Ian Bolland caught up with Clementine Auffray, group innovation and compliance director at STERIMED Infection Control about its new product POLYBOND CGP 85 – a new substrate for rigid packaging.
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The aim of the new product, launched and showcased at Pack EXPO and COMPAMED, is to provide medical device manufacturers with environmentally friendly, sustainable products and packaging with less plastic content and a lower impact on the environment. Or to put it more simply, reducing plastic waste and becoming more environmentally friendly.
The material is water-based, has solvent-free coating technology, in addition to a share of a renewable raw materials, with the aim of making it a greener solution.
Its fibre mesh structure mixes cellulose together with a high content level of synthetic binders. Synthetic binders are used for optimal mechanical characteristic and cellulose contributes to breathability and efficient sterilisation process.
Auffray said: “For a medical device we significantly reduce the quantity of plastic which is used in the packaging and it's also important to note that STERIMED is working on the biodegradability and bio compostability.”
The approximate 70% reduction in plastic, and with approximately 80% of renewable material used in the project, not only makes it renewable, but the company also states there will be no extra cost for the product.
Explaining what else makes it different from other packaging solutions for medical devices, Auffray said the company’s expertise when it comes to regulations and ISO standards, particularly surrounding standards which specifies for the packaging of terminally sterilised medical devices – including requirements for forming, sealing and assembly processes, and requirements for materials, sterile barrier systems and packaging systems.
“It's a unique project. It's really linked to our knowledge of regulatory affairs and the regulation on the Medical Device Regulation on ISO 11607.”
Auffray also highlighted a project that the company has been working on – when using a Class III implantable medical device – 100% plastic material would be used in the packaging, and STERIMED feels it has been able to demonstrate that POLYBOND has sufficient performance to maintain the safety of those devices.
“The goal of STERIMED is to help the medical device manufacturer to be sure that we reach the target of the performances need needed for the medical device.”
In terms of the devices that this can be used for, Auffray says it depends on both the weight and the shape. The earlier that STERIMED is contacted in the development process, the earlier the company feels it can help use its POLYBOND packaging offering to suit the device in question.
“We classify the possibility to use POLYBOND depending on the medical device class and on the medical device weight. For example, we have some medical devices which are as a low weight medium weight and high weight.
“It's very important for the customer to understand the performance that is required by the medical device. So, we look at the weight, we look at the shape, we look at the packaging, in fact how its packaged, what could be the transportation and the manipulation during the life cycle of the product. So, we need to help the customer to choose the good project, we need to understand the full life cycle."
