Dordan is a custom thermoformer of medical packaging, so all pricing is based on specific project requirements. However, there are shared pricing indicators implicit in all medical packaging quotes. These are package size, material type and thickness, order quantity, tooling, quality control, and production environment.
Package Size: Typically, the larger the thermoformed package the more expensive, because more material is required for production when compared to smaller parts. Determining the appropriate size for medical packaging is based on the product size and functional packaging requirements. Additionally, the package size needs to incorporate features of the thermoforming process, like draft, radii, draw ratio, etc. The package size informs the layout of the thermoform tooling, which impacts the tooling cost.
Material Type: A large indicator of packaging cost is the material. There are many materials available that fluctuate in performance, capabilities, pricing, minimums, and lead times. Below are the main materials used for medical packaging:
Medical Grade PETG is the standard for medical packaging. Popular in clear or blue tint, Medical PETG is compatible with most sterilization methods. “Medical Grade” means that there is lot traceability to the resin level and QC inspection and documentation throughout the entire production process. The material is high quality, has great clarity, and is easy to thermoform and die cut. Non-Medical Grade PETG is like Medical Grade PETG, but doesn’t offer the same assurance of supply chain transparency. This material is typically used for lower-risk medical devices. Non-medical PETG performs just like Medical PETG, the only difference being the level of quality procedures executed in the production and handling of the material.
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FDA APET is like PETG, but without the glycol; it is a harder material, making it more challenging to die cut. “FDA” means the material has been approved for use in food, drug, and cosmetic applications. While FDA certification is not as stringent as Medical Grade PETG, it offers more confidence of quality when compared to non-certified materials. FDA APET is available in clear, blue tint, black, white, and custom color-matching. Non-FDA APET is the same material as FDA APET, but without the FDA certification. It is a virgin material, which allows for more confidence of quality when compared to recycled materials (RPET).
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Medial HIPS is a non-transparent material with a matte finish. Usually black or white, Medical HIPS also offers transparency to the resin level. Non-Medical HIPS is the same material as Medical HIPS, but without the certification. It is a virgin material, offering higher quality when compared to recycled materials.
Material Thickness: Usually, the thicker the thermoformed part, the more expensive. Determining the appropriate material thickness is complex—it’s always a compromise between cost and performance. If the package is too thin, for instance, there is potential for pin holes or voids in the seal. The size and weight of the product, functional packaging expectations (disposable vs. reusable), and quality control requirements must be considered when determining the appropriate material thickness.
Order Quantity: Medical packaging pricing is largely dictated by the order quantity. Dordan is a custom medical thermoformer that purchases all material per order. Minimum order quantities for materials range in poundaged from 1,000 to 5,000 lbs., based on fluctuating market demands. Typically, the more exotic the material i.e. color-matching, the higher the minimums. Once the material minimums are met, thermoform part pricing decreases with elevating quantities and the amortization of machine set up and maintenance over the production run.
Tooling: Thermoform tooling includes the form tool, syntactic foam plug assists, water plates, pressure boxes, headers, and die build ups. The cost of standard tooling is largely based on the size of the machine on which it will be used and the complexity of the design. Dordan has small and large thermoforming machines, tooling for the latter being more expensive. Cleanroom tooling is more expensive than standard-production tooling, because it uses higher-quality materials and requires more complex engineering and machining time, tools, and technologies. The quality requirements for medical packaging include tight tolerances that need superior control over the material distribution during the thermoforming process. Dordan’s cleanroom tooling is machined to extreme flatness, allowing for a robust seal between the pressure box and the form tool, and therefore, the production of high-quality medical packaging.
Quality Control: Dordan performs first article inspections, first article validations, IQ OQ PQ, and PPAPs (and other). The type of quality procedure implemented is based on the customers’ requirements. All jobs include a first article inspection and all cleanroom jobs receive a first article validation. Process capabilities studies (IQ OQ PQ, PPAPs, etc.) incur an additional fee. First article inspections measure and document production sample conformance to established specifications. First article validations are a robust version of First Article Inspections where more samples are measured and a report is generated that confirms the package meets the target CPK for critical dimensions and tolerances. IQ OQ PQs require a validation run to confirm that the production process is in control per the target CPK. Dordan is ISO 9001:2018 certified, ISO 13485:2016 certified, and has a Class 8 Cleanroom for manufacturing medical packaging.
Production Environment: Dordan’s ISO Class 8 Cleanroom works to monitor, manage, and mitigate the level of particulate and bioburden agents in the environment by enforcing and maintaining rigorous quality control procedures. Medical packaging manufactured in our cleanroom is more expensive than packaging produced in our standard facility because of the high level of quality control required. Dordan is ISO 9001:2015 and ISO 13485:2015 certified, providing medical device manufacturers comfort over product safety, sterility, efficacy. Dordan’s standard production facility manufacturers medical packaging products as well, though the environment is not controlled, and the equipment is more limited in its execution than cleanroom thermoforming machines.
About Dordan: Dordan Manufacturing, Inc., is a 60+ year-old family-owned and operated custom thermoformer of medical packaging like medical device trays, blisters, kits, and assembly trays. Based 60-miles northwest of Chicago, IL., Dordan is a full-service thermoformer with in house design, prototyping, tooling, thermoforming, and cleanroom manufacturing. ISO 9001:2015 and ISO 9001:13485 Certified with an ISO Class 8 Cleanroom, Dordan is a diligent supplier of thermoformed packaging solutions to medical device manufacturers worldwide.
Above: Dordan's ISO Class 8 Cleanroom for manufacturing medical packaging