A vital stage in developing an orthopaedic device is to design and then validate a proper, efficient and ultimately effective packaging configuration. Product packaging and sterilization must go through extensive validation processes, following stringent standards. Yet companies may not leave ample time to plan and execute on packaging, which can lead to missteps.
Common problems that OEMs face during packaging validation include determining what validations are actually necessary, understanding all timelines and costs associated with each validation type and re-executing if validation fails. OEMs have to understand packaging validation requirements to attain smooth and successful product launches. A failure during the process can create significant delays in reaching the market.
Further, failure in the field (either from unpreparedness or not being well-equipped to overcome challenges) can lead to expensive product recalls, liability and ultimately harm to the end user.
With these considerations in mind, we spoke with medical device packaging consultant Mr. David DiVaccaro, a Six Sigma Certified Process Excellence Black Belt who has worked in the medical device and pharmaceutical industries for over 25 years. He is also a contributing author to The Medical Device Validation Handbook.
What are the different validation steps in packaging design?
DiVaccaro: Design is focused on meeting and exceeding customer needs. These include product protection, such that the packaging maintains functionality, is undamaged and is able to aseptically transfer the product to the sterile field. All of this assumes that package integrity is maintained. Once the needs are identified, we move into prototyping and feasibility. Prototyping can be used to garner customer feedback before spending substantial amounts on tooling and verification activities.
Feasibility is an engineering study activity typically achieved by subjecting the product/package to worst-case sterilization, environmental conditioning and distribution simulation to ensure that the package maintains integrity and properly protects the product. It’s not unusual to experience some failures in feasibility. This allows for root cause determination, where modifications can be made to ensure confidence prior to formal design verification.
Have validation steps changed in recent years? Do you expect them to change in the future?
DiVaccaro: Not substantially, but documentation requirements have increased. Specifically, there seems to be significantly different levels of scrutiny for the larger vs. smaller companies. Not long ago, large companies were doing feasibility studies very informally with little to no documentation. Some now require full traceability, a pre-approved feasibility plan, technical reviews, production records, etc.There is an interesting balance between companies that only know how to follow their standard operating procedures and are not privy to the “spirit” of the standards, and those that understand the intricacies of medical device packaging and inherently cover all the bases.
I don’t expect validation steps to change significantly, but all of the processes are subject to continuous improvement. For instance, several companies still seek to improve their test method validations. This is not a new requirement, but the science is always improving to support more robust evaluations.
Which specific validations are most challenging for companies, and why do those challenges continue?
DiVaccaro: Relative to packaging, we are tasked with process validation, design verification and stability testing. Whenever a product requires a modified atmosphere (such as protection from moisture exposure or oxidation), the complexity is exponential in all of the validations.
Process validation requires a detailed understanding of the sealing equipment and packaging materials to be sealed. Typical documenting procedures would be Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ):
- IQ: Objective evidence that the manufacturing equipment is installed and connected to appropriate utilities in accordance with its approved design criteria and the manufacturer’s specifications.
- OQ: Objective evidence that the process equipment and ancillary systems as defined in the IQ are capable of consistently operating within established limits and tolerances.
- PQ: Objective evidence that the process is effective and reproducible and that the outcome produced meets all requirements for safety and efficacy.
Packaging materials and designs can present large variables in process validation. The premier medical device packaging equipment manufacturers stay up to date with regulatory and validation changes that affect their customers, and can be great partners in developing, executing and maintaining stable, reproducible processes.
Good sealing technologies involve systems that have a constant heat source and mass that evenly distribute the heat, ensuring against significant fluctuations and monitoring systems with alarms that prevent the operator from sealing a package if the temperature is not in the validated range. Alarms should also be in place for pressure and time. Trying to validate inexpensive sealing technologies or materials normally results in significant extra resources and continued process monitoring that far outweighs the original capital costs of high-quality, reliable systems.
There are some inexpensive sealers that are very difficult (some would say impossible) to “validate” and therefore require significant resources in ongoing verification, such as lot-by-lot testing of seal strength and seal integrity in order to demonstrate confidence in the sealing process. This wastes materials, operator and testing technician time when compared to a fully validated machine with alarms in place and lockouts that are validated to a high level and can be confirmed less frequently to still be producing quality results.
Regarding materials, major film and coating suppliers have listened to their customers and developed coatings with wider sealing ranges and better performance during distribution testing. Device manufacturers are now challenged to qualify their sealing processes and generate the aging data to use these new and improved offerings.
Some packaging material combinations cause difficulty in differentiating good from bad seals when performing visual inspection. For example, depending on the mating film (sealant) layer, the “adhesive transfer” that remains after peeling an uncoated Tyvek/film pouch may not appear homogeneous, even though it is a good seal. In this case, it can be challenging to provide visual guidance to operators indicating the differences in “homogeneous transfer” for different material combinations, especially because most operators would have difficulty knowing whether a pouch used coated or uncoated Tyvek.
Design verification involves material selection, specification and testing of the sterile barrier system. Tests involve sealing and sterilizing worst-case products in worst-case conditions, performing environmental conditioning, distribution simulation and then inspections to confirm sterile barrier maintenance, aseptic transferability and product protection. This area seems to exhibit the most variability in companies’ interpretation of standards like ISO 11607-1: Packaging for Terminally Sterilized Medical Devices; Requirements for Materials, Sterile Barrier Systems and Packaging Systems. Staying updated on the standards, engaging in discussions with other experienced medical device packaging professionals, referring to ISO 16775: Packaging for Terminally Sterilized Medical Devices and receiving guidance on the application of ISO 11607-1 and ISO 11607-2 Validation Requirements for Forming, Sealing and Assembly Processes can all help with interpretation.
Stability testing revolves around the aging of the packaging system. Most regulatory bodies permit the launch of a system with accelerated data, but must be accompanied by an ongoing, real-time aging study. Some products and packages have interaction and must be aged together. Others may be aged separately, but proper rationales must be included in the documentation. With high-quality materials, sealing systems and proper storage, the risks of failing stability are typically low.
What steps do successful companies take to ensure that validation is met with a timely response?
DiVaccaro: Planning is critical; keeping up with regulatory standards is invaluable. A culture of continuous improvement and desire to be best-in-class, instead of just meeting minimum requirements, sets companies up for long-term success. Detailed procedures and protocol/report templates help ensure that critical elements are considered. Additionally, membership in the Institute of Packaging Professionals (IOPP) and learning events, such as the HealthPack innovative technology conference, can keep your team up-to-date with requirements and lessons learned.
I advocate that the time to engage your packaging development team is as soon as you know you have a viable product. This way, they can plan for any special materials or sealing operations that might be required for the product and ultimately provide the company with a high quality sustainable solution.
How should companies think about validation, considering that speed to market is a constant pressure?
DiVaccaro: Packaging platforms that use established materials and designs that are future-looking can obviate the need for new validations, going forward. Ideally, designs are tested worst case, and the new products fall within the “bracketed footprint” and do not create a new worst case. Therefore, they can be rationalized as “no new risk” and no new packaging validation/verification would be required. This all takes a fair amount of advance planning, but can pay significant dividends in speedier time to market for subsequent products. These packaging platforms can apply to design, process and aging.
Forward-looking packaging designs/systems that have a high probability of success are:
- Designed with sustainable materials
- Purchased from reliable suppliers with solid business continuity plans
- Intuitive for operators to assemble
- Robustly designed to protect the intended range of products and maintain package integrity (thus a new validation is not required if the new product fits within bracketed criteria of the prior validated products)
- Intuitive for user interaction in the surgical suite
These types of packaging designs are geared toward a range of products, such as a femur packaging platform that is similarly designed but may have three different sizes to support small, medium and large. Same goes for hip stems, cups and tibia trays. Examples include Arthrex’s Total Knee Arthroplasty Femoral Packaging System and Wright Medical’s Extremities Clamshell: A Universal Packaging System Design. Each won IOPP Ameristar Awards in 2013.
I think companies use these strategies more often as validation/verification becomes more onerous. If a new blockbuster product doesn’t fit in an existing packaging platform, new systems could be developed to help that become a new platform for whatever made it unique. But the use of existing designs, assuming that they are well documented, is typically the fastest speed to market.
What trends do you see in orthopaedic device packaging design? How do these help to address the robust validations that companies face?
DiVaccaro: Materials suppliers are listening and can help provide targeted solutions for product protection. If they don’t have an off-the-shelf solution, they have design resources to help provide alternatives.
With some forethought and involvement from product development specialists, packaging engineers can create platform solutions and subsequent validations that, when executed and documented properly, can minimize the need for revalidation for the foreseeable future.
Mr. DiVaccaro is a long-time member of the IOPP, currently serving as the Ombudsman for the IOPP’s Medical Device Packaging Technical Committee. Since 2013 he has consulted with medical device firms as part of DiVaccaro Consulting Group, LLC.