Validation


 
In order to comply with regulatory standards, there are certain steps required to develop a validated product. E-BEAM Services will help guide you through the ANSI/AAMI/ISO 11137 validation requirements for the sterilization of medical devices using radiation, and USP guidelines for the sterilization of pharmaceuticals.

Materials Testing and Establishing Maximum Dose

In order to determine if your product is compatible with e-beam sterilization, E-BEAM Services will set up a simple experiment we call a material test. This experiment includes exposing a number of samples to a range of doses to see the effects of the radiation on both the product and the packaging. Not only will the experiment determine the product compatibility, it is also used to determine the maximum acceptable dose for the product.

A typical material test involves:

  • Exposing a number of product samples to a range of doses greater than anticipated during routine sterilization.
  • The number of samples depends on what you, the manufacturer, need in order to test the functionality of the product.

The wider the range between the minimum and maximum doses, the greater the flexibility there is in the sterilization process – which leads to cost savings for you!

Product Dose Map (and Subsequent Validation Runs)

In electron beam processing, a dose map measures the distribution of dose within a case of product.

The process of a dose map involves placing a number of dosimeters within a case of product to identify the location of the minimum and maximum internal doses. The number of dosimeters used and location of the dosimeters depends on the uniformity of the packaging and the geometry of the devices inside–just leave that to us! The dosimetry results show the distribution of dose throughout the case, and each data point is considered relative to a monitored surface dose.

These relationships are then used to create a complete plan for processing your product. The product information required includes: the minimum dose to achieve sterility (usually determined by a micro lab) and the maximum dose allowable (determined by the material test). Using the dose relationships and the minimum and maximum internal dose, we can calculate an acceptable surface dose range, which is used to monitor the routine production process.

After the dose map is completed, we then perform three subsequent dose map validations to verify the initial findings.

Once this work is completed, a formal report is prepared for you with specified processing parameters. This product will then be validated and as long as there are no changes to the product or packaging!

Establishing Sterilization Dose and Sterilization Dose Audits

The sterilization dose can be established by a micro lab by determining the actual bioburden of a product and establishing an average, or by using a 25 kGy dose and substantiating it. It is a requirement of ANSI/AAMI/ISO 11137 to audit your sterilization dose before the initial production run, and then at intervals thereafter to ensure that it has not changed.

The sterilization dose audit is a product validation test designed to establish or confirm the sterilization dose by exposing test product to sub-cycle conditions. Dose audits are then sent to a microbiological lab to be evaluated.

Keep in mind that while E-BEAM Services does not provide microbiological services such as bioburden testing or sterility testing, we can recommend reputable labs who provide these services.