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What Medical Device Manufacturers Need From Surface Cleanliness Testing

Written by Pierce Geary

Quality tests during medical device production need to check a lot of boxes for manufacturers. Testing must increase confidence in product reliability in order to be worthwhile to manufacturers. What’s more, that confidence needs to be measurable and reportable because companies cannot tolerate doubt or hesitation when it comes to the efficacy of their products. Products that people rely directly upon for their very lives.

A critical aspect of medical device manufacturing is the surface preparation and surface cleaning that enables adhesion processes to be successful. This key component dramatically increases the reliability of the devices once they are in the hands of the end user, where it matters the most.

Surface quality inspections that measure surface energy are the quality tests that are able to calculate the success of these processes. Surface energy (or surface free energy) is the potential surfaces have to react with another substance or material and higher surface energy can correlate to stronger adhesion.

Surface inspections cannot just be concerned with the sterilization of surfaces (although that is essential in the manufacture of medical devices) but must assess the presence of contamination that can directly cause weak adhesion. Cleanliness evaluation in a manufacturing process must include measurements of contamination that is not bacterial in nature but still exists at the molecular level and has a profound impact on the reliability of products.

Surface Energy Measurement Equipment to Validate Surface Treatment and Preparation

Surface preparation and treatment are critical manufacturing processes that enable sealing, bonding, painting, coating, printing and cleaning. By utilizing appropriate surface preparation processes, medical device manufacturers can speed production, ensure product safety, and decrease the likelihood of recalls.

 

To learn more about how to bring a new level of contamination sensitivity to your surface critical processes, download our eBook: How to Streamline Process Design to Production for Medical Devices

 

Despite the critical nature of these processes, the majority of manufacturers are still relying upon outdated surface evaluation methods such as dyne ink and water break tests. These current methods lack precision, allow for subjective interpretation, and are often destructive.

For surface quality tests to be actually beneficial to medical device manufacturers they need to:

  • Reduce costs as opposed to just adding to the already tremendously expensive production of intricate devices and instruments.
  • Be deployable in production areas.
  • Be as accurate or even more accurate than quality tests conducted in highly controlled laboratory environments.
  • Quantitatively evaluate how prepared a surface is to be coated, printed on, bonded to or sealed.
  • Have the ability to track, with extreme precision, how close surfaces are to falling outside cleanliness and quality tolerances.
  • Be equipped to share data instantaneously with all stakeholders and quality engineers regardless of whether they are present at the production facility or in a remote location.
  • Have the capability to measure quality levels on surfaces that are traditionally very difficult to evaluate due to size (it’s much harder to accurately measure surface energy

How Medical Device Manufacturers Can Strategically Meet Quality Challenges with the Right Inspection Equipment

The things that are holding back medical device manufacturers from seeing higher productivity with few to no defects, and what surface quality inspection equipment is best suited to meet the requirements of these manufacturers, are an increasingly relevant topic.

At the annual American Medical Device Summit, BTG Labs’ Materials and Process Experts were interviewed by officials from Generis, the parent company that organizes the manufacturing event. They asked us about gaps in surface cleanliness testing common to medical device manufacturers and the solutions to issues those gaps create. The conversation can be downloaded in the form of an eBook here.

Here are the highlights from that interview:

What are the biggest challenges that medical device manufacturers face when properly preparing surfaces?

The biggest challenge that medical device manufacturers face when properly preparing surfaces is verification.

Questions that need to be asked and answered give a lot of insight into where manufacturers are at and how their current testing techniques are letting them down. These questions include:

  • How does the OEM know if the product has been treated?
  • What contaminants can interfere with successful treatment?
  • What is the best treatment method?
  • What is too much treatment?
  • What is too little treatment?

There are many treatment technologies available that are best suited to specific applications’ but without the proper processing parameters and verification, there is very little guarantee for success.

What surface preparation processes are medical manufacturers currently using?

Currently, the medical device industry uses vacuum plasma, atmospheric pressure plasma, and corona treatments for polymer bonding.

For sterilization and more complex surface chemistries most manufacturers utilize a combination of ultrasonic baths and vacuum plasma chambers. There are also UV curable adhesives and inks that are commonly used in the industry for the processing of electronic components. All of these processes suffer from a lack of verification and understanding of Process.

The use of accurate contact angle measurement equipment provides this verification during the production process for the first time in the industry.

What are some of the issues manufacturers face when using these processes?

The largest issues really stem from lack of process optimization and no true verification on the factory floor.

These material systems are fairly sensitive to contaminants as well. If a supplier changes something, or handling is introduced, many times the processing method cannot deal with these changes. This can result in poor bonding, cleaning, or sealing. A process which, at one point worked well, is suddenly unreliable.

If the processing method is not optimized, and then not maintained (due to lack of available tools in the past) pre- and post-treatment, how can the manufacturer design, manufacture, and guarantee success?

How can manufacturers improve the efficiency of their surface preparation processes?

The Surface Analyst allows manufacturers to understand, quantify and control their surface critical processes, whether bonding, coating, sealing, printing, or cleaning. Manufacturers can use this contact angle measurement system to bring greater visibility to what their surface is (chemically speaking), what it requires for processing, and how to maintain that process day after day, shift after shift. This is accomplished through a well-documented process design DOE and then following through with continual monitoring with the quantitative data gathered with the Surface Analyst.

What benefits will manufacturers attain by updating their surface preparation processes to the Surface Analyst?

Manufacturers will be able to measure their surface at an unprecedented sensitivity level on the factory floor. This allows them to prevent failures, recalls, and rework. This also allows medical manufacturers to have a full audit trail for quality control, FDA compliance, and liability purposes. At the end of the day, the Surface Analyst makes verification of the processes critical to reliability possible.

To learn more about how to bring a new level of contamination sensitivity to your surface critical processes, download our eBook about the benefits of production level verification for medical device manufacturers. In How to Streamline Process Design to Production for Medical Devices, you’ll get insight into confronting the biggest challenges facing manufacturers whose customers rely on their products with their lives. Get your free copy today.

how to streamline process design to production for medical devices

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