Changing Orthopedic Devices Inspire Sterilization and Packaging Creativity

Packaging and sterilization is most often the last step in the medical device before a device reaches the market. It is as important as any other step in the supply chain of the product, but because it comes right at the end, packaging and sterilization providers are expected to be extremely fast and efficient. At this stage of the device’s life cycle, all the hard work has been done: Research & development, design, manufacturing and clinical trials have been completed; U.S. Food and Drug Administration (FDA) regulations have been met; OEMs are eager to get the device out the door and into the hands of those who need it.

Several factors can come together to slow down this last step of device development, but service providers try to stay on top of any surprise that might come along. President of Millstone Medical Outsourcing LLC, Kelly Lucenti, has noticed an uptick in disposable products for the orthopedic industry, and new materials can pose challenges to companies who need to make sure packaging materials and sterilization methods do not cause harm to products made out of new, novel materials.

“There’s a trend toward the disposables in the orthopedic industry,” Lucenti told Orthopedic Design & Technology. “There are disposable instruments with special requirements affecting the ability to be able to ultrasonically clean the product. Ultrasonic cleaning and sterile packaging are standard processes designed to keep the bioburden low. These new polymers have different humidity and moisture requirements, so we have to look at them differently and we have to be creative at times. We have to make sure they still pass the cleaning validation. They have to pass the sterilization validation, but it’s a little bit different than how we’ve handled it in the past.”

Although Millstone focuses heavily on orthopedic devices, and those don’t usually include electronic components, the company does come across electronics from time to time. Sterilization methods in place today have been in use for years, and there is little need for radically updated methods. Irradiation serves most product sterilization needs, and devices that cannot withstand the high heat and radio waves of gamma sterilization usually undergo ethylene oxide sterilization (EtO). However, this gas-based sterilization method still poses the challenge of humidity.

“[Sterilizing electronic devices] is definitely a different process, but it’s the same process that we’ve done with electronics for years now,” said Lucenti. “There haven’t been a lot of changes over the years in how we handle the process. It’s very customer specific. Some products come in to Millstone and they’ll be double-bagged and cleaned at the manufacturer. Millstone then opens them up inside our clean room and performs the sterile packaging here. And then there are other customers who have us do [an alcohol] wipe on certain sections so we can reduce the bioburden but not affect the quality of the instruments.”

Millstone has more than 8,000 square feet of class 10,000 and ISO 7-rated clean room operating space. The company’s facilities also have class 100 laminar flow hood for syringe-fill operations, argon gas glove box operations for oxygen-free processing, and a dedicated sterile-process-only ultrasonic clean line.

Lucenti said that one of the first steps to understanding how to package or sterilize an OEM’s products is to review the dimensions and materials of the device. That way, he said, Millstone “can understand exactly what their needs are and what might be best, whether it’s going to be a pouch, a thermoform tray with a lid, a nitrogen flush because the polymers, or whether the materials they’re using are sensitive to oxygen, which we have to work around so the plastic doesn’t degrade over years.”

“In our industry a lot of the products are me-too products,” Lucenti continued, referring to devices that are cleared by the FDA under the 510(k) program. Products cleared with 510(k)s are based on comparable devices that are already on the market.. “The trick is that it’s all about time to market and passing the validations that are required. So they may turn to Millstone so they can launch a product in half the time that it would take internally because we have a dedicated crew. If an OEM performs packaging and sterilization internally, they’re borrowing and sharing resources; we have a team dedicated strictly to passing these validations and bringing something to market quickly.”

Millstone also recently added advanced inspection, which is usually performed by OEMs themselves. According to Lucenti, it is one of the fastest growing services Millstone currently offers, which suggests how eager OEMs are to outsource such final-stage processes.