IEST-RP-CC003 Garment System Considerations for Cleanrooms and Other Controlled Environments

The “IEST-RP-CC003 Clothing system considerations for clean rooms and other controlled environments” standard, developed by the Institute of Environmental Sciences and Technology (IEST), includes several sub-standards under the same title.

The recommended practice in these standards considers the clothing worn by personnel as an important aspect of cleanroom contamination control. The specification and use of an appropriate clothing system is essential to limit human contamination from reaching and affecting the product or processes in the cleanroom. These standards provide non-mandatory guidance for the selection, specification, maintenance and testing of clothing and accessories suitable for use in non-aseptic and aseptic cleanrooms and other controlled environments. This recommended practice includes an appendix to the Guide to Measuring Cleanroom Garments, which provides recommended garment measurement specifications.

These recommended practices do not specify design or performance requirements for garments or control limits for specific cleanroom applications such as food processing. They do not address personal protection or health and safety requirements for cleanroom garments and accessories. The limitations, applicability, precision and interpretation of data from recommended tests presented in the annexes to the standards should be considered (Annex B).

The practice recommended in the IEST-RP-CC003.3 standard , within the scope of the IEST-RP-CC003.5 standard, addresses the gowns worn by personnel as a critical aspect of cleanroom contamination control. Identifying and using an appropriate gowning system is essential to limit the access and impact of human-derived contamination on products or processes within the cleanroom.

This standard is intended to assist the end user, system designer, supplier, and processor in defining the performance criteria, test methods, and procedures required for the operation and maintenance of the clothing system and in developing a quality control plan for garments and accessories that may be incorporated into the system. This standard includes a section on the use of advanced tracking systems, such as bar codes and radio frequency identification (RFID) chips, to monitor garment service life. A section is also provided describing the types of fabrics and related properties of materials used in cleanroom garments and test methods, and the design and construction of suitable configurations and special features of such garments.

For the purposes of this standard, the following terms and definitions apply:

• An aseptic cleanroom is a cleanroom operated with stringent controls designed to minimize the presence of microorganisms.
• The body box is the test chamber used to measure the retention properties of the garment assembly.
• A cleanroom is a room in which the concentration of airborne particles is controlled through air filtration and airflow management and is constructed and operated in a manner designed to minimize the entry, formation and retention of particles in the room and other relevant parameters such as temperature, humidity and pressure are controlled.
• A contaminant is an unwanted substance found on a material or surface in a cleanroom.
• A controlled environment is an environment in which parameters such as temperature, pressure, humidity, and contaminant levels are controlled within specified limits.
• Jumpsuits are one-piece, full-length garments that usually cover the body from the neck to the wrists and ankles.
• A filament is a fiber or group of fibers long enough to be seen without magnification (usually 100 pm or longer).
• Materials are the non-fabric elements used in the construction or addition of cleanroom garments (e.g. snaps, belts, straps, fastenings, buckles, zippers and other closures)
• Cleanroom garments are specially designed pieces of clothing (e.g. coveralls, shoes, shoe covers, gloves and headgear) worn by cleanroom personnel to prevent or reduce the spread of contaminants that may be shed or released.

This standard describes the types of fabrics and their associated properties and test methods for materials used in cleanroom garments, as well as the design and construction of suitable configurations and special features of these garments.

Annexes to this standard include:

• Annex A Recommended garment system configurations applicable to various air purification environments: Garment system configurations are described for different air purification classes.
• Annex B Guide to measuring cleanroom garments: Provides recommended garment measurement specifications.
• Annex C Recommended requirements for clothing providing protection against short-term fire and arc flash hazards: Provides considerations for adapting flame-retardant clothing for use in cleanrooms or other controlled environments.
• Annex D provides test recommendations and methods that allow meaningful evaluation of the effectiveness of clothing system contamination control procedures.
• Appendix E References

The IEST-RP-CC003.4 standard addresses personnel aprons as a critical aspect of cleanroom contamination control. Specifying and using a suitable apron system is essential to preventing human-sourced contamination from reaching and affecting cleanroom products or processes. Designed for end users, system designers, suppliers, and processors, the document defines the performance criteria, test methods, and procedures required for apron system use and maintenance. It also includes guidelines for developing a quality control plan for garments and accessories that may be part of the system. It also includes guidelines for using advanced tracking systems, such as bar codes and radio frequency identification (RFID) chips, to track the service life of a garment.

The annex to this standard describes the Helmke drum test method, which is based on circular tests (Annex B). This method is used to measure particles dislodged by the application of mechanical energy under dry conditions as a means of simulating particle shedding from the surface of the garment during use. The garments under test are spun in a rotating drum to release particles from the fabric in a controlled manner, while a separate particle counter is used to sample the air inside the drum. The concentration of particles is counted by a particle counter. Due to the high variation in particle formation between individuals, the relative performance of garment systems can only be compared if the tester and test parameters are the same. However, the Helmke drum test method does not simulate actual wear conditions, and garments may not fall off uniformly due to stiffness, size or other factors.

The recommended practice in IEST-RP-CC003.5 is intended to assist the end user, system designer, supplier, and processor in defining the performance criteria, test methods, and procedures required for the operation and maintenance of a clothing system and in developing a quality control plan for garments and accessories that may be incorporated into the system. The standard includes a section on the use of advanced tracking systems, such as bar codes and radio frequency identification (RFID) chips, to monitor garment service life. A section is also provided describing the types of fabrics and related properties of materials used in cleanroom garments and test methods, and the design and construction of suitable configurations and special features of such garments.

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