FAQ about product validation

No. 1. Product validation. In the eyes of the regulators, product validation is defined as:

“Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.”

1. What’s in a validation protocol? The protocol is the foundation of the validation and it includes:

   • The objectives and detailed references to all standards and equipment qualification studies

   • A detailed description of the process and the equipment

   • A detailed description of the device and its packaging

   • Numbers of devices reserved for testing—including a rationale for choosing a specific device

   • A detailed description of the loading configuration

   • Estimation of product bioburden and a bioburden recovery efficiency method analysis

   • A resistance study between the hardest to sterilize location within the device and an external PCD (ePCD)

   • A sub-lethal cycle to demonstrate the chosen ePCD is harder to sterilize than the natural product and includes product sterility testing and validation of the chosen sterility test method

   • Three (3) cycles below nominal process conditions at half-lethality to demonstrate process lethality

   • One full cycle at nominal process conditions to demonstrate the ability to achieve the desired acceptance criteria—including EO residual testing and pyrogen testing (if necessary)

   • One repeat full cycle to demonstrate process capability at upper process tolerances—including EO residual testing, and product functionality testing

   • A comprehensive acceptance criteria list

   • A comprehensive report bringing all parts together to demonstrate process capability and repeatability

   • Requirements for ongoing maintenance of the process

2. Do you generate the protocol? Yes. Our validation packages are a turnkey process. We generate the protocol, perform all the cycles, coordinate and outsource any third-party tests, and generate a fully comprehensive validation report; everything is included in the quoted price. All we need from you is the devices and your signature.

3. How many products do you need for the validation? For each validation, we need a) dunnage (filler) product, and b) newly manufactured (non-sterile) real product. We need approximately two and four loads of product (a load is the number of products that fit in a flexible chamber) to act as dunnage and approximately 18 - 46 real products for testing—some of which are destructive. The number of products required depends on the size of the load and the numbers needed to demonstrate proper device functioning after sterilization.

4. Do I need to have all the devices sent to you before the validation begins? No. We can begin the validation with as little as one or two dunnage (like the real devices, but may not be fully functioning) loads of product. As the validation progresses, we will need the remaining devices. This means you can begin the validation before all your test and load samples have been created.

5. How long does validation take? 12 - 15 weeks, although a validation can be put on STAT and reduced to as low as 8 weeks.

6. What tests are included and how many products do I need per test? ISO 11737-1 Bioburden (QTY. 3) and bioburden recovery (QTY. 3), ISO 11737-2 test of sterility (QTY. 8-20) and bacteriostasis/fungistasis (QTY. 3), ISO 10993-7 EO residual testing (QTY. 4-8), USP<85> LAL testing—if required (QTY. 3), and post-sterilization product functionality testing (determined by you).

7. How often do I need to revalidate? We recommend a paper review each year and a reduced requalification every two (2) years. Both services are a tiny fraction of the validation cost.

8. Do I have to validate all my products separately? No, not necessarily. We can group your products into families and validate the worst-case load.

9. What needs to happen if I change my product, my packaging, or I have a new device. Do I have to revalidate? In most cases, no. Introduction of new products, product changes, load density alterations, and packaging changes can often be performed using an abbreviated validation study—see product adoptions.

10. Do I need to use real functioning devices? No. Many of the devices can be dunnage. However, most devices used for device testing (listed in section 4) should be functioning devices that have gone through all the appropriate manufacturing steps.

11. Does my product or dunnage need to be labeled? That depends. If your devices will be labeled when sterilized, then the devices used in the validation should be labeled. It does not need to be a finished label, it can be blank at this stage.

12. What sterilization category does your process use? The FDA considers our process as a Category type B sterilization method. It is NOT considered to be a novel technology. Our validations have been reviewed by FDA and numerous notified bodies. Devices processed using this technology have received 510(k) approvals and CE marking for sale in Europe. A master file with the FDA is currently in the works to make your submission easier. All you need to do is reference the FDA Master file number when submitting your 510(k).

13. What standard do you use when validating the process? We use ISO 14937.