01
High Reliability
Dose monitoring and process control support a consistent and repeatable irradiation process.
Key Advantages of Gamma Irradiation Sterilization
Sterilization Insights
Why Choose Gamma Sterilization?
For medical device manufacturers and users, the label “Gamma Sterilized” represents a well-established sterilization method known for its consistent performance and reliability—a mark of quality that inspires confidence.
Sterility assurance is expressed in terms of the probability that a viable microorganism remains on a product after sterilization. A sterility assurance level SAL 10⁻⁶ represents a probability of no more than one in a million and is a commonly specified target for sterile medical devices. The ISO 11137 series provides requirements and guidance for developing, validating, and routinely controlling radiation sterilization processes.As quality requirements for medical devices become increasingly stringent, gamma sterilization offers a dependable solution with five key advantages:
02
Strong Penetrating Power
Gamma rays can penetrate packaging and reach internal areas of products, enabling treatment of products with complex structures.
03
Sterilization in Final Packaging
Products can be sterilized in their final sealed packaging, reducing the risk of recontamination during subsequent handling.
04
No Chemical Sterilant Residues
Gamma sterilization leaves no chemical sterilant residues and requires no aeration period. Products can be shipped once the applicable release requirements have been met.
05
Ambient-Temperature Processing
The process requires neither high temperatures nor high pressures, making it suitable for a wide range of heat-sensitive products and materials.