A guide to leak and block testing in medical device manufacturing

Medical leak and block testing is a critical medical device manufacturing process. This quality control measure is a safeguard against product failure and plays a key role in ensuring the safety and performance of your medical product.

A blockage or a leak in your medical device could have serious consequences – they pose a potentially serious risk to patients and healthcare professionals, not to mention cost of recall and loss of brand reputation. Testing helps verify the products are correctly and constantly produced.

Given the key role of medical leak and block testing, it is important that you are aware of what is involved in these processes and that your medical device contract manufacturing partner has the expertise and resources to deliver consistently high-quality testing services.

What is medical block testing and what it is used for?

A blockage in a medical device, whether caused by a manufacturing defect or a glue overspill, can have dangerous consequences, both for patients and health professionals, and you and your brand.

Medical block testing helps find blockages and the technology is quick and effective. The block testing sensor works by passing air through a device and using pressure to measure flow integrity and to calculate if there is a blockage. It can be calibrated to different product specifications.

In addition, medical block testing sensor technology can also be used to identify if the parts of your medical device are properly in place, helping you avoid any costly assembly errors.

What is medical leak testing and what it is used for?

Medical leak testing, or differential pressure decay leak testing to give it its full name, is used to find leaks in medical products that could pose a serious risk to patients and healthcare professionals, and negatively affect your company and its performance.

Working in a similar way to block testing, this medical testing technology is quick and effective, which helps optimise the efficiency of the overall manufacturing process. Dry, filtered air is passed into a medical device, where it is held at set pressure. The testing machinery measures the loss of pressure over time to calculate if there is a leak.

Notably, to be effective in identifying leaks, this type of testing requires advanced machinery and specific expertise with regard to the measurement of pressure and the interpretation of measurement data. This is, in part, why choosing the right partner is important.

Medical leak and block testing – what you need to consider

When you choose a medical device contract manufacturer, it is critical that you carry out the necessary due diligence with regard to the services that you intend to use, and this includes medical block and leak testing.

With regard to medical leak and block testing, you should consider the following:

  • Does your prospective partner have the right expertise and experience? It is vital that you trust your partner to provide high-quality services. They should have the expertise and experience to assess whether you need leak and block testing (it is not always necessary), and if you do, to create a bespoke testing program for your products and ensure that the testing is carried out to a high standard.
  • Does your prospective partner have high-quality testing technology? Leak and block testing requirements vary for different applications, so it is imperative that your medical device contract manufacturing partner offers advanced testing machinery, such as Furness technology, that has the capacity and flexibility to provide high-quality testing services that can be tailored to your products.
  • Does your prospective partner have the proper testing facilities? Leak and block testing of medical devices must take place in a medical cleanroom. This guarantees that your products are suitable for medical use. As such, it is vital that your partner has the appropriate cleanroom facilities, certified to the necessary ISO standard.

Why your partner must offer advanced leak and block testing

Medical leak and block testing are key medical device manufacturing processes, which if carried out to a high standard, will help ensure the delivery of a high-quality product and protect your brand and its reputation.

Given the direct bearing that this testing technology has on product safety and performance, if the manufacture of your medical product requires this testing technology, it is critical that you use the right contractor.

This is why it is important to take the time to thoroughly assess your prospective partner’s medical leak and block testing expertise, experience and resources.

Meridian Medical is an established and experienced contract medical equipment manufacturer specialising in a wide range of medical device design, development and supply services.

To find out more about how Meridian Medical can help you with your medical product design and manufacture, get in touch today by filling out our online form or contacting us on 01903 732344 or info@meridian-medical.com.

A guide to leak and block testing in medical device manufacturing