Sterilisation Validation for Auto Injectors

👉 What is an auto-injector? 

Also considered a drug-device combination device, an auto-injector is a medical device designed to deliver a dose of a particular drug. According to the FDA’s Industry Guidance (2009) the term injector includes, but is not limited to: jet injectors, pen injectors, piston syringes, needle-free injectors, mechanically operated injectors, and injectors with computerized or electronic elements. 



👉 What is Sterilisation Validation? 

The Sterilization Validation process is designed to assist the manufacturer in the development of a sterilisation process that delivers the appropriate sterility assurance level and ensures repeatability for each product type developed.



👉 Where to start with the Sterilisation Validation for auto-injectors ? 


Medistri’s Sterilisation Validation Team leverages Medistri's laboratory & sterilisation infrastructure to work with you and determine the most suitable process for your product to demonstrate compliance with the relevant regulatory standards.


Auto-Injector Sterilisation incorporates two aspects:

1️⃣ The sterility assurance necessary for the injector itself

2️⃣ The sterility assurance necessary for the final finished injector-drug/biological product as a whole. 


For general use auto-injectors that are intended to be used with a wide range of marketed drugs/ biological products, the technical considerations should include sterilisation information for the injector.

If the injector is provided as sterile, the technical data should demonstrate a probability of a non-sterile unit not greater than 1 x 10-6. 


In addition, the components comprising the fluid pathway should be shown to be non-pyrogenic. 


For all sterile components, the technical validation considerations should also contain a description of the injector packaging, including a list of all its core and packaging materials. 


FDA recognises that the following standards may be useful for determining sterilisation processes and test methods for auto-injection devices:


✅ ANSI/AAMI/ISO 17665-1: 2006

✅ ANSI/AAMI/ISO 11135-1: 2007

✅ USP 27: 2004

✅ AAMI/ANSI/ISO 11737-1: 2006

✅ ANSI/AAMI/ISO 11607: 2006


For an injector that will be in a co-package or will be pre-filled with a specific drug/biological product, the auto-injector manufacturer should address the possible effects of the method of sterilisation on the package.



👉 A Technology-First Approach to EO Sterilisation Validation.


As Europe’s largest independent contract sterilisation company, Medistri partners with our customers through the entire process of sterilisation validation from protocol generation to final report completion.



🎯 To learn more about our Sterilisation Validation Services for auto-injectors, visit on our website at or directly contact our team at


- The Medistri Team