The requirements for gloves in a cleanroom centre around cleanliness, protection, suitability and compliance to avoid contamination of the production environment or product, as follows:
- Cleanliness requirements:
◦ The gloves must meet the corresponding cleanliness levels (e.g. Class 100, Class 1000, etc.), with no visible dust particles, fibres or contaminants on the glove surfaces, and they must be tested for particle release and microbial content.
◦ Production and handling process should be carried out in a clean environment to avoid secondary pollution.
- Material and performance requirements:
◦ The material needs to be inert and not easy to shed particles, common such as nitrile, latex (need to confirm that there is no allergy risk), PVC (specific scenarios), etc., to avoid the use of easy to fall off, easy to aging materials.
◦ Good tensile strength, abrasion resistance and tear resistance to prevent breakage in use leading to contamination; also need to be resistant to chemicals (e.g. detergents, solvents, etc.) that may come into contact with in the workshop.
◦ Powder-free or use compliant clean-grade powders (e.g. corn starch) to reduce contamination from powder shedding; powder-free gloves are required for some high-clean requirement scenarios.
- Applicable and use specifications:
◦ The size of the gloves should fit the hand, avoiding too loose or too tight, which may lead to operation inconvenience or gloves slipping off or breaking.
◦ Wear and replace according to cleanroom procedures, e.g. sterilisation before entry, regular replacement (depending on length of operation and risk of contamination), avoiding reuse (disposable gloves) or reuse after strict sterilisation (reusable type).
◦ Prohibit contact with non-clean area items and dispose of them after use according to regulations to prevent cross contamination.
- Compliance Requirements:
◦ Need to comply with industry or regional cleanliness standards (e.g., ISO 14644, FDA related specifications, etc.), as well as specific requirements for product production (e.g., specialised standards for the pharmaceutical and electronics industries).
Post time: Sep-04-2025