Watch this video for an introductory discussion of sterile medical packaging types, supply chain scenarios, quality considerations, and pricing structures. Video script pasted below.
Today I’m going to talk to the engineers out there, who are investigating how to package their medical device; to those managing their first medical packaging project; to those interested in converting their medical packaging from pouches to trays; and, to those in the information gathering stage of their research on medical packaging.
Tyvek pouches or rigid plastic trays sealed to tyvek lidding are typically the two ways to package a medical device. Choosing between the two is determined by what the product is and the requirements of the packaging.
Medical device tray packaging provides superior product protection from assembling through the supply chain, and into the hands of the end user:
Custom cavities with press-fit features keep the medical device secured in the tray; and, an intuitive orientation allows for ease of device removal by the healthcare practitioner, facilitating procedural workflow efficiencies.
Medical packaging trays are typically sealed to tyvek lids. The lid allows for sterilization of the device and internals of the tray, creating a sterile barrier unit.
If a rigid tray and tyvek (or other substrate) lid is the direction that you want to go for packaging your medical product, then you’ll need to decide if you want to load and heat-seal the packaging in house; or, outsource the loading and sealing (prior to sterilizing).
Some of my customers have compared the cost of buying a heat sealer vs. outsourcing, and in most instances, they chose to bring a sealer in house and perform the kitting and sealing internally. This is because it reduces supply chain complexities and mitigates risk.
If you don’t want to deal with lidding and heat sealing equipment, then there is the option of making a thermoformed tray and insert and placing inside a pouch for sterilization. Just make sure that the thermoform package has channels that allow the gas (if ETO) to penetrate the package to sterilize the device.
Next, is the design of the tray. Dordan can design trays from scratch, or modify customer-provided designs for thermoforming. The design should be developed with a fundamental understanding of the customer’s functional and quality requirements, married with expertise in thermoform tooling and production. Thermoformers with certified quality management systems like ISO 9001 should be enlisted, because the SOPs require that the entire packaging development process be documented, transparent, and pragmatic.
Part-in-parcel to the design of the tray is the tray material type. Medical grade PETG is the premier tray material, because it allows for great forming and cutting; and, seals to lidding well. The tray material thickness should be at least 30 mil, to ensure that the seal flange thickness is robust enough to provide a strong seal. Heavy and/or large products usually require a thicker material, so that the thermoform meets the necessary form/fit/function requirements.
Now, quality. Our ISO Class 8 cleanroom monitors, manages, and mitigates particulate; particulates are tiny fibers, skin cells, what have you. The less particulate you have floating around the cleanroom the better, because it ensures the cleanliness of the package and therefore, the device. Cleanrooms also employ extremely sophisticated and comprehensive QC procedures, insofar as inspection, documentation, analysis, and reporting. If our customer provides a CPK target, or critical tolerances and dimensions are called out, we work to ensure that our parts fall within that spectrum. In most instances, however, our customers allow us to determine the critical tolerances and potential problem areas, based on our expertise and understanding of the customers’ requirements. When a CPK target is not provided, we conduct a process capability study and provide data to our customers to ensure our parts meet our reported CPK.
It is typical that if the medical product is being made in a cleanroom, then tray should be, as well. If the product will be kitted and sealed in a cleanroom, prior to sending to a sterilizer, then that’s great. Some customers just double bag the product inside the cleanroom and pass-through into the factory, where it is then packed in cartons for shipment to the kitter and sealer. In this scenario, it is strongly encouraged that it be packed and sealed in a cleanroom.
I do have customers that bring non-cleanroom produced trays into a cleanroom for packing. Others clean non-cleanroom produced trays prior to bringing into a cleanroom, which is usually cumbersome. Basically, it is on the customer to determine what level of risk is acceptable.
Last but not least, pricing! Typically, the larger and thicker the tray, the more expensive it will be. However, very low run QTYS pose some pricing challenges, because we have to purchase the material minimum from our supplier, which can be 1K, 3K pounds. If the run QTY does not consume the material minimum, we have to factor in the cost of the scrap to the part price. Once you get to a thousand or two trays, the pricing starts to level off, because we have met out material mins. Obviously once you get to high volumes, the pricing is very compelling.
Cleanroom tooling is more expensive than non-cleanroom tooling, but not significantly so. Cleanroom part pricing is more expensive than production in our standard facility, but again, not significantly so. It is at our customers' discretion as to where they want their medical trays produced, and to what level of QC. Dordan accommodates clients at both sides of the spectrum, from those procuring medical packaging for high risk medical devices, to those looking for high-quality packaging for their healthcare product.
Dordan's cleanroom for manufacturing medical packaging