Sterilisation & Validation

Sterilisation

To implement sterilization quality system into your business, Fpster have options available to you. We has a great knowledge of sterilization and can help you to identify the most appropriate method of sterilisation for you products.
Fpster is conversant with the requirements of: ISO 13485, ISO 11135-1, ISO 10993, ISO 1138-2, ISO 11137-1, ISO 11138-1, ISO 11134, FDA 21CFR part11…

Validation

Fpster can apply the principles of validation to any of your validation projects and have specific skills and understanding in the following areas:

• Ethylene Oxide Sterilization
• Irradiation (γ,ß) Sterilisation
• Steam sterilization
• Bio burden Recovery Methods, sterility tests methods
• Ethylene Oxide Gas Residuals methods
• Process Change
• Cycles development