Your product, sterilized and proven sterile — without owning a single piece of equipment
Duraline Systems processes and verifies customer products using steam, EO, hydrogen peroxide plasma, VHP, dry heat, and custom protocols. Some labs use us as their ongoing third-party sterilization partner. Others send a single batch direct, when they need it. Either way, every load comes back documented, traceable, and independently verified.
The case for sending it to someone who already does this every day
Owning sterilization equipment makes sense for an organization running hundreds of cycles a week. It rarely makes sense for anyone else — including large laboratories and manufacturers who would rather not validate, staff, and maintain an EO chamber or steam autoclave for a process that runs on its own schedule.
No equipment, or the wrong equipment. Steam, EO, and hydrogen peroxide plasma each have different validated parameters and material compatibility. Few organizations have access to all of them — Duraline does.
Validation studies. New product validation often calls for multiple runs with full documentation, biological indicator results, and traceability to support a regulatory submission or internal qualification protocol.
Small or one-off production runs. Sterilizing 30 units doesn’t justify building an in-house sterile processing department.
Prototype and early-stage development. Startups developing medical devices often need a handful of sterile units for testing, long before a manufacturing line exists.
Regulatory and quality requirements. FDA- and ISO-driven quality systems frequently call for documented, traceable, third-party-verified sterilization.
Independent verification. Even organizations with their own equipment sometimes want a second, independent set of eyes on a critical load.
Whether you’re a medical device manufacturer, a university or pharmaceutical research lab, a veterinary or dental device manufacturer, a contract manufacturer, or a healthcare facility that occasionally needs overflow capacity, the need is the same: get the product sterile, and be able to prove it.
Key takeaway: Outsourcing sterilization isn’t just about access to equipment — it’s about access to documented, defensible verification you can stand behind.
Process, not just a button press
Sterilization is more than running a cycle
A defensible sterilization process is built from several distinct steps, and getting any one of them wrong undermines the whole result.
Load configuration. Spacing, orientation, and density inside the chamber determine whether sterilant reaches every surface. A load packed too tightly can produce a printout that looks correct while leaving cold spots that never reached sterilization conditions.
Product compatibility. Polycarbonate, certain plastics, electronics, and some packaging don’t tolerate every method equally. Matching the product to steam, EO, hydrogen peroxide plasma, VHP, dry heat, or a custom protocol happens before the cycle ever starts.
Process monitoring. Temperature, time, pressure, and gas concentration are tracked throughout the run, not just confirmed at the end.
Documentation. A printout, an integrator result, and a biological indicator result only have value once they’re captured, dated, and tied to a specific load.
Traceability. Every load connects the customer’s product, the specific cycle, and the verification results, so any later question has an answer on file.
Verification. Confirming sterility assurance is the entire point — covered next.
Sterilization verification services
A printout proves the machine ran. A biological indicator proves the product is sterile.
Depending on your product and documentation requirements, verification can include any combination of the following:
Biological indicators (BI). The gold standard for sterility assurance — a known population of highly resistant spores is killed if the cycle is effective. Rapid-read BIs, such as 20-minute spore tests, allow same-day or next-day confirmation rather than the multi-day incubation older formats require.
Chemical indicators and Class 5 steam integrators. Class 5 integrators respond to the full range of critical cycle variables and give an immediate visual pass/fail confirmation, distributed throughout the load to confirm uniform exposure.
Sterilizer cycle printouts. A direct, time-stamped record of the parameters the equipment actually achieved.
Incubation and reporting. Biological indicators are incubated and read, with results documented and provided as part of the final package.
Load records and traceability documentation. Every load is logged so the product, the cycle, and the verification results can always be matched back to one another.
Key takeaway: Biological indicator testing, chemical indicators, and cycle data work together — no single record tells the whole story on its own.
Why choose Duraline Systems
Four decades inside the sterile processing world
40+ years in the field
Our background is maintaining and servicing the same sterilization equipment hospitals depend on every day — not just running cycles, but understanding them.
Multiple modalities
Steam, EO sterilization services, hydrogen peroxide plasma, VHP, dry heat, and custom protocols — matched to your product, not the other way around.
Custom protocols
When a product doesn’t fit a standard cycle, we configure one that does.
Flexible project sizes
From a handful of prototypes to recurring production runs for large labs and manufacturers.
Complete documentation
Biological indicator testing, chemical indicators, cycle printouts, and load records, packaged and delivered with your product.
Responsive support
Direct access to people who understand sterilization, not a call center reading from a script.
Industries served
Who we work with
Medical device manufacturers
Startups developing devices
Universities & research labs
Pharmaceutical companies
Veterinary device manufacturers
Dental device manufacturers
Contract manufacturers
Healthcare facilities
Product development firms
Documentation package options
Documentation built around what you actually need it for
Every job includes documentation matched to its purpose — a regulatory submission, an internal quality record, or simply proof of sterility for your own files. Standard packages can include sterilizer cycle printouts, biological indicator incubation and result reports, chemical indicator and Class 5 integrator results, and load traceability records. Tell us what your quality system or regulatory pathway requires, and we’ll build the package around it.
One-time vs. recurring
A single validation run, or an ongoing schedule
Some customers need sterilization processing once — a single validation run, a one-off prototype batch, or overflow capacity for an unusually large job. Others need it on a recurring basis as part of an ongoing production or testing cycle. We support both, and recurring customers benefit from established load configurations and documentation formats, so each subsequent run is faster to schedule and process.
Product development & validation support
Support before your process is even finalized
Early-stage medical device companies frequently need sterilization support before a manufacturing process is finalized — a handful of units for bench testing, a small batch for a validation study, or repeated cycles to confirm a product’s compatibility with a given sterilization method. We work with product development teams through this stage, helping confirm which modality is appropriate for a given material and what documentation a validation study will require.
Frequently asked questions
What customers ask before their first project
Request a quote
Tell us what you’re looking to sterilize
Every project is different — the right method, load configuration, and documentation package depend on your specific product. Share a few details and we’ll follow up with the rest: which sterilization method fits, what verification you’ll receive, and what the process looks like for your project.
