General5 Industries That Use ISO-8 Cleanrooms

The use of ISO-8 cleanrooms has become increasingly common in industries like pharmaceuticals, microelectronics, aerospace, and medical devices. They’re also used for research and development in biotechnology and nanotechnology. Whether you’re a manufacturer or a research scientist, here’s what you need to know about ISO-8 cleanrooms:

What Are ISO-8 Cleanrooms and How to Create Them?

ISO-8 is a standard for cleanroom environments, which is used to ensure that particles do not contaminate products and equipment. In other words, it’s how clean the air inside an ISO-8 cleanroom is. The ISO 8 class cleanrooms must maintain 5-60 air changes every hour with a 5-15% ceiling coverage. Additionally, they should provide a maximum cleanliness level of 100,000 particles (≥0.5 um) per cubic foot.

Creating an ISO 8 cleanroom requires careful planning and the use of specific equipment to achieve the desired air cleanliness. ISO 8 is one of the lower cleanroom classifications, with particular requirements for particle count per cubic meter.

Hence, a particle counter is one of the most critical components of an ISO 8 cleanroom. A cleanroom particle counter is a crucial instrument used in cleanrooms and controlled environments to monitor and measure the level of airborne particles. These particles can include dust, microorganisms, pollutants, and other contaminants that might affect the cleanliness of the air within the controlled space.

According to American Cleanroom Systems, particle counters pass a fixed amount of air through a laser chamber. This chamber counts the total number and size of the particles in the air sample. Hence, as the size of the air sample increase, so does the accuracy of the results. Thus, they play a vital role in ensuring the ISO 8 cleanroom maintains its specified cleanliness class.

5 Industries That Commonly Use ISO-8 Cleanrooms

Now that you know what ISO-8 cleanrooms are and how to create them, here are some industries that use them.

Pharmaceutical Manufacturing and Packaging

Pharmaceutical manufacturing and packaging are among the most common uses for ISO-8 cleanrooms. The pharmaceutical packaging market is growing at a CAGR of 6.2%. With this growing market, the need and demand for ISO-8 cleanrooms are also increasing.

The products in these facilities are often life-saving, so they must be manufactured with no contaminants present. Contaminants can harm human health and product quality, so they must be removed as much as possible.

Cleanrooms also help keep out dust particles and other airborne particles during packaging. This helps prevent damage to delicate pills or tablets when sealed in bottles or other containers.

Aerospace Manufacturing and Testing

ISO 8 cleanrooms play a critical role in the aerospace industry for various manufacturing and assembly processes. These cleanrooms adhere to the ISO 14644-1 standard, which specifies the maximum allowable particle count in the air to maintain a controlled environment. Here’s how ISO 8 cleanrooms are used in the aerospace industry:

• Component manufacturing: Aerospace components, such as critical engine parts, avionics, and electronic components, require a contamination-free environment during production. ISO 8 cleanrooms ensure that these parts are fabricated and machined without contaminants affecting their performance or reliability.
• Precision assembly: Cleanrooms are used for the precision assembly of aerospace systems and equipment. Sensitive devices like satellites, communication systems, and aircraft avionics demand a controlled environment to prevent damage and ensure optimal performance.
• Satellite integration: Satellites are assembled in cleanroom environments to safeguard them from contamination, which could cause malfunctions or degrade sensitive instruments in space. ISO 8 cleanrooms provide the necessary environment for assembling and integrating satellite components.
• Testing and calibration: Testing and calibration of aerospace equipment and instruments must be done in contamination-controlled environments to ensure accurate and reliable results. ISO 8 cleanrooms provide a suitable setting for conducting various tests and calibrations.
• Spacecraft and aircraft assembly: In aerospace, where precision and reliability are paramount, ISO 8 cleanrooms are used for the final assembly of spacecraft and aircraft. This ensures the assembled vehicles meet stringent quality standards and perform flawlessly in their intended environments.
• Research and development: Aerospace companies often use cleanrooms for research and development purposes, especially when developing new materials, technologies, or cutting-edge aerospace systems. Cleanrooms help researchers maintain a controlled environment to study the effects of specific variables without interference from contaminants.
• Contamination control: Cleanrooms are essential for contamination control during aircraft and aerospace equipment maintenance, repair, and overhaul (MRO) activities. When servicing critical components, working in a controlled environment is vital to avoid any adverse effects on the equipment’s performance.

Medical Device Manufacturing

Medical device manufacturing is one of the largest industries in the world. They produce devices used in hospitals and other care facilities, at home, in research labs, by the military, and even in space. Medical devices include everything from pacemakers to surgical instruments to diagnostic equipment such as X-rays machines.

Medical device companies often need to use ISO 8 cleanrooms to test their products before production. This ensures that every product is designed with safety as its priority. This helps ensure abiding by all safety regulations imposed on medical manufacturing companies.

Without ISO 8 cleanrooms, medical devices can get contaminated, resulting in malfunction, which can be fatal. For instance, if a medical device created to monitor vital starts malfunctioning, it can give wrong readings. This can delay the treatment or raise false alarms, which can be hazardous.

Biotechnology Research and Development

ISO 8 cleanrooms play a critical role in this industry by providing controlled environments that minimize contamination and ensure the integrity of sensitive processes. They offer a controlled atmosphere with low particulate matter, microbes, and other contaminants.

One of the primary applications of ISO 8 cleanrooms in biotechnology R&D is cell culture work. Cell cultures are essential for various biotechnological processes, including cell-based assays, tissue engineering, and the production of therapeutic proteins. Maintaining a sterile environment in the cleanroom helps ensure that the cell lines remain uncontaminated and their genetic integrity is preserved. This controlled setting also facilitates reproducibility and consistency in experimental results, which is crucial for developing new biotechnological products and therapies.

Another vital area where ISO 8 cleanrooms find extensive use is in the production of biopharmaceuticals. Biopharmaceuticals are drugs derived from biological sources such as proteins, antibodies, and nucleic acids. During their manufacturing, any contamination can compromise product purity and efficacy. ISO 8 cleanrooms help minimize the risk of particulate and microbial contamination, ensuring the production of safe and high-quality biopharmaceuticals.

Furthermore, gene editing and gene therapy are rapidly advancing fields in biotechnology R&D. These techniques involve precise manipulation of genetic material and even minute levels of contamination can lead to unintended outcomes. ISO 8 cleanrooms provide an environment where researchers can confidently handle genetic material, reducing the chances of introducing foreign DNA and cross-contamination.

Nanotechnology Production

Nanotechnology is the science of working with materials and devices at the atomic, molecular, and supramolecular levels. It has uses in many fields, including medicine, manufacturing, and energy production. Nanomaterials are used in products we use daily, such as clothing, paints, food containers, or packaging materials like plastic drink bottles.

In nanotechnology production, ISO 8 cleanrooms are utilized for various processes, such as nanomaterial synthesis, nanodevice fabrication, and nanoparticle assembly. Researchers or engineers create nanoparticles or nanostructured materials during nanomaterial synthesis using chemical vapor deposition, sol-gel synthesis, or nanoparticle precipitation.

These processes are highly sensitive to external impurities, and even minute amounts of contamination can alter the properties of the resulting nanomaterials. Contamination can lead to wasting time and materials, as contaminated products cannot be used efficiently.

ISO 8 cleanrooms help prevent such contamination, ensuring the consistency and reproducibility of the nanomaterials. ISO 8 cleanrooms can help work with such nanoparticles. This is because they work with atomic-sized impurities. The HEPA filtration system inside the clean room traps particles of sizes more than 0.3 μm and helps eliminate contaminants.

Conclusion

With so many different industries using ISO-8 cleanrooms, it’s easy to see why they are so popular. For example, nanotechnology production is a very new area of research that could have enormous implications for our world in the future. As you can see from this article, many different types of cleanrooms are available today. They all have their unique benefits depending on what kind of industry needs them most urgently.