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By Steve Baker | Sep 21, 2017
Technical printing projects must face strict qualification procedures before moving into full-scale production.

In the final blog of our three-part series on technical printing, we will discuss the qualification procedures that technical printing projects endure.

In the last blog, we described the five phases of development for technical printing projects. Once that process is complete and stable, the project goes through qualification procedures as it moves on to production. GM Nameplate (GMN) carefully applies these procedures with technical printing projects, especially those belonging to highly regulated industries such as aerospace and medical.

There are three qualifications that projects must pass during production to be validated as parts ready to sell:

Installation qualification (IQ)

Correct installation of machinery is vital, because if the equipment isn’t properly installed, the parts it produces won’t be viable. IQ is typically conducted for new pieces of equipment purchased for a particular job. This involves testing the equipment and understanding the ins and outs of how it works. One of the most important factors when conducting IQ is learning the equipment’s variability when being used so we know the accuracy of the machine. With technical printing projects, only so much variability is allowed, and the variance of the equipment used must be carefully considered during production. If the piece of equipment has been used before, past qualification tests can be referenced.

Operation qualification (OQ)

This process is to ensure that variables and critical operational parameters are held constant throughout production. In the previous blog, we described the initial development process that technical printing projects go through when moving from concept to production. OQ is all about understanding variability in our operation processes and how to maintain consistency during large-scale production. This is essentially development on the production level, requiring testing of many variables to gain a better understanding.

Since technically printed parts belong to pieces of equipment like medical devices, many variables must be controlled strictly, such as drying temperature, ink dispensing, ink thickness, and substrate materials. During OQ, the parameter windows are set with a minimum and maximum level of variances allowed, and it is critical to stay within these throughout production. For example, once we know the optimal temperature at which the ink will cure, the optimal thickness of the ink, and which substrate material is best for the ink to adhere to, we can move forward with production knowing the variables will be held constant at the appropriate level.

Production qualification (PQ)

Production qualification is testing our production processes and the materials used when we manufacture parts (our suppliers’ control parameters). Since technically printed parts belong to highly regulated industries, we must make sure the substrates, dielectrics, carbons, silvers, and other materials are without defect and that our production processes are keeping the many variables in the middle of their parameter window. This process is done by doing three different runs/setups with different lots of materials during initial production. Once the parts are produced, each lot is examined to make sure it falls within the tight parameter windows. If it doesn’t, a root-cause analysis is conducted to determine whether the failure was due to poor materials, an issue with production setup, or another factor. This process is a final review which ensures that by the time the part is completed, it will be ready for the customer.

Since technically printed parts belong to highly regulated industries, they often go through this process when initially setting up for production. GMN employs an expert team of quality control inspectors and quality engineers and utilizes IQ, OQ, PQ processes to ensure quality and repeatability throughout production.

To learn more about technical printing, check out the other blogs from this series:

By Steve Baker | Jun 16, 2017
GMN's membrane switch assembly for Welch Allyn.

GM Nameplate’s (GMN) Singapore Division supported Welch Allyn, a medical company, to develop and manufacture a membrane switch panel with backlit indicators for their resting electrocardiogram (ECG) device. As a device used to test a patient’s heart activity, it is critical that the backlighting appropriately indicates how much battery power the device possesses.

GMN offers an array of backlighting options including discrete LEDs, fiber optic weave, light guide film, and electroluminescence. The part had strict spacing requirements between its tactile buttons, which influenced GMN to choose discrete LEDs. Discrete LEDs are cost-effective and ideal for lighting up small indicators.

Instead of using three different colored LEDs, GMN installed one bi-color LED to occupy as little space as possible and reduce costs. The two colors within the LED were green to indicate the battery was charged, and red to indicate the battery was dead. To create the amber color that indicates when the device needs charging, the LED was positioned off-centered from the indicator window to effectively blend the red and green colors together.

Another factor GMN had to consider was the material for the overlay. GMN utilized polyester (PET) film, a common overlay material for devices in the medical industry due to its resistance to abrasion and harsh chemicals. As an extremely durable, long-lasting material, PET film is ideal for applications with tactile switches because it’s abnormal for the material to crack. 

By Brian Rowe | Oct 12, 2016
Membrane switch panel for  Given Imaging's medical device.

Given Imaging, a medical technology company, came to GM Nameplate (GMN) to assemble a membrane switch panel for their medical device. When configuring a membrane switch, many factors about each component layer must be taken into consideration. 

As the user interface for a medical device, the screen printed and embossed overlay needed to satisfy stringent requirements. The overlay must act as a sealant to prevent moisture and fluids from reaching the membrane. Additionally, the overlay must be chemical and scratch resistant to combat the strain of daily use. 

Common overlay materials include polyester and polycarbonate. Both materials are affordable options that will protect the circuit membrane from scratches, chemicals, and liquids. Due to the durability of screen printed inks, backprinting is a frequent practice to mitigate product wear and tear from everyday use.    

This Given Imaging overlay contains three colors - teal, white, and a black opaque layer. The opaquing layer was selectively applied around the LEDs which allowed light to shine through and prevented light bleed through unwanted areas of the overlay. Because of the opaquing layer, light only showed through the indicator icon on a button instead of throughout the whole part.

When looking at membrane circuit materials, printed silver ink in lower volumes provides a cheaper option than copper etched circuits, such as Kapton, while still offering comparable performance capabilities. Finding the right membrane circuit for the product application is necessary to manufacture a quality membrane switch.

For more information about GMN’s membrane switch assemblies, visit our capabilities page.  

By Steve Baker | Jan 20, 2015
Acel Rx membrane switch assembly

As a printed electronics manufacturer, GM Nameplate manufactures membrane switches and other electronic components for various industries including medical. GM Nameplate has been working with specialty pharmaceutical company AcelRx since 2009, printing a membrane switch and overlay for their Zalviso device. The device is used for post-operative pain management.

The overlay features a selectively textured front surface and tactile buttons to make it more use friendly. It also features a window for the device’s display screen. This window added a challenge to the part, as it required rigidity and durability without increasing the size of the membrane switch or thickness of the overlay material. GMN created a unique solution for AcelRx by combining the dome spacer with a window stiffener layer and optically bonding  this component to back of the overlay.

In the electronics industry where components are constantly getting smaller, it is imperative to have adequate technical printing resources to yield robust and reliable circuits to avoid any malfunction when in use – and when the component is used on a medical device the stakes are higher. Stringent printing and inspection procedures are in place to ensure that every element of the membrane and overlay meets customer specifications.

This membrane switch is a great example of GMN’s expert electronic printing capabilities in highly regulated industries, and the type of products we will be showcasing at MD&M West in a few weeks. The final parts meet all the technical customer’s requirements while provide the necessary durability and wear resistance needed.

To learn more about GMN’s recent electronics projects visit some of our other blogs.