What is cleanroom consumables sterilization?
Cleanroom consumable sterilization is the process of using radiation or gas technologies to eliminate or reduce microbial contaminants on items used in cleanrooms, such as labware and attire.
Why are cleanroom consumables sterilized?
Sterilizing cleanroom consumables is crucial to prevent the introduction of contaminants into the controlled cleanroom environment. Cleanrooms are commonly used in the manufacturing of single-use healthcare products.
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How are cleanroom consumables sterilized?
Cleanroom consumables are sterilized using a variety of methods including:
- Gamma: exposed products to a Cobalt 60 radiation field
- Electron beam (E-beam): exposed products to high-energy electrons
- X-ray: uses ionizing energy from high-powered electron beam accelerators
- Ethylene oxide (EO): uses a 3-part gas process which includes pre-conditioning, sterilization, and aeration
- Vaporized hydrogen peroxide (VHP): uses a deep vacuum, low temperature vapor sterilization process
- Moist heat (steam): exposes product to saturated steam under pressure
What are commonly processed cleanroom consumable products?
Commonly processed cleanroom consumables products include:
- Disposable headwear
- Facemasks
- Disposable clothing
- Overshoes
- Body and arm protection
- Surface wipes and chemistries
- Eyewear
- Petri-dishes
- Environmental swabs
STERIS support services
In addition to irradiation and gas sterilization services, STERIS provides Customers with laboratory testing, technical support, dosimeters, and equipment and technology solutions at every stage of the sterilization design process, from product development through routine processing.
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STERIS AST operates under a quality system that is in compliance with 21 CFR Part 820 and applicable sections of 21 CFR Part 211. In addition, STERIS is registered to the ISO 13485 Quality Standards and adheres to the requirements of ISO 11137 (Radiation) and ISO 11135 (EO).