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Cleaning and packaging validations are often treated as “we’ll get there when we get there” requirements during orthopedic product development projects. That’s the wrong way to view validating the processes, which require a strategic approach from the outset to reduce risk, avoid costly delays and launch successful products.
Wesley Gensch, Sales and Global Key Account Manager – Medical at Ecoclean, and Gregg Olson, Chief Commercial Officer at Millstone Medical, shared common — and often overlooked — problems that can hamper validation efforts and ways to prevent them from derailing new product commercialization.
Standardize the Methods. Gensch revealed a misconception he sees across the industry that undermines cleaning validation efforts. “OEMs often think that a process description equals a process outcome,” he said.
A documented process might outline how a device should be cleaned, but Gensch said it rarely captures the full range of variables that determine whether the cleaning is performed as intended. Key factors such as how parts are fixtured in the cleaning unit, the capabilities and variability of ultrasonic systems and the condition of the cleaning bath can significantly influence outcomes.
That gap becomes especially apparent during cleaning validation, which is typically done under ideal operating parameters. But real-world environments are very different. Equipment runs continuously. Bath quality degrades over time. Residual buildup and repeated use introduce variability that isn’t always accounted for during initial validation.
This disconnect can lead to not understanding true worst-case conditions. What is defined as “worst case” in a validation protocol may not reflect realistic environments.
“OEMs need to look beyond process descriptions and focus more deeply on how those processes behave over time and under real operating conditions,” Gensch said. “Those are elements that companies could focus on a little better.”
Address the Variables. The challenge of transferring validated processes such as work instructions, cycle parameters and acceptance criteria from one cleaning system or environment to another shows up in the design and validation of machine systems.
Challenges arise when OEMs attempt to standardize cleaning practices across multiple manufacturing sites or transfer validation assumptions that are built on legacy methods of testing into newer technologies or more precise measurement systems. Engineers need to avoid replicating prior validation frameworks and critically evaluate whether newer measurement approaches provide a more accurate reflection of real-world conditions.
According to Gensch, cleaning validation and documentation practices vary significantly among OEMs. Each organization tends to develop its own internal language and preferences for how systems are documented and validated. That creates in-house consistency but adds to the complexity when companies diversify their manufacturing sites or transition to newer technologies.
User Requirement Specifications (URS) provide a detailed framework that defines what a cleaning machine must be able to do, but Gensch notes that these documents often emphasize capabilities more than how those capabilities will be validated in practice.
That’s where gaps can emerge and even well-designed systems can become difficult to transfer cleanly from one machine or environment to another. To address this issue, Gensch said, some companies are beginning to integrate validation protocols into factory acceptance testing (FAT) and site acceptance testing (SAT) to document and request that cleaning machine qualifications are tested and delivered.
Reduce Human Error. Automation advances have helped standardization cleaning processes, but the variability that people introduce is difficult to eliminate entirely. For example, the way parts are loaded into cleaning systems varies from person to person.
“Even seemingly minor differences in hand size, height and handling technique can influence how components are positioned, which can cause ultrasonics to hit parts differently,” Gensch said.
These variables are mitigated through improved fixturing of the parts to be cleaned and smarter mechanical design of the baskets that hold them. Gensch said his team has spent considerable time thinking through operator differences to reduce variability in how parts are placed and secured in cleaning units.
Human error can also show up in more basic ways. One of the most common, Gensch said, is simply running the wrong cleaning program.
Barcode scanning and smart systems help confirm the right programs are run for the right parts, but Gensch believes that automation needs to be paired with intelligent software and Programmable Logic Controller (PLC)-level awareness. If a system is designed to run different part families under specific validated cycles, the machine should be able to recognize mismatches in real time.
Typically, batch paperwork accompanies incoming parts, and when those parts are loaded into a cleaning batch, maintaining lot integrity is essential. Assigning a unique barcode or identification number to each tray provides an added level of control and is particularly beneficial when running multiple part types within the same basket.
“Traceability is massively important and upfront programming is essential, especially when working closely with customers to define the full scope of the cleaning process,” Gensch said. “While scope creep is a real and understandable challenge, it’s far better to address it early in the process.”
Drill Down to the Specifics. Gensch believes device manufacturers often combine too many objectives into a single, generalized cleaning goal. Attempting to address manufacturing residues and organic contamination without clearly distinguishing between the two creates potential issues.
Gensch suggests designing specific cleaning steps that directly address identified residues rather than relying on broad guidance about what each step is expected to accomplish.
“We often test what we can see or what we can easily reach, but residues can form in complex geometries such as blind holes, internal channels and hidden cavities, even when external surfaces appear clean.” he said. “Testing only the surface might generate a positive validation result when testing should include the worst case.”
By shifting the focus toward worst-case conditions and hard-to-reach areas, newer approaches such as vacuum-assisted cleaning and vacuum passivation aim to validate cleaning performance more realistically across the full geometry of a part.
“That’s been a massive improvement in cleaning validation in recent years,” Gensch said.
Leverage Existing Solutions. Gregg Olson, Chief Commercial Officer at Millstone Medical, said packaging validation can carry significant lead times, so reusing existing solutions can speed time to market.
For example, a company that’s developing a new spine implant should evaluate their current portfolio. In many cases, existing packaging configurations used for similar products may be suitable predicates, allowing for streamlining the development process and avoiding unnecessary revalidation work.
The need to start from scratch when validating a current packaging solution depends on how much you plan to change in the base system’s design. When using a Tyvek peel pouch to maintain the same materials and sealing process, you can often leverage your existing validated packaging. Staying within established parameters can significantly reduce the need for additional validation work.
Ensure Up-to-Date Labeling. Unlike packaging systems, which typically remain consistent after validation, product labeling may be updated more frequently. Even minor changes — adding a new claim at product launch or updating a statement once a pending claim is approved — must be reflected in the labeling language.
Even if the packaging and sterile barrier system are fully validated, incorrect labeling can result in FDA noncompliance. Ensuring that all labeling is current and accurate is a critical component of a comprehensive regulatory strategy.
“Generate labels by accessing the quality management system and pulling the most current, approved version,” Olson said. “This creates a built-in checks-and-balances to confirm that all labeling is up to date.”
Maintain the Sterile Barrier. Packaging components are typically sourced separately. Orthopedic companies could procure a thermoformed tray from one supplier and a Tyvek lid from another and rely on their packaging provider to perform the final heat-sealing operation.
“A critical part of sterile barrier system validation is ensuring seal integrity, which is typically verified through pull testing to confirm that the heat seal consistently meets required performance standards,” Olson said.
Sterile barrier verification is not a one-and-done activity, however. The initial validation must be continuously monitored through ongoing AQL (Acceptable Quality Limit) inspections to ensure the sealing process continues to produce validated results over time.
Consolidate Outsourcing Services. If you’re outsourcing sterile packaging, supplier selection becomes critical. According to Olson, one of the most important criteria should be a proven track record of meeting aggressive project timelines. “You want a partner who can execute quickly while still maintaining full regulatory compliance and proper validation,” he said.
“We’ve found that many OEM customers prefer not to manage multiple suppliers,” Olson added. “Instead, they favor a ‘one PO’ approach in which a single purchase order is issued to a packaging partner that oversees the entire process.”
Under this model, the supplier coordinates suppliers, performs the sterile barrier testing and manages the sterilization process. They also oversee post-sterilization activities, including sterility and release testing, to confirm the product has been effectively sterilized and meets required specifications.
“With that single purchase order, the customer receives a sterilized, finished good,” Olson said.
Editor’s notes:
Secure your spot at OMTEC 2026 to attend Wesley Gensch’s in-booth presentation about the importance of standardized cleaning processes.
