Autoclaves for Medical Device and Prosthetics Testing
Leaching. Corrosion. Material fatigue. The long-term durability of plastics and epoxies.
When designing prosthetics and other medical devices, engineers must feel confident that their device will yield reliable and valid results through repeated use (or, in the case of single-use surgical instruments and medical supplies, after transport and storage). As such, engineers routinely subject prosthetics and devices to accelerated aging and life-cycle tests.
In many cases, an off-the-shelf environmental chamber is sufficient for this task. But there are some applications that require more rigorous testing. This is especially true when testing advanced synthetic materials, electronics, medical devices, or package integrity to ASTM standards (e.g., ASTM F1980).
In these cases, an autoclave steam sterilizer is ideal for simulating the passage of time and rigors of pre-surgical sterilization. The heat and pressure inside an autoclave are the perfect atmosphere for evaluating the long-term performance, safety, and stability of medical prosthetics that will eventually be used inside the body. As such, a steam autoclave is vital to medical device life-cycle testing and the design and development of new prosthetics—just as it’s vital to any medical clinic or operating room.
But the type of autoclave used to sterilize surgical instruments and implants prior to a procedure is almost never the right choice for the engineers and designers creating new medical devices, instruments, and implants.
Choosing the Right Steam Sterilizer for Developing Medical Devices, Instruments, and Prosthetics
While steam-jacketed medical autoclaves are essential for clinical applications, they are more often an obstacle to life-cycle testing and medical device development.
Surgical suites and medical clinics need jacketed medical autoclaves because these are designed to meet strict FDA sterilization guidelines for surgical instruments and implants. They do that job very well. But jacketed autoclaves perform at great expense, in terms of purchase price, utility consumption, and ongoing maintenance. Additionally, because they are designed for a single task, they provide little operational flexibility outside the narrow range of common steam sterilization cycles needed in medical settings.
Biomedical research and development labs need more. They need steam autoclaves that are dependable, efficient, and flexible, suited to a much broader range of tasks and designed to tolerate much longer cycles. Priorclave’s non-jacketed research-grade sterilizers are optimized for daily prototyping and durability testing. These machines subject your prototypes to the same stress and strain as an FDA-approved jacketed medical-grade sterilizer—but in an easily automated and replicable fashion, without high maintenance and operating costs.
As one medical device designer put it: “When testing is easier, product development teams can run more test cycles. When lives are on the line, more product testing is always better.”
We furnish steam autoclaves that make life-cycle testing as easy as possible.
Outfitting a Medical Device Manufacturer for Life-Cycle Testing
In 2015, a medical device manufacturer was pioneering a new robotics-assisted method for partial and total knee-replacement surgery. This innovation would ultimately reduce both patient discomfort and risk, first by eliminating the need for repeated pre-surgical CT scans, then by improving surgical accuracy.
The method relied on several complex, reusable electronic instruments, including a specialized electrical sensor encased in a unit made of metal, plastic, held together by epoxy. The designers had several concerns about how this device would hold up to repeated uses and sterilization:
Would the sensor continue to function reliably over time? Would the epoxy loosen after repeated steam sterilization cycles? Would the plastic deform, discolor, change texture, or grow brittle as it aged? Would the device continue to operate after at least 100 uses?
They initially tried to perform life-cycle testing using a small medical sterilizer, but discovered that its limited control system was impractical for this application. While it was theoretically possible to run up to six sterilization cycles per day, doing so demanded an unsustainable level of monitoring. In practice, the manufacturer rarely ran more than two or three cycles per day. After weeks, the designers had still completed only seventy sterilization cycles. That fell far short of their minimum benchmark—and they’d only tested a single prototype model.
Priorclave North America outfitted them with a similarly sized non-jacketed research-grade steam autoclave. This model could functionally approximate the pre-surgical cycles a jacketed autoclave would run. More importantly, this Priorclave sterilizer came with the flexible Tactrol Control System (standard on all Priorclaves), allowing for fine control of every operating parameter, extended cycle times, and automated cycle repeats.
Researchers immediately went from running one or two staff-supervised cycles per day to running ten to fifteen cycles per night—with no staff supervision required.
Service and Support for Your Autoclave Sterilizer
Priorclave sterilizers are regularly used to determine product durability, including products as diverse as disposable contact lens packaging, cell phone solder points, spacecraft thermal tiles, and complex medical devices and instruments.
Our dedicated team of seasoned experts ready to guide your autoclave purchasing decision, even if you are unsure about your specific needs. We can help you find the right sterilizer, whether it’s one we have ready to go, or a custom autoclave built specifically for your lab. In our experience, life-cycle tests for prosthetics and medical devices most often benefit from sterilizers with:
- in-chamber steam generation
- fully programmable control systems
- widely adjustable cycle lengths
- automatic cycle repeat
- load-sensed process timing
- vacuum-cycle capabilities
- customizable temperature/pressure ramps and dwell times
Priorclave sterilizers meet all these needs—with cycle times up to 999 hours, and automated repeat up to 999 cycles. And they do so while using substantially less water and energy than comparable jacketed and medical autoclaves.
But what truly distinguishes Priorclave is customer service and support. Our customers consistently report 93 to 100 percent satisfaction with their purchase over time—and that rating improves the longer they’ve owned the unit. In our most recent customer satisfaction survey, most owners rated installation and first use “very satisfactory,” with more than a quarter calling it “delightful.”
Every Priorclave sterilizer is covered by free lifetime remote technical support and consultation and one of the best warranty programs in the industry. Priorclave also maintains a global network of factory-certified authorized service agents (ASAs).
Wherever you are, we are as close as a call or click.