressed gas and vacuum lines. The integrity of the airtight system is further safeguarded by FDA-grade sealants that fill any interstitial spaces, thereby eliminating microbial colonization points.
Structural robustness is guaranteed by the use of GMP-rated materials that are resistant to scratches, corrosion, and cleaning agents like Spor-Klenz, quaternary, and phenolic cleaners. It is noteworthy that UV-sensitive materials, particularly painted steel components, must maintain a minimum 20-inch distance from UV light sources to prevent degradation.
ISO 6 cleanrooms are common environments for the production, testing, and calibration of precise lasers, lenses, or optical devices. Generally, these facilities require a cascade of partitioned rooms that may range from ISO 4 up to ISO 8.
Pictured above, is a three-room cleanroom suite designed by Terra Universal for an optical assembly operation.
For calibration labs and testing facilities, ISO 6 Cleanrooms provide an environment where precision equipment can be evaluated and calibrated under stable and contaminant-free conditions. This is particularly pertinent for instruments that have extremely fine tolerances and are sensitive to environmental fluctuations, such as mass spectrometers or laser interferometers. In these settings, an ISO 6 Cleanroom ensures that readings are neither skewed nor compromised by ambient particulate matter.
Pictured above, Terra Universal designed this hardwall cleanroom with an anteroom to reach class 1,000/ISO 6 clean air standards, thus allowing the reliable operation of precision subatomic particle detection instruments.
The aerospace industry employs ISO 6 Cleanrooms for the fabrication and assembly of components like navigation systems, sensors, and specialized coatings for aircraft and spacecraft. Contaminant-free conditions improve the short-term and long-term reliability and functionality of these components, given the harsh and unforgiving environments in which they must operate. In this sector, adherence to ISO 6 standards ensures that production standards maintain industry-specific and facility-specific benchmarks contributing to mission success.
In these environments, Terra's BioSafe® cleanroom wall and panel systems are designed to be moisture and humidity-resistant, ensuring an airtight seal that precludes the ingress of contaminants. Utility connections are seamlessly integrated into the design, offering end-users a streamlined approach to service integration, including compressed gas and vacuum lines. The integrity of the airtight system is further safeguarded by FDA-grade sealants that fill any interstitial spaces, thereby eliminating microbial colonization points.
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