2 1 Incorporate packaging early in the product development lifecycle Without firsthand experience in packaging, many team members think packaging as a simple last step in getting a product to mark. Have you ever heard someone say “just put it in a pouch and a box”? Unfortunately, packaging development can be a lot more complicated, costly, and time consuming than originally thought causing disruption late in the game. Major considerations: Packaging design (time, resources, complexity) Manufacturing planning (demand, capacity, layout, personnel) Lead times for tooling and materials (dies, molds) Lead times for equipment (sealer, printer, test equip) Screening, benchmarking, and challenging Validation activities such as sealing qualification, transportation testing Sterilization validation Labeling development and UDI compliance Accelerated and real time aging Training / implementation Planning, scheduling, and budgeting appropriately can mean the difference in a successful product launch or significant delay. 2 Perform a Product Package Assessment (PPA) Engaging the packaging team early is half the battle – making the most of the opportunity is the other half. This step is about asking the right questions, capturing key information up front, and feeding that into the project plan, schedule, and budget. Have you considered? Countries of Sale User needs Marketing requirements Sterilization Product morphology Device sensitivities Shelf life Product mix and volume Distribution channel Manufacturing environment Labeling strategy Responses to these questions create design inputs that can be used to establish design requirements, design constraints, and subsequent design verification/validation requirements. These also are pertinent to risk management activities such as DFMEA, Hazard Analysis, etc. While these topics may not have an 4334 Brockton Dr SE Suite E Kentwood, MI 49512 www.pkgcompliance.com 616.227.4540 3 answer up front, or may evolve with time, it is important to start the dialogue and plan accordingly. The PPA is just one of the many tools that PCL uses to deliver “Speed to Market with Confidence.” 3 Evaluate several types of packaging systems and sealing equipment Unfortunately there isn’t a one system fits all when it comes to medical device packaging. Many varieties exist including pouches, trays, sleeves, bags, tubes, cartons and more. Equipment can range with tray sealers, bar sealers, band sealers and form-fill-seal machines all that do something unique. Many companies mistakenly revert back to what was used on previous projects, which may be expensive, inadequate, or not applicable to the next project. It is critical to evaluate each product- packaging system uniquely, containing its own unique challenges. During this “Design Concept” or “Napkin Sketch” phase (that’s what we call it at PCL) it is imperative to compare alternative designs side by side and evaluate for: Fulfillment of design requirements identified during the PPA Capital requirements including equipment, tooling Staffing / personnel requirements Manufacturing capacity / throughput Total packaging system cost including materials, protective packaging, waste, labor, sterilization, other soft costs Schedule Project complexity and risk 4 Create Prototypes and perform feasibility testing Feasibility studies are the key to optimizing packaging design for performance and cost. Blindly selecting a packaging design, making the investment in materials and tooling, and moving into validation without upfront due diligence can be a recipe for disaster – we call it the Hail Mary approach. There is not a crystal ball that will give you insights on the success or failure of your project, but feasibility testing is the next best thing! We encourage our clients to make data driven decisions on packaging design by prototyping and verifying performance before moving forward on a project. This doesn’t have to be a costly exercise, get creative! Hand-cut larger Tyvek pouches down to size, create 3-d printed parts, mock up corrugated designs using scrap boxes, use nuts/bolts to simulate weight. Many packaging material suppliers have ways to quickly and efficiently create prototype parts and are happy to support this effort at your request. Take those prototypes and challenge them. Perform screening and benchmarking studies and simulate worst case conditions. Results of feasibility testing can uncover potential failure modes, highlight areas of concern, or provide confidence in a package design before initiating qualification/validation activities. A simple drop and vibration simulation on your proposed packaging system will make for a good night’s sleep. 4334 Brockton Dr SE Suite E Kentwood, MI 49512 www.pkgcompliance.com 616.227.4540 4 5 Create a Risk Management strategy and stick to it. It may be surprising to learn that the FDA considers packaging to be an element of the product itself. This means that packaging development activities require the same design control and risk management scrutiny that accompany device development. Design Control ensures that there are clear design & performance requirements, tracks the evolution of designs as they progress through a project; and covers the verification / validation of designs through services offered at PCL such as package integrity, simulated distribution and shelf life testing. Risk management is how risks in designs and processes are identified, what effects those risks might have (especially on patient safety), and how those risks are mitigated through the use of design improvements or process controls. PCL has developed many tools and templates that can be used during packaging development to ensure that key requirements are not forgotten. Outputs of these deliverables will drive decisions on validation strategy, sample sizes, process controls, and many other important considerations that keep your project audit-friendly. 6 Evaluate Labeling requirements Labeling is critical for safe and effective product use. Key elements include reference numbers, product description, lot numbers, expiration dates, quantities and identifiers that healthcare professional rely on prior to using a device. Additionally, the FDA is rolling out the Unique Device Identification (UDI) program that requires all medical devices to be uniquely registered in a public database and be labeled with specific content Key aspects for successful UDI implementation: Procurement: all products must have a UDI which can be obtained from several FDA-accredited issuing agencies. Identification: The UDI must be added to the product label and include Device Identifier (DI) and the Production Identifier (PI). This is displayed as a barcode and human readable text. Registration: It is required to register the UDI with FDA’s Global UDI Database (GUDID). Implementation: The final step is to adhere to FDA established timelines. PCL has developed a quick-implement program for companies seeking UDI compliance. 7 Be aware of key requirements for packaging OQ / PQ activities Many medical device manufacturers mistakenly treat packaging process qualification (e.g. forming and sealing validation) the same as other assembly qualifications. But there are some key differences: Define Package Families: It is vital to properly plan. It is not sufficient to perform a process qualification on a PET/Tyvek pouch and then assume a Nylon/Tyvek pouch is also qualified. Differences in materials, size, process settings, and sealing technologies may drive multiple process qualification activities. 4334 Brockton Dr SE Suite E Kentwood, MI 49512 www.pkgcompliance.com 616.227.4540 5 Define the Critical Process Parameters: The focus of validation efforts should be on to the defined parameters. Usually this consists of time, temperature, and pressure but others may be identified depending on the unique nature of the process. Optimize Process Window: Before entering OQ / PQ, properly optimize the process window using engineering studies such as Design of Experiments (DOE). ISO16775 Annex Q provides some excellent tools and discussion. Define Quality Attributes: Per ISO11607-2, critical to quality characteristics for sealing include seal integrity, seal width, punctures/tears, wrinkles/creases, peel-open characteristics, and process repeatability/reproducibility. Don’t miss them. Be Production Representative: PQ should be treated as production-representative, meaning the use of trained operators, following written work instructions, producing typical lot sizes, and incorporating product or simulated product. Have a Plan: Establish Lower Process Limits (LSLs) for seal strength and film thickness. Auditors are beginning to ask “why is that 1.0lbs/inch the LSL”. It is best to develop your own LSLs uniquely based on capability of the process and subsequent validation of worst case process limits during transit testing and aging studies. Defending your protocols in front of an FDA auditor is never a welcomed task but being equipped with rock solid IQ/OQ/PQ documents will give you the confidence that all details have been accounted for. 8 Properly define “Worst Case” ISO11607-1 addresses “worst case” in three areas and in each case, it means something slightly different. Start by understanding these key definitions: Sterile Barrier System – this is minimum package which prevents ingress of microorganisms Protective Packaging – configuration of materials designed to prevent damage to the sterile barrier system and contents. Packaging system – combination