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As Posted by Partner Teknor Apex: First Medical-Grade TPEs that Can Be Calendered Provide Alternative to PVC in Bags, Bladders and Pouches

First Medical-Grade TPEs that Can Be Calendered Provide a Real-World Alternative to PVC in Bags, Bladders and Pouches

O’Sullivan Films, with contract manufacturer Genesis Plastics Welding, Produces Calendered Films from Teknor Apex Company’s Medalist® MD-500 Elastomers that Have Performance Advantages over PVC and Save Weight and Cost

PAWTUCKET, RI, U.S.A., June 10, 2013: New technologies from three cooperating suppliers to the medical device market make possible film products that combine the advantages of thermoplastic elastomers (TPEs) over PVC, the quality benefits of calendering, and the sealing efficiency of radio frequency (RF) welding, it was announced today by Teknor Apex Company, which will highlight the technologies at MD&M East (Booth 3811). collaboration with O’Sullivan Films (Winchester, VA) and Indianapolis-based Genesis Plastics Welding (Booth 3137), Teknor Apex Company has demonstrated that films produced from its Medalist® MD-500 Series elastomers eliminate the traditional disadvantages of TPEs in such applications as fluid drainage and storage bags, cushioning bladders, and surgical pouches, exhibiting performance that is fully comparable to PVC in processing, bonding, assembly, and clinical handling. In fact, tests by Teknor Apex and cooperating customers have shown that Medalist MD-500 Series TPEs provide a number of property improvements over PVC, along with substantial savings in weight and cost, according to Elliott Pritikin, global medical market manager for the Thermoplastic Elastomer Division of Teknor Apex.

teknor apex tpeWhile calendered PVC film is widely used in medical applications, traditional TPEs have not performed well in calendering, a process which typically provides better thickness uniformity, more consistent physical properties, and greater thermal stability than film extrusion. Working with Teknor Apex, O’Sullivan Films has demonstrated that Medalist® MD-500 Series medical elastomers can be formulated for successful calendering.

“Our company has attempted to calender a wide range of plastics besides PVC and concluded that most are simply not calenderable,” noted Chuck Stronach, O’Sullivan Films commercial manager for healthcare products. “We were intrigued to discover that Medalist 500 Series compounds can be adapted for this process, and together with Teknor Apex we carried out a lot of R&D work to optimize the production and properties of Medalist calendered films.”

Film and bag applications for Medalist MD-500 Series TPEs include cushioning bladders (for mattresses, wheel chairs, and gurneys); IV and saline bags; medicine storage and delivery pouches; bags for enteral and parenteral nutrition storage and delivery; dialysis bags; and surgical pouches.

Medalist® MD-500 Series TPEs Provide Range of Advantages over PVC

“While there is pressure on medical device companies to replace PVC in a number of applications, the track record and excellent cost-performance profile of PVC have in the past made it difficult to replace,” said Teknor Apex’s Elliott Pritikin. “Recently, however, Medalist MD-500 Series elastomers have been commercially successful as alternatives to PVC in medical tubing, and now they are proving to offer clear-cut advantages over PVC in film products.”

Two of the greatest advantages cited by Mr. Pritikin involve:

  •     Raw material economy. Film made from Medalist MD-500 Series TPEs exhibits the same degree of strength as PVC film that is twice as thick (see table).
  •     Weight savings. Because the Medalist compounds are 30% less dense than flexible PVC and can be down-gauged without compromising strength, finished products can be 66 to 70% lighter.

In addition, Medalist elastomers are available at lower hardness ranges than flexible PVC, provide a broader processing window, exhibit greater elasticity and tear strength, have superior flexibility and impact strength at low temperatures, are less permeable to nitrogen and moisture, and have a wider range of service temperatures. These TPEs exhibit 25% less color change upon exposure to gamma irradiation than standard (i.e., not gamma-stable) grades of flexible PVC.

Making the Switch to TPEs ‘as Simple as Possible for the Customer’

In developing Medalist 500 Series compounds for film products, Teknor Apex was guided by the concept of making the process of changing over to Medalist TPEs as simple as possible for the device manufacturer, according to Richard Faulkner, Teknor Apex medical market manager.

“Teknor Apex started off by listening to the voice of the customer, consulting with manufacturers of medical devices to identify all of the regulatory and performance considerations that may arise in film applications and to learn how traditional TPEs and PVC compare,” said Mr. Faulkner. “As in our development of compounds for tubing, we partnered with companies that have longstanding expertise in the target applications.”

One key partner is O’Sullivan Films, Inc., whose healthcare products include both PVC and TPE. The company’s PVC products are manufactured by calendering. This process produces film by fusing compound in a mixer and then passing the material through a series of synchronized nip rolls. In its ISO 13485-certified operation for medical films, O’Sullivan Films has calendered Medalist MD-500 Series compounds into films with widths up to 76 in. (193 cm), using special vision monitoring systems for quality control and a dedicated “healthcare” slitter capable of producing widths down to 1 in. (25 mm).

Teknor Apex also collaborated with Genesis Plastics Welding, an ISO 13485:2003 certified medical device contract manufacturer. Genesis’ proprietary radio frequency (RF) welding technology, ecoGenesis™, enables sealing of polar and non-polar plastics, including film produced from a Medalist elastomer. While the alternative technique of heat sealing produces only a straight-line bond, RF welding with ecoGenesis makes it possible to form strong permanent bonds in complex geometric patterns; including sealing two mono-layered film to tubing producing traditional infusion bags.


For information on O’Sullivan Films, Inc., visit

SOURCE: This release originally posted at:

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Inside INdiana Business: Manufacturer Benefitting from Onshoring Trend

‘Onshoring’ Gains Momentum in Indiana

A Hancock County manufacturer appears to be part of a trend that is bringing production back to the United States. Fortville-based Genesis Plastics Welding says it is being approached by more customers who want products made in the U.S., as opposed to countries with traditionally cheaper labor like China. Chief Executive Officer Tom Ryder says those labor costs are becoming more comparable and there are fewer logistics and quality issues with American made items. He discussed the “onshoring” trend on Inside INdiana Business Television.

Ryder says his company is a supplier for the medicial device industry and military.

He says at least one client approached the manufacturer after quality and logistics issues with a previous China manufacturer.

Ryder believes more companies are discovering more advantages about U.S. production instead of outsourcing including fewer quality issues and less transportation time.

He says there are strong indications the “onshoring” trend will continue to gain momentum.

Source: Inside INdiana Busines

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Medical Plastics News: Genesis Plastics Welding Adds Third Class 7 Cleanroom

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US contract welder Genesis Plastics Welding has added a new class 7 cleanroom at its facility near Indianapolis, Indiana. The investment brings the total number of class 7 clean rooms to three.

“Recent national mandates have made infection prevention a leading concern of health care providers, creating this increasing need for these products,” says Genesis Plastics Welding CEO Tom Ryder. “We are in a great position to help supply products to meet those increasing demands.” Room/genesis-plastics-welding-clean-room-workers.pngGenesis’ expertise in RF welding, including its proprietary heat-sealing technology, ecoGenesis, enables them to manufacture cost-efficient, greater integrity, phthalate-free products.

“Recent additions to our staff, including engineering experts in product and process development, have enhanced our research and development abilities; we are serving clients from concept to commercialisation,” says Ryder.

Genesis manufactures a wide array of products including blood pressure cuffs, instrument covers, media reservoir bags, inflatable bladders, hot and cold therapy devices, compression therapy sleeves and coolant bags, and fluid drainage bags. Members of the Genesis team, including Ryder, will be updating industry leaders regarding the company’s expanded capabilities in manufacturing single-use, disposable medical products at the Medical Design & Manufacturing (MD&M) East, June 18 – 20 in Philadelphia, USA.

In February 2013 Genesis achieved its ISO13485 certification, demonstrating that the company has met the requirements for a comprehensive quality management system for the design and manufacture of medical devices.

“Achieving ISO 13485:2003 certification is a critical milestone for Genesis Plastics Welding,” says Tom Ryder, president and CEO of Genesis. “Receiving this certification furthers our position as a one-stop partner for all development and manufacturing of medical device equipment using RF welding and heat sealing applications.”

The ISO 13485 is based on ISO 9001 standards, but includes requirements specifically for medical devices including regulatory requirements, effectiveness monitoring, records management, work environment (sterile, cleanroom, etc), risk analysis and design and development validation. The review was performed by SGS North America according to ISO 13485:2003 requirements, and focused on Genesis’s role as a contract manufacturer providing heat sealing applications including assembly and packaging.