When One is Better than Many
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.
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.
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.
Product Line Director - LSR Components and Healthcare & Medical