How is Pres-Flex made and what are its main capabilities?

Beth Guinn: Pres-Flex polyvinyl chloride (PVC) and ethylene vinyl acetate (EVA) films are extruded in our facility in Sherman, Texas. The PVC line is custom compounded in a dry blend process that allows us to have full control of the formulation from start to finish. We can blend other polymers with the PVC for extra physical characteristics.

In addition, we can also extrude PVC onto non-wovens and fabrics for composites that are utilised in various products, such as disposable blood pressure cuffs. The PVC film can be extruded in thicknesses from 1.65-28mil and in widths up to 94in wide. We can formulate PVC with a variety of plasticisers to meet various industry regulations, such as California Prop 65 and REACH.

The Pres-Flex EVA film is extruded from pellets in our Sherman facility and is available in clear taffeta, matt or suede embosses in thicknesses from 6-18mil, and widths of up to 65in wide. EVA is Pres-Flex’s first non-PVC polymer extrusion capability expansion. Our customers in the medical market needed an alternative to PVC for regulatory requirements and we answered them by expanding our capabilities into EVA.

What originally prompted Presco’s entry into the medical device space?

Pres-Flex has been supplying the medical industry with various films that are mostly designed for inflation for almost ten years. In 2015, a targeted push into the drainage and feeding bag market, as well as the disposable blood pressure cuff market was initiated. We identified an opening in these markets for a domestic-film manufacturer that was willing to innovate, adapting formulations to conform to new regulations and performance expectations. Our competitors seemed to be on ‘autopilot’ and not providing the medical device market with innovative solutions.

Can you tell us more about the quality-control system Presco has in place for the manufacture of Pres-Flex?

Pres-Flex’s quality-control system meets the stringent requirements of the medical device industry. First and foremost, Presco fosters long-term partnerships with our raw material suppliers. These partnerships have afforded Presco stable supply chains and state-of-the-art technical support.

In addition, Presco controls the full manufacturing process of our films, providing us with excellent raw material traceability from start to finish. In 2016, Pres-Flex installed inline-vision systems to monitor physical properties, including porosity, reflectivity and haze, and accurately identify defects in the film and composites, such as pinholes and contamination. The system maps defects as small as 50μm (half the width of a human hair).

What kinds of products can Pres-Flex typically be found inside in the medical space?

Pres-Flex can be found in a wide variety of medical device products, including sequential-compression devices that have inflatable internal bladders that are made of flexible PVC. The PVC film is formulated to expand and contract consistently throughout the life of a single patient device. Other inflatable devices, such as disposable blood pressure cuffs, use a PVC inflatable bladder. These devices use our PVC/non-woven composites for increased patient comfort.

The drainage and feeding bag market uses PVC and EVA films in devices, such as total parenteral nutrition disposable IV, urinary drainage and enteral feeding bags. We formulate films with a variety of plasticisers and meet regulatory requirements, including US Pharmacopeia Class VI for various medical products.

How important is sustainability in the production process behind Pres-Flex?

Sustainability is a priority in our Pres-Flex engineered film division. Our goal is to consume 100% of the waste the company’s manufacturing process generates. Pres-Flex extrudes films for other industries outside of the medical sector. Those industrial markets allow outside regrind content to be present in their films and act as an outlet for our production scrap. Because of this, we have managed to recycle more than five million pounds of PVC film over the past five years on select industrial formulations in our Pres-Flex PVC product line.

Pres-Flex medical films are 100% virgin and contain no outside regrind. However, all our start-up and edge-trim scrap is recycled back into medical film production orders in real time.