Clothing and hygiene of cleanroom personnel of ISO 8 and ISO 7 classes

Published: 3-Jan-2023

Cleanrooms belong to an exclusive group of areas with special requirements regarding infrastructure, environmental monitoring and staff competence and hygiene. Words by Patrycja Sitek, PhD, CRK owner

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The increasing proportion of controlled environments in various areas of industry, is a source of new challenges for production staff and thus expectations on management to implement new standards.

Various data indicate that more than 80% of all microbiological incidents and dust cleanliness exceedances are generated by the presence and activities of personnel in clean rooms. In fact, the process of entry, changing, handling of starting materials and equipment generate the release of large quantities of particles and, consequently, the transfer of biological agents from the skin surface and materials to the environment. Also, equipment such as tools, cleaning agents and packaging materials have a significant impact on clean room functioning.

Since personnel are the largest source of contamination in the cleanroom, it is important to ask how the transmission of animate and inanimate particles can be effectively reduced so that the requirements of ISO 14644 can be met in the personnel transfer process to the cleanroom area.

The use of specialised clothing prevents the dispersal of particles and microbiological agents from the surface of the worker's body into the surrounding production area

The most important element in preventing the transmission of contaminants in cleanrooms is the selection, appropriate to the cleanliness class, of dust-free clothing. In this publication, we will focus on reusable garments up to ISO 8/D and ISO 7/C classes, indicating the requirements for materials, surface breathability, specific design.

However, before we look at the requirements for cleanroom clothing we will briefly discuss the basic requirements for ISO8/D and ISO7/C cleanroom class personnel.

Basic requirements for Pollution Control and Cleanroom Clothing

Firstly - in order to effectively prevent the transmission of contaminants into cleanrooms, detailed SOPs (Standard Operating Procedures) describing the basic principles of cleanroom operation in an organisation should be developed and implemented in every cleanroom. Such procedures should be written in the native language, implemented, understood and followed by the users. Equally important in preparing for work is adequate training for personnel responsible for the operation of the controlled area, as well as requirements for the provision of medical examinations appropriate to the hazards identified in the workplace. The possibility of random checks on the cleanliness of staff's hands, tests for the carrying of infectious diseases or even periodic dental check-ups are just some of the 'pleasures' awaiting those starting out in the cleanroom. 

The basic requirements for maintaining good clean preparation hygiene include:

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