Ultrasound Gel Gamma Validation and Dose Study
Project Description
MULTIPLE PRODUCTS
MULTIPLE TESTING
Medical Device Production Company needs Contract Research Organization (CRO) for sterile ultrasound gel gamma validation and dose study. We produce medical devices such as sterile lubricant gel, ultrasound gel, solutions. We have a lot of questions about the process:
1) How can you performed method validation to our bioburden test or can you tested standard procedure for our product? Because we want to make a method validation for our ultrasound gel products. This type of gel products deteriorate at 30 kGy irradiation dose. Yellowing in color and structural changes (decreasing the viscosity..) are observed. We are wondering if you worked on such products?
2) Do you use the cf value for all products and this value is it really necessary?
3) Do you test all stage gamma validation such as Bioburden, determined cf value, dosing and sterilization?
4) How many days do you need all validation Process?
Project Information
Number:23-01451
Industry:Medical Devices
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Other medical devices laboratory services.
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