When One is Better than Many

Cleanroom
Date: 28.04.21
SILICONE: IDEAL FOR MEDICAL DEVICESSilicone is ideal for medical devices and equipment, not only because it is inert, biostable and biocompatible with favorable physical and hapticattributes, but also because it can be processed in a multitude of ways. This encompasses methods, such as, extrusion, molding, casting, coating, and immersion; on its own or in combination with other materials and substrates, including API (Active Pharmaceutical Ingredients).

As medical devices become ever more sophisticated and smaller in size, the challenge for the component manufacturer is how to fit multiple functions into a limited space. Multicomponent LSR technology offers a solution to this that, in addition, provides designers with the latitude and flexibility to enhance their applications. Ursula Nollenberger, Product Line Director - LSR Components and Healthcare & Medical takes you through the process.

 

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ONE OF THE PRIMARY ADVANTAGES OF 

multicomponent liquid silicone rubber (LSR) technology for medical devices is that complex geometries can be created. These can combine multiple separate elements that would have been assembled into a single component.

 

Eliminating assembly

 

The cost and risk associated with assemblies, such as potential leak paths or undesirable spaces for bacterial growth, are therefore eliminated. The technology also provides the developer with the ability to create considerably more robust and cost-effective solutions that are of higher integrity and which can fit into a smaller design envelope.


In addition, assemblies can be value engineered, something that offers tangible benefits to the device manufacturer in terms of improved performance, prevention of contamination, the opportunity for automating a customer’s production lines, elimination of risk of misassembly, lower inventories and ultimately, reduced total cost of ownership.

 

Involvement from concept stage

 

For new multicomponent LSR applications, most customers involve us as early as possible in the development process; from the concept stage so applications can be optimized for market and manufacturing. Trelleborg Healthcare & Medical provides customers with access to specialists in product design and functional modeling, material selection, as well as manufacturing, quality, and validation engineering, to help accelerate time to market.

Part functionality and maximizing performance of an application are primary considerations in the design, but also, right from the earliest point possible, Design for Manufacturing(DfM) considerations should be included along with solutions for automation, creation of flash-less parts, waste-free production, in-process quality checks, batch by cavity and packaging. This and short cycle times, makes the production of extremely complex multicomponent LSR components possible in the high volumes needed for medical devices, which at full series demand could reach tens of millions.

LSR
ABOUT MULTICOMPONENT LSR TECHNOLOGY
Multicomponent LSR technology is the simultaneous injection of Liquid Silicone Rubber in combination with engineered plastics and potentially other substrates. In what is also commonly referred to as 2K, 2shot, 2C LSR, multicomponent injection molding, or co-injection, it is used to develop innovative solutions, combining two or more individual materials into one fully bonded component in hard-soft and soft-soft combinations. This is challenging due to the differing process requirements of LSR and other substrates.
Quality

Automation and quality

At Trelleborg’s multicomponent LSR facilities, automation is taken to the ultimate level of process efficiency and quality consistency. Most parts are untouched by human hands until packaged, all in a 24/7 fully automated operation.

 

For medical devices quality is paramount, and the holy grail of quality is to ensure quality in process rather than have post-production quality checks. Depending on customer requirements, this can be in an ‘uncontrolled’ or controlled environment of class 100,000, ISO 8 or class 10,000, ISO 7 cleanrooms.

 

Quality is equally considered in the holistic approach, with certified quality systems and process controls built into the production process based on a mindset of producing 100% good quality. The ability to segregate suspect product effectively with minimal disruption in the case of a quality concern, is key to a high-volume, fast-paced production process. In-line quality checks are electronically recorded allowing full traceability, with products separated by cavity. Any issue can therefore be isolated to just a small number of components and delivered quality from the production line can be checked for that batch in detail.

 

Cleanroom

Good manufacturing practice

Fundamental to the disciplines of any high-quality manufacturer involved in supplying ‘clean’ product, whether from within or outside a classified cleanroom, is a Good Manufacturing Practice (GMP) discipline firmly rooted in the facility’s quality systems. Industry guidelines provide minimum requirements that a manufacturer must meet to assure that products are of high quality and do not pose any risk to the consumer or public.

 

It is therefore critical for any manufacturer to apply due diligence in the establishment of GMP standards so that they are appropriately set to the specific application concerns and risks of parts produced. Standards, for example relating to medical devices, may vary depending on whether production relates to a low risk Class 1 device or a long-term implant.

Ursula-Nollenberger
“ At Trelleborg’s multicomponent LSR facilities, automation is taken to the ultimate level of process efficiency and quality consistency.”

URSULA NOLLENBERGER

Product Line Director - LSR Components and Healthcare & Medical

The future

In summary, Trelleborg Healthcare & Medical, through its leading edge multicomponent LSR technology and holistic approach to design and manufacturing can provide medical device manufacturers with real benefits, especially in terms of miniaturization of devices and their integrity. As medical applications become ever more sophisticated and smaller, multicomponent LSR components will play a significant part in the future of medical devices.