In health care settings, cleanliness and avoiding contamination are very important. The presence of germs and other microorganisms will increase the risk of diseases and constitute a safety risk for patients if cleanliness is not strictly enforced.
Along with viruses, air pollution can also have an impact on a medical device’s performance by building upon its microscopic components. Cleanliness and hygiene are guaranteed when these products are made in a controlled environment (like a clean room).
Cleanrooms are important not just for the medical sector but for any industry where a little contamination or unsafe hygiene practices can ruin the whole product. More and more industries are investing in clean rooms now. That is why global cleanroom technology sales were USD 4.0 billion in 2020, and between 2021 and 2028, they are expected to increase at a CAGR of 5.4%.
The Function of Clean Rooms
A clean room is a space designed specifically to keep germs and airborne pollutants out. It is a particular area with specialized filtration that is typically found inside a production facility and is intended to get rid of airborne contaminants like dust, bacteria, and aerosol particles.
Manufacturers of pharmaceuticals, medical devices, and electronics regularly use clean rooms to create their goods. In addition to preserving cleanliness and preventing contamination, clean rooms control temperature, airflow, and humidity, all of which can affect the quality of finished goods. For such procedures, it is very important to be aware of and adhere to cleanroom ISO standards.
In order to allow air to enter or exit the room, clean rooms frequently lack windows and other entryways in addition to doors. The permitted number of particles, particle size, and HEPA-filtered air flow changes per hour that satisfy ISO-4, ISO-5, ISO-6, ISO-7, and ISO-8 requirements are described in ISO 4644-1 clean room standards.
It is based on measurements in cubic meters. The Fed Standard 209E in the US, based on measurements per cubic foot, is comparable to it. The equivalent classes under Fed Standard 209E are 10, 100, 1000, 10k, and 100k.
The required level of cleanliness depends on the type of medical device in question. For instance, Class III equipment requires more strict clean room particle control than Class I.
Manufacturers of medical devices use these sterile, regulated environments to construct and assemble their products, keeping them free of infection. By adopting clean rooms for both medical device assembly and production, it is ensured that contaminants and pathogens won’t compromise the functionality or security of medical equipment.
Relevant Clean Room Regulations for Medical Devices
The design, production, and labeling of medical devices are subject to stringent regulations that must be adhered to by companies that make them for the medical industry. Medical device manufacturers must keep their facilities clean throughout the manufacturing process, regardless of the type of equipment used or how the FDA has classified it.
To ensure patient safety, ISO controls cleanliness and contamination during the development and production of medical products. It places a particular emphasis on cleanliness during the assembly and packaging of medical equipment. The ISO has also laid out guidelines for occupational safety and pollution prevention. The company must recognize and document the working conditions, surrounding environment, and techniques for preventing contamination that compromises the device’s quality.
The entire sterilizing process is pointless if contamination occurs during the post-sterilization steps. Manufacturing and supplying organizations must establish requirements for the control of contamination with bacteria and particle substances in the workplace to maintain the necessary level of cleanliness throughout the assembly and packing operations after sterilization.
The Importance of Clean Rooms For Medical Devices
Controlling the atmosphere in a clean room can stop dust and other particulates from contaminating the components of medical equipment. There is a significant risk of potential microbiological contamination if disposable and non-disposable devices are not produced in a controlled environment.
The following are the main reasons why clean rooms are so important for the manufacture and assembly of medical devices:
Businesses that build clean rooms need to have certification from various authorities that they must abide by severe requirements and specific constraints. It will be feasible to guarantee hygienic conditions throughout the creation of every piece of medical equipment by developing and utilizing these regulated facilities.
Training of Staff
The design and implementation of clean rooms require employees who have the necessary professional qualifications. To preserve cleanliness throughout the development and installation procedures, medical manufacturing enterprises must hire clean room service providers with trained workers.
Businesses in the medical manufacturing sector require clean rooms to ensure the safe production, distribution, and use of various disposable and non-disposable medical equipment. These needs can be satisfied by a reputed medical device manufacturer that offers clean room production by using sterile spaces, following strict procedures, and ISO standards.
Cleanrooms are becoming more popular everywhere. The world market for these cabinets is split into five main areas: Latin America, Europe, Asia-Pacific, North America, Africa, and the Middle East. The biggest share of the market was in North America. North America has a big share of this market. This might be because the government in the area puts money into research.
With a cleanroom, you can start small and grow your business over time. If you decide to make a new cleanroom later, it’s easy to store the old ones. This type of cleanroom is ideal for healthcare applications that want to grow or simplify their operations.