Sealing solutions are a critical element in almost all industrial applications, but even more so in those serving the medical and pharmaceutical industries. OEMs of medical devices have the added responsibilities of ensuring that their products surpass minimal requirements, offering quality and assurance when it comes to the risk of cross-contamination and the nature of medical environments.

Beyond low contamination levels, successful medical sealing must also demonstrate mechanical performance and chemical resistance. But what attributes should OEMs look for when selecting a sealing manufacturer for their medical devices?

Whether a medical application requires diaphragms, O-rings, gaskets, lip seals or custom parts, here are key elements for OEMs to look out for in medical seal manufacturers.

Elastomer materials

Medical sealing must demonstrate resistance to harmful and toxic chemicals. These seals must be able to withstand a wide range of process media, potent active pharmaceutical ingredients (APIs) and aggressive cleaning regimes.

Depending on medical application, there may be certain qualities required of the seal’s elastomer material and so it is important to choose a sealing manufacturer with a wide range of materials available.

In order to ensure chemical resistance, OEMs must also ensure that their medical sealing is manufactured from the highest-performing elastomers of the highest qualities.

Examples of specially developed elastomer materials with properties suitable for medical sealing applications include perfluoroelastomers for sealing applications where chemical resistance and high temperature performance are critical and metal detectable elastomers for containment and contamination control (also largely used in food applications).

Assured medical sealing quality

There are international standards across industries that demonstrate assured quality in a component’s material. When selecting sealing components made of high quality, compliant materials, look for:

  • FDA approval — United States Food & Drug Administration
  • USP Class VI— United States Pharmacopeia

Cleanroom manufacturing

In keeping with the requirement for low contamination levels in medical sealing, it is important that OEMs opt for sealing solutions that offer a wide range of services and engineering capabilities. Perhaps the most significant for medical and pharmaceutical applications is that of cleanroom manufacturing.

Cleanrooms provide an impeccably clean environment in which manufactures can closely examine their products to ensure that each component leaves their facility without any compromise on quality standards, including contamination levels.

As manufacturers make and supply sealing solutions for a range of applications designed for human consumption — across not only medical or pharmaceuticals, but also food and dairy — it is imperative they can demonstrate compliance with the appropriate governing standards set by the International Standards Organisation (ISO).

Services

In assuring quality across critical applications, look for a sealing solutions provider that offers a comprehensive sealing service and that can demonstrate a wide range of engineering capabilities. Indicators of such include:

  • Engineering consultancy: independent testing and consultancy
  • Custom component design: finding bespoke sealing solutions for the application at hand
  • Finite element analysis (FEA) simulation: predicting how a component will perform in real-life applications
  • Manufacturing capabilities: services include injection molding and compression technology
  • Cleanroom manufacturing: maintaining a high level of cleanliness and low contamination levels
  • Laboratory testing: research and development, testing and analysis of polymer materials
  • Surface treatment: enhancing the performance of components

 

 Salvatore De Marco is a mechanical engineer and head of sales at Novotema.

Novotema specializes in the manufacture and supply of elastomer medical sealing components, providing a wide range of materials, assured quality, cleanroom manufacturing and a range of engineering services and capabilities.