Category: Plastic Machining

Why it’s essential to have ISO 13485 for Manufacturing Medical Devices

September 23, 2022

A Universal Standard of Safety and Quality

Every medical innovation begins with design and manufacturing. Before a small spinal implant goes to the patient, it must meet strict universal industry standards for safety, handling, and product consistency. Afterall, a failure in a medical device can have serious repercussions for not only the health and safety of end users, but also loss of credibility and resources for a manufacturer.

 

That’s why medical device OEMs demand that machining facilities follow the ISO 13485 standard for medical device manufacturing.

 

In this informative brief, we take a deeper look at the benefits of this essential certification and how a precision machining facility can get certified.

 

The Benefits of having an ISO 13485 Certification

 

Global Standard

The ISO 13485 international standard is the world’s most widely used means of measuring the effectiveness of a medical device manufacturer’s quality management system (QMS). While different countries may have different standards for measuring quality and effectiveness, ISO 13485 provides a globally harmonized model of QMS requirements for international markets.

 

 

Quality Assurance

When it comes to machining for the Medical, Healthcare, and Life Sciences sector, true culture of quality and consistency in manufacturing techniques are paramount. An ISO 13485 certification ensures that machining processes, product handling, storage, and shipping are all accounted for in a facility’s processes. 

 

 

Requirement for Business 

Most medical device OEMs require compliance with ISO 13485, including all European Union members, Canada, Japan, Australia, and more (165 member countries in total). Therefore, precision manufacturers that want to serve the Medical sector must show proof of and adherence to ISO 13485 guidance. 

 

 

Works at the Federal & Civil Enterprise Level

The FDA recently proposed aligning current Quality management system regulations with ISO 13485. This means that at the federal and civil enterprise level, ISO 13485 would satisfy standards for quality, consistency, risk management, and in medical device manufacturing.

 

 

How to get ISO 13485 certified

The International Standardization Organization establishes and maintains standards, but it is not an enforcement agency. Certification for ISO 13485 is evaluated by third party agencies. The first step is establishing a QMS that is in alignment with the guidance. Then, an independent certification body audits the performance of the QMS against the latest version of the ISO 13485 requirements. The agency must be part of the International Accreditation Forum (IAF) and employ the relevant certification standards established by ISO’s Committee on Conformity Assessment (CASCO). Once an organization passes the ISO 13485 audit, they are issued a certificate that is valid for three years. Manufacturers must undergo a yearly surveillance audit and be recertified every three years. 

 

Here’s what the ISO 13485 certification will assess: 

  • Promotion and awareness of regulatory requirements as a management responsibility.
  • Controls in the work environment to ensure product safety
  • Focus on risk management activities and design control activities during product development
  • Specific requirements for inspection and traceability for implantable devices
  • Specific requirements for documentation and validation of processes for sterile medical devices
  • Specific requirements for verification of the effectiveness of corrective and preventive actions
  • Specific requirements for cleanliness of products

 

Unrivaled Expertise in Precision Medical Plastics

Performance plastics play a huge role in medical device composition. Whether it’s hip replacement or a PEEK spinal implant, these life-saving technologies require durability, cleanliness, and high temperature and moisture resistance. This is no simple process…it’s precise. 

 

That’s where AIP, global leader in Precision Plastics Machining, provides unrivaled expertise in medical machining practices. For over three decades, we’ve served the medical community providing custom designed thermoplastic components for surgical devices, orthopedic equipment, and performance PEEK implants. 

 

We take quality management seriously because we know that performance is only half the equation for medical device manufacturing. For these reasons, we are an ISO 13485 certified facility and FDA compliant. We have been successfully audited by some of the most stringent OEMs in the orthopedic and medical device industries. Our plastics are processed with strict hygienic procedures to ensure innovative medical advancements continue striding forward. Let our team go to work for you! 

 

Find out more by visiting https://aipprecision.com or call us at +1 386.274.5335.

 

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Vespel® Vs. Torlon®: Which Should You Choose?

September 10, 2022

When the Heat Is on, These High-Temperature Plastics Perform Under Pressure

Vespel®, Torlon® and, polyimide-based plastics are all part of a class of materials known as high-performance plastics. These plastics are characterized by their excellent mechanical and thermal properties, as well as their resistance to chemical attack.

 

Vespel® is a registered trademark of DuPont, and their material is often used in applications where extremely high temperatures are involved. Torlon® is a registered trademark of Solvay Advanced Polymers; it’s often used in electrical applications due to its excellent dielectric properties.

 

While these polymers each perform well under pressure and high temperatures, they have slight differences that set them apart. It’s important to know these distinctions when planning out the material selection for a performance plastic. In this informational brief, we’re covering all the nuances between Vespel® and Torlon® down to the molecular level.

 

Features and Capabilities

Both Vespel® (PI) and Torlon® (PAI) are considered high-performance thermoplastics and share similar capabilities. However, there are slight differences in chemical makeup at a molecular level.

For instance, Polyimides are performance polymers containing imide group (-CO-N-OC-) in their repeating units. The polymer chains are either an open chain or closed chain. On the other hand, Polyamides all consist of amide (-CONH-) linkages in their polymer backbone. The amide group is classified as a polar group, which allows polyamides to build hydrogen bonds between chains. By doing this, they improve the interchain attraction.

These slight differences in the chemical makeup enhance various properties of Polyamide-imide over Polyimide and vice versa. The following chart displays the strengths and weaknesses of these two materials.

 

Strengths Weaknesses
 

Vespel® (PI)

 ·         Thermal stability

·         Excellent chemical resistance

·         Dielectric strength

·         Mechanical toughness

·         Superior temperature adaptability

·         Excellent tensile and compressive strength

·         Transparency in many microwave applications

·         Radiation resistance

·         Superior bearing and wear properties

 ·         High manufacturing cost

·         High-temperature requirement in the processing stage

·         Specified operating processes such as annealing operations at specified temperatures

·         Sensitive to alkali and acid attacks
 

Torlon® (PAI)

 ·         Excellent Chemical Resistance

·         Excellent Stress Resistance

·         Excellent Thermal Resistance

·         Excellent Wear Resistance

·         High Stiffness

·         High Strength

 ·         Higher moisture absorption rate than other performance plastics

·         High manufacturing cost

·         Narrow processing window when temperatures exceed 600°F

·         Melt viscosity that is highly sensitive to temperature and shear rate

·         Thermal cure for 20 or more days at 500 F to optimize properties after melt processing

 

 

 

Applications of Vespel® and Torlon®

Vespel® and Torlon® both maintain stability and functionality under high temperatures and pressures. For this reason, they are often found in applications with harsh, demanding environments, including:

  • energy
  • automotive
  • aerospace
  • and military & defense

 

Does one material perform better than another in certain cases? Let’s take a look.

 

Vespel®: An all-around performer

Polyimides like Vespel® are often used in electrical insulation, aerospace components, and high-temperature bearings. Unlike most plastics, Vespel® Resin does not produce significant outgassing (even at high temperatures). This makes it useful for lightweight heat shields and crucible support. It also performs well in vacuum applications and extremely low cryogenic temperatures. Although there are polymers that surpass individual properties of this polyimide, the combination of these factors is Vespel’s® primary advantage.

 

Torlon®: Bring on the heat

On the other hand, Torlon® is a polyamide-imide with even better mechanical and thermal properties than Vespel®. It is often used in pump housings, valves, and chemical-resistant seals. PAI comes in several grades, including TORLON® 4203 (electrical and high strength), TORLON® 4301 (general purpose wear), TORLON® 4XG (glass-reinforced), and TORLON® 4XCF (carbon-reinforced).

 

Takeaway: Both Vespel® and Torlon® are widely used in industries that require reliable performance under extreme conditions. It’s important to consider the environment, especially for Torlon®, as it has a higher moisture absorption than other performance plastics.

 

Vespel® polyimide Torlon® polyamide-imide
·         Aerospace Applications

·         Semiconductor Technology

·         Transportation Technology

 ·         Bearing Cages

·         High-Temperature Electrical Connectors

·         Structural Parts

·         Valve Seats

·         Wear Rings

 

 

 

CNC Machining Vespel® vs Torlon®

Let’s talk about processing and machining. While Vespel® and Torlon® can be injection molded, extruded, or CNC machined, we’re going to focus on the protocols for subtractive CNC machining.

 

Annealing

As with any performance plastic, annealing preps the material and ensures that it will not crack or craze in the future. AIP Precision Machining has programmed annealing ovens for plastics that heat the material above its recrystallization temperature. By maintaining the heat at that specific point, the structure of the material changes to become finer and more uniform. This process relieves internal stresses in the material. Both Vespel® and Torlon® require specific temperatures and cool-down time after annealing. This is why AIP uses computer-controlled annealing ovens for the best outcome.

 

Machining

Vespel®

Vespel® can be machined using conventional CNC methods. However, there are a few things to keep in mind in order to achieve the best results.

 

First, Vespel® has a relatively low coefficient of thermal expansion (CLTE), meaning it will expand and contract differently than most metals. This can cause tooling and fixtures to loosen over time, so it’s important to check them regularly.

 

Second, Vespel® is a very hard material that can wear down tools quickly. Use sharp cutting tools made of carbide and take light cuts in order to avoid premature tool wear.

 

→ [READ NOW] Machining Vespel: A Plastics Guide

 

Torlon®  

Torlon® is one of the most difficult materials to machine due to its extremely high hardness and wear resistance. In order to machine Torlon® or any polyamide-imide, it is necessary to use a CNC machining center with special tooling and cutting parameters. The cutting tools must be made of extremely hard materials such as carbide or diamond, and the cutting parameters must be carefully optimized to prevent tool wear. With the proper tools and techniques, Torlon® can be machined into parts with very tight tolerances and smooth finishes.

 

→ [READ NOW] Machining Torlon: A Plastics Guide

 

Torlon® or Vespel®? Ask the experts at AIP

Are you looking for a performance material that works continuously under pressure and heat? Not sure if Torlon® or Vespel® is the right material for your project? Our team of engineers and machinists are skilled craftsmen in reviewing your project parameters and design needs. We will ensure that every facet of your project is taken into consideration and work with you to define the best material for your project needs and budget.

 

We pride ourselves on our industry knowledge and partnerships with leading suppliers of top materials: Vespel® SP, Vespel® SCP products, and a variety of Torlon® grades. Contact an AIP engineer today, and we will be happy to help with your unique project.

 

Get a quote on Torlon® and Vespel®

 

 

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Vespel®: Extreme Polymer For Mission-Critical Applications

August 23, 2022

Push the Boundaries of High Performance and Sustainability With Precision Polyimides

When it comes to choosing a polymer for critical applications, there is no room for compromise. You need a material that can withstand the most challenging conditions while still providing the performance you need. For extreme environments, there is no better choice than DuPont’s Vespel® polyimide.

This unique polymer has been proven to exceed the performance of other materials in demanding applications, making it an essential component for mission-critical systems. With its exceptional strength and thermal stability, polyimide is ideal for use in aerospace and automotive engineering. So if you’re looking for a polymer that can handle anything, look no further than Vespel® polyimide.

 

Vespel® Works Overtime in Harsh, Demanding Environments

 

Image Source: Alan Turing Institute

 

Polyimide or Vespel® is a high-performance polymer made to withstand extreme environments where continuous friction and vast temperature variations are the norms. It’s most commonly found in engine components for the automotive and aerospace industries, as well as bushings and seals in industrial and energy applications. These mission-critical parts might come as small pieces, but they make a significant difference in weight, stability, and material longevity. Let’s take a closer look at how Vespel® benefits the Aerospace and Defense industry.

 

Aerospace applications of PI include:

  • compressors
  • fans
  • externals
  • nacelles
  • and engine oil system seals

 

The engine of an aircraft, whether for military or commercial use, is the most essential part of the plane. Keeping an aircraft in the sky and ensuring it reaches its destination is more than mission-critical; it’s non-negotiable. Vespel® meets the challenges of these environments, providing engineers with an innovative material advantage.

 

Vespel® Features and Benefits

Vespel® thrives in some of the most punishing environments like aircraft engines or gas-fired turbines. Here, we explore the top three features and benefits of Vespel®:

 

Feature Benefit
Vespel® is a lightweight alternative to metal. It offers a high tensile (8,750 psi) and flexural (16,000 psi) strength at one-half the weight of metal. Save weight – Vespel® offers astounding weight-saving benefits for aircraft by replacing metal or aluminum parts that add unnecessary weight.
Continuous service temperature – cryogenic temperatures to 260°C (500°F). Resist wear – With high temperatures, high speeds, and constant environmental fluctuations, Vespel® is a top choice for impact resistance and material preservation. It’s often found on bushings, fan blade root wear strips, as well as custom bumpers and pads.
Lower friction versus metal with a dynamic coefficient of 0.2 or less. Minimize friction losses – Components such as bushings need to withstand impact, cantilever loading, and accommodate designs with tight fits. Vespel slows part degradation and improves overall aircraft operability.

 

How Vespel® Compares to Other High-Performance Plastics

Vespel® is a high-performance plastic that is used in a variety of applications where strength, stability, and resistance to extreme temperatures are required. How does it stack up to other performance plastics like PEEK (Polyetheretherketone) and PEI (Polyethylenimine)?

Image Source: Performance Plastics Chart

 

When it comes to precision plastics, PEEK and PEI hold their own as exceptional engineering plastics. PEEK is often used in the medical field as a material for bone implants. PEI is most commonly used in high voltage electrical insulation applications due to its high dielectric strength. In comparison to PEEK and PEI, Vespel® has superior mechanical strength and flexibility.

 

Additionally, Vespel® is resistant to a wide range of chemicals, making it an ideal material for use in harsh environments. While Vespel® has many advantages over other high-performance plastics, it remains more expensive than these materials due to its complex manufacturing process.

 

Why Choose AIP for Your Vespel® Project?

When you’re working with a material like Vespel®, there is no margin for error. That’s why choosing a machining shop includes how they handle the material and how they handle your project from concept to completion.

 

38 Years of Precision Plastics Expertise

At AIP Precision Machining, we have over 38 years of experience in precision thermoplastics. Unlike other shops that may machine metals or other materials alongside plastics, our shop is 100% dedicated to plastics machining. It makes a difference in quality at the end of the day, as you can be assured that your machined parts will not deteriorate or crack from exposure to metal machining fluids.

 

Quality Assurance From Beginning to End

From start to finish, we take quality and compliance seriously. AIP is certified and adheres to the following regulations and standards:

  • ITAR
  • AS9100:2016
  • FDA Registered
  • ISO 13485.

 

Partnering With Leading Industry Suppliers

We have close ties with leading plastics manufacturers to give us even further insight and access to technical help in material selection, sizing, and machining protocols.

 

Through these partnerships, we offer a variety of materials available for expert machining services, including:

  • Vespel® SP and Vespel® SCP products
  • Ultem®
  • Ertalyte®
  • Radel®
  • Torlon®
  • Delrin®
  • and more

 

Unrivaled Expertise. Unparalleled Results

If you are interested in a quote for machined Vespel® or want a consultation for your precision project, give our team a call at (386) 274-5335 or click here. No matter how unique or complex your project may be, we are here to provide unrivaled expertise and guidance.

Find your next aerospace material for your mission-critical application.

 

 

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5 Advantages of PEEK Versus Metals

August 14, 2022

Here’s Why PEEK Is Kicking Metal to the Curb in Performance Engineering Applications

In the thermoplastic industry, there are a few materials that reign supreme. Among these, PEEK (polyetheretherketone) is king. This polymer has several advantages over traditional metal fabrication.

 

In this PEEK guide, we’re exploring why high-performance thermoplastic PEEK is kicking metal to the curb. PEEK has the strength and durability of metal, but at a fraction of the weight and resists chemicals and hydrolysis. It’s these qualities that allow PEEK polymers to replace metals in precision engineered components.

 

Industries That Benefit From PEEK Versus Metals

Let’s take a look at how PEEK improves performance and functionality in some leading mission-critical industries.

 

Aerospace and Defense

The aerospace and defense sector often replaces aluminum parts in favor of PEEK for weight reduction and its tolerance to high temperatures. The benefits include fuel reduction and longer part lifespan. PEEK is also a safer material to use, since its low conductivity allows for lower heat build-up.

Another strength of PEEK over metals is inherent to all plastics. PEEK has exceptional thermal and electrical insulative properties, which comes in handy with equipment designed to undergo extreme stress. Thermal insulation ensures the pieces won’t melt or damage neighboring equipment, much in the same way electrical insulation will stop damaging currents of electricity from harming critical systems on the plane.

 

Medical and Life Sciences

Material choice and design functionality make a vast difference for surgical instrumentation in the medical field. As a chemically inert thermoplastic, PEEK wins over metal in areas where chemicals may be present. Furthermore, PEEK offers radiolucency for scanning machines that need to produce clear readings of the interior of the body. Metals often muddle or interfere with the imaging.

PEEK has passed all ISO 10993 biocompatibility tests for both short and long-term implants. However, because PEEK is so durable, it’s generally only recommended for long-term implants.

 

Oil and Gas

With excellent resistance to abrasion, chemicals, and hydrolysis, PEEK thrives in tough environments, such as offshore oil rigs. The equipment in the oil and gas industry is placed deep underground where conditions, chemical reactions, and forces are unpredictable. PEEK is a common material for seals and valve plates to ensure a fail-safe environment.

 

Precision Devices

The use of PEEK in precision devices is not just for its elevated level of structural rigidity but also because it provides electrical insulation. Connector covers and transducer cases are made from this material to avoid interference with signals passing through the wires within a device. Since this industry engineers streamlined lighter designs, PEEK is an ideal choice for weight reduction.

 

Weight Reduction

 

 

One of the leading reasons for choosing PEEK over metallic competitors like aluminum or titanium is its lightweight properties. This has opened the door to many engineering material innovations.

 

One area, in particular, is aerospace and defense. Using PEEK over metals can cut fuel usage and create weight savings of up to 60 percent. This translates to lower annual fuel costs, reduced emissions, lower carbon footprints, and extended flight ranges.

 

Enhanced Performance

Polyetheretherketone PEEK provides performance-enhanced products by extending service life and resistance to corrosion with a lower coefficient of friction. In dynamic applications such as bearings or seals, this tough plastic can increase load capacity while also operating at temperatures of up to 480°F. This translates to fewer instances of maintenance and a longer overall performance from the system as a whole.

 

Design Freedom

One of the greatest strengths of thermoplastics is their contribution to design processes. PEEK can be CNC machined, injection molded, and even 3D printed. This type of versatility enables greater design freedom for complex engineering and custom geometries. Thermoplastic PEEK versus metals can be machined to specific tolerances as low as 0.002mm with the right machining shop.

 

High Purity

 

 

The medical sector demands nothing less than complete purity from materials, especially in the case of orthopedic implants, for instance. Metallosis is a real concern for metal implants as they can leach into the body. PEEK ,including Glass-Filled, PEEK-HT (High Temperature), and PEEK-UHP (Ultra-High Purity) are all desirable alternatives for metal applications in food processing, biomedical, and semiconductors.

 

Total Lower System Cost

When it comes to individual material costs, PEEK can range from 20 to 30 times the cost of some metals like stainless steel. Yet, the stand-alone cost cannot be the main factor in high-performance design decisions. Engineers look at the big picture in the long run of material value.

With the overall improvement in material performance, longevity, weight reduction, and purity factors, PEEK significantly decreases the cost of a total system. This is why it’s a popular material choice for high-performance engineering components.

 

The Global Leader for Performance PEEK Components

Precision and performance are what we strive for at AIP Precision Machining. With decades of experience in the industry, our dedicated craftsmen and close ties with leading plastic manufacturers allow us to provide unrivaled knowledge and consulting services in material selection, sizing, manufacturing techniques, and more to best meet your project’s needs.

If you are looking to use PEEK for your precision project, reach out to our team for a consultation. We are here to help solve your plastics puzzle and provide technical expertise and diligent craftsmanship from concept to completion.

 

Thinking about PEEK for your precision project?

Discover what this polymer can do

 

 

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Why it’s essential to have AS9100D for aerospace manufacturing

July 27, 2022

Not just a standard…THE standard

 

AS9100D Logo

AS9100 is a company level certification based on the ISO 9001 quality standard requirements, but with additional requirements based on the needs of the aerospace industry. These satisfy both ISO 9001 quality standards and DOD, NASA and FAA requirements.

Companies in the business of manufacturing parts and components for both federal and civil enterprises in the aerospace sector are required to provide the highest level of quality assurance for their manufacturing techniques. Why? A single malfunctioning part on an aircraft could have a devastating impact on the entire apparatus. Not only is it dangerous for operation, but maintenance for an unknown malfunction is costly in time, budget, and resources.

That’s why the Aerospace and Defense industry has developed a strict quality management process for manufacturers to follow known as AS9100D. Here’s why it’s essential for precision plastics manufacturers to have an AS9100D certification.

 

Benefits of AS9100D Certification for Aerospace Machining Standards

 

Satellite orbiting Earth

Global Standard

An AS9100D certification is internationally recognized around the world, but with different numbering conventions. The International Standards Organization equivalent is ISO 9001. Major aerospace manufacturers and suppliers worldwide require compliance and/or registration to AS9100 as a condition of doing business with them.

Quality Assurance

When it comes to machining for the Aerospace and Defense sector, quality and consistency in manufacturing techniques are paramount. An AS9100D certification ensures that machining processes, product handling, storage, and shipping are all accounted for in a facility’s processes.

Requirement for Business

Material suppliers that wish to serve the Aviation, Space and Defense (AS&D) industry must attain this certification to prove the high level of competence required by the industry.

Works at the Federal & Civil Enterprise Level

The guidance recommended by AS9100D satisfies standards for NASA, DOD, and FAA. Whether a manufacturer is working with a federal-level defense contractor or a commercial jet line, an AS9100D certification shows commitment to quality processes around manufacturing aerospace parts.

 

How to get AS9100D certified

Certifying your machining processes are safe and consistent is a requirement for doing business in the Aerospace and Defense sector. In order to get an AS9100D certification, a company must prove its ability to remeasure and reassess a product during the construction phase, ensuring uniformity among mass-produced items. The certification does not focus on product quality, but product consistency in the end result. Here are a few areas to pay attention to if seeking the certification for manufacturing aerospace materials:

  • Emphasis on Risk Management
  • Attention to “Special Requirements”
  • Attention to “Critical Items”
  • Measure: Requirements conformance
  • Measure: Delivery performance
  • Adopt Proven Product Development Processes
  • Eliminate “recurring corrective actions”

 

 

Expert Aerospace Machining for Aircraft Plastic and Composite Parts

Jet fighters, satellites, and in particular spaceships need the highest level of precision engineering to accomplish their goals. To that end, machining plastic components to these exacting standards isn’t easy…it’s precise. At AIP, we’ve been working in precision plastics machining for over three decades. Our projects include major aerospace companies like Lockheed Martin and GE, all demanding the highest level of risk assessment and quality management throughout the entire machining process.

To that end, we are setting the standard for Aerospace and Defense plastic machining. In aerospace and defense applications, adherence to stringent industry specifications is something AIP takes seriously. AIP is a certified and registered ITAR facility and AS9100D certified. We are capable of satisfying all customer DOD, NASA and FAA quality requirements recommended by our OEM customers. We understand the need for lot and batch traceability, as well as materials that can survive extreme operating environments.

Every product we develop is made from carefully selected materials for your specific application and needs. Our high-performance thermoplastics and compounds made for the aerospace and defense industry feature:

  • Chemical resistance
  • Conductive or insulative properties
  • Corrosion protection
  • Extreme Precision tolerance (up to 0.002 mm)
  • Finished smooth surface
  • High-temperature resistance (exceeding 750 F, 400C)
  • Lightweight
  • No stress-induced distortion
  • Radar absorption

Want to contact us about aerospace manufacturing?

Get in touch with us online, or see our  AD9100D:2016 certification.

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What Does It Mean To Be As9100 Certified?

April 7, 2022

What Is an AS9100 Certification?

 

Developed by the International Aerospace Quality Group (IAQG), the AS9100 is an international quality management certification. Material suppliers that wish to serve the Aviation, Space and Defense (AS&D) industry must attain this certification to prove the high level of competence required by the industry. AS9100 applies to both military and civil businesses.

 

The standard is accepted worldwide, with different parts of the world having their own numbering systems, but crucially, they all prove the same level of competence. Whether a company is made up of thousands of individuals or just one person, it will require the AS9100 to provide supplies to the aerospace industry.

 

However, just because a company could theoretically consist of one person doesn’t mean the certification is attained on an individual level. The AS9100 is a company-wide certification, meaning that it can only be acquired and applied to a company. So, if Darrel is the sole owner and employee of ABCD Inc. and earns the certification, Darrel isn’t certified, ABCD Inc. is.

 

Becoming AS9100 certified also means earning an ISO 9001 certification along the way. The reason is that the AS9100 is an extension of the ISO 9001 with an additional focus on aerospace regulations. So, companies that achieve an AS9100 will be qualified in multiple quality management systems.

 

Finally, the AS9100 certification is not a standard of product quality. Rather, it’s a standard of the processes taken to ensure a quality, consistent product. To attain the certification, a company must prove its ability to remeasure and reassess a product during the construction phase, ensuring uniformity among mass-produced items. The certificate may not focus on product quality, but the end result is the same.

 

Why Must a Plastics Machining Facility Be AS9100 Certified?
 

 
The quick and easy answer is that the certification is required by many aerospace manufacturers. If a plastics machining facility wishes to do business in this industry, attaining the certificate is an entry-level requirement.

 

The longer answer is that several large aerospace entities endorse the certification. Some of these groups include the U.S. Department of Defense (DoD), the Federal Aviation Administration (FAA), and the National Aeronautics and Space Administration (NASA). To become an official supplier to any of these entities, a plastics machining facility Must have the certification.

 

But why do these institutions require the certification? Jet fighters, satellites, and especially spaceships need the highest level of precision engineering to accomplish their tasks; creating plastic components to such exacting standards isn’t easy. So, every stage of the creation process, all the way down to the small plastic materials, must go through a strenuous quality management system to ensure a low-risk management level for the final product.

 

What About AIP Precision Machining Allows Us to Achieve an AS9100 Certification?

 

 
We’ve made it no secret that precision machining is vital to who we are as a company. So much so that we’ve put it in our name! With AIP Precision Machining, you’re investing in a partner that not only understands the needs of the industry but has the decades of experience needed to perfect the processes that go into creating the perfect components.

 

With the regulatory requirements being as stringent as they are, there is no room for the kind of mistakes human factors tend to introduce to the manufacturing process. That’s why we involve several quality control checks in line with AS9100’s requirements during the creation process to guarantee the level of service quality expected from us.

 

We’ve satisfied several aerospace and defense industry requirements in the past, so we know the kind of qualities these industries need in their components. Our highly trained engineers, machinists, and programmers have been specially trained to create components with the types of qualities aerospace and defense organizations look for:

 

  • Lightweight
  • Durable
  • Extreme Temperature Resistance
  • And much more.

 

At AIP Precision Machining, product and service quality assurance is the norm for our customers and ourselves. We are proud to offer the aerospace industry our services in machining quality components. We have proven time and again that we are quick to deliver, cost-effective, and, more often than not, surpass customer satisfaction. Our safe and reliable products meet all statutory and regulatory requirements and are guaranteed to help see your project through to the end.

 

To contact us, call our main office at (386) 274-5335 or visit our website to schedule a consultation. With AIP, you have a manufacturing partner you can rely on.

   

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AIP Is Your One-Stop Shop For Reliable And Precise Medical Plastics

March 14, 2022

Few industries require precision and reliability as much as the medical industry. When lives are literally on the line, you can’t risk the chance of arming medical professionals with equipment that’s anything less than perfect.

 

There’s also the burden of choice to deal with. The medical device industry has seen plastics soaring in use due to their numerous benefits, but it’s those same qualities that can make them so frustrating to machine. Choosing the best possible polymer for your needs requires trained professionals that know the options like the back of their hands.

 

So who can you trust? The search for a high-quality polymer manufacturer begins and ends with AIP.

 

Plastic Components Machined to Perfection

 

We at AIP pride ourselves on the level of precision we can achieve when manufacturing polymers for the health care industry. We work at the highest levels state-of-the-art machinery will provide, allowing us to construct medical components within ten-thousandths of an inch precision. With quality checks completed after every stage of the development process, we can guarantee a quality product every time.

 

Reusable Medical Plastics

 

An unfortunate byproduct of increased plastics in the medical industry is the expanding weight of medical waste. As creators of polymer materials, we’re especially conscious of unnecessary waste, which is why our materials are built to last.

 

Our high-performance precision plastic parts offer the medical industry all the advantages of metal, along with the crucial ability to withstand repeated autoclave sterilization sessions. Furthermore, many of our polymers have a low coefficient of friction, making the steaming process faster, and putting them back in the hands of medical professionals more efficiently.

 

Quality Assured

Precision and reliability go hand in hand, and we consider precision important enough to put it in our name. That’s why our materials are put through a quality check through every step of the creation process. But we go one step further than the competition.

 

Many polymer manufacturers double as metal producers, and they tend to create their products together in the same warehouse. The problem is that many of the ingredients used to treat metal are hazardous to the structural integrity of plastics. If they mix, the plastic’s lifespan falls to only a short few months before premature cracks begin to show.

 

We decided long ago that the risk to your product’s quality wasn’t worth it. Our main production facility specializes in polymers, removing the threat of metal contamination entirely from the equation. All our clients consider reliability vital, but when creating components for medical devices, there’s an increased ethical onus on us to build an exceptional product, and we respect that.

 

The Many Roles Medical Grade Plastics Must Fill

 

While there are several kinds of medical-grade polymers, the choices skyrocket when you consider that each has dozens of different grades suited to specific tasks. Crucially, they must all be safe for human contact, but some of the other qualities our polymers can satisfy are:

 

  • Radiolucency
  • Corrosion Protection
  • Extreme Tolerance (up to 0.002 mm)
  • High Dielectric Strength
  • Sterilization Compatibility
  • Lightweight Properties
  • Extreme Thermal Performance
  • Extreme Chemical Resistance
  • Extreme Low Friction

 

Our materials are relied upon in some of the most delicate medical applications. Surgical instruments, orthopedic equipment, even spinal and dental implants utilize our medical-grade plastic parts.

 

 

The Materials and Their Qualities

With each plastic boasting different strengths and weaknesses, you need to know which one will suit your needs the best. Some of our options include:

 

  • PEEK – One of the most diverse materials, thanks to its many different grades; it boasts high strength and excellent resistance to chemicals, steam, and abrasion. PEEK is frequently utilized in both medical implants and instruments.
  • PPSU (Polyphenylsulfone) – Extremely tough and able to withstand nearly unlimited sessions of steam autoclave sessions. PPSU is the perfect material to make reusable medical instruments with.
  • UHMW-PE (Ultra-High Molecular Weight Polyethylene) – Significantly higher impact strength and abrasion resistance compared to most plastics on the market. Its low coefficient of friction due to its self-lubricating, non-stick surface makes it a great candidate for hip and knee joint replacement components

 

Ease of Access and the Cost-Efficient Choice

 

With Covid placing an incredible weight on material transportation, many metals and other materials have become difficult or simply too expensive to get a hold of. Polymers don’t suffer the same difficulties, as they can be readily manufactured anywhere in the world and remain cost-effective.

 

 

By utilizing more plastic materials in your medical equipment, you safeguard your business against strained supply lines and expensive materials, allowing you to keep your costs and your prices below the competition.

 

AIP Is Here for Your Medical Plastic Needs

 

AIP is registered with the FDA and ISO 13485:2016 certified. Our plastics are processed with the strictest hygienic procedures, and these quality assurance procedures ensure you’ll receive the exact materials you need for the job. We’re proud to be of service to health care providers by playing a part in the tools they use.

 

To contact us, call our main office at (386) 274-5335 or visit our website to schedule a consultation. With AIP, you have a manufacturing partner you can rely on.

   

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Machining Acrylonitrile Butadiene Styrene (ABS) A Plastics Guide

June 22, 2021

An Informational Brief on Polymer Machining

 

Known for its ease of machining, coloring and adaptability to additives, ABS is a versatile performance thermoplastic.  While it may be used in household toys, it is also used for mission critical applications like electrical insulators and automotive interior and exterior parts.

 

AIP has over 37 years of experience machining complex components from thermoplastics like Acrylonitrile Butadiene Styrene (ABS).  In this insightful technical brief, we will discuss what goes into machining ABS and how it differs from other manufacturing options such as metal machining, injection molding, and 3D printing.

 

Properties of ABS

 

Machinists should keep data on the properties of the thermoplastics they use.  This aids in selecting the right material for a project.  Also, it helps determine if the material is a good candidate for the end-use.  Below are some of the key characteristics of Acrylonitrile Butadiene Styrene (ABS):

 

Key Properties

  • Impact resistance
  • Chemical resistance
  • Ideal electrical insulator with added moisture resistance
  • Good strength and stiffness
  • Platable grades
  • Excellent aesthetic qualities
  • Colorable
  • Various gloss levels (Matte to High Gloss)

 

Description

ABS is one of the most common thermoplastic polymers manufactured. It is relatively cheap compared to other performance thermoplastics, such as, PEEK or VESPEL.

 

It provides good mechanical properties, including, impact resistance, toughness and rigidity compared to other common polymers. It is also easy to modify with additives to improve any of its properties. It is often a polymer of choice where aesthetics and color are concerned, since its natural color is translucent ivory to white. Pigments and additives are often added to this resin to improve the qualities based on the project needs.

 

Two major categories could be ABS for extrusion and ABS for injection molding, then high and medium impact resistance. Generally, ABS would have useful characteristics within a temperature range from −20 to 80 °C (−4 to 176 °F). As an amorphous polymer, it does not have a true melting point.

 

The table below displays an overview of the material properties, units and values for machining ABS:

 

Material Property Units Value
Tensile Elongation at Break @73 F % 20
Flexural Modulus of Elasticity @ 73 F psi 340000
Tensile Modulus of Elasticity @ 73 F psi 346000
Flexural Strength @ 73 F psi 9300
Specific Gravity @73 F ASTM D792 1.04
Tensile Strength @73 F, (ult)/(yld) psi 5500 (ult)
Notched Izod Impact @73 F ft-lb/in of notch 7.0
Heat Deflection Temperature @ 264 psi F 220
Flammability Rating UL94 HB(6.10mm)
Coefficient of Linear Thermal Expansion @73 F in/in/F 5.2E-05
Dielectric Strength, Short Term Volts/mil 450
Water Absorption, Immersion, 24 hours
Water Absorption, Saturation		 % by weight
% by weight		 0.30
0.70

 

Applications of ABS

 

ABS is mostly found in a wide variety of consumer products. Some of which include – Legos®, recorders and other musical instruments, golf club heads, household vacuums, and so on. ABS is a household staple for many consumer goods.

 

It also finds several end-use applications in the industrial sector. Applications include – automotive trim and components, inhalers, tendon prostheses, drug-delivery system tracheal tubes, enclosures for electrical and electronic assemblies, protective headgear and more.

 

Common Applications

  • Structural components
  • Automotive interior and exterior parts
  • Medical devices
  • Electrical components and assemblies
  • Toys
  • Housings/covers
  • Kitchen appliances

 

AIP Machining Capabilities: Unrivaled Expertise

 

Our close ties with the industry’s leading plastics manufacturers give us even further insight and access to technical help in material selection, sizing and manufacturing procedures. If you are looking for a trademarked material for your project, we have a host of material bases available for expert machining. Whatever your application, our machinists can help you in material selection, sizing and manufacturing techniques from concept to completion.

 

Our Suppliers

 

Machining ABS

 

Annealing ABS

As with any CNC machined part, annealing and stress-relieving is crucial to the machining process. Coolants, lubricants and trained procedures prevent cracking and crazing in a precision machined component. We recommend slow heating and cooling during the annealing process of thermoplastics. This reduces the chances of these stresses occurring from the heat generating during machining polymers like ABS. Our AIP machinists use computer controlled annealing ovens for the highest quality precision temperatures and time control. .

 

Machining ABS

PVC can be injection molded, extruded or thermoformed.  At AIP, we CNC machine compounded PVC.  For the best results, use sharp tools, avoid excessive clamping and cutting forces and use coolants to prevent overheating.  We recommend non-aromatic, water-soluble coolants because they are most suitable for ideal surface finishes and close tolerances. These include pressurized air and spray mists. Coolants also preserve and extend the life of tools.  These guidelines are general and are not a substitute for a conversation with your machinist.  For further information, speak to a CNC machinist at AIP to get specific machining information on PVC and other performance thermoplastics.

 

Although it is often blow molded, ABS can be CNC machined and milled for precision parts. ABS is manufactured in a variety of grades, but for precision machining of ABS structural parts, it is recommended to use Machine Grade ABS. For the best results, use sharp tools, avoid excessive clamping and cutting forces and use coolants to prevent overheating. We recommend non-aromatic, water-soluble coolants because they are most suitable for ideal surface finishes and close tolerances. These include pressurized air and spray mists. Coolants have the additional benefit of extending tool life as well.

 

Some companies machine both metals and plastics, which has detrimental outcomes for machined polymer products. Many past experiences have shown parts going to customer without cracks, only to develop surface cracks and warping over time due to exposure to metal machine shop fluids. Be sure to use a facility like AIP that only machines polymers.

 

Preventing Contamination

Contamination is a serious concern when machining polymer components for technically demanding industries such as aerospace and medical sciences. To ensure the highest level of sanitation down to the sub-molecular level, AIP Precision Machining designs, heat-treats, and machines only plastics with any sub-manufactured metalwork processed outside our facility. This allows us to de-risk the process from metallic cross contamination.

 

ABS Machining Guide: Supportive Information

 

Quality Assurance Certifications
Miscellaneous Materials

 

How will the heat from your machining project affect your project? Make sure to talk to your machinist about the CLTE of your machined part.

 

Read Our Blog
 

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Understanding Heat Deflection Temperature (HDT) of Plastics

June 8, 2021

What is HDT?

 

The Heat Deflection Temperature (HDT), or Heat Distortion Temperature, is a measure of a polymer’s resistance to alteration under a given load at an elevated temperature.  It is also known as the ‘deflection temperature under load’ (DTUL) or ‘heat deflection temperature under load (HDTUL)’.  Basically, it tests the stiffness of a material as the temperature increases.

 

It is the temperature at which a polymer test bar will be bent at 0.25 mm under a given weight.  It is one of the two basic test methods for assigning a value to the performance of a plastic at high temperature.  The 0.25mm value is arbitrary and does not have any significant meaning.

 

Why is HDT significant?

 

As with any machined part, during the design phase, it is critical for a machinist to know how a material will react to heat produced while machining occurs.  Tools produce heat when they come in contact with materials and plastics have a tendency to move with heat.  In order to get a finished product with the right dimensions and tolerances, it is important to understand the heat deflection temperature of a given polymer.

 

Other reasons include:

  • HDT represents a value which can be used to compare different materials with each other
  • It is applied in product design, engineering and manufacture of products using thermoplastic components
  • A higher HDT temperature means a faster molding process in injection molding processes

 

Tests to Measure Heat Deflection Temperatures of Plastics

 

The American Society for Testing and Materials, or ASTM, standard for measuring HDT is called ASTM D 648; this standard is equivalent to the ISO 75.

 

The two common loads used in heat deflection testing are:

  • 0.46 MPa (67 psi) – this load is usually for softer grades of plastic like polyethylene (PE) or LDPE.
  • 1.8 MPa (264 psi) – this load is used for more durable grades of plastic like PEEK or polycarbonate (PC).

 

There are tests performed at higher loads such as 5.0 MPa (725 psi) or 8.0 MPa (1160 psi), but we won’t discuss them in this brief.

 

Limitations that are associated with the determination of the HDT is that the sample is not thermally isotropic and, in thick samples in particular, will contain a temperature gradient.

 

During the ASTM D 648 test, a testing rod made of the selected polymer is placed on an apparatus like the one in the diagram below.

 

 

 

Source: SEKISUI Polymer Innovation
 

The bar is molded a specific thickness and width.  The sample is then submerged in oil while the temperature incrementally increases (usually about 2 oC per minute).  The constant applied force, or load, is pressed to the midpoint of the test bar.  The temperature at which a bar of material is deformed 0.25mm is recorded as the HDT.

 

HDT at 1.8 Mpa (264 psi) Values for Common Polymers

 

 

Polymer Name Min Value (o C) Max Value (o C)
ABS – Acrylonitrile butadiene styrene 88 100
PA – Nylon Polyamide, 66 30% Glass Fiber 230 255
PAI – Polyamide-Imides (TORLON) 275 280
PBI – Polybenzimidazole (CELAZOLE) – 426.6
PC – Polycarbonate, high heat 140 180
PE – Polyethylene, 30% glass fiber 121 121
PEEK – Polyetheretherketone 150 160
PEI – Polyetherimide (ULTEM) 190 200
PP – Polypropylene (30-40% Glass fiber-reinforced) 125 140
PP – Polypropylene Homopolymer/Copolymer 50 60
PS – Polystyrene, high heat 85 100
PSU – Polysulfone 160 174
PTFE – Polytetrafluorethylene 45 50
PVC – Polyvinyl chloride, rigid 54 75
PVDF – Polyvinylidene fluoride (KYNAR) 50 125

 

Factors That Influence HDT

 

The HDT gives a short-term performance under load at elevated temperatures for a polymer by measuring the effect of temperature on stiffness.  Yet, this is only an estimate and should not be used to predict how the final part or component will perform.

 

Other factors will significantly influence the final thermal performance of an application.

 

These factors include:

  • The time of exposure to elevated temperature
  • The rate of temperature increase
  • The part geometry

 

The HDT measure for a specific polymer grade also depends on the base resin and the presence of reinforcing agents, fillers or plasticizers.

 

For instance, in the chart above, the homopolymer or copolymer of polypropylene has a HDT value range of 50-60 oC. Compare that value to the 30-40% glass-fiber reinforced grade of polypropylene, which is more than double the temperature (125-140 oC).  A factor like this would influence the material choice for a designer wanting to use polypropylene for the end use product.

 

A combination of additives will always have a different effect on the HDT and the performance of a polymer overall.

 

  • Reinforced and filled grades have a higher HDT (harder and stiffer under the heat)
  • Plasticizers decrease HDT by making the polymer softer and more flexible

 

AIP:  Unmatched Precision.  Unrivaled Experience

 

Data charts can give you the heat deflection temperature, glass transition and other values.  However, a chart can give a general idea of these values, but an entire data set with the curve of a material is the best way to determine the right material for your project.

 

Be sure to work with a plastics machining company that can provide you a wide range of data on the HDT and other values of polymers and composites.  Your machinist will be able to give you a detailed response on how the heat deflection temperature will affect your project’s design and functionality.  Talk to one our engineers at AIP about your project design, and we will work with you to provide unrivaled expertise from your project’s initial concept to completion.

 

Supporting Materials

Certifications and Technical Data Resources

 

Learn more about the material properties we consider when
working on a precision plastics machining project.

 

Read our blog on the CUT of Polymers
 

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MACHINING PVC: A PLASTICS GUIDE

May 18, 2021

An Informational Brief on Polymer Machining

 

PVC, or polyvinyl chloride, is a rigid material that exhibits high corrosion resistance, high chemical resistance, low moisture absorption and excellent dielectric strength.  These qualities make it a choice material for a wide range of industries, including:  medical devices, industrial/construction components and everyday household items.  It is the world’s third largest thermoplastic material by volume only after polyethylene and polypropylene.

 

AIP has over 37 years of experience machining complex components from thermoplastics like PVC.  In this insightful technical brief, we will discuss what goes into machining PVC and how it differs from other manufacturing options such as metal machining, injection molding, and 3D printing.

 

Properties of PVC

 

All machine shops should keep data on the properties of the thermoplastics and materials they use.  The data helps in selecting the right material for a project and a material’s suitability for the end-use product.  Below are some of the key characteristics of PVC:

 

Key Properties

  • Good insultation
  • Dielectric strength
  • Durable
  • Flame Retardant
  • Low maintenance and long life span
  • Abrasion resistant
  • Light-weight
  • Chemical resistance

 

Description

Polyvinyl Chloride (PVC or vinyl) is a highly durable thermoplastic material.  It is versatile and economical for applications in medical, construction, industrial and consumer end use markets.

 

PVC has excellent dielectric strength which makes it a good insultation material.  It is also resistant to weathering, chemical rotting, corrosion, shock and abrasion – therefore, a preferred material choice for long-life and outdoor products.  PVC is resistant to all inorganic chemicals. It has very good resistance against diluted acids, diluted alkalis and aliphatic hydrocarbons. Attacked by ketones; some grades swollen or attacked by chlorinated and aromatic hydrocarbons, esters, some aromatic ethers and amines, and nitro- compounds.

 

It is available in two forms – rigid and flexible – but it is often mixed with additives to enhance properties and improve machineability.

 

The table below displays an overview of the material properties, units and values for machining PVC Gray Type 1:

 

Material Property Units Value
Tensile Elongation at Break @73 F % –
Flexural Modulus of Elasticity @ 73 F psi 455000
Tensile Modulus of Elasticity @ 73 F psi 392000
Flexural Strength @ 73 F psi –
Specific Gravity @73 F ASTM D792 1.43
Tensile Strength @73 F, (ult)/(yld) psi 7300 (yld)
Notched Izod Impact @73 F ft-lb/in of notch 0.7
Heat Deflection Temperature @ 264 psi F 169
Flammability Rating UL94 –
Coefficient of Linear Thermal Expansion @73 F in/in/F E-831(TMA)
Dielectric Strength, Short Term Volts/mil –
Water Absorption, Immersion, 24
Water Absorption, Saturation		 % by weight
% by weight		 –
–

 

Applications of PVC

 

PVC comes in two general forms – rigid and flexible.  However, it can be combined with several different materials to enhance its qualities for use in a range of applications from medical devices to industrial construction components.  Here is a list of the most common applications:

 

Common Applications

 

Application Rigid PVC Flexible PVC
Construction Window Frames, Pipes, House Siding, Ports, Roofing Waterproof Membranes, Cable Insultations, Roof Lining, Greenhouses
Domestic Curtain Rails, Drawer Sides, aminates, Audio and Videotape Cases, Records Flooring, Wall Coverings, Shower Curtains, Leather Cloth, Hosepipes
Packaging Bottles, Blister Packs, Transparent Packs and Punnets Cling Film
Transport Car Seat Backs Under Seal, Roof Linings, Leather Cloth Upholstery, Wiring Insultation, Window Seals, Decorative Trim
Medical – Oxygen Tents, Bags and Tubing For Blood Transfusions, Drips and Dialysis Liquids
Clothing Safety Equipment Waterproofs for Fishermen and Emergency Services, Life-Jackets, Shoes, Aprons and Baby Pants
Electrical Insultation pipes, jacketing, electricity distribution boxes, switches, transparent distributor box housings, plug housings and battery terminals Cable and wire insultation, plugs, cable jackets, sockets, sable heads and distributors
Other Credit Cards, Traffic Signage Conveyor Belts, Inflatables, sports goods, toys, garden hoses

 

AIP Machining Capabilities: Unrivaled Expertise

 

Our close ties with the industry’s leading plastics manufacturers give us even further insight and access to technical help in material selection, sizing and manufacturing procedures.  If you are looking for a trademarked material for your project, we have a host of material bases available for expert machining.  Whatever your application, our machinists can help you in material selection, sizing and manufacturing techniques from concept to completion.

 

Machining PVC

 

Annealing PVC

Annealing and stress-relieving prevents cracking and crazing in a precision machined component with lubricants, cooling agents and trained procedures.  We recommend slow heating and cooling during the annealing process of thermoplastics.  This reduces the chances of these stresses occurring from the heat generating during machining polymers like PVC.  Our AIP machinists use computer controlled annealing ovens for the highest quality precision temperatures and time control.  If you have a specific question about the annealing process for PVC or other thermoplastics, our machinists at AIP can provide an in-depth consultation.

 

Machining PVC

PVC can be injection molded, extruded or thermoformed.  At AIP, we CNC machine compounded PVC.  For the best results, use sharp tools, avoid excessive clamping and cutting forces and use coolants to prevent overheating.  We recommend non-aromatic, water-soluble coolants because they are most suitable for ideal surface finishes and close tolerances. These include pressurized air and spray mists. Coolants also preserve and extend the life of tools.  These guidelines are general and are not a substitute for a conversation with your machinist.  For further information, speak to a CNC machinist at AIP to get specific machining information on PVC and other performance thermoplastics.

 

Some companies machine both metals and plastics, which has detrimental outcomes for machined polymer products.  Past experiences have shown parts going to customer without cracks, only to develop surface cracks and warping over time due to exposure to metal machine shop fluids. Be sure to use a facility like AIP that only machines polymers.

 

Preventing Contamination

Contamination is a serious concern when machining polymer components for technically demanding industries such as aerospace and medical sciences. To ensure the highest level of sanitation down to the sub-molecular level, AIP Precision Machining designs, heat-treats, and machines only plastics with any sub-manufactured metalwork processed outside our facility.  This allows us to de-risk the process from metallic cross contamination.

 

PVC Machining Guide: Supportive Information

 

Quality Assurance Certifications
Miscellaneous Materials

 

Looking for more plastics machining guides on polymers with chemical resistance?

 

Read Our PCTFE Machining Guide
 

 

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