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Validation Questionnaire

Help us design the right validation protocol for your device. Complete this form so we can assess your requirements and recommend a validation approach.

Validation Questionnaire

Section A. Company Information

Section B. Sterilization Volume, Frequency & Temperature

How frequently do you anticipate sending sterilization runs?
Sterilization temperature preference
We strongly recommend 50°C for most applications.

Section C. Validation-Specific Information

The following questions help us develop a validation protocol. Please complete to the best of your ability.

Maximum file size: 516MB

Please ensure: (1) The entire device is in the photo. (2) Taken on a neutral background. (3) Device is not in its sterile barrier/pouch.

Section D. Device Packaging (Sterile Barrier System)

Is the device double packaged?
e.g., An inner and an outer Tyvek pouch.

Section E. Device Testing & Sample Numbers

We will need between 15-66 non-sterile packaged devices for testing (23-26 is typical). These may be destructive tests.
Do you want the devices used for testing returned?
Some devices are cut up (destructive), and some are not (non-destructive). This depends on device type and configuration. Additional fees apply for returns.
Testing is performed by the client after exposure to a 2X sterilization cycle. It demonstrates the device is fit for its intended use. Samples should conform to predetermined criteria and be compared to non-exposed controls.

Bioburden & Recovery Testing

Do you have bioburden reports for this product?
Bioburden is the number of microorganisms on the non-sterile device.

Maximum file size: 516MB

Do you have a bioburden recovery report?
Bioburden recovery is normally performed when bioburden has been previously tested.

Maximum file size: 516MB

Has the device been submitted for bacteriostasis/fungistasis (B/F) testing?
This is usually yes only if the device has been tested for sterility in the past.

Maximum file size: 516MB

EO Residuals & Patient Safety

We will use this as the simulated-use extraction time for EO residuals.
Used to calculate EO tolerable contact limits (TCL). Please ensure the calculation is accurate.
Will the device be used on neonates or infants?
There is a lower EO residual requirement for devices used on neonates and infants.
Is the device labeled pyrogen free?
Normally yes for implants and devices contacting cerebral spinal fluid.
Does the device need to be disassembled for proper LAL extraction?
This is a standard requirement. It demonstrates the device is fit for its intended use. Test samples should conform to predetermined criteria and be compared to controls.

Having trouble with the form? Contact us directly at [email protected] or call (919) 388-5844.