Reducing the Overall Cost of Validation

By PTI Engineered Plastics

Reliable medical devices and equipment are essential for researchers and doctors to accurately diagnose and treat a wide range of diseases. That is why there is such stringent oversight from the FDA to ensure these products meet the necessary requirements and specifications. To ensure compliance with regulators, manufacturers follow installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) guidelines. IQ/OQ/PQ certifies the necessary equipment is present and the manufacturing process to create devices that consistently perform to the desired specifications. Several key areas with specific criteria are critical to the process, yet they are often overlooked or underestimated.

Material Selection:

First and foremost, availability is a key factor when it comes to material selection for a medical device. It is important to choose a material that is widely available in the market in wh…

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PTI Engineered Plastics donating thousands of face shields against COVID-19

PTI Engineered Plastics has a goal of manufacturing 100,000 face shields. [Image courtesy of PTI Engineered Plastics]

PTI Engineered Plastics has collaborated with industrial designers at PTI Design to create a protective face shield that can be quickly produced using injection molding manufacturing — helping to boost the supply of protective equipment for health providers treating people with COVID-19.

The Macomb, Mich.–based company says production of the shields started last week, with a goal of manufacturing 100,000 pieces in total.

PTI Engineered Plastics is coordinating donations with hospitals, skilled nursing facilities, hospice care and dental offices. Once more critical requests are met, donations could go to first responders and law enforcement personnel, followed by grocery stores and other essential workers.

PTI turned to existing designs or reference — but also made improvements:

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