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ISO 13485 Certification Becoming More Essential for Medical Device Manufacturers

With billions of dollars in contracts at stake, medical device manufacturers are pushing steadfast to conform to ISO 13485 regulatory requirements. Despite its widespread commercial implications, the popular standard is squarely focused on improving patient safety.

ISO 13485 Certification -->
The Importance of a One-Stop-Shop - White Paper

6 Questions to Ask Your Fluid-Management Component Supplier

A one-stop-shop fluid management component supplier assures quality, streamlines processes, and limits costs. To be certain you receive the preeminent and safest single-use component, take time to evaluate your fluid-management supplier or a supplier under consideration by asking 6 important questions.

Download White Paper -->
ISO 80369 Standards on Small-Bore Tubing Connectors Inch Forward Toward Release

The luer connector has been one of the most common types of small-bore connectors used in hospitals and other healthcare facilities to link or join medical devices, components and accessories for the purpose of delivering fluids or gases. But just as the luer's universal design has allowed for ease of use in diverse patient care applications, so too has it made possible the inadvertent connection of wrong systems with unfortunate consequences to patients. An international effort has begun to develop and implement standards for non-interchangeable connectors for small bore medical connectors to prevent tubing misconnections and consequently reduce patient injuries and deaths. Value Plastics is actively participating in the development of these standards and is keeping the latest news on our website.

The Release of ISO 80369 -->
Value Plastics presents needlefree swabable valves designed to combat infection in medical applications!

Value Plastics, a Nordson MEDICAL company and premier supplier of precision plastic components, introduces a cost efficient needlefree swabable valve series featuring higher flow rates, low priming volumes, and a straight through design for unobstructed flow. Designed for the injection and aspiration of fluids, particularly for IV applications, urology, blood processing, cardiology, pharma, and disposable biopharm, the hermetic septum seal reduces the risk of biofilm formation and contamination in an industry where infection is a particular concern. These valves are available in widely-used polycarbonate and copolyester materials, and are compatible with all industry standard luer syringes and connectors, validating them as the ideal component solution for the OEM market. Value Plastics' needlefree swabable valves' normally closed system negates the need for caps in order to reduce the risk of infection. Not made with natural rubber latex or DEHP, the materials are gamma radiation stable and EtO compatible for sterilization.

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Value Plastics introduces the RQC Series of tubing connectors, a new alternative to bioprocessing and quick connect fittings.

A more robust alternative for bioprocessing needs, the RQC Series offers a cost effective solution for flexible tubing connections in single use systems. The connector set features a user-friendly interface that includes a large button, making it easy to connect and disconnect the components. The optional, integral, and easy to use locking feature gives you peace of mind knowing your connection is secure. The RQC Series also includes caps and plugs to support sterilization, and being available in widely used polypropylene and polycarbonate materials, these connectors are compatible with most industry standard quick connects. The single barb open flow design provides security and mitigates flow path obstruction. No longer do you have to worry about your tubing connection and the transfer of valuable fluids! -->
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Value Plastics, a premier OEM supplier of precision plastic components and a Nordson company, introduces an acrylic-based multipolymer compound

The material is resistant to chemicals and plasticizers found in flexible tubing and provides antimicrobial capabilities against a variety of microorganisms commonly found in healthcare facilities as tested by JIS Z 2801 protocol. Value Plastics’ luer fittings are part of a standardized system of small-scale tubing connectors used to make secure leak-proof unions in medical devices and laboratory instruments. Available in the FTLL230-CM550 and MTLL230-CM550 luers, the antimicrobial material will give you peace-of-mind knowing you have a secure connection, with sanitary fittings fighting against harmful microbes. Value Plastics will add additional parts with the antimicrobial resin based upon customer demand. Please contact your sales representative to discuss further.

FTLL230-CM550 -->
MTLL230-CM550 -->
Full Press Release -->
Value Plastics, a Nordson Company, Releases a Medical Grade Barbed Check Valve Line to Ease Assembly and Avoid Risks Common to Most Check Valves

SCV Series barbed check valves were developed to provide a reliable mechanical connection and simplify tubing assemblies that often require multiple parts needed for in-line check valves. Available in medical grade materials and multiple barb sizes the valves feature more precise, lower crack pressures, higher flow rates, low priming volume, air bubble mitigation during priming and operate in any spatial orientation.

The check valves feature 3/32” (2.4 mm) and 1/8” (3.2 mm) single barb ends in barb to barb straight through, reducing and barb to male/female luer configurations. All check valves feature DEHP- and latex-free silicone diaphragms and all materials of construction satisfy USP Class VI and ISO 10993 criteria. -->
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Value Plastics introduces the BPL Series of tubing connectors, a new alternative to luer fittings.

The luer is a standard tubing connector prevalent in medical devices largely due to its ease of use and affordable nature. Unfortunately, however, the common use of this standard design has resulted in the risk of tubing misconnections within healthcare environments. Alternatives to these fittings have therefore begun to increase in popularity.

The BPL Series of connectors incorporates a quarter-turn design that is commonly used in blood pressure applications – particularly in blood pressure cuffs. Features such as Value Plastics’ patented 10-point grip coupled with the BPL’s winged male fitting provide for top-of-the-line ergonomics, and the snap-on connection presents the end user with confidence that a secure fit has been made. These attributes can be crucial in healthcare environments due to hindrances such as dark rooms, baggy rubber gloves, and the potential for situations that don’t allow time for fumbling. -->
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Value Plastics, a Nordson Company, Introduces a More User-Friendly, Single-Use Sanitary Clamp to Biopharmaceutical Market

Value Plastics, a Nordson Company (Nasdaq: NDSN), announces the PharmaLok™ Series – a new line of ergonomic, single-use sanitary clamps for securing fittings to bag ports and filters in the biopharmaceutical market.

PharmaLok clamps provide a significant advancement for the industry, as a number of existing solutions either require tools for closure or consist of multiple components, which turns what should be a simple operation into a difficult and awkward process.

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Full Press Release -->
Value Plastics, a Nordson Company, Signs New Distributor for Australia and New Zealand

Value Plastics, a Nordson Company (Nasdaq: NDSN), announces that they have signed a new distributor, John Morris Scientific Pty Ltd (JMS), to strengthen their presence in Australia and New Zealand.

Value Plastics manufactures innovative, high-quality fluid fittings and other fluid management components used with the flexible tubing employed in many healthcare, biopharmaceutical, and industrial applications. After serving more than 100 Oceania companies directly from their factory in Colorado, Value Plastics is pleased to be able to provide these customers with local service from 12 JMS offices throughout the region.

Full Press Release -->
Value Plastics introduces a technologically advanced series of ports for the single-use bags used to transfer media and drug compounds in the biopharmaceutical industry.

Value Plastics’ new high tech series of bag ports offers a variety of benefits new to the biopharmaceutical industry through a combination of Value Pharma™ resin and a unique design. Value Pharma™ resin holds credentials that many manufacturers deem fundamental, such as animal derivative free qualification, USP Class VI certification, and the guarantee of heat sealing and conformance with polyethylene bags. The resin then goes even further to provide a strong, 24-hour resistance to alcohol stress cracking.

Their unique design sets these new ports apart from existing solutions. They not only conform with frequently utilized tubing sizes from 1/8" (3.2 mm) to 1" (25.4 mm), but they are also designed to ASME and BPE ferrule specifications, allowing them to work with leading industry fittings, filters and other devices. However, the most notable of the bag ports’ specifications are those that are new to the industry – the parabolic lead and the alignment ribs. These two features, respectively, reduce the amount of time it takes to drain a bag by 24 percent and improve flow dynamics through the port.

Full Press Release -->

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Value Plastics Leads Industry with Both Print and Interactive Digital Catalog

Value Plastics, a Nordson company (Nasdaq: NDSN), is pleased to announce the immediate availability of their latest precision fluid management component catalog, Vol. 25. The new catalog contains detailed information on over 4,000 off-the-shelf parts as well as several new products, including the MQC Series of quick connect fittings and a new innovative line of single-use sanitary clamps – the Pharmalok Series.

Selecting from thousands of tubing connectors can be an unforeseen hindrance on speed to market – a competitive edge on which companies thrive. Therefore, to increase ease of use and efficiency, Value Plastics has chosen to make two catalog formats available to end users. For those more comfortable with solid, dependable ink, the printed desktop version will be available. For a deeper level of interaction with technical details and commercial availability, the new catalog will also be provided in an interactive, electronic format located on Value Plastics’ website. With the click of a button, customers can now:

  • Immediately access dimensional part drawings
  • See inventory status and forecasted availability
  • View pricing information and minimum order quantities
  • Add parts to an online shopping cart
  • Check resin chemical resistance, regulatory information and sterilization properties
Full Press Release -->

PCV025 PDF Version -->

PCV025 Printed Catalog Request -->

We are pleased to inform you that Nordson Corporation of Westlake, Ohio, has completed the acquisition of Value Plastics, Inc.

Nordson is one of the world’s leading producers of precision dispensing equipment that applies adhesives, sealants, coatings and other materials in a broad range of manufacturing processes. Value Plastics will operate within Nordson’s Advanced Technology Systems segment, where Nordson serves the healthcare industry with expertise in a variety of applications including biomaterial dispensing, dental molding, glucose test strip production, and catheter, stent, and pacemaker assembly. Nordson has direct operations and sales support offices in more than 30 countries. Value Plastics looks forward to leveraging this global reach and infrastructure to provide additional capabilities, products, and services that will benefit our customers.

Nordson purchases companies with the intent of investing in their technologies and growing their capabilities. Value Plastics will continue to operate as a separate entity providing the same high quality products and service you are accustomed to receiving. We believe the combination of Nordson and Value Plastics is an excellent one, and we look forward to meeting your needs with a growing portfolio of innovative products. All Value Plastics operations, including order fulfillment, customer service and technical support will continue the same way for our customers, with no immediate changes anticipated.

If you have any questions, please email the Value Plastics sales department at

Full Press Release -->

Introducing the MQC Series™ Quick Connect Fitting Line

The MQC Series™ is an intuitive Push-to-Connect design and arguably one of the most versatile quick connect solutions on the market. With its large, ergonomic buttons and wide selection of colors, both designers and end users will embrace its unique features. This fitting is available for 1/8” (3.2 mm), 5/32” (4.0 mm), and 3/16” (4.8 mm) ID tubing and can be manufactured in either standard or USP Class VI certified nylon. The MQC also comes in 10 different color options, enabling customers to create their own custom-made solution and allowing for unique color-coding verification techniques. Between the audible click on connect, the unique design, and the large versatility this line presents, the MQC Series™ is a great luer alternative for preventing misconnections.
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Value Plastics Expands Press-In Plug Line

Value Plastics, manufacturer of plastic tubing connectors, announces the expansion of their press-in plug (PIP) line. PIPs are frequently used by biopharmaceutical and medical device companies to seal off tubing during the sterilization process. Due to increasing production volumes, companies have trended towards using larger tubing and as a result, the biopharm industry has expressed a need for larger PIP sizes - particularly 3/8" and 1/2" fittings. Value Plastics is accommodating this need and providing these parts in the industry's preferred resin, USP Class VI animal-free polypropylene.
View all Press-in Plugs -->
Press Release -->

Value Plastics Makes Animal-Free Polypropylene a Standard USP Class VI Offering

Due to increased customer demand and a change in supplier certifications, Value Plastics, manufacturer of plastic tube fittings, has chosen to include a certified USP Class VI polypropylene as one of their core resin offerings. Any part that is currently offered in the company's standard polypropylene (parts ending in '-6') will now also be offered in the Flinthills P5M6K-080 resin (-6005) that provides the USP Class VI and animal-free certification desired by medical and biopharm companies. This change has resulted in a significant increase in Value Plastics' total product offering.
Press Release -->

Value Plastics Goes Vertical - Plant Tour (Injection Molding Magazine)

IT, moldmaking, and marketing are just some of the functions that the self-described “control freaks” at fluid connector molder Value Plastics have kept in-house, to great success.

"Understand what we’re good at, focus on that, and continue to get better at everything else."
- John Gibson, Vice President of Operations, Value Plastics, A Nordson Company
Read Full Article on Page 30 -->

Taking Total Control, Achieving Total Success (Plastics Today, Modern Plastics and Injection Molding)

Founded by an entrepreneur so displeased with the quality of the fittings he was being supplied that he launched a business to make them himself, Value Plastics approaches its 45th year in business still believing that the best place to find great products and services is within its own walls.
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Single-Use Systems - Savings, the Environment, and Cogeneration - Free Whitepaper

About a decade ago, the debate about Single-Use Systems (SUS) vs. traditional stainless-steel was just a whisper: reusable steel was favored because it was the system that process designers and users had relied on for years. Then awareness of the cost savings and environmental benefits of SUS grew, and a shake up in the industry started. We present the facts in this whitepaper so that you can best determine the system that is right for your company.
Download Whitepaper -->

Retrospective: 25 Years of Making Connections

When it comes to healthcare advances over the last 25 years, it may be easy to overlook some of the simplest, yet most significant improvements in patient care and the mitigation of preventable threats. However, patient-care connectors are among the most-critical components of any instrument in that they often represent the primary user and patient interfaces.
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ISO 80369 - News Hub

Value Plastics has created a new ISO 80369 section on our website to serve as a reference for medical device manufacturers who could be affected by the upcoming ISO 80369 standards. Value Plastics is an active member of the Association for the Advancement of Medical Instrumentation (AAMI) and participates in the ISO 80369 Series of Small Bore Connector Standards, working group. Visit the ISO 80369 - News Hub now -->

(UPDATED!) LyondellBasell Pro-fax PD626 Polypropylene Announcement

Value Plastics has been notified by our supplier of Pro-fax PD626 polypropylene, LyondellBasell, that an additive used in this resin has been discontinued. The additive is used to reduce the yellowing effect that can result from radiation sterilization. The company currently making and supplying the additive to Lyondellbasell has made this additive obsolete, which has required the specification of a new additive. NOTE: There is currently a sufficient supply of the current PD626 material with the old additive, therefore, this change will not become effective for 9-12 months from the beginning of 2011.
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Making Connections with Tubing and Suppliers

Tubing connectors are often a forgotten piece of the development puzzle. Several tips can help OEMs find the appropriate part and partner. Medical Device and Diagnostic Industry article authored by Chuck Philipp and Riley Phipps.
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Seasoned Manager Joins Company to Drive International Growth Opportunities

Value Plastics, A Nordson Company, the world leader in molding precision fluid management components, today announced that Jim Skog, a marketing professional with over 25 years experience, has joined their Sales and Marketing teams as the Director of International Accounts. In this role, Skog will work to further enhance current international partner programs, as well as identify and qualify new international partners to continue Value Plastics’ commitment to providing world-class service and delivery on a local level.

Skog brings to Value Plastics an abundance of experience working with national and international sales channels in such capacities as Enterprise Sales Program Manager, Solutions Marketing Manager and Industry Marketing Manager for a Fortune 100 company. His involvement in startups, business planning, and product line management are a great complement to his role developing and growing new international business.

“Joining a people-oriented organization with a leadership role in providing high quality components to medical device manufacturers is very exciting. The process-oriented culture feels similar to my experience in the information technology industry. And I love being a part of a US-based manufacturing company using sophisticated automation to compete in global markets” says Skog.

Value Plastics announces the latest additions to their online flexible tubing fitting tools. - 1. 2. 3. Done!

Value Plastics has been listening to customer feedback regarding the website. For many Value Plastics customers the current site works well. It is the industry leading informational hub for fluid connections and the latest news regarding Value Plastics.

Some customers, however, already know what fitting, size and material they need and just want to get to it fast. With this new site customers can get to the fitting they need with 3 simple clicks. The full line of over 4,000 hundred tubing fittings has been reorganized and streamlined in this format.

Value Plastics announces the immediate availability of its newest full-line catalog of precision fluid management components, Vol. 24.

You can download your very own digital copy, or order a desk reference copy today to find out about our latest tube fitting products and services!

  • SBL Series quick connect fittings for small-bore reusable applications in all fluid delivery areas (pg.9)
  • SCV Series single check valves, available in anti-siphon or one-way check valve configurations (pg.12)
  • XQ Series quick connect fittings add convenience to your repetitive connect-disconnect requirements (pg. 10)
  • DCV Series double check valves are designed to enable clean transfer of a fluid from a storage container to a point of use (pg. 14)
  • SF Series sanitary fittings (sanitary couplers) mate our 600 series barb to a sanitary end flange (pg.16)
Value Plastics introduces groundbreaking quick connect fitting

Fort Collins, Colo. – Feb. 10, 2009 – Value Plastics, a premier OEM supplier of precision plastic components, has broken new ground in the quick connect fittings arena with the development of its newest product line – the SBL Series connector system. The plastic small-bore quick connector, which was unveiled at Medical Design & Manufacturing West (MD&M West), Feb. 10-12, 2009 in Anaheim, Calif., is ideal for medical device designers focused on health care fluid application arenas.

Created with the end user top-of-mind, the unique, patent-pending design is intuitive, easy to use, safe, secure, and reliable. The SBL Series quick connect fittings are intended to take the guesswork out of in-hospital and consumer-operated medical equipment.

Product overview:

  • Four component options in nylon and a color combination of blue and grey are available from stock.
  •  Options include male and female hose barbs in 1/8-inch (3.2 mm) and 3/16-inch (4.8 mm) in a straight-through flow configuration.
  •  The male portion includes a Buna-N o-ring, ensuring a secure seal.
  •  Users can interconnect the 1/8-inch and 3/16-inch options if their application requires.

To provide engineers additional design freedom, SBL Series products do not interconnect with ISO 594 luer components. In addition, the fittings can be sterilized using either ethylene oxide sterilization (EtO) or gamma techniques.

Jim Pisula, Vice President of marketing for Value Plastics, explained that the company saw a real gap in the marketplace for connectors that support health care fluid applications, particularly in terms of ease of use, safety and reliability. “Connectors should be easy to understand and use whether by professionals or by the consumer at home,” said Pisula. “Every aspect of the SBL Series – from the color selections to the quick snap fitting – was intentionally designed to cut down on the likelihood of human error and ultimately provide an added level of security for health care fluid applications.”

Value Plastics received enthusiastic feedback from one early adopter who stated, “this product is fantastic.” The customer looked at approximately 26 different solutions before selecting the SBL Series for its wound therapy application. The SBL was rated superior to all other solutions considered, including designing and molding it in-house.

Value Plastics introduces more check valves to its product line

Fort Collins, Colo. – February 10, 2009 – Value Plastics, a premier OEM supplier of precision plastic components, introduces SCV Series check valves for medical devices. These new check valves come in multiple medical grade materials and sizes to meet a diverse set of fluid management applications. The check valves, which are being unveiled at Medical Design & Manufacturing West (MD&M West), Feb. 10-12, 2009 in Anaheim, Calif., are ideal for medical device designers focused on infusion, drainage and irrigation applications.

Following on the introduction of DCV Series double check valves in January, 2008, SCV Series products are available in anti-siphon or one-way check valve configurations in a variety of materials and end fitments. The valves feature low priming volume, ease of removing air bubbles during priming and operate in any spatial orientation. The patented design of the latex-free platinum-cured silicone diaphragm prevents sticking and assures trouble-free operation. All materials satisfy USP Class VI and ISO 10993 criteria. End fitments include .118” (3.0 mm) x .161” (4.1 mm) and .122” (3.1 mm) x .165” (4.2 mm) tubing, and male and female luer tapers complying with ISO 594-1 and 594-2 standards. All products are suitable for EtO or gamma sterilization, and autoclavable options are available on special order. All SCV Series check valves are suitable for use with air or liquids.

Jim Pisula, Vice President, Marketing for Value Plastics, explained that the company has received many requests for check valves from their customers, saying, “Given this high degree of interest and a unique feature set, we knew the time was right to expand our product offering.”

Sanitary Fittings Series offers more choices for Single-Use applications

Now Biopharmaceutical companies have additional choices for their Single-Use needs. The Sanitary Fitting (SF) Series, the latest product addition from Value Plastics, is the perfect solution for biopharm applications.

These new components allow drug manufactures to realize the business advantages of single-use technology including

  • Less capital investment
  •  Major reduction in labor and cleaning expense
  •  Major reduction in turnaround time between campaigns • Simplified process layout
  • Reduced complexity
  •  Reduced risk

The new SF series is based on design concepts calling for a heavy-duty part with superior side load strength, while providing superior flow through characteristics; making it the connector of choice for Single-Use processes. “Pharmaceutical professionals find this connector offers all the benefits of a disposable part while offering performance capabilities not found in earlier versions of flange fittings; says Jim Pisula VP Marketing.

Animal-Free Polypropylene

Value Plastics is pleased to announce the availability of our fittings and connectors in animal-free polypropylene. Polypropylene is by far the most widely used resin for flexible tube fittings in the biopharmaceutical industry. The new animal-free polypropylene significantly reduces our customers’ BSE-related paperwork by completely eliminating the documentation requirement for fittings made with this material.

Since the first reported outbreak of BSE (bovine spongiform encephalopathy or “mad cow disease”) in the United Kingdom, suppliers of healthcare products, in conjunction with global healthcare agencies, have diligently worked to reduce the threat of this serious disease. BSE is a progressive neurological disorder of cattle that can be transmitted to humans. Worldwide healthcare agencies have recommended a number of steps to reduce the risk of BSE to humans including documenting that those products containing animal derivatives only use material from BSE-free countries. Plastic products commonly use beef tallow as a lubricant in the manufacturing process and tracking all of them to their source can require a significant expense for a medical device and biopharmaceutical manufacturer.

The new animal-free polypropylene is in addition to Value Plastics’ extensive line of animal-free PVDF and polycarbonate fittings and connectors for the medical device and biopharmaceutical industry, including the 600 Series line of large connectors. All animal-free and 600 Series products are Class VI certified and suitable for gamma sterilization.

For more information on the implications of Mad Cow disease to medical products, see the editorial “The Curse of the Mad Cow” at

Free samples can be obtained by calling Value Plastics Inside Sales at 970-267-5200 (toll-free in U.S.A. at 888-404-5837) or by completing an online request at

Founding Member - Bio-Process Systems Alliance

Value Plastics is pleased to announce that they are a founding member of the Bio-Process Systems Alliance (BPSA), a special purpose group of The Society of the Plastics Industry, Inc..

What is the BPSA?
The Bio-Process Systems Alliance (BPSA) was organized to meet the challenges of the emerging single-use bioprocessing industry. There is a great need to educate, standardize, and develop guidelines that safeguard the quality of drugs produced using this technology. The goal of BPSA is to globally promote confidence in the application of single-use products in the biotech/pharmaceutical manufacturing industry.

  • The alliance consists of leading companies engaged in the manufacture and use of single-use bioprocessing products.
  • Brings together the diverse know-how necessary for single-use bioprocessing, ranging from manufacturers of plastic film, bags, bioreactors, filtration, to fittings and connection devices.
  • Provides an integrated knowledge base for the development, implementation, validation, and operation of single-use bioprocesses.
  • Provides a forum for the development of compatible technologies and standards to facilitate the use of disposables for pharmaceutical manufacturing.
  • Facilitate the acceptance of single-use technology by regulatory agencies.

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