Dynatec Scientific Laboratories now offers sterilization services to the medical device industry.
Our services are specifically related to Ethylene Oxide Sterilization.
Dynatec has introduced the 3M GS 8X Sterilizer. Dynatec offers services intended for the development and validation of Ethylene Oxide Sterilization process parameters. This information is used for product development for 510k applications for products that require 100% Ethylene Oxide Sterilization.
In addition to the medical device industry Dynatec will offer sterilization services to research organizations, veterinary and surgical operations.
Dynatec will be able to operate under 28 different programming parameters. Dynatec will also offer custom cycle development with respect to various attributes such as Bioburden Resistance Studies, Internal and External Process Control Device; (IPCD & EPCD), and Penetration Studies.
Dynatec also offers Residual and Dissipation Studies. In addition, Dynatec can offer Packaging Configuration Studies, Penetration Studies and a host of other physical and biological studies.
"From Protocol Development to 510k Application"
Dynatec operates in compliance to:
ISO 11135, AAMI TIR 16
Committee Member, AAMI/ST/WG
63 – Sterilization Residuals and AAMI/ST/WG 01 Industrial EO Sterilization
The Sterilization Department at Dynatec Labs has developed a flow chart to simulate the steps required to achieve a validation of a medical product.
The flow chart is intended to simulate a general approach and may require revisions and or modifications to meet customer specific needs.
In addition the flow chart may not encompass all the steps as stipulated in documented standards and product validated protocol.
Please contact Dynatec’s Sterilization Department for further information.