Performance Plastics – USP Class VI Medical Compliance

June 29, 2023  |  , ,

In order to ensure the safety of medical devices, USP Class VI testing is required.  Developed by the United States Pharmacopeia, the Class VI test is a specific test conducted on medical devices to assess their biocompatibility.  It is designed to evaluate the potential adverse biological effects of the materials used in a medical device when they come into contact with living tissues or bodily fluids. Performance Plastics is proud to announce we have passed the test – we now offer material and process expertise.

The USP Class VI test is particularly important for medical devices that directly or indirectly interact with the human body, such as implants, surgical instruments, catheters, and tubing. The test helps to ensure that these devices are safe and do not cause harmful reactions or toxicity when used in clinical settings.

Here are a few key reasons why the USP Class VI test is conducted on medical devices:

  1. Patient Safety: The primary objective of the USP Class VI test is to ensure patient safety. By assessing the biocompatibility of the materials used in medical devices, it helps identify any potential risks or adverse reactions that may occur when the device is used in the human body.
  2. Regulatory Compliance: Compliance with regulatory standards is a crucial aspect of the medical device industry. Many regulatory bodies, including the U.S. Food and Drug Administration (FDA), require medical device manufacturers to demonstrate the biocompatibility of their products. Conducting the USP Class VI test helps meet these regulatory requirements.
  3. Material Selection: The USP Class VI test aids in material selection for medical devices. It helps manufacturers evaluate different materials and determine which ones are the most suitable in terms of biocompatibility. This allows them to make informed decisions about the materials used in their devices, minimizing the risk of adverse reactions.
  4. Product Development and Improvement: The test is also valuable during the product development and improvement stages. By identifying any potential biocompatibility issues early on, manufacturers can modify or optimize their device design or materials to enhance safety and efficacy.
  5. Industry Standard: The USP guidelines are widely recognized and accepted within the medical device industry. Conducting the USP Class VI test demonstrates a commitment to quality and safety, providing confidence to healthcare professionals, regulatory bodies, and end-users.

It’s worth noting that the USP Class VI test is just one of several tests and evaluations conducted to assess the biocompatibility of medical devices. Other tests, such as cytotoxicity, sensitization, and irritation tests, may also be performed depending on the specific device and its intended use.

For more information on Class VI testing and how Performance Plastics can assist in certifying your medical device, please contact Rich Reed, Vice President of Sales & Marketing at [email protected], or visit our website at www.performanceplastics.com.

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Performance Plastics – PEEK use in Medical Devices

June 22, 2023  |  ,

PEEK Resin Thermoplastic Component

Engineered Plastic Medical Devices are revolutionizing the healthcare industry. The growth of polymers has transformed the marketplace, with plastic medical devices steadily replacing other materials such as glass, ceramics, and metals, wherever applicable.

Peek (Polyether Ether Ketone) plastics are widely used in the medical device industry due to their excellent mechanical properties, biocompatibility, and resistance to chemicals and high temperatures. Here are some ways Peek plastics are used in medical devices:

  1. Implants: Peek is commonly used in orthopedic implants, such as spinal fusion cages, joint replacements, and trauma fixation plates. Its mechanical properties closely resemble those of bone, making it an ideal material for load-bearing applications. Peek’s biocompatibility allows it to integrate well with the surrounding tissue.
  2. Dental Applications: Peek is used in dental applications like dental implants, temporary crowns and bridges, orthodontic brackets, and dental surgical instruments. It provides good strength and stability, and its tooth-colored variants offer aesthetic benefits.
  3. Surgical Instruments: Peek is utilized in the manufacturing of surgical instruments, including forceps, retractors, and endoscopic components. Its high strength, durability, and resistance to sterilization methods such as autoclaving make it suitable for repeated use.
  4. Medical Device Housings: Peek is used for the housing and structural components of various medical devices, such as handheld surgical tools, electronic devices, and monitoring equipment. Its mechanical strength, resistance to sterilization, and biocompatibility make it suitable for these applications.
  5. Ophthalmic Devices: Peek is used in the manufacture of intraocular lenses (IOLs), which are artificial lenses implanted in the eye during cataract surgery. Peek’s optical clarity, biocompatibility, and resistance to degradation within the eye make it a preferred material for IOLs.

Peek plastics offer several advantages for medical devices, including their radiolucency (compatibility with X-rays), high strength-to-weight ratio, chemical resistance, and biocompatibility. These properties make Peek a versatile and reliable material choice in various medical applications.

For more information on PEEK and its use in medical applications, please contact Rich Reed, Vice President of Sales & Marketing at [email protected], or visit our website at www.performanceplastics.com.

 

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Endurosharp® Torlon® Tools vs Traditional Metal Scrapers

June 15, 2023  |  , ,

Correctly and efficiently performing aircraft maintenance requires the correct tools.  Patented EnduroSharp® Torlon® aircraft maintenance tools, exclusively from Performance Plastics, are the correct tools.  They are non-metallic scraper tools that quickly and effectively remove silicone, sealants, adhesives, and coatings while keeping an effective edge and not damaging underlying materials.

At the time of development, many nonmetallic scrapers were available and approved for various material removal applications. But, the effectiveness of the existing tools varied, and the tools were generally inefficient & short-lived. Some even pose a great risk to the underlying structures.

Under contract with the Air Force Research Laboratory’s Materials Integrity Branch (AFRL/RXSA), the University of Dayton Research Institute (UDRI) developed the EnduroSharp® line of Torlon® material removal tools.

After sampling available tools on the market for material and design, the material Torlon® by Solvay was chosen, along with a spiral-fluted design for the GFR Bit. Torlon® is a polyamide-imide (PAI) resin that is a high-end niche material that proved to be ideal for the application.  Initially, three types of tools were developed:

  • Gap Filler Removal Bits (GFR Bit)
  • Torlon Scraper Blade (TSB)
  • Torlon Gap Blade (TGB)

All three tools were extensively tested and summarized. It was concluded that Torlon® was indeed a great material for the application.  The material offered significantly less damage potential than other often-used tools.  It offered faster material removal rates and required less operator effort.  Additionally, the material proved to be resharpenable.

At the request of our users, EnduroSharp® is soon to release our new TSR Cutter, The Torlon Sealant Remover Cutter (TSR) is a rotary cutter designed to safely remove thick layers of sealants and adhesives from larger areas, such as fuel cells, without damaging the underlying coatings and surfaces.

The EnduroSharp® line is offered by over 100 organizations and is under evaluation for 11 weapons systems at 10 DoD locations.

For more information on the EnduroSharp® line of products, please contact Rich Reed, Vice President of Sales & Marketing at [email protected], or visit our website at www.performanceplastics.com.

 

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Performance Plastics – How a mold flow analysis can save you time and money.

June 13, 2023  |  , ,

A Mold flow analysis is a software simulation that can show how resin will fill the mold during the injection molding process. By understanding material fill, injection mold designers can better position gates, anticipate where knit lines will appear, and locate difficult-to-fill spots in the mold.

The predictive process of mold flow analysis can uncover design issues, save resources, allow for preemptive correction, speed up overall cycle time, and present your business with an abundance of benefits. Mold flow analysis is essential to ensure that a mold can produce the strongest and most consistent parts.

Here are our top six reasons why you should always perform a mold flow analysis:

  1. Optimization of Design

Without the investment of tooling or molding, all the what-if questions can be addressed ahead of time. Mold flow analysis can point out many concerns or production factors, including:

  • Material selection issues
  • Thickness/thinness problems
  • Structural concerns
  • Residual or structural stress issues
  • Filling concerns
  1. Quick & Immediate Decisions

With mold flow analyses, you can make immediate, informed decisions. These decisions can impact multiple areas of the process including:

  • Product design
  • Material and process selection
  • Tooling
  1. Optimization of Injection Molds and Tooling

You will have all the information upfront to make the most optimal choices in injection molds and tooling to create the perfect product. Mold flow analysis can show you everything you need:

  • The optimal gate locations
  • Balanced filling and packing
  • Cavity layout
  • The best cooling layouts
  • Structural and thermal analyses for tool life
  1. Trying Different Materials

You’re able to test out different materials and designs without building any prototype parts or tools. You can get virtual parts with a simulation as well, so you can have a full process simulation with minimal upfront investment.

  1. Optimize Overall Cycle Time

Mold flow analyses can optimize your overall cycle time by up to 10-30%. That reduction percentage on just one part can cancel out the cost of a complete flow analysis of multiple molded parts!

  1. Specification

Plastic parts can be optimized for exact machine specification, cycle time, cooling, DOE, and more, without reducing production time or putting any tools on molding machines; this can help improve your bottom-line profit.

The predictive process of mold flow analysis can uncover design issues, save resources, provide for preemptive correction, speed up overall cycle time, and present your business with an abundance of benefits.

Performance Plastics provides mold flow analysis to help your business improve manufacturing processes by saving time and money. For more information on how mold flow analysis can provide simplicity and quality to products, please contact Rich Reed, Vice President of Sales & Marketing at [email protected], or visit our website at www.performanceplastics.com.

 

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Performance Plastics – Experts in Micro Molding Technology

June 6, 2023  |  , ,

 

Micro injection molding is a specialized form of injection molding that is used to produce small, intricate parts with high precision and accuracy, It has gained significant attention in various industries, including medical devices, electronics, automotive, and aerospace/defense.  In recent years, several innovations have emerged in micro injection molding, improving its capabilities, and expanding its applications.

  • Advanced Tooling: Innovations in micro injection molding tooling have significantly contributed to improved part quality and increased production efficiency. High-precision molds with complex geometries and tight tolerances can now be manufactured using advanced machining techniques like micro-milling and electrical discharge machining (EDM). These techniques enable the creation of intricate features and microstructures in molds, producing highly detailed micro parts.
  • Material Selection: Micro injection molding has benefited from the development of new materials specifically designed for small-scale molding. These materials offer enhanced flow properties, dimensional stability, and improved mechanical properties. They include specialized engineering plastics such as high-temperature thermoplastics. The availability of a broader range of materials expands the potential applications of micro injection molding.
  • Process Monitoring and Control: The integration of advanced sensors and monitoring systems has improved the control and consistency of the micro injection molding process. Real-time monitoring of key process parameters, such as temperature, pressure, and flow rate, allows for better process optimization and early detection of issues. Closed-loop feedback systems can automatically adjust process parameters to maintain consistent part quality, reducing scrap rates and improving overall productivity.
  • Microfluidic Devices: Micro injection molding has found extensive use in the production of microfluidic devices, which are used in applications like medical diagnostics, chemical analysis, and drug delivery systems. Innovations in microfluidic design and fabrication techniques have enabled the integration of complex fluid channels, valves, and sensors into small, disposable devices. Micro injection molding provides a cost-effective and scalable manufacturing method for producing these devices with high precision and reproducibility.
  • Multi-Material and Overmolding: Recent innovations in micro injection molding have focused on enabling multi-material molding and over-molding processes. Multi-material molding allows for the integration of different materials or colors within a single micro part, expanding design possibilities and functionality. Overmolding, on the other hand, involves molding one material over another, creating bonded layers or adding soft-touch grips to parts. These capabilities enhance the versatility and aesthetics of micro-injection molded products.
  • These innovations in micro injection molding have expanded its capabilities, enabling the production of smaller, more complex parts with improved quality and functionality.

Micro injection molding is widely applied for parts and devices in medical, pharmaceutical, electronics, automotive, optical, and other industries. In general, the medical micro injection molding market is the leading one, due to an increase in the usage of sophisticated micro components for endoscopic surgery, minimally invasive treatments, and other advanced technology developments.

Performance Plastics are experts in precision injection molding.  We have developed proprietary tooling, unique metallurgy equipment, and processes that produce custom-molded plastics such as fluoropolymers, Ultem®, PEEK, and Torlon®.  We leverage our high-performance polymer expertise and technology to develop thermoplastic compounds and techniques to deliver the best possible results on our projects.

For more information on how micro molding can benefit your application, please contact Rich Reed, Vice President of Sales & Marketing at [email protected] or visit our website at www.performanceplastics.com.

 

 

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Performance Plastics – Family Molds for Advanced Materials

June 1, 2023  |  , , ,

Family_Mold

A family mold is a mold that produces different parts using the same base.  There can be multiple cavities for different part numbers.  Family molds often have a building cost advantage over molds dedicated to a single part number.

A common usage is to combine two halves of housing into a family mold. Halves are purchased in sets which makes running them together a good option.  They don’t have to be run together, so a shut-off runner must be included which allows one or more cavities to be turned off during production.

Family molds are often more practical than dedicated molds with moderate production volumes, whereas dedicated multiple cavities would be more expensive.  But family mold layout design is demanding and requires experience when dealing with advanced materials.

There are big differences between the properties, processing methods, and applications of various advanced materials.  Engineers need to understand the properties of the materials when using a family mold.  All advanced materials have benefits and deficiencies, so this understanding is key to the success of a project.

The conditions encountered when forcing molten plastic through a mold’s sprues, runners, and gate change as the mold becomes larger, and more complex, which impacts the molding process and material quality.  Thermal variations within a family mold become more of a concern, increasing the risk of partially filled cavities as well as part deformation.

Performance Plastics are experts in precision injection molding.  We have developed proprietary tooling, unique metallurgy equipment, and processes that produce custom-molded plastics such as fluoropolymers, Ultem®, PEEK, and Torlon®.  We leverage our high-performance polymer expertise and technology to develop thermoplastic compounds and techniques to maximize your family mold and provide the best quality on your mold investment.

For more information on family molds and how they can benefit your application, please contact Rich Reed, Vice President of Sales & Marketing at [email protected] or visit our website at www.performanceplastics.com.

 

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