Gamma
Contact us to find out more about our global contract sterilization, testing, and validation services.
Contact UsGamma Irradiation Processing
What is Gamma Irradiation Processing?
The gamma irradiation process uses Cobalt-60 radiation for a variety of applications, including sterilization, decontamination and materials modification. Gamma irradiation offers good penetration of dense products and is ideal for many types of materials and their packaging.
How Does the Gamma Irradiation Process Work?
The gamma irradiation process uses Cobalt-60 radiation to kill microorganisms on a variety of different products in a specially designed cell.
Gamma radiation is generated by the decay of the radioisotope Cobalt-60, with the resultant high energy photons being an effective sterilant.
A key characteristic of gamma irradiation is the high penetration capability, which allows for delivery of the target radiation dose to areas of products that may be higher in density.
The unit of absorbed dose is kiloGray, expressed as kGy.
Delivery and absorption of dose by product is determined by product density, packaging size, dose rate, exposure time and facility design.
What are the Benefits of Gamma Irradiation?
Gamma irradiation is safe, reliable and highly effective at treating a wide variety of products.
Key benefits of gamma irradiation include:
- Ability to process products with varying densities, configurations and orientations
- Ability to process products in final packaging
- Compatibility with most materials when compared to other sterilization modalities
- Ability to process raw materials
- Improved supply chain efficiencies
- No chemical residuals or induced radioactivity remain on processed products
Standards for Gamma Irradiation:
Gamma sterilization is supported by the internationally recognized consensus standard, ISO 11137, which describes the approach to validating a dose to achieve a defined sterility assurance level (SAL).
Gamma Irradiation Support Services:
In addition to irradiation sterilization, STERIS AST provides our Customers with laboratory testing and technical support solutions at every stage of the sterilization design process, from product development through routine processing.
Our Radiation TechTeamTM guides Customers through the irradiation validation process, provides solutions for unique project needs, and supports routine processing through periodic dose audits.
Our Radiation Technology Centers (RTCs) supports our Customers with radiation test activities such as product trials, dose establishment and dose verification.
The RTCs provide high-precision dose delivery for validation, dose mapping, dose audit, and research purposes.
Our laboratory testing services provide Customers with:
Microbiological testing, including bioburden testing, test of sterility, microbial identification and more
Product and packaging testing.including accelerated & real-time aging, transportation/distribution testing, sterile barrier integrity and more
As part of our complete radiation validation program, we will develop a protocol, assemble all testing and validation data, summarize results and make recommendations based on your product, as well as provide ongoing support through a dedicated Radiation TechTeam Project Manager.
What is Gamma Irradiation Used For?
The gamma irradiation process can effectively treat a wide variety of products composed of different materials, with varying densities, configurations and orientations, including:
Sterilization of single-use medical devices, human, animal and synthetic tissue and pharmaceuticals
Contamination control in packaging materials, cosmetics, and toiletries, restoration & salvage, and horticulture.
For a comprehensive list of products commonly treated by gamma irradiation, please click here.
Technology Variables
- TIME IN CELL
- ISOTOPE LOAD
- PRODUCT CONVEYANCE
Product Considerations
-
MATERIAL COMPATIBILITY
- Compatible with most materials
-
DENSITY
- Good penetration on dense products
Possible Effects
On certain materials, embrittlement, discoloration, change in viscosity due to irradiation
Exposure Time
- HOURS
- (time varies based on dose requirements)
Why Choose STERIS for Gamma Irradiation?
With over 50 years of experience as a global leader, STERIS AST provides safe and effective gamma irradiation with comprehensive laboratory testing and technical support through every stage of the sterilization design process - from product development to routine processing.
- Global Strength, Local Focus: Facilities across the Americas, Europe, Asia, and South Africa
- Customer Experience: Continuous feedback to drive process improvements
- Industry Leadership: TechTeamTM Technical Professional guidance through detailed and complex sterilization and laboratory testing processes
- Technology-neutral: Radiation and gas technologies tailored to Customer needs
- Excellence in Quality: Proactive approach to drive efficiencies, reduce rework, and improve quality
- Innovative Technologies: Innovative offerings to support routine services and processing redundancy capacity
- Service Commitment: Dedicated to timely routine processing and testing turn times
- Business Investments: Upgraded equipment and quality systems, new locations, and expansions of existing facilities