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Using Steam Autoclaves for Medical Device Accelerated Aging

autoclave for medical device accelerated aging

Autoclaves play an important role in product development and testing. They’re play a key role in medical device accelerated aging, where can simulate years of wear-and-tear or exposure to harsh environmental conditions in just days

But steam autoclaves are especially important when developing new reusable surgical instruments. Such medical device accelerated aging takes two distinct forms:

  1. Destructive Testing
  2. Sterilization Durability Testing

This is one of the few situations where a medical research lab doesn’t need to use their expensive/high-maintenance GLP/GMP/FDA-approved autoclave. Non-clinical safety/efficacy studies with human or animal models generally require GMP/GLP compliance. But accelerated aging almost always falls within the sort of exploratory/feasibility testing that doesn’t require an FDA-approved autoclave. That’s great news, since most FDA-approved medical-grade autoclaves are a poor fit for accelerated aging and durability testing.

Medical Device Accelerated Aging: Destructive Testing

Prosthetic and medical device accelerated aging is no different from any other destructive testing process. It’s based on the fact that many chemical reactions approximately double with each increase of 10º Celsius. This makes accelerating the aging of most monolithic synthetic materials—such as a plastic housing or rubberized fitting—quite straightforward. Put your prosthetic socket or medial instrument housing in an autoclave. Hold it at 120º for a full 24 hours, and it will come out having aged approximately three years. (With natural materials, things are trickier because some, like paper, may age hundreds of times more quickly with a 10-degree increase in temperature.) autoclave for medical device accelerated aging

Priorclave lab autoclaves are favored in many industries for this sort of destructive testing. This is because engineers can easily program their Priorclave to run a single cycle of not just 0 to 120 minutes (standard medical cycles) or 0 to 999 minutes, but 0 to 999 hours. A range of product development labs runs samples for days and weeks at a stretch, simulating decades of daily exposure to the elements.

Sterilization Durability Testing for Medical Devices

Sterilization durability testing is a little more involved. Many modern medical tools are complex. They include integrated sensors and electronics, and are composed of a variety of materials held together with epoxy. Nonetheless, medical teams will still need to sterilize that tool between each procedure, just like any old scalpel. Sterilization durability testing means running such a tool through an autoclave repeatedly, using a hospital-style protocol, in order to establish a benchmark for how many procedures hospitals can expect the tool to survive.

Here, the advanced programming capabilities and flexibility of a Priorclave lab autoclave are especially useful. Every Priorclave ships with a fully featured control system that makes it possible to vary temperature mid-cycle in order to emulate the temperature ramps inherent in hospital-style sterilization (or any other protocol). More importantly, Priorclaves are capable of not only extended cycle times (up to 999 hours each) but Automatic Cycle Repeat (up to 999 consecutive iterations). This is something that’s simply not possible with many FDA-approved medical sterilizers. That means that each sterilization cycle needs to be manually triggered.  By combining precise cycle programming and Automatic Cycle Repeat, engineers can subject a prototype component (or entire finished surgical tool or prosthetic device) to hundreds of identical sterilization cycles without human intervention or “babysitting.”