The COVID pandemic has created a massive demand for medical packaging.
Experts project that the value of the global Medical Device Packaging Market will rise by $31 billion by 2028 (from $31 billion in 2020 to $62 billion), with North America holding 37.9% of the market share by 2027.
While a broad range of factors, such as the prevalence of chronic diseases, innovations in automation, and Digital 4.0, drive this demand at a geometric rate, there are also universal parameters to which every producer must hold:
“All medical packaging must maintain sterility across the supply chain and preserve the quality and integrity of the product by protecting it from damage and contamination at every stage.”
That is a given.
However, although these truths apply to all packagers within the sector, medical packaging methods and systems vary from packager to packager, making them unique.
As a producer, you have a specific formulation for the capacity of your potential packaging system, the size of your products, and operational requirements. These parameters affect everything from packaging web width and the mechanical advance to ancillary systems (printers, vision systems, etc.) and the overall size of your machine.
Most importantly, this also means implementing thermoforming for your medical packaging is never a “one size fits all” proposition.
As a result, collecting and providing as much mechanical and process data as possible is essential – even from the earliest stages of system conception. This information gives your equipment vendors direction concerning your thermoformer machine design, manufacturing, installation, and maintenance. It can also ensure peak performance for your medical packaging, allow for easy scalability for the future with minimal interruption and expenditure, and provide an overall system layout to ensure a suitable physical footprint and system size for your facility and clean room.
What Do My Equipment Vendors Need to Know?
Designing and optimizing thermoforming equipment for medical packaging takes time and depends on a variety of custom factors. However, there are specific criteria that, when obtained, can determine precise throughput speeds, explicit packaging materials, film-forming times, and more for your thermoforming system:
Begin by defining capacity for your thermoformer. This data helps you understand essential operational factors, such as cycle rates, number of operators needed to load product, number of loaded products and the array for machine design, and the process timeframe for line balance.
Determining capacity begins with inputting basic numerical values to determine cycle rates for your unique production.
For instance, if you need 60 parts per minute as a production rate, that means, according to the available equipment and product size, there would be a 6 x 1 tooling ratio. So using those values as factors in the calculations would measure a 10-second cycle rate.
But along with cycle rates, capacity also touches upon other factors such as:
The inclusion of manual labor in your operations requires physical space for standing or sitting. Therefore, understanding how products will be presented on the line, the cycle rates, and the worker array is vital. This information not only determines the number of manual workers necessary but also allows for the creation of what is called a “knee-free area” (open bottom of the thermoformer) to accommodate your workforce comfortably.
Web Width & Draw Depth for Thermoformed Medical Packaging
One of the first questions your film vendor will ask is:
“What web width do you need?”
To answer this question, you must know your product dimensions and the capacity of your machine.
Determining overall capacity and packaging more product means increasing your thermoformed package’s overall web width (and sometimes draw depth). While the draw depth can be customized to up to 210mm with specialized inserts, web width is generally specified once during machine design (420mm is most common). Ultimately, the size of the machine determines the web width (ranging from 110-1000mm) during the design phase.
Thermoforming machinery is always fit inside a whole production process. Cycle rates help to balance your line overall. When you know the correct cycle rate, your thermoforming equipment can create corresponding pockets for your product at the same rate. This process minimizes material and product waste, as well as performance lapses, and balances the line.
Functional Requirements for Thermoformed Medical Packaging
Functional requirements center around determining the requisite seal strength and width necessary for product to survive after the thermoformed package has been created.
While the medical packaging industry sets standards around these values (6mm seal width for medical packaging with a 1-lb minimum for each 1-inch cut strip), your thermoformed packages may require customization. Perhaps you need a tamper-evident package or a package with tight tolerance on the opening force. Functional requirements will always be tailored to your unique operations.
Understanding and communicating these customizations, required materials, and downstream packaging needs help equipment vendors to design the right sealing equipment (more controls for the sealing stations and plates) beyond these industry standards to optimize overall seal strength and width overall for your thermoformed medical packaging.
Labeling for Thermoformed Medical Packaging
Modern medical packaging offers various dynamic technologies for inline printing and labeling. Whether you select static preprinting, variable inline printing, or a combination of both capabilities on the same machine, your choice will affect the color scheme and combinations for your print apply and medical package labeling, as well as your machine’s printer model and design.
Static preprinting creates a singular design according to your product requirements that is then imprinted onto large film rolls via a third-party film vendor. This film is then fed continuously into your thermoformer machine during production for accurate, uniform labeling.
Equipment vendors accommodate static preprinting by integrating numerous internal mechanical features, such as photo eyes and registration marks, to precisely locate the printing within the machine and place it accordingly during high-speed production.
Unlike static preprinting, variable printing allows medical packages to be individually customized during the digital printing process. These customized elements can be anything from Unique Device Identifiers (UDIs) to Serial Numbers.
This information is essential for equipment vendors when determining your labeling. It designates the printer model and design and, subsequently, provides a way for inputting unique, shifting data to be printed inline.
Validating Your Thermoformer
Providing the unique production parameters and requirements for your thermoformer is the first critical step in optimizing your operations. It provides your vendors with precise operational requirements according to your space, budget, and needs.
However, another step must be completed before live production can begin: system validation testing.
This validation process takes place in three critical stages to ascertain the overall equipment effectiveness (OEE) of your thermoforming line and to the test viability of your product and production process under live conditions:
Installation Qualifications (IQ) for Thermoformed Medical Packaging
Simply defined, IQ testing ensures the utilities required to run your thermoforming system – air, electrical, and exhaust – have been installed correctly.
This testing is essential, not only for guideline compliance with governing bodies like the Food and Drug Administration (FDA), but also for the fact that each element contributes to your system’s overall throughput and mechanical sustainability. Not conducting this testing can cause your machine to “starve,” running lines incorrectly or running product downstream at lower rates.
Measuring and testing each in succession during IQ involves several steps but ensures peak performance overall:
During IQ, testing obtains measurements for the compressed air (CO2) necessary to run the various components of your thermoformer. Additionally, IQ air testing detects the presence of moisture, oil, and total viable aerobic count and pathogens that may come in direct contact with the product or primary packaging materials. As a result, you can use these values to determine any air system upgrades that must be made to your facility to accommodate your new thermoformer machine.
Having the correct electrical phases and amperage for all your equipment can help you avoid mechanical failure during medical product packaging cycles. After evaluating your facility’s electrical output, you can employ “step up” and “step down” generators if you do not meet requirements. This equipment corrects the electrical amperage, raising it higher or lowering it to the correct operating levels, depending on your unique electrical designations.
Thermoforming equipment for medical packaging is designed with integrated exhaust ports to expel excess or contaminated air. To create a sterile environment for your medical packaging and preserve the integrity of your product, you will need to install and test chasing or tubing for these ports. This ancillary equipment transports any “dirty air” – sources of particle contamination – from your cleanroom.
Operational Qualifications (OQ)
Once the IQ testing process is complete, testing product packaging is the next step in the validation process. These integral steps include finding the limits of time, temperature, and pressure at which the machine will run and still provide viable product.
Measuring this data allows you to ascertain and adjust the viable production range, OQ High and OQ Low, and confirm that your products still meet the necessary production requirements.
During this stage, you can make the changes and adjustments necessary, in collaboration with your equipment vendors, to develop optimal high and low parameters based on expertise and film type. Though these changes do come down to the individual facilities, gaining this vital knowledge feeds into the next validation phase: Performance Qualifications (PQ).
Performance Qualifications (PQ)
PQ testing simulates live production as closely as possible, creating test product or product to be released and sent onto customers after periods of quarantine and applicable testing.
Utilizing validated OQ High and OQ Low values, you will conduct one to three tests (on average), packaging product within a defined range to check for viability. This testing can include implementing automation and unique mechanical features (sensors, vision systems, etc.) at upstream and downstream packaging stages and bringing in manual operators to package and guide product.
You may also conduct predetermined risk assessment viability at this stage, according to the parameters defined by your Risk Assessment or Quality Assurance Specialists. This testing helps to highlight any necessary system or production line adjustments.
Make the Most of Your Thermoformed Medical Packaging with Expert Guidance
Following steps to implement thermoforming for medical packaging properly can seem like a daunting process. The sequence may feel overwhelming, as you must carefully collect data points, test, retest, and communicate all findings with equipment vendors to optimize your system according to your customized needs.
But you don’t have to do it alone.
Harpak-ULMA Packaging makes you a priority partner in all design and testing from initial consultation to final installation and beyond. Our packaging experts help you avoid the “mechanical starvation” and decreased production rates that lead to deficient performance and extra costs to do more.
Together, we create a tailor-made thermoforming system for your medical packaging that is agile, compliant, swift, and scalable for the future. With our help, you save more on materials and labor and reduce the physical footprint for your packaging lines.
We invite you to talk to our medical packaging experts and let us guide you every step of the way to design and implement an optimized medical packaging system that perfectly matches your operations.