When is a validation required?: All medical devices labeled with a sterile label claim MUST be validated.

Andersen Scientific, Inc., offers a complete turn-key sterilization packages. Our typical package includes:

 

  • Protocol generation

  • Bioburden testing

  • Product sterility testing

  • Bacteriostasis and Fungistasis testing

  • PCD development

  • BI placement and incubation

  • ETO and ECH residual testing

  • Post-sterilization pouch tensile strength testing.

Benefits: Our validation process requires significantly fewer devices than traditional sterilization facilities since the number of devices required to fill our individual 1 to 1 cubic foot chambers is significantly less than the numbers required to fill a traditional pallet chamber (10 pallets or 696 cubic feet). We typically require a minimum of four small chambers to validate the process PLUS 12 to 44 devices for third-party laboratory testing (these devices can be returned but are typically not used).

 

 

 

Packaging validations, including accelerated ageing and simulated shipping and transportation studies are also available. Packaging validation is required to ensure that sterility is maintained throughout product distribution. A series of special packaging tests are used to measure the ability of the package to maintain sterility. We can develop the protocols, perform the testing in-house and generate the final report--please call us for more information about these services.

 

A full validation usually takes 8 to 12 weeks (work permitting). However, we have managed to complete a validation in only 4 weeks. The diagram below provides an example of a 6 - 7 week validation timeline. Our validation personnel will generate a custom timeline specific to your validation. This way, you can converse with our experts using the same technical "buzz words" and stay on top of the projected completion date.