A Closer Look at State-of-the-Art Clean Room Packaging & Assembly


In the medical device industry, it’s the topic on everyone’s minds, at all times. And for good reason: risk affects patients and outcomes, supply chain and productivity, manufacturers’ reputations, and companies’ bottom lines.

Risk can take many forms, one of them being the risk inherent in designing and validating medical packaging that ensures devices get to—and into—patients safely. To address and manage this specific type of risk, it’s critical to establish and maintain superior quality systems. Meticulous attention to detail during the cleaning, sterilizing, and packaging processes can help reduce patient risk by ensuring that a product is 100% clean, sterile, and ready for aseptic transfer in the operating suite.

At Millstone, we maintain stringent quality systems on par with those of our OEM clients. With 15,000 square feet of class 10,000/ISO7-rated clean room operating space, including state-of-the-art equipment and quality control processes, Millstone can help you reduce risk and safeguard patient safety through the medical packaging process. Here is a closer look at the technology in our clean room.

Real-time Particulate Monitoring System

Real-time monitoring of the environment ensures that we constantly and consistently maintain the highest standards for this environment. Constant monitoring also enables us to guard against downtime, helping us meet urgent daily timelines for packaging, cleaning, distribution, and other post-manufacturing and aftermarket services.

Tray & Bar Sealers

ISO 11607 and CE compliant, our tray and bar sealers are 100% validatable and calibratable, ensuring we can meet the needs of an array of packaging configurations that successfully pass the validation process.

Vacuum and Nitrogen Flush Technology

Removing the ambient air or reducing/removing the oxygen in a package can extend its shelf life and ensure cleanliness. With our expertise in a variety of processes for cleaning, sterilization, and packaging, we can meet a wide array of customer needs in a single facility.

Fast Lane Pouches

These pre-validated pouch packages can fit medical devices of a variety of different dimensions. Pre-validated packaging solutions can cut time-to-market up to 50% by accelerating the traditional package validation process. Fast Lane pouches can fit up to 80% of spine and extremity products.

Peel Testing

Peel testing measures the seal strength of packages to determine if they can withstand the stresses of distribution. Typical tests measure the force required to pull a one-inch strip of the sample packaging and can determine if there are areas of weakness in a package design that may present risk during transit.

Our clean room capabilities include:

  • Medical kitting and assembly
  • Poly-bagging and tubing
  • Boxing and labeling
  • Reboxing and relabeling
  • Overlabeling
  • Shrink wrapping

Any medical device manufacturer must be constantly vigilant in addressing the risks presented during the medical packaging process. An expert partner can be invaluable in helping to establish and maintain quality systems and processes to ensure patient safety as well as speed and efficiency in go-to-market timelines.

At Millstone, we get it. We believe quality drives patient success. That’s why we’ve perfected all the capabilities medical device manufacturers need to get to market. Today we offer post-manufacturing and aftermarket services to more than 50 customers, including some of the top 10 orthopedic companies in the world. We are constantly evolving our processes and services to help OEMs achieve sustainable success. We offer clean room packaging, medical device specific warehousing, finished goods distribution, loaner kit management, advanced inspection and reverse logistics services—all with an unparalleled focus on quality.

What could we help you do better? Learn more at http://millstonemedical.com.


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