A faster path to a sterile lot
Not every device needs a full validation program yet. When you are heading into a clinical study or releasing a single production lot, we sterilize and release that specific lot with the testing and documentation required to support it.
Sterile label claim without a full validation program
Works with small device quantities
Supports IDE and clinical trial submissions
Release documentation and testing included
Built for devices not yet ready for full validation
First-in-human and early clinical studies
IDE submissions
Individual clinical trial lots
Single or small production lots
Everything required to release the lot
A focused scope built around one lot, with the same documentation discipline we apply to full validation programs.
Controlled Cycle Processing
Your lot is processed under a monitored EO cycle with recorded parameters.
Biological Indicator Testing
Sterility confirmation using biological indicators placed with the load.
Release Documentation
A release package covering cycle data, test results, and lot traceability.
A practical, risk-based approach to every project
We apply the same disciplined framework whether you need a single feasibility run or a full validation program.
Understand the Product
Evaluate the device, materials, configuration, and intended sterilization process.
Define the Risk
Identify the conditions and variables that challenge the process and determine what must be demonstrated.
Build the Strategy
Develop a proportionate testing and validation approach supported by scientific rationale and applicable standards.
Document the Rationale
Carry the technical justification through testing, qualification, and reporting so the decisions are clear and defensible.
Four steps from intake to release
We review your device, packaging, and study timeline
We confirm the testing your lot requires and the quantities needed
We sterilize your lot and coordinate release testing
We deliver the release documentation for your submission
Single lot release or full validation?
If you are moving toward routine production, a full validation program is the right investment. For a single study or lot, this is the faster route.
Single Lot Release
One lot, one study. A sterile label claim for the specific lot we process, with no full validation program required.
Sterilization Validation
Routine production. A validated process supporting sterile label claims across every future lot.
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