Product Adoption for Sterilization Validation

Posted by Jill Warren, Technical Specialist on October 16, 2018

When your product has had a material change, a component added, or a new size developed, does this necessarily mean you must complete the sterilization validation of each?

There is another option:  product adoption.

WuXi AppTec Technical Experts answer common questions about product adoption when completing a sterilization validation.  The question to be answered is - whether or not to validate independently or adopt into a family?

What are the first steps when considering product adoption?

To start the product adoption process, define your product family, and if already defined, then state your candidate product. There are numerous aspects to consider when defining a product family, which are outlined in the AAMI/ISO standards.

Why have product families?

There is cost savings associated with validation and dose maintenance testing by product family.

With product families, it is not necessary to independently validate each product within the family. Instead, an equivalent or master product represents the family in validation as well as periodic verification testing (e.g., dose audits).

How do I determine my products within a family?

The most important aspect of defining product families is bioburden.

Once you’ve defined the product family and candidate product, determine if the candidate product can be included into the defined product family. For product family inclusion, bioburden is the key – numbers, types, and resistance. Beyond the product design, WuXi AppTec Technical Experts advise our clients to consider variables such as materials, manufacturing processes and manufacturing environment that may affect bioburden.

How do I determine when to adopt a product within a product family?

WuXi AppTec helps guide you in this process.

Executing product adoption may be completed through a documentation assessment, testing for bioburden evaluation, or performing a dose audit of the candidate product. These options are based upon the differences between the candidate and family representative product.

The basis to determine the necessary sterilization validation testing, if any, is whether product differences significantly impact the sterilization dose. With instances where the candidate challenges the sterilization process less than or equal to the representative product, a documentation assessment without testing may be the most suitable approach.

When testing is required, our technical experts develop and perform any testing necessary to validate a product, whether it will be adopted into a product family or validated independently. Furthermore, we will continue to support the product through verification testing, such as dose audits and bioburden, for the entire product lifecycle.

For more information about testing to validate a product within a family or independently, contact us.   

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Topics: Medical Device, Technical Expertise, Bioburden, Regulatory Expertise, Sterilization Validation