Many of the medical devices found on the market today must pass rigorous sterilization testing before they can be placed into a patient’s body. With medical companies around the world increasing their focus on proper sterilization planning and testing, we decided that we would use this week to talk about sterilization management and how it plays into the design and manufacturing of a device.
What do people mean when they talk about “sterilization management”?
According to Jake Wakley, VP of Quality at Biomerics, “Sterilization management encompasses a multitude of processes. Sterilization validation, bioburden testing, sterilization documentation, and the management of the sterilization supply chain are all pieces of the sterilization management process.
“Unfortunately, when most people hear the words ‘sterilization management’ they think it only relates to the logistics and delivery of devices to and from the manufacturer and the sterilization facility, but sterilization management covers so much more than that. Any design or manufacturing process associated with the sterilization of a device falls under sterilization management.”
When does sterilization occur? When is it planned for?
“The sterilization process typically happens after the final assembly and packaging of the device,” explained Jake. “In certain cases, sterilization is performed after the primary packaging processes are complete. In this situation, the device is packaged, sterilized, and then packaged once more for final delivery.
“For device sterilization to be successful, it must be addressed and planned for during the design and development of the device. If sterilization isn’t planned for during the early stages of the design lifecycle, the device can run into costly problems down the road. For example, certain materials are resistant to certain sterilization techniques. If a device is designed without sterilization in mind, it could be made of a material that can’t be sterilized by the preferred method. When this happens, the device must be redesigned and revalidated with a new material or an alternate sterilization technique must be employed. This mistake, although easily avoidable, can end up costing a company time and money.”
Is sterilization necessary or required?
When asked this question, Jake answered, “Whether or not a device needs to be sterilized is the decision of the device owner/designer. Some devices don’t require any sterilization at all, while certain reusable devices require a round of sterilization after each use. The device owner/designer must considers a variety of factors to determine what type (if any) of sterilization to use—inputs such as the device’s material composition, application, and manufacturing environment are typically the most critical when deciding which sterilization route to take.”
Does sterilization take up a significant amount of time or cost?
“This depends entirely on the device and its manufacturing requirements,” explained Jake. “Before devices can be sterilized for patient use, the sterilization process itself must be validated and various types of testing must be performed. Aside from the validation and testing time, the actual sterilization of the devices can take longer than all of the other manufacturing processes combined, depending on the type of sterilization and type of device.
“Sterilization costs can fluctuate greatly from device to device. Generally, however, sterilization is a fixed cost; a chamber is rented and the manufacturer can place as many devices as they want into it as long as everything fits reasonably and the validation accommodates a full chamber. Due to this pricing structure, manufacturers often wait until they have enough devices to fill a chamber, as it lowers the per piece sterilization cost. Shipping is an important, but often overlooked, expense that can significantly impact sterilization costs. Because only a select few companies are modeled and certified to sterilize devices, the location of the manufacturing facility where the device is being made can affect the cost of sterilization greatly—if there isn’t a sterilization facility within a reasonable distance of the manufacturer’s plant, shipping expenses can end up being well above what was expected.”
What sterilization management solutions does Biomerics have to offer?
At Biomerics, we understand that sterilization management begins with product design, which is why we partner with our customers to develop the sterilization plan that brings their devices to market in the most efficient way possible. We have the necessary experience and expertise to validate sterilization processes, maintain sterilization qualifications, and manage the entire sterilization supply chain. Our engineering team supports customers throughout the material selection and device development stages to ensure that the optimal sterilization techniques and methodologies are utilized.
To learn more, send us an email (email@example.com), give us a call (801-355-2705), or visit the Sterilization Management section of our website.
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