Strength in numbers: Collaboration and thorough testing key for Eastman
Collaboration, thorough testing key to bringing HIPS alternative to European medical packaging market, says Eastman.
The importance of successful supply and value chain management in medical device manufacturing is coming even more into focus as patient safety issues persist and regulations are ever-evolving. Manufacturers carry the weight of ensuring their sensitive devices successfully navigate complex supply and value chains, all the way through packaging, with the devices’ integrity intact. Because of this, something that seemed next to impossible in the past is now becoming a key for success — collaboration throughout the process. Collaboration throughout the supply and value chains can reveal mutually beneficial innovations, leading to improved efficiency and effectiveness.
Collaboration and testing
In search of ways to ease the burden to medical device manufacturers and stay ahead of ever-evolving regulations Nelipak Healthcare Packaging collaborated with Europe-based extruder Carolex packaging and global material supplier of medical-grade polymers Eastman Chemical Company to help bring a new packaging product to the European medical market.
“Collaboration early in the development of this new product helped guide our teams, drive the testing of this new material and ensure all parties were aligned from the start on customer needs and priorities,” said Ferdi Faas, market development manager, Eastman Chemical Company.
When testing a new material, collaboration early in, as well as throughout, the process brings the expertise of multiple companies together, builds upon each company’s knowledge and ensures the best-possible outcome.
“The testing process for a new material needs to encompass all companies’ vital expertise,” said Sean Egan, group marketing manager, Nelipak. “We identified the need in the market and then tested trial material. Eastman provided access to its technical teams and delivered data on the material, while we shared our experience and outcomes with the product samples produced.”
Testing was conducted over a six-month period and included running tests on tooling, forming characteristics, particulates, as well as heat sealing trials and peel tests. Ultimately, they found a material that tested well compared with styrene and had some additional features, including living hinges, cleanliness, good cushioning and potential to run at a higher speed without increasing processing temperature.
New material
The material that came out on top was Eastman Eastalite copolyester, the first opaque offering in the company’s medical packaging portfolio. The most important challenge was met with the new material — it is made without materials of concern, such as butadiene, bisphenol A, bisphenol S, ortho-phthalates, or halogens such as chlorine or bromine. This was a key consideration for Nelipak, a company that is focused on the health care market and whose packaging solutions are specifically designed to protect and maintain the sterile integrity of the product. The material also is compliant with select ISO 10993 requirements for medical-device biocompatibility and applicable parts of ISO 11607 requirements.
“As an extruder, we focused on the material’s thermoformability and potential for lightweight medical packaging with greater yield,” said Laurent Bouchet, commercial director, VitasheetGroup Carolex. “In working with Nelipak, we found that Eastman Eastalite copolyester ran at comparable speeds to traditional material such as HIPS and less heat input was required, which suggests it is possible to run at higher production speeds.”
Although sheet extruded from Eastman Eastalite copolyester can be processed with the same thermoforming, trimming and sealing equipment as HIPS, Nelipak and Carolex found the lower process temperatures offer greater opportunities for sustainable packaging. Thermoforming Eastalite into rigid trays can reduce waste and cleaning through a reduced risk of particulates and angel hair generation, as well as lessen processing and inspection times.
Ensuring safety with cleanrooms
Because of Europe’s strict guidelines on cleanrooms, Nelipak, Carolex and Eastman worked to ensure the material is easy to use in a cleanroom environment with a process that creates less particulates than HIPS. Eastman Eastalite copolyester is easy to cut with no angel hairs and is not prone to static buildup like HIPS, which can attract particulate to the product during production. Eastalite also can provide greater tear strength while retaining color stability and functional integrity following sterilisation by ethylene oxide (EtO) or gamma irradiation.
“Intended for medical packaging, this material went into testing having to meet many requirements and address a variety of customer needs while still performing well,” Egan said. “Eastman Eastalite™ copolyester quickly met many of our expectations. I’m looking forward to the new market opportunities this material will create by allowing brand owners to produce differentiated products that satisfy growing market needs for sustainable and lightweight rigid medical packaging.”