Sterilization Services, Validation & Cycle Development
From engineering runs through validated production and product release — for EO and chlorine dioxide, with biological testing under the same roof.
Reduction in validation timeline versus a typical multi-vendor path.
Cost savings from co-locating assembly, sterilization, and testing.
Sterilization validations completed each year across both methods.
What we do
One quality system spanning development, validation, production, release, and testing.
Cycle development & engineering runs
R&D and engineering cycles to establish parameters before formal validation — for both EO and CD.
Validation (IQ/OQ/PQ)
Full installation, operational, and performance qualification to ISO 11135 (EO) and ISO 14937 (CD), typically in 8–10 weeks.
Single-lot release
A documented sterility decision on a single lot in 5–7 weeks for products that need to ship quickly.
Production processing
Routine validated production across six EO chambers and the world’s largest contract CD chamber.
Overkill-method release
Worst-case bioburden assumption with a large safety margin and minimal routine testing.
Lethal-rate (bioburden-based) release
Actual-bioburden cycle design for a less aggressive, lower-cost validated process.
In-house biological testing
BIs/PCDs, sterility, endotoxin, bioburden, and EO/CD residuals tested on site — no inter-vendor shipping.
Cleanroom assembly & packaging
ISO Class 7 final assembly and ISO 11607 packaging on the same campus as sterilization.
Choosing EO vs. chlorine dioxide
We run both, so the recommendation follows your device. The criteria we weigh:
| Criterion | Favors EO | Favors chlorine dioxide |
|---|---|---|
| Device geometry | Long lumens, dense loads, sealed packaging | Open or surface-accessible geometries |
| Residual tolerance | Aeration time is acceptable | Must avoid carcinogenic EO/ECH residuals |
| Device size | Standard chamber footprint | Large assemblies up to ~8 ft |
| Materials | Established EO-compatible materials | Sensitive electronics, sustainability-driven |
| Regulatory / ESG | Existing validated EO process | Reducing EO emissions exposure |
Product release pathways
Overkill-method release
Worst-case bioburden assumption with a large safety margin and minimal routine testing — simple, robust, and fast to validate.
Lethal-rate (bioburden-based) release
Uses your actual product bioburden to design a less aggressive, lower-cost validated cycle — ideal for sensitive materials.
Services & Validation FAQ
How long does a sterilization validation take?
A new validation typically completes in 8 to 10 weeks including cycle development, and single-lot release runs in 5 to 7 weeks. Validated production cycles and engineering R&D runs complete in four business days.
How do you decide between EO and chlorine dioxide?
We weigh material and packaging compatibility, device geometry (lumens, density, load), residual tolerance, device size, turnaround needs, and regulatory or sustainability drivers. Because we run both methods, the recommendation is driven by your device — not by the single method we own.
What is the difference between overkill and lethal-rate release?
The overkill method assumes a high, worst-case bioburden and demonstrates a large safety margin without routine bioburden testing — simple and robust. The lethal-rate (bioburden-based) method uses your actual product bioburden to define a less aggressive, lower-cost cycle. We scope the right pathway to your device and risk profile.
Do you handle cycle development and engineering runs?
Yes. We run engineering R&D and cycle-development runs to dial in parameters before formal validation, then move into IQ/OQ/PQ qualification and validated production — all on the same campus with in-house biological testing.
Ready to scope a validation or release?
Tell us about your device and timeline. We will propose a validation and release plan — EO or CD — within one business day.