Sterilization
Cycle development from first principles and validation by any approved approach \u2014 ethylene oxide, radiation, steam and emerging low-temperature agents, under an ISO 13485:2016 certified quality management system.
What Is a Sterilization Validation?
A sterilization validationdemonstrates that a defined process reliably achieves the required sterility assurance level for a specific device in its final packaging — and that whatever the process leaves behind is within accepted limits.
It is not a single test. It is a documented argument assembled from the device and its materials, the packaging system, the bioburden the product carries, the process parameters themselves, and the residuals remaining afterwards. Each element carries its own standard, and the conclusion has to hold across all of them.
Groenakker manages that argument end to end — plan, laboratory work and report — under one purchase order.
We develop cycles from first principles for new products, and validate by whichever approved approach the device and its bioburden support — not a single templated route. Twenty years in sterilization also means we know which contract sterilizers and laboratories perform for each one, and we connect you directly.
Ethylene oxide
Cycle development from first principles for new products, and validation by whichever approved approach the device and its bioburden support — overkill, bioburden-based, or a combined BI and bioburden route.
WHAT THE PROGRAM COVERS
- Cycle development from scratch for new products
- Overkill (including half-cycle), bioburden-based or combined BI/bioburden
- Validation cycles executed at your contract sterilizer
- EO and ECH residual analysis to ISO 10993-7
- Biocompatibility and shelf-life impact evaluation
- Product adoption and scheduled requalification
Sterilization Simplified
Turnaround is scoped per program. Cycle development for a novel product and a requalification against an existing validation are different pieces of work, so we quote the schedule with the plan rather than publishing an average that fits neither.
Phase I
Planning & Scoping
01 - Initial Meeting — Understand Device(s), materials and packaging, and agree to scope of project.
02 - Client issues purchase order to Groenakker for project scope.
Phase II
Method & Product Assessment
03 - Review materials, geometry and packaging against candidate sterilization methods.
04 - Document the selected method and the rationale supporting it.
Phase III
Cycle Development
05 - Establish worst-case challenge locations within the product and load.
06 - Process challenge device determination and selection.
07 - Establish comparative resistance baselines.
08 - Select key cycle parameters and document the validation plan.
Phase IV
Validation Execution
09 - Bioburden determination and sterility testing per ISO 11737.
10 - Validation cycles executed at your contract sterilizer against the approved protocol.
11 - Residual testing at an ISO 17025 accredited laboratory per Groenakker's plan & methods.
12 - Biocompatibility evaluation of the device in its sterilized, final form.
13 - Product and packaging shelf-life impact evaluation, including accelerated aging and sterile barrier integrity.
Phase V
Reporting & Release
14 - Validation report issued under Groenakker cover, in our template or in yours on request at no extra cost.
15 - Documentation package delivered ready for your technical file.
Phase VI
Lifecycle Management
16 - New product introductions into a validated family.
17 - Product change assessments — material, supplier, geometry or packaging.
18 - Product adoptions where the challenge is equivalent or lower.
19 - Routine requalification, periodic cycle review and radiation dose audits (4 weeks).
We Know Who Delivers
Two decades in sterilization means we know which contract sterilizers and which laboratories actually perform — for a given method, a given material and a given deadline. That judgment is not published anywhere. You get it in the first conversation, and we connect you directly.
Cycle development, bioburden, residual chemistry, biocompatibility, packaging and shelf life, and the documentation tying them together are otherwise split across separate providers, each with their own schedule and format. Groenakker selects them, runs the whole program under one plan, and issues a single report you can put straight into your technical file.
WHAT YOU RECEIVE
- Method selection rationaleThe documented basis for the process chosen.
- Validation protocolWritten to the applicable standard before work begins.
- Residual, biocompatibility and shelf-life dataThe downstream evidence the method generates.
- Validation reportSubmission-ready, issued under Groenakker cover.
- Your templates or oursClient templates on request at no extra cost.
Sterilization FAQ
What is the difference between a sterilization validation and a sterility test?
A sterility test examines a sample of product at a point in time. A validation demonstrates that the process reliably achieves the required sterility assurance level for the device in its final packaging, every time it runs.
We are moving away from ethylene oxide. Can you validate an alternative?
Yes. Alongside radiation and steam, Groenakker validates low-temperature methods including vaporized hydrogen peroxide under ISO 22441, and chlorine dioxide and nitrogen dioxide under ISO 14937. Which alternative suits a device depends on its materials, geometry and packaging, and the Phase II assessment works through those before a method is committed to.
What is a sterility assurance level?
The probability of a single viable microorganism remaining on a device after processing. Terminally sterilized devices are generally validated to a sterility assurance level of 10⁻⁶.
What does Groenakker need to begin?
A device description, materials and packaging details, intended markets, and any existing bioburden or manufacturing data. Where information is incomplete, the Phase II assessment identifies what has to be generated.
Do you support requalification and dose audits after validation?
Yes. Requalification intervals, periodic cycle reviews and radiation dose audits are managed on a schedule and executed against the original validation, so the file stays current between submissions rather than being rebuilt when something lapses.
Can a new device be added to an existing validation?
Yes — where the new device presents an equivalent or lower challenge to the process than the product already validated. An adoption compares the new device against the validated family on the factors that drive lethality: geometry, density, materials, packaging and bioburden, and documents the justification. Groenakker specializes in product adoptions, which are substantially faster and less expensive than validating from scratch.
Twenty years in sterilization, and a network of contract sterilizers and laboratories we know by performance rather than by brochure.
Whatever your device requires, we have the solution and the expertise to drive success.
INTEGRATE
CREATE
EXECUTE