- Service Description
- Experienced - MO BIO has over 22 years of experience in providing radiation sterilization validation to many major medical device companies and suppliers of plastic consumables
- Qualified - All MO BIO Services technicians receive extensive training in radiation sterilization validation and follow current AAMI method 1 guidelines
Radiation sterilization is the exposure of a material, object, or body to ionizing radiation in order to destroy microorganisms. A radiation sterilization validation determines the appropriate radiation sterilization dose for a product that will be labeled as sterile.
This test follows current AAMI method 1 guidelines to calculate the appropriate irradiation dose needed to sterilize any of a wide range of products. This test also includes a validation of the calculated irradiation dose that is delivered to the product. Quarterly Dose Audits (QDA) are established using this validation.
Sterility assurance testing has become a common practice among general laboratory plastics manufacturers as well as medical device and pharmaceutical companies. Radiation Sterilization Validation is an important part of the sterility assurance package and can be combined with our other offerings, including Bioburden testing and USP Sterility testing.
- Sterilization Process Validation Protocol
- Sample Item Portion (SIP) Preparation (for large or complex devices only)
Validation Test Components
- Contact Services
Our Services team has over 23 years of experience in providing services that keep your products competitive and in demand. Our customers include many of the top plastics and medical device suppliers in the industry. Our services specialists can also work with you to develop a custom testing schedule and/or custom tests that fit the specific needs of your products. We are located in Carlsbad, CA, USA.