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May 18, 2020

The Vital Role of Seals in Medical Devices

Category: Pharmaceutical

2020 is proving to be hugely challenging for all industries – and nowhere is this more evident than in the field of manufacturing. One outcome of the Covid-19 pandemic is the global shortage of vital medical equipment, such as ventilators and dialysis machines. This has led to some countries, including the UK and USA, appealing to manufacturers to design and prototype essential pieces of life-saving equipment, with firms as diverse as Airbus and Dyson rising to the challenge.  

In the US, the motoring industry has also stepped up to the mark, with General Motors and Ford lending their assistance. During such unprecedented times, it’s highly likely that manufacturing production in other countries, such as Australia, will also follow suit. 

When Seal Quality Makes a Life or Death Difference 

 The humble seal might not immediately spring to mind when you consider the technology available to clinical staff in the provision of life-saving treatment. However, in any medical device that contains, pumps, drains, transfers, dispenses or regulates a gas and/or liquid, the ability of a seal to keep the substance in and contaminants out is crucial. 

One real challenge for manufacturers turning their hand to the creation of medical devices – something likely to be way outside of their area of regular expertise – might be the failure to understand the level of importance of what is likely to be the least expensive component – the seal. 

The following must be taken into account when selecting the ultimate solution that addresses the physical application requirements of this tiny, but vital, component: 

  • Pressure/vacuum 
  • Temperature 
  • Motion 
  • Media contact 
  • Hardware dimensions 

Working with the right supplier ensures these critical factors have all been considered.  

In addition, certain medical devices demand materials that can withstand radiation sterilisation. Of course, it’s also essential that seals meet necessary regulatory compliance too. 

Suitable Material Grades for Medical Application 

Manufacturers need to be aware that not all seal materials are suitable to be used in medical equipment. While prototypes might be created using those created from industrial-grade materials, when it comes to finalising the design it’s essential that only seals composed of high quality compatible materials are utilised. 

For example, nitrile rubber is commonly used in the construction of O-rings. However, due to the risk of containing phthalates and the risk of fracturing if exposed to ozone, this means its use has been banned in medical devices. 

How Seal Professionals Are Assisting Manufacturers in This Time of Crisis 

The key for engineering manufacturers is the consideration of seal construction and material from the outset. The consequences of sub-standard parts or the wrong design choices can lead to reduced longevity or – in worst-case scenarios – the failure of a medical device to gain regulatory approval. Rather than only focusing on the seal at the end of the process, savvy manufacturers ensure they get the selection right by engaging with the right supplier during design and testing. 

Working with industry specialists ensures: 

  • The correct material selection for the utmost performance 
  • Seal reliability and safety in the most critical situations 
  • Seal longevity and optimum design 
  • Assistance with seal profile selection 
  • Material compatibility solutions 
  • Hardware refinements for better performance 
  • Assistance with testing and monitoring 
  • Fully traceable quality materials 

Examples of Australian company success stories in the manufacturing of superior quality medical devices include: 

  • ResMed Inc (who’re looking to double/triple their output of ventilators during the coronavirus crisis) 
  • Ansell Ltd 
  • Nansonics Ltd 
  • SDI Ltd

Manufacturers Look to Chesterton Customseal for Medical Device Sealing Needs 

The design and production of a medical device demands seals that are specifically tailored for the task. Large OEM companies that are looking to switch up and offer assistance in the creation of ventilators and medical equipment, gain essential advantages working with a seal specialist such as Chesterton Customseal. 

Ensuring the integrity of the small components is vital for safety, reliability, longevity and full peace of mind. 

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