Food & Cannabis
Scientists have developed a process to grow plants and produce them in a perfectly sterile environment without any exposure to outside air. The sterile environment removes the risks of viruses, dirt, chemicals, pesticides, insects, and bacteria contaminating or altering the plants, essentially meaning that it's unnecessary for the customers to even wash the food. The customer can also buy the produce knowing that it is completely contaminate-free. These cleanroom farms are known as plant factories, and every element of the plant's environment is controlled, from the temperature to lighting, humidity, water, and carbon dioxide level.
ICCAT is here to certify using ISO 14644, ISO 14698, and IEST Recommended Practices test methods to ensure compliance for a contamination free environment for the foods of the now and the future.
Medical Devices
Many medical devices are surgically placed in living bodies. For example, when manufacturing pacemakers, it is critical to manufacture them in a cleanroom that is routinely disinfected to eliminate harmful bacteria or pathogens to which a living body would be vulnerable. To ensure that good quality assurance practices are used for the design of medical devices and that they are consistent with quality system requirements worldwide, the Food and Drug Administration revised the Current Good Manufacturing Practice (CGMP) requirements by incorporating them into the Quality System Regulation, 21 CFR Part 820, and assurance that the Cleanroom in which the devices are manufactured meet the criteria for which they were designed in compliance with ISO 14644 and ISO 14698, Cleanrooms and associated controlled environments.
Pharmaceuticals
The cleanroom is an integral part of the manufacturing process required to produce sterile drug products, vaccines, and bio-medical devices. The industry is engaged in the discovery, development, manufacture, and marketing of prescription drugs. Certification is according to ISO 14644 and ISO 14698 Cleanrooms and Associated Controlled Environments of the Cleanroom and the Recommended Practice (RP), IEST-RP-CC006, testing methods for measuring the performance of the cleanroom for operational compliance.
Semiconductors
Almost all of today's technology involves the use of semiconductors, with the most important aspect being the integrated circuit (IC). To create an ideal semiconducting material, chemical purity, and cleanroom technology are paramount. Any small imperfection can have a drastic effect on how the semiconducting material behaves due to the scale at which the materials are used. Strict cleanroom cleaning protocols keep the cleanroom environment used for manufacturing semiconductors dust-free to limit contamination that could cause product failure. Some examples of devices that contain integrated circuits include laptops, scanners, cell phones, smart devices, etc. ISO 14644 Certification and Testing provides assurances the Cleanroom is operating within its design criteria standards.
Solar Panels
Today, renewed interest in environmentally sustainable energy supplies has drawn attention once again to solar power.
Solar cells are essentially semiconductors, conveying electrons from one place to another. As the industry continues to expand and costs continue to drop, just as the semiconductor industry has pushed for smaller and thinner geometries, so too will the solar industry. Cleanrooms are built to provide stricter environmental controls, and compliance is measured and certified to ISO 14644 Cleanrooms and Associated Controlled Environments and Recommended Practice (RP), IEST-RP-CC006, covers testing methods for measuring the performance of cleanrooms and clean zones. The tests are used to evaluate and characterize the overall performance of the cleanroom or clean zone system.
With the thinner wafers, processes, contamination control strategies, and environmental controls to get stricter. The cleanroom environment is less forgiving of contamination. Any mistake can affect yield.
When it comes to contamination, ACM is here to ensure controls and methods are in place for maximum yields.
Aerospace
The aerospace industry relies on the cleanroom environment and its state-of-the-art enhancements to perform experiments as well as create items like space-flight lasers, the space shuttle, satellites, missiles and space exploration vehicles. Creating aerospace tools requires controlled environments so that no contaminants or pollutants can compromise the tools used in the manufacturing process or the product itself. In the case of space-flight lasers, absolute accuracy is essential. Some of these lasers are used to charge the batteries of aerial vehicles. Other aerospace lasers have been designed with an eye toward ablation; that is, the laser is used to vaporize space debris in the Earth's orbit. ISO 14644 Cleanrooms and Associated Controlled Environments and Recommended Practice (RP) IEST-RP-CC006 are used as guidelines and standards for measuring particulates in the environment and providing assurances that the cleanroom is in compliance for which it was designed.
Automotive
Painting automobiles is usually performed in a dust-free clean zone to limit any paint buggers. ISO 14644 Standards provide guidance for the level of the cleanroom and clean zones. ICCAT certifies that these standards are in compliance. ISO was formed from the US Federal Standard 209E Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones. The need for a single standard, used worldwide, for cleanroom classification and testing was long felt. After ANSI and IEST petitioned to ISO for new standards, the first document of ISO 14644 was published in 1999, ISO 14644-1.
Vaccines
Vaccines such as the flu shot or meningitis are manufactured in GMP-controlled cleanrooms and continuously validated following ISO 14644 and ISO 14698 Cleanrooms and Associated Controlled Environments. Standards were first formed from the US Federal Standard 209E Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones. The need for a single standard for cleanroom classification and testing was long felt. After ANSI and IEST petitioned ISO for new standards, the first document of ISO 14644 was published in 1999, ISO 14644-1. A contaminated vaccine voids the effectiveness of the vaccine intent, and the batch is destroyed.
Pharmacy
Pharmacies in hospitals, industry and labs are regulated by the USP 797 issued by the United States Pharmacopeia to ensure the safety of the compounded product is consistent in strength, quality, purity and consistency, and free of unwanted contamination. USP 797 includes the procedures and environmental regulations for compounding sterile preparations (CSP) for protection of the consumer. Recently USP 800 was included for the protection of the personnel compounding the CSP.
