Shipping Validation Repository Program

Reduce duplication. Maintain compliance. Share validated processes.

Through this voluntary program, EBAA-member eye banks may share completed shipping validation reports with their peers. This reduces duplication, conserves resources, and strengthens operational consistency across the profession.

EBAA supports this initiative by serving as a secure repository and document facilitator. EBAA does not re-perform scientific validation, certify results, or guarantee regulatory acceptance; ultimate responsibility for compliance remains with each participating eye bank.

For Eye Banks Submitting a Validation Report

Purpose of Submission

By submitting a validation report, you allow other eye banks to use your completed validation, provided they use the exact same specifications and process parameters and verify the validation at their own eye banks.

Required Submission Components

To be included in the repository, your submission must include:

1. Summary & Approval

• Eye bank name
• Validation date
• Purpose and scope
• Executive Director and Quality Assurance Director Signatures

2. Validation Protocol

• Objective
• Acceptance criteria
• Risk summary
• Test conditions (including seasonal/environmental assumptions)
• Sample size and duration

3. Exact Specifications

• Cooler manufacturer and model
• Refrigerant type and placement
• Pack-out configuration (include diagram if available)
• Insulation components
• Data logger placement
• Shipping method and carrier assumptions (if validated)

4. Environmental Conditions

• Seasonal profile
• Worst-case temperature assumptions
• Simulated or actual transit conditions

5. Results

• Raw temperature data
• Performance graphs
• Deviations (if applicable)
• Final pass/fail determination

EBAA Review Process

Eye bankers serving on EBAA’s Quality Assurance Taskforce will:

• Confirm all required documentation is included
• Ensure specifications are clearly documented
• Verify acceptance criteria are defined
• Assess the validation study design

EBAA will not:

• Re-perform scientific validation
• Certify the results
• Guarantee regulatory acceptance

Important Legal Notes

• The submitting eye bank retains ownership of its data.
• The repository does not replace regulatory obligations.
• EBAA acts solely as a document repository and facilitator.

Submit a Validation Report

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For Eye Banks Using a Shared Validation Report

In order to use another eye bank’s validation report, your shipping process must be identical in every material respect AND you must complete your own verification. There cannot be partial adoptions. If any component differs, you must perform your own validation.

IMPORTANT: Your eye bank must verify that your process matches the validated process and produces the same results described in the validation report. After completing this verification, EBAA recommends preparing a brief report documenting your review and confirmation so it can accompany the original validation report if it is submitted to regulatory bodies. An example outline for this report can be found here. You should also ensure that your SOP matches the process described in the validation report to ensure continued compliance and that your SOP allows for use of external resources.

You Must Use Identical:

1. Cooler manufacturer and model
2. Refrigerant type and configuration
3. Pack-out arrangement
4. Insulation components
5. Validated transit duration
6. Environmental/seasonal assumptions
7. Shipping carrier parameters (if included in the validation)

No substitutions. No modifications. No parameter changes.

Revalidation of packaging and sealing processes or re-verification of package performance shall be conducted if changes are made to the equipment, tissue, packaging materials or packaging process, which compromise the original validation and affect the sterility, safety, or quality of the finished tissue.

Regulatory Responsibility

• The repository does not replace FDA licensure, EBAA Accreditation, or other regulatory requirements.
• Each eye bank remains fully responsible for compliance.
• Any deviation from the original validated specifications voids the use of the shared report.