From Microchips to Medical Devices: The Role of Cleanrooms in High-Tech Manufacturing

Cleanrooms play a vital role in manufacturing high-tech products such as microchips and medical devices. These specialized environments are designed to maintain a controlled level of cleanliness, temperature, humidity, and air pressure to prevent the introduction of contaminants. These contaminants could compromise the quality and reliability of the products being produced.

From manufacturing microchips to medical devices, the advantage of a cleanroom is limitless. It is the reason why cleanroom technology use is becoming common each day. 

The cleanroom technology market in North America, as valued by Business Market Insights in 2021, was approximately $1867 million, and they expect it to reach $3024 million by 2028. Hence, you may see cleanroom usage becoming common in almost every industry in the coming years.

How Cleanrooms Help Protect the Environment?

Cleanrooms are controlled environments designed to minimize the introduction, generation, and retention of airborne particles and microorganisms. These spaces are critical for many industries, including electronics, pharmaceuticals, and biotechnology, where even tiny particles can contaminate products and compromise safety. However, cleanrooms also play an essential role in protecting the environment.

One way cleanrooms help protect the environment is by preventing the release of harmful particles and chemicals into the air. For example, in semiconductor manufacturing and pharmaceutical production industries, there is a high risk of generating airborne contaminants that could harm the surrounding environment.

Another way a cleanroom protects the environment is by reducing waste disposal costs. According to the EPA, in 2018, each day, about 292 million tons of waste was generated in the US alone. A cleanroom can help to minimize waste disposal costs by reducing the number of waste bins, trips to the dumpster, and time spent on waste disposal.

Cleanrooms use specialized ventilation systems, air filters, and other equipment to ensure that any contaminants generated within the room are captured and disposed of safely. In addition, it helps prevent their release into the environment.

1. Designing, Testing, and Engineering

During the design phase, engineers create detailed blueprints and schematics that specify the components and materials used in the final product. Once the design is complete, prototypes are created and tested in cleanrooms to verify that they meet the required performance specifications. Testing may involve exposing the product to various stressors or subjecting it to rigorous quality assurance processes.

Cleanrooms are also essential during the engineering phase, as engineers must develop processes that can be performed under strictly controlled environmental conditions. It may involve designing specialized equipment or developing unique procedures for handling and assembling components.

Cleanrooms are designed to allow a given number and size of particles in the air, typically measured per cubic meter. However, the most commonly used system is developed by the Federal Standard 209E. It defines cleanrooms based on the number of particles that are 0.5 microns or greater in size, measured in µg/m3. The cleanrooms are classified from Class 1 to 9, with Class 1 considered the cleanest and Class 9 the least clean.

While Class 1 cleanrooms should not have particles of 0.5 microns or larger per cubic meter of air, Class 9 cleanrooms can contain 352 million particles µg/m3, as per News Medical Life Sciences. However, it should be noted that the cleanroom classification system is not rigid, and various other systems and standards, such as ISO 14644-1, are utilized globally.

In short, cleanrooms are essential for the design, testing, and engineering of high-tech products, ensuring that they meet the strict standards required for their respective industries.

2. Manufacturing, Assembly, Packaging, and Shipping

Cleanrooms are essential in these stages to prevent contaminants that could compromise the product’s integrity. Components are processed and fabricated in a cleanroom environment in the manufacturing phase to ensure they meet the required specifications. This process requires specialized equipment, including deposition, etching, and lithography.

The assembly phase involves careful handling and assembly of components in a cleanroom environment to prevent damage or contamination. Depending on the product’s complexity and precision requirements, this stage may be performed using automated equipment or human operators.

After assembly, the product is packaged in a cleanroom environment using sterile bags, specialized containers, or cleanroom-grade packaging materials to ensure it remains free of contaminants.

3. Testing and Inspection

In many cases, testing and inspection take place in a cleanroom environment to prevent contaminants from interfering with the accuracy of the results.

During testing, various methods are employed to evaluate the product’s performance and functionality, including stress, performance, and environmental tests. These tests are designed to ensure that the product can withstand various conditions and operate as intended.

After testing, the product undergoes inspection, where every aspect of the product is carefully examined to identify any potential defects or non-conformities. This process may involve visual, automated, or specialized equipment inspections.

4. Training and Education

Cleanrooms require specialized knowledge and skills. In addition, the operators must follow strict protocols to ensure that the products manufactured within them meet the required quality and performance standards.

Training for cleanroom operators typically includes instruction on the correct use of cleanroom equipment, techniques for avoiding contamination, and protocols for entering and exiting the cleanroom environment. Cleanroom training also includes education on the hazards of different contaminants and their potential impact on product quality.

To maintain the highest cleanliness and quality standards in a cleanroom environment, all personnel must understand and follow the established protocols and procedures.

5. Quality Control and Assurance (QA/QC)

QA/QC is a process that involves monitoring and controlling the quality of the product at every stage of production to ensure that it meets the required standards.

QA/QC personnel work to maintain the cleanliness and sterility of the production environment. It ensures that contaminants are eliminated and the final product meets the required specifications. They perform regular inspections, use specialized equipment to measure particulate levels and test for potential contaminants, and maintain detailed records of every step in the production process.

QA/QC personnel also work with design and engineering teams to establish quality standards and protocols that guide the production process. In addition, they develop and implement quality control plans and procedures to ensure that the product is consistent, reliable, and meets the end-users expectations.

6. Sterilization

In a cleanroom environment, sterilization is typically achieved using various methods, such as gamma radiation, ethylene oxide gas, and vaporized hydrogen peroxide (VHP). These methods effectively sterilize surfaces and equipment without introducing harmful contaminants that could interfere with the final product’s quality.

In addition to equipment sterilization, personnel working in cleanrooms must follow strict hygiene and cleanliness protocols. It includes using personal protective equipment, such as gloves and gowns, and regular hand washing to minimize the risk of contaminating the production environment.

To Wrap It Up

These specialized facilities are designed to control and minimize contamination, ensuring the quality and reliability of the end products.

Cleanroom technology continues to evolve and advance to meet the growing demands of the high-tech manufacturing industry. As technology advances, cleanrooms will remain an essential component of the manufacturing process, enabling the production of innovative products that improve our lives and advance society.