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       Cleanrooms belong to a group of special areas with special requirements for infrastructure, environmental monitoring, staff competence and hygiene.Author: Dr. Patricia Sitek, owner of CRK
       The increase in the share of controlled environments in all sectors of the industry creates new challenges for production personnel and therefore requires management to implement new standards.
        Various data show that more than 80% of microbial incidents and dust cleanliness exceedances are caused by the presence and activities of personnel in the cleanroom. In fact, ingestion, replacement and handling of source materials and devices can result in the release of large amounts of particles, which can lead to the transfer of biological agents from the surface of the skin and materials into the environment. In addition, equipment such as tools, cleaning products and packaging materials have a great influence on the functioning of the cleanroom.
       Since people are the largest source of contamination in a cleanroom, it is important to ask how to effectively reduce the spread of living and non-living particles in order to meet the requirements of ISO 14644 when moving people into cleanrooms.
       The use of special clothing prevents the spread of particles and microbial agents from the surface of the worker’s body into the surrounding production area.
        The most important factor in preventing the spread of contamination in a cleanroom is the choice of cleanroom clothing that meets the cleanliness class. In this publication, we will focus on reusable clothing conforming to ISO 8/D and ISO 7/C classes, describing the requirements for materials, surface breathability and special design.
       However, before we look at the cleanroom clothing requirements, we will briefly discuss the basic requirements for ISO8/D and ISO7/C cleanroom class personnel.
        First, in order to effectively prevent contaminants from entering the clean room, a detailed SOP (standard operating procedure) should be developed and implemented in each clean room, describing the basic principles of cleanroom operation in the organization. Such procedures should be written, implemented, understood and followed in the user’s native language. Equally important in preparation for work is the appropriate training of persons responsible for performing operations in the controlled area, as well as the requirement to conduct appropriate medical examinations, taking into account the hazards identified at the workplace. Random checks on the cleanliness of employees’ hands, testing for infectious diseases, and even regular dental check-ups are just a few of the “pleasures” that await those who are just starting to work in cleanrooms.
        The process of entry into the cleanroom takes place through the vestibule, which is designed and equipped in such a way as to prevent cross-contamination, especially in the way of the incoming person. Depending on the type of production, we classify locks or add aerodynamic locks to clean rooms according to increasing cleanliness classes.
        Although the ISO 14644 standard imposes rather lenient requirements for ISO 8 and ISO 7 cleanliness classes, the level of pollution control is still high. This is because control limits for particulate matter and microbiological contaminants are very high and it is easy to give the impression that we are always in control of contamination. That’s why choosing the right clothing for work is such an important part of your pollution control plan, meeting expectations not only in terms of comfort, but also in terms of construction, material properties and breathability.
        The use of special clothing prevents the spread of particles and microbial agents from the body surfaces of workers into the surrounding production areas. The most common material used to make cleanroom clothing is polyester. This is due to the fact that the material has a high dust resistance and at the same time is completely breathable. It is important to note that polyester is a recognized material for the highest ISO cleanliness class in accordance with the requirements of the Fraunhofer Institute CSM (Cleanroom Suitable Materials) protocol.
        Carbon fiber is used as an additive in polyester cleanroom clothing to provide additional antistatic properties. They are usually used in amounts not exceeding 1% of the total mass of the material.
       It is interesting that the choice of clothing color according to the cleanliness class, although it may not have a direct impact on pollution monitoring, allows maintaining labor discipline and monitoring the activities of workers in the cleanroom area.
       According to ISO 14644-5:2016, cleanroom clothing must not only trap particles from the worker’s body, but just as importantly, be breathable, comfortable and unbreakable.
       ISO 14644 Part 5 (Annex B) provides precise recommendations on function, selection, material properties, fit and finish, thermal comfort, washing and drying processes, and garment storage requirements.
       In this publication, we will introduce you to the most common types of cleanroom clothing that meet the requirements of ISO 14644-5.
        It is important that ISO 8 class clothing (commonly referred to as “pyjamas”), such as a suit or robe, be made from polyester with carbon fiber added. Headgear used to protect the head may be disposable, but often reduces its functionality due to susceptibility to mechanical damage. Then you should think about reusable covers.
        An integral part of clothing is footwear, which, like clothing, must be made of materials that are mechanically resistant and resistant to the release of pollutants. This is usually rubber or a similar material that meets the requirements of ISO 14644.
       Regardless, if the risk analysis indicates that protective gloves are worn at the end of the shift procedure to minimize the spread of contaminants from the worker’s body to the production area.
       After use, reusable clothing is sent to a clean laundry where it is washed and dried under ISO class 5 conditions.
       Post-sterilization of clothing is not required due to ISO 8 and ISO 7 classes – clothing is packaged and sent to the user as soon as it is dry.
       Disposable clothing is not washed and dried, so it must be disposed of and the organization must have a waste policy.
        Reusable garments can be used for 1-5 days, depending on what has been established in the contamination control plan after risk analysis. It is important to remember that the maximum time that clothing can be safely used should not be exceeded, especially in production areas where microbiological contamination control is required.
        The right choice of clothing rated ISO 8 and ISO 7 can effectively block the transmission of mechanical and microbiological contaminants. However, for this it is necessary to carry out a risk analysis of the production area, develop a pollution control plan and implement the system through appropriate training of employees, referring to the requirements of ISO 14644.
       Even the best materials and the best technologies will not be fully effective unless the organization has in place internal and external training systems to ensure the proper level of awareness and accountability for adhering to pollution control plans.
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