Cleanrooms are controlled environments where the level of contamination is strictly monitored and controlled. These environments are commonly used in industries such as pharmaceuticals, electronics, and aerospace, where even small amounts of contamination can have significant consequences.
There are certain standards and regulations that apply to cleanrooms, such as ISO 14644 and GMP (Good Manufacturing Practice) guidelines. These standards and regulations set guidelines for the design, construction, operation, and maintenance of cleanrooms, as well as the testing and certification of cleanrooms.
In the United States, the FDA (Food and Drug Administration) is responsible for enforcing GMP regulations for the pharmaceutical and medical device industries. The FDA conducts inspections of cleanrooms and can take regulatory action if they find non-compliance with GMP guidelines. Similarly, the Federal Aviation Administration (FAA) regulates cleanrooms in the aerospace industry.
To ensure the integrity and effectiveness of products manufactured in cleanrooms, strict standards and regulations must be followed. In this article, we will discuss the various standards and regulations that apply to cleanrooms, with a focus on American cleanroom technology.
The ISO Standards
The International Organization for Standardization (ISO) has established a series of standards for cleanrooms, known as ISO 14644. The ISO 14644 standards provide the minimum criteria for a pharmaceutical-grade cleanroom, namely the number of airborne particles acceptable per volume of air, and are graded from ISO 1 to ISO 9, depending on the number of particles and their size.
ISO 1 allows only two particles larger than 0.2 microns per cubic meter. On the other hand, ISO 9 is the least restrictive level while still being substantially cleaner than conventional isolation rooms.
ISO 14644 also includes specifications for cleanroom design, such as requirements for airflows, temperature and humidity control, and guidelines for cleanroom garments and equipment, as well as procedures for cleanroom testing and monitoring. These standards are widely recognized and used internationally, and are considered the benchmark for cleanroom compliance.
In addition to the ISO 14644 standards, there are also other industry standards that apply specifically to cleanrooms and associated controlled environments. For example, ISO 14698 provides guidelines for the assessment and control of microbiological contamination in cleanrooms and associated controlled environments.
Industry standards specify the requirements for cleanroom design, construction, testing, and operation, and are widely recognized and used internationally.
The American Society of Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE) also has standards for cleanrooms, known as ASHRAE 170. These standards focus on the HVAC design and operation of cleanrooms, including requirements for airflows, temperature, and humidity control.
The global cleanroom technology market is predicted to grow at a compound annual growth rate of 5.3% over the course of 2018-2028, according to a study by Mordor Intelligence. The study also states that the market is significantly driven by North America.
A 14,270 square foot ISO Class 8 modular cleanroom was recently finished by US-based Brycon as part of a design-build project for the Hamilton Company, another US-based international corporation.
When it comes to cleanroom technology, there are a number of companies that specialize in the design and construction of cleanrooms that comply with the ISO Standards and industry standards. These companies use a variety of materials and technologies to create controlled environments that minimize contamination.
One such company is American Cleanroom Systems. They specialize in the design and construction of cleanrooms that comply with ISO Standards and industry standards while also offering cleanroom products, such as HEPA filters, laminar flow units, and pass-through chambers.
One of the most important components of American cleanroom technology is the use of HEPA filters. These filters are used to remove particles from the air, and are essential for maintaining the cleanliness of the environment.
In addition to HEPA filters, American cleanroom technology also includes the use of laminar airflow systems and positive pressure systems, which ensure that clean air is continually being supplied to the cleanroom and that contaminants are not able to enter the room.
Other important components of American cleanroom technology include the use of cleanroom garments, such as gloves, shoe covers, and face masks, to prevent the shedding of skin cells and other particles, as well as the use of cleanroom cleaning supplies and protocols to maintain the cleanliness of the environment.
Ensuring compliance with cleanroom standards and regulations is essential for maintaining the integrity and effectiveness of products manufactured in cleanrooms. The ISO Standards, as well as industry-specific standards, provide guidelines for cleanroom design, construction, and operation.
Advanced cleanroom technologies include the use of HEPA filters, laminar airflow systems, positive pressure systems, and cleanroom garments, an important aspect of ensuring compliance with these standards.
While North America has long been a dominant player in the cleanroom technology market, the Asia Pacific region is expected to see significant growth in the cleanroom technology market in the next few years, as reported by Expert Market Research. This is primarily driven by increased healthcare expenditures and heightened concerns post-COVID-19.