What is cleanroom consumables sterilization?
Radiation and gas technologies are utilized to process cleanroom consumables such as attire and labware, providing sterilization or microbial reduction to control contaminants present in a cleanroom setting. Cleanrooms are controlled environments designed to minimize the presence of contaminants and are commonly used in the manufacturing of single-use healthcare products.
Go here to learn more STERIS’s cleanroom testing and consultancy services.
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.
Testing services
Our laboratory testing and product and packaging testing services provide Customers with validation support and microbial testing, ensuring medical devices processed with irradiation and gas technologies perform as expected for the life of the product, and packaging maintains the sterility of the device until its point of use.
Radiation TechTeam® technical support
Our Radiation TechTeam technical professionals guides Customers through the irradiation validation process, provide solutions for unique project needs, and support routine processing through quarterly dose audits.
The Radiation Technology Center (RTC) supports Customers with radiation test activities such as product trials, dose establishment and dose verification. The RTC provides high-precision dose delivery for validation, dose mapping, dose audit, and research purposes.
Gas TechTeam technical support
Our Gas TechTeam technical professionals are available to assist with ethylene oxide and moist heat (steam) related queries. Our TechTeam provides individual processing requirements and assists in experimental design and documentation. From process development in accordance with the innovative Sustainable EO® sterilization services program to full sterilization validation, our team is focused on helping our Customers through all phases of the sterilization process.
Dosimeters
Our dosimeter offering supports radiation sterilization processing with both red perspex and alanine pellet dosimeters used to measure ionizing radiation.
Equipment and Technologies
Our comprehensive STERIS Equipment and Technologies offering supports Customers with integrated electron beam accelerators, product handling systems, process management, automation, and radiation protection system design solutions as well as control systems that fully integrate with the sterilization process. Click here to learn more.
STERIS regulatory
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).
Resources
View our TechTeam Resources to learn more about the radiation and gas sterilization processes.