Triple Protection for Your Medical Devices: An Innovation by Top Clean Packaging Group
Triple Protection for Your Medical Devices: An Innovation by Top Clean Packaging Group
What is this concept about?
We have designed a packaging solution that offers exceptional protection.
Adaptable by design, this concept suspends any type of medical device between two TPU membranes, which are enclosed between one or two shells with a lid. The space created between these two components plays a key role in absorbing impact by effectively isolating the medical device from the outer surfaces.
Thus, the membranes form a protective envelope in which the medical device is freely suspended and stabilized, avoiding any direct contact with rigid areas and greatly reducing the risk of damage in case of impact.
In addition, our concept ensures the secure positioning of the medical device through precise mechanical placement, guaranteeing safe handling during procedures and eliminating risks for the patient.
Beyond these technical features, its modular design offers great adaptability, making it suitable for a wide variety of medical devices — from vaccine vials to orthopedic implants, as well as more complex devices such as pacemakers, and many others.
Our development team, made up of around ten people, designed this medical packaging while taking into account the specific constraints of medical devices, complying with regulatory requirements, and integrating today’s environmental concerns.
A Barrier to Ensure Sterility...
This new packaging solution has also been designed to meet the stringent sterilization requirements — a crucial step in the preparation of medical devices. It is compatible with several common sterilization methods used in the industry, such as steam, gamma irradiation, and ethylene oxide (ETO). This versatility ensures that the sterility of the device is maintained.
...Designed for Complete Protection and Optimal Resistance
This concept also provides strong protection against external shocks throughout the entire product’s lifecycle. Since medical devices can be sensitive - even to low impact collisions, the packaging must absorb shock energy and prioritize protecting the most exposed areas.
It must also resist abrasion and withstand devices with aggressive or porous shapes, all while preventing friction and scratches that could impair device functionality.
Additionally, it is essential that the packaging ensures safety during handling, especially by healthcare professionals. This involves the development of an aseptic opening system that facilitates handling while minimizing the risk of dropping the device.
Compliant with themost stringent standards
To validate the effectiveness of this technical solution, our team conducted a series of rigorous tests, including drop tests on all faces, edges, and corners, in compliance with current industry standards. Additional evaluations were also performed to ensure the medical device’s safety during handling in an operative context.
Moreover, in response to the tightening of international transport standards, particularly ISTA and ASTM standards, this new packaging concept guarantees full compliance. The tests required by these globally recognized standards simulate realistic transport conditions : vibrations, drops, compression, and extreme temperatures. On top of that, each material used must be capable of being sorted and recycled separately.
An Innovation Already Adopted!
Confident in this innovative packaging concept, we have filed a patent. Several customers have already adopted this technical solution for their medical devices, attracted by its performance in terms of protection and compliance. It stands out as a reliable and innovative answer to today’s challenges of medical transport.
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A major milestone in Top Clean Injection developmentTop CIean Injection reaches a major milestone with the completion of its facilities’ expansion. This initiative shows our resolutely customer-oriented dynamic, with not only a significant increase in our operational capacities, but also investments that illustrate our mission : to design healthcare devices and packaging that enhance the experience of medical practitioners while guaranteeing the safety of their patients.
