Most polymers have a natural tendency to absorb water. In fact, some superabsorbent polymers are highly sought after in advanced applications for medical, construction and more. Yet, moisture absorption of thermoplastics leads to changes with regard to processing and properties.

 

It is crucial for machinists and designers to understand the moisture absorption of thermoplastics for CNC machining. During the design phase, this not only helps with initial material selection, but plays a role in predicting the life span of a part. At AIP, we take great care in providing unrivaled results to ensure the optimal dimensions and properties for machined polymers and composites. Join us in this technical brief as we give an in-depth explanation of the effects of moisture absorption for machined polymers.

 

Plastics Machining and the Importance of Water Absorption

 

Moisture / water absorption is the capacity of a plastic or a polymer to absorb moisture from its environment. Absorbed moisture sometimes acts as a plasticizer, reducing the glass transition temperature and strength of plastic (this is a reversible side effect). However, absorbed water also can lead to irreversible degradation of the polymer structure.

 

Some effects include:

  • Dimensional and mass changes (swelling) caused by water absorption
  • Extraction of water-soluble components
  • Changes in mechanical (elasticity, tensile strength, impact strength) and electrical performance

 

Water absorption is expressed as increase in weight percent or % weight gain of a plastic specimen under the following testing procedures:

  • Water Absorption 24 hrs at 23°C – Immersion of a plastic specimen in distilled water during 24 hours at 23°C
  • Water Absorption 24 hrs at 100°C– Immersion of a plastic specimen in distilled boiling water during 24 hours Water Absorption at saturation – Immersion of a plastic specimen in distilled water at 23°C.  Measurement occurs when the polymer does not absorb water anymore
  • Water Absorption at Equilibrium– Plastic specimen is exposed to a humid environment — generally at 50% relative humidity — at a specified temperature — 23°C or 73.4°F — for 24 hours

 

(Source: Omnexus)

 

Exposure to humidity, immersion and boiling water can result in different material responses. The equilibrium moisture content can be used to compare the amount of water absorbed by different types of plastics when they are exposed to moisture.

 

Plastics Processing and Properties

 

Polymers are affected by moisture from their environment or from simply sitting on a shelf waiting to be used.  This is not a huge concern, but when the moisture absorption reaches more than 1% or 2%+, this can result in enough dimensional movement to create concerns.

 

Moisture Absorption Affects:

  • Mechanical properties
  • Wear properties
  • Dimensions

 

For example, parts made from TORLON (PAI) require special attention due to a 1.7% moisture at saturation value.  While this number may not sound like much, it is enough to cause a precision machined TORLON part to exceed tolerance; in this scenario, the part cannot be used.

 

Therefore, it is important to properly package these mission critical polymers for lasting shelf-life and function.  This can be achieved in two ways:  1) Vacuum-sealing them in a moisture-impermeable layer or 2) packaging them with bags of desiccant.  This prevents moisture uptake in humid environments.

 

Tests to Measure Water Absorption of Plastics

 

Source

 

ASTM D570 – Standard Test Method for Water Absorption of Plastics

 

This test method for rate of water absorption has two main functions:

  1. A guide to the proportion of water absorbed by a material and consequently, in those cases where the relationships between moisture and electrical or mechanical properties, dimensions, or appearance have been determined, as a guide to the effects of exposure to water or humid conditions on such properties.
  2. A control test on the uniformity of a product. It is particularly applicable to sheet, rod, and tube arms when the test is made on the finished product.

 

Procedure:  Parts are dried in an oven for a specified time and temperature and then placed in a desiccator to cool.  Upon cooling, the specimens are weighed to establish a point of reference.  The material is then submerged in water at standardized conditions (usually 23°C for 24 hours or until equilibrium).  Specimens are removed from the liquid, dried and weighed.

 

What affects water absorption?

  • Type of plastic
  • Morphology (crystalline, amorphous…)
  • Type and proportion of additives, fillers and reinforcements used
  • Fiber fraction and orientation (in composites)
  • Relative humidity and temperature
  • Length of exposure

 

Water Absorption Values for Common Polymers

 

Polymer NameMin Value (% weight)Max Value (% weight)
ABS – Acrylonitrile butadiene styrene0.051.80
PA – Nylon Polyamide, 66 30% Glass Fiber0.801.10
PAI – Polyamide-Imides (TORLON)0.100.30
PBI – Polybenzimidazole (CELAZOLE)0.45
PC – Polycarbonate, high heat0.100.20
PE – Polyethylene, 30% glass fiber0.020.06
PEEK – Polyetheretherketone0.100.50
PEI – Polyetherimide (ULTEM)0.200.30
PP – Polypropylene0.010.10
PS – Polystyrene, high heat0.010.07
PSU – Polysulfone0.200.80
PTFE – Polytetrafluorethylene0.0050.015
PVC – Polyvinyl chloride, rigid0.040.40
PVDF – Polyvinylidene fluoride (KYNAR)0.030.05

 

As the chart notes, some polymers such as Nylon (PA) have a higher rate of % gain from moisture absorption.  However, polymers like PVDF and PTFE have a very low % gain in weight after the ASTM D570 test – which makes them excellent candidates for applications where moisture is a factor.

 

Performance thermoplastics are often exposed to high temperature applications (aircraft engines) which also absorb high levels of moisture.  This is common in materials such as PBI (Celazole) and PAI (Torlon), since these polymers absorb moisture at high rates but are also specified in high temperature applications.

 

Basically, what can happen is that these materials absorb the moisture if not properly stored and packaged.  Then if subject to high levels of heat without time for the moisture to dissipate, the internal moisture boils and turns to steam causing the parts to crack and blister.

 

Managing Moisture Absorption

For predictable machined part fit and performance, stock shapes and finished parts should be stored in a dry environment.  Both finished parts and stock shapes should be packed in moisture barrier packaging.  Only open packaging just prior to use.  In the event that a part may have adsorbed so much moisture as to risk shocking it when placing it in high temperature or vacuum service, consider drying the material prior to use or re-use.

 

Your machining facility will have specifications on temperature and storage procedures for all polymers, stock shapes and components.  When it comes to critical applications, work with a machine shop that has high standards for storing products.  After all, machining a polymer is only part of the entire process; wasted machining, revenue and parts is not worth risking poor storage conditions.  The table below shows some common packaging for polymers to increase and preserve shelf-life.

 

 

Generally, you can find a polymer’s 24 Hour and Saturation Moisture Absorption Values on a data chart.  A chart can give a general idea of the moisture absorption, 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 moisture absorption of polymers and composites.  Your machinist will be able to identify how moisture and humidity 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 Regulatory Resources

 

Want to learn more about factors that contribute to effective CNC machining?

Read Our Blog on CLTE
 

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What is Thermal Expansion (and Contraction)?

 

Thermal expansion or contraction occurs when a material is exposed to temperature change and thus leads to change in all dimensions, as well as other physical properties.  While this effect is most noticeable in gasses and liquids, it is also notable in solids.  Softer materials such as unreinforced polymers experience greater levels of dimensional change per each degree change in temperature.

 

When it comes to machining polymers, heat is always part of the equation.  Increasing the temperature on any polymer or composite can lead to significant changes in dimensions, to part warpage or to internal stress.  Therefore, it is crucial for machinists and designers to understand the amount of thermal expansion a material will undergo during machining operations.  Ideally, reducing any and all thermal contributors during machining would provide for the least machinist stress during production.

 

One of the tests that engineers and designers use to measure the dimensional stability of a material under the effects of heat is the coefficient of linear thermal expansion.  At AIP, we take great care in providing unrivaled results to ensure the optimal dimensions and properties for machined polymers and composites.  Join us in this technical brief as we give an in-depth explanation of the coefficient of linear thermal expansion (CLTE).

 

The CLTE Equation

 

The linear coefficient ‘CLTE or α for plastic and polymer materials is calculated as:

 

a = ΔL / (L0 * ΔT)

 

Where:

a is coefficient of linear thermal expansion per degree Celsius

 

ΔL is change in length of test specimen due to heating or to cooling

 

L0 is the original length of specimen at room temperature

 

ΔT is temperature change, °C, during test

 

Calculate a by dividing the linear expansion per unit length by the change in temperature. When reporting the mean coefficient of thermal expansion, the temperature ranges must be specified.  It is important to note that with many materials, a can change as temperature changes.  It is not always linear, but many times assumed to be linear for most less critical applications or quick estimates.

 

Recently we were brought in to evaluate a material cracking issue with a Polycarbonate Lens.  The cracks were noted around the fastener holes.  The fasteners mounted the lens to an aluminum frame.  It was discovered that there was basically no or minimal clearance between the fasteners and holes in the Polycarbonate.  As the thermal environment deviated over a 100 oF range, the lens obviously expanded and contracted resulting in the fracture.  Updating the design to allow for additional clearance solved the problem.

 

Applications of CLTE

 

Thermal expansion in materials causes premature cracks and stresses that can lead to part failure.  Understanding the CLTE is not only a fiscal concern, but also helpful in determining the type of material for quality and function.

 

  • It is required for design purposes.
  • It helps determine dimensional behavior of machined parts subject to temperature changes.
  • It also determines thermal stresses that can occur, and cause failure of a solid item composed of different materials when it is exposed to temperature (specially to predict efficient material bonding or while using plastics with metals).

 

 

How to Measure CLTE

 

The most widely used standards to measure coefficient of linear thermal expansion in plastics are ASTM D696, ASTM E831, ASTM E228 and ISO 11359.

 

Common methods for determining CLTE include:

  • Dilatometry
  • Interferometry
  • Thermomechanical analysis

 

Dilatometry

 

With this technique, the specimen is heated in a furnace and displacement of the ends of the specimen are transmitted to a sensor by means of push rod.  The push rods may be vitreous silica type, high-purity alumina type, or the isotropic graphite type.

 

ASTM D696 – This test covers determination of the coefficient of linear thermal expansion for plastic materials having coefficients of expansion greater than 1?µm/(m.°C) by use of a vitreous silica dilatometer. The nature of most plastics and the construction of the dilatometer make -30 to +30°C (-22°F to +86°F) a convenient temperature range for linear thermal expansion measurements of plastics, since most plastics are commonly used within this temperature range.

 

ASTM E228 – This test is used for temperatures other than -30°C to 30°C to determine linear thermal expansion of solid materials with a push-rod dilatometer.

 

Interferometry

 

Using optical interference methods, displacement of the material ends is measured in terms of the number of wavelengths of monochromatic light.  While precision is great that with dilatometry, interferometry is not used much above 700 °C (1290 °F).

 

ASTM E289 – provides a standard method for linear thermal expansion of rigid solids with interferometry that is applicable from –150 to 700 °C (–240 to 1290 °F). It is more applicable to materials having low or negative CLTE in the range of <5 × 10-6/K (2.8 × 10-6/°F) or where only limited lengths of thickness of other higher expansion coefficient materials are available.

 

Thermomechanical Analysis

 

Measurements are made with a thermomechanical analyzer that has a material holder and probe that transmits changes in length to a transducer.  The transducer converts the movements of the probe into an electrical signal.

 

ASTM E831 (and ISO 11359-2) – These tests are applicable to solid materials that exhibit sufficient rigidity over the test temperature range.  It is applicable to the temperature range from −120 to 900°C. The temperature range may be extended depending upon the instrumentation and calibration materials used.

 

 

Factors Affecting CLTE Measurements of Plastics

 

  1. Fibers and other fillers significantly reduce thermal expansion.
  2. The magnitude of CLTE increases with rising temperature.
  3. Molecular orientation also affects the thermal expansion of plastics. The thermal expansion is often affected by the cooling time during processing. This is especially true with semi-crystalline polymers whose crystallization process requires time.

 

List of CLTE Values for Precision Plastics

 

 

Polymer NameCLTE Value (10-6 / oC)
ABS – Acrylonitrile butadiene styrene72-108
PA – Nylon Polyamide, general purpose110
PAI – Polyamide-Imides (TORLON)3-4
PC – Polycarbonate65-70
PE – Polyethylene108-200
PEEK – Polyetheretherketone4.5-5.5
PEI – Polyetherimide (ULTEM)5-6
PP – Polypropylene72-90
PS – Polystyrene70
PSU – Polysulfone55-90
PTFE – Polytetrafluorethylene112-135
PVC – Polyvinyl chloride54-110
PVDF – Polyvinylidene fluoride (KYNAR)128-140

 

As the chart notes, some polymers such as Polyethylene (PE, HDPE, UHMWPE) and Nylon (PA) tend to move more with temperature change. However, polymers like PEEK and TORLON (PAI) have a resistance to heat that rivals those of metals like aluminum (21-24).

 

Carbon and glass reinforced polymers can result in metal like levels of CLTE.  This can be advantageous when mission critical polymer parts are to be mounted to metallic components without an allowance for expansion or contraction.

 

A chart can give a general idea of the CLTE, 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 CLTE of polymers and composites.  Your machinist will be able to identify how temperatures 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 Regulatory Resources

 

What should you ask your machinist about the material pick for your project?

 

We’ve got 3 tips on choosing the right material for your design.

 

Read Our Blog
 

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An Informational Brief on Polymer Machining

 

Polybutylene Terephthalate, also known as PBT, is a crystalline polyester thermoplastic that is a household name in everyday applications. You can find it under the hood in automotive applications, such as brake cable liners or sockets due to its ability to endure harsh environments and resist chemicals. In food processing and electrical applications, it is chosen for its resistance to staining and low moisture absorption. As industries continue to expand and populations grow, the demand for this thermoplastic “miracle worker” only continues to increase.

 

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

 

Properties of PBT

 

It is beneficial to keep information on the properties of a thermoplastic pre-machining. This helps in selecting the right thermoplastic for a project. Furthermore, it assists in evaluating if the end use requirement would be fulfilled or not. Below are some of the key characteristics of Polybutylene Terephthalate:

 

PBT (Polybutylene Terephthalate) is a thermoplastic polyester that is very similar to PET (Polyethylene Terephthalate) but has a slightly better impact resistance. As a semi-crystalline engineering thermoplastic, it has outstanding processing properties for molding, thermoforming and machining. It is often a prime candidate for injection molding as the material crystallizes rapidly, so mold cycles are short and temperatures can be lower than for many thermoplastics.

 

PBT is produced by polycondensation of terephthalic acid or dimethyl terephthalate with 1,4-butanediol using special catalysts.

 

PBT Scientific Breakdown Infographic

Molecular Structure of PBT

Chemical Formula: (C12H12O4)n


 
Key features of Polybutylene Terephthalate

PBT displays excellent mechanical and electrical properties like good chemical resistance, impact resistance, low moisture absorption, rigidity, low co-efficient of friction and staining resistance. It is often reinforced with glass-fibers or minerals to improve its tensile, flexural and compressive strengths and moduli.

 

Material PropertyValue
Elongation at Break5-300%
Elongation at Yield3.5-9%
Flexibility & Stiffness (Flexural Modulus)2-4 GPa
Hardness Rockwell M70-90
Hardness Shore D90-95
Tensile Strength40-50 MPa
Notched Izod Impact at Room Temperature27-999 J/m
Notched Izod Impact at Low Temperature27-120 J/m
Young Modulus2-3 GPa
Coefficient of Linear Thermal Expansion6-10 x 10-5/oC
Shrinkage0.5-2.2%
Water Absorption 24 hours0.1-0.2%

 

Applications of PBT

 

PBT finds many applications in the electrical and automotive industries. It is particularly common in food processing applications as it offers very low moisture absorption, resistance to staining and resistance to cleaning chemicals.

 

At room temperature, PBT is resistant to the following chemicals: aliphatic hydrocarbons, gasoline, carbon tetrachloride, perchloroethylene, oils, fats, alcohols, glycols, esters, ethers and dilute acids and bases. However, they are attacked by strong bases.

 

For this reason, PBT can endure extreme and harsh environments such as automotive under-hood applications, outdoor electrical applications where fire is a concern, and valves or insulation in food processing or autoclave components.

 

Other common applications include:

  • Cams
  • Food Piston Pumps
  • Fuel Pump Components
  • Gears
  • Wear Strips
  • Housing Components

 

The broad use of PBT is also shown by the numerous regulatory approvals held by various grades. These include VDE or UL-approvals for the electrical and electronics market or FDA approval for the nutrition and medical market.

 

Grades of PBT

 

At AIP, we machine various grades and brand name Polybutylene Terephthalate, including Hydex PBT. Branded names include the following:

 

  • CELANEX
  • DURANEX
  • HYDEX 4101
  • HYDEX 4101L**
  • SUSTADUR PBT
  • TECADUR
  • VALOX
  • TECADUR PBT GF30

 

**PBT is also available as Hydex 4101L in a bearing grade.

 

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. Whatever your application, our machinists can help you in material selection, sizing and manufacturing techniques from concept to completion.

 

Machining PBT

 

Annealing PBT

Annealing and stress-relieving plastics is crucial to the machining process. If not machined with coolants, lubricants and trained procedures, this material is subject to cracking and crazing. The annealing process at AIP greatly reduces the chances of these stresses occurring from the heat generated during machining polymers like PBT. Our machinists use computer controlled annealing ovens for the highest quality precision temperatures and time control.

 

Machining PBT

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.

 

PBT is a semi-aromatic thermoplastic that is easily molded and thermoformed. Since it crystallizes rapidly, mold cycles are short and molding temperatures can be lower compared to other engineering plastics.

 

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.

 

Polybutylene Terephthalate Machining Guide: Supportive Information

 

General Engineering Materials
Quality Assurance Certifications

 

Providing unrivaled expertise and unparalleled results is at the heart of our mission at AIP Precision Machining.

 

Tell us about your project’s specifications and we will help you solve your plastics puzzle.

 

 

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A discussion on the importance of ITAR registration

 

Whether it is distributing M16 rifles for military operatives or manufacturing landing gear components for AC-130J gunships, facilities that deal with USML Defense Articles in the United States must be compliant with and registered under the International Traffic in Arms Regulations (ITAR). 

 

ITAR regulates the production, sale and transport of munitions categorized under the United States Munitions List (USML).  There are 21 groupings in the USML Defense Articles including:  spacecraft, aircraft, rockets and missiles, weapons, nuclear munitions as well as technology and data.  Precision machined parts for sensitive aerospace and defense programs fall within this list of regulated items.

 

At AIP, we not only guarantee a quality assurance program, we are ITAR certified and registered in order to assure protection of vital United States technology assets.  Our certifications also include ISO 13485:2016 certified, AS9100D:2016 certified and FDA registered.  For the past 37 years, we have worked with leading aerospace and defense engineers and contractors to machine components for the aerospace and defense sectors.  We understand the value and necessity of being ITAR certified and registered to these customers and our country.

 

In this issue of our monthly blog, we discuss what it means to be ITAR certified and how it emphasizes our commitment to excellence.

 

Why should a plastics machining facility be ITAR certified? 

 

The International Traffic in Arms Regulations (ITAR) is the United States regulation that controls the manufacture, sale, and distribution of defense and space-related articles and services as defined in the United States Munitions List (USML).

 

Besides rocket launchers, torpedoes, and other military hardware, the list also restricts the plans, diagrams, photos, and other documentation used to build ITAR-controlled military gear. This is referred to by ITAR as “technical data”.  Under ITAR, access to physical materials and technical data related to defense and military technologies is restricted to US citizens.  

 

Annual Fee and Registration

The ITAR certification incurs an annual registration fee of $2,250.00 along with an application.  All companies required to register must document and keep records of their ITAR related activities and make them available for inspection upon request from DDTC.  Additionally, ITAR registered companies are required to have a formal technology control plan (TCP).

 

Infractions and Penalties

The basic premise of ITAR is to protect sensitive military and defense material made in the United States from any harmful activity.  Any infraction against the ITAR regulations can result in heavy fines and significant brand and reputation damage.  Additionally, noncompliance can mean the loss of business to a compliant competitor.

 

Fines

  • Civil fines up to $500,000 per violation
  • Criminal fines up to $1 million and/or 10 years imprisonment per violation

 

Who needs to be ITAR compliant?

Any company that handles, manufactures, designs, sells, or distributes items on the USML must be ITAR compliant. The State Department’s Directorate of Defense Trade Controls (DDTC) compiles and manages the list of companies that can deal in USML goods and services. Companies must establish their own regulations to uphold ITAR compliance. Some examples of companies and entities who must be ITAR registered and certified include the following:

  • Wholesalers
  • Contractors
  • Distributors
  • Third-party suppliers
  • Computer software/hardware vendors

 

An example would be a steel manufacturer who machines triggers for automatic rifles specifically for the United States Military. This manufacturer is required to have ITAR registration and certification to produce this specific part of the weapon. They must also follow the guidelines and establish company regulations to align with ITAR.

 

As a precision plastics machining company, we work closely with companies and contractors in the aerospace and defense sector. In aerospace and defense, high-performance thermoplastics are sought after for their strength and weight-saving capabilities.

 

Mechanics working on the inner workings of a plane
 

Our products machined for these industries include:

  • Aircraft engines, systems and structural components
  • Chemical detection devices
  • Landing gear components
  • Military targeting and defense sensors
  • Space and Satellite devices

 

Our machined polymers and components for aerospace and defense must pass through rigorous quality management assurance and testing while simultaneously meeting the ITAR regulations. This helps us to ensure not only that we are meeting our own personal standards of unrivaled expertise, but that we are meeting the industry standards to create unparalleled results.

 

How does ITAR certification help AIP serve the aerospace and defense sectors?

 

At AIP, we promise “unrivaled expertise and unparalleled results”. These guiding principles have made us seek out the highest levels of certifications and industry standards for these major markets: aerospace, medical, power and energy and specialized industrial.

 

In order to survive the rigors of the aerospace and defense industry, AIP produces components with the utmost level of precision. These products are lightweight, radar absorbent and made to last in extreme temperatures. Additionally, they follow strict adherence to industry specifications.

 

We know that product durability, weight and resistance to high temperatures and corrosive materials are essential for our customers. In our commitment to quality custom plastic components for aerospace and defense industry, AIP is a certified and registered ITAR facility. We are capable of satisfying all customer DOD, NASA, and FAA quality requirements flowed down from our OEM customers.

 

At AIP, quality assurance is a norm not only for our customers but for ourselves. As an ITAR certified and registered facility, we are proud to offer a complex quality assurance process that focuses on product quality, fast delivery and cost-effective options.

 

What about AIP Precision Machining allows us to achieve ITAR Certification

 

“Consistency and commitment define our company,” says John MacDonald, president of AIP Precision Machining. “While management pursued and procured the means to establish the ITAR registration and certification, it is our team and their daily attention to their craft and expertise that allows us to uphold the regulations. That’s what makes us better every day at exceeding the needs of our valued customers.”

 

Supporting Materials

AIP’s Aerospace and Defense Capabilities

Certifications and Regulatory Resources

 

What’s the most lightweight solution for aircraft operators today? We’ll give you one guess.
Learn more about the secret to fuel-efficiency in aircraft.

 

Read Our Blog

 

 

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A discussion on the importance of FDA registration to ensure QMS in plastics machining facilities

 

FDA LogoFor businesses and facilities involved in the production and distribution of medical devices, FDA Registration is a requirement to machine or manufacture any plastic material that will be used in the United States medical market.

 

Therefore, if your manufacturer or machining shop is not FDA registered, start looking for a new facility with the appropriate certifications and industry standard regulations. There is no compromise on safety and quality assurance when working with plastics for critical applications.

 

At AIP, we not only guarantee a quality assurance program, we are FDA registered, ISO 13485:2016 certified, AS9100D:2016 certified and ITAR certified. As a precision plastics machining company with over 35 years’ experience, we have worked with medical OEMs and R&D representatives to machine critical components for the medical and specialized industrial sectors. We understand the value of a transparent QMS program through the FDA Registration.

 

In this issue of our monthly blog, we discuss what it means to be FDA registered and how it emphasizes our commitment to quality, safety and excellence.

 

Why should a plastics machining facility be FDA registered?

 

FDA registration is a set of mandates that regulate manufacturing operations for facilities involved in the production and distribution of medical devices in the United States. It determines whether a facility has the appropriate resources, including equipment and personnel, to perform the manufacturing operations. This registration includes an annual audit to ensure compliance with the FDA registration requirements.

 

This audit includes an annual registration fee for device establishments. Additionally, most facilities that are FDA registered must provide a list of devices that are made there and the activities that are performed on those devices.

 

As per the FDA device registration and listing, “If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also provide the FDA premarket submission number (510(k), PMA, PDP, HDE, De Novo).”

 

The use of an unregistered device or material can be very dangerous. This means it hasn’t been listed, cleared, tested or approved by the FDA. What if the device is unsafe or ineffective for the user or client?

 

Learn about how to ensure sterilization and industry
standards applied to plastic machined medical applications

 

Read More

 

Additionally, using a device not listed with the FDA means there is no protection for a healthcare or wellness professional should a client have a harmful experience.

 

If you’re unsure if a medical device is listed with the FDA, you can search for the manufacturer in the Registration & Listing Database.

 

How does FDA registration help AIP serve the medical market?

 

Employee Quality assessing a plastic part

At AIP, we promise “unrivaled expertise and unparalleled results”. These guiding principles have made us seek out the highest levels of certifications and industry standards for these major markets: aerospace, medical, power and energy and specialized industrial.

 

We know that product durability, cleanliness and safety are essential for our customers. Our FDA registration allows us to create highly precise and extremely resilient machined plastics for critical applications.

 

We have been successfully audited by some of the most stringent OEMs across all market sectors. Our plastics are processed with strict hygienic procedures to ensure the highest level of sanitation down to the sub-molecular level.

 

At AIP, quality assurance is a norm not only for our customers but for ourselves. As an FDA registered facility, we are proud to offer a complex quality assurance process that focuses on product quality, fast delivery and cost-effective options.

 

What about AIP Precision Machining allows us to achieve FDA Registration

 

“At AIP, it’s about the people and their commitment to this company as a team,” said MacDonald. “We have been FDA registered for the last 35 years, and our team consistently displays attention to maintaining the standards of this regulation on the machine shop floor. That’s what makes us better every day at meeting the needs of our valued customers.”

 

If you are interested in learning more about our quality assurance
program or have a machined plastic part design, reach out to our team.

 

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PART SUMMARY:

 

One of the high-performance thermoplastics that AIP machines is Polyetherimide (PEI), known by its tradename ULTEM.  Due to its weight-saving properties, high chemical and hydrolysis resistance and tensile strength, ULTEM is popular across several industries: Automotive, aerospace and defense, electrical and electronic market, medical and life sciences and industrial applications and appliances.  Read on to learn about what this incredible polymer can do!

 

MATERIAL PROPERTIES:

 

Polyetherimide (PEI) is an amorphous thermoplastic.  Polyetherimide was developed to provide sufficient flexibility and good melt processability while maintaining excellent mechanical and thermal properties.

 

Key properties of ULTEM PEI include:

  • Handling at temperatures up to 340°F (171°C)
  • Heat Resistance
  • Flame Resistance
  • Chemical Resistance
  • High Rigidity
  • Highest Dielectric Strength
  • Hydrolysis Resistance
  • Low Thermal Conductivity

 

ULTEM Applications

As mentioned previously, ULTEM is a highly sought-after thermoplastic for weight-saving capabilities in aerospace components to reusable autoclave sterilizations in medical applications.  However, it’s most commonly used in high voltage electrical insulation applications.

 

Common uses include:

  • Analytical Instrumentation
  • Dielectric Properties Required
  • Electrical Insulators
  • High Strength Situations
  • Reusable Medical Devices
  • Semiconductor Process Components
  • Structural Components
  • Underwater Connector Bodies

 

So, what can this polymer do?  Let’s take a closer look at how ULTEM (PEI) is applied in the Aerospace & Defense, Medical & Life Sciences and Specialized Industrial markets:

 

WHAT CAN ULTEM DO FOR AEROSPACE & DEFENSE?

 

In the Aerospace & Defense Industry, ULTEM is often applied to aircraft components for weight reduction in place of metal parts.  Additionally, since it has a high thermal resistance rating, polymer components have the benefit of evading radar detection in military aircraft.

 

AIP machines ULTEM 1000 & ULTEM 2300

 

ULTEM 2300 is a 30 percent glass filled version of virgin ULTEM 1000.  The addition of glass increases ULTEM 1000’s dimensional stability by almost three times.

 

For over three decades, AIP has provided flight control, fuel system, interior, engine and aerodynamic-related ULTEM components for various aircraft OEM and MRO providers worldwide.  As this industry continues to expand, evolve and innovate, the demand for high-performance materials like ULTEM contribute significantly to streamlined operations.

 

WHAT CAN ULTEM DO FOR MEDICAL & LIFE SCIENCES?

 

In the Medical Industry, biocompatibility and sterilization are paramount to medical instruments and implants. ULTEM is often a popular choice in this sector due to its resistance to chemicals and lipids.  Polyetherimide also withstands dry heat sterilization at 356°F (180°C), ethylene oxide gas, gamma radiation and steam autoclave.

 

Some popular medical applications include disposable and re-usable medical devices and medical monitor probe housings.  These could be surgical instrument handles and enclosures or non-implant prostheses.  It gets extensive use in membrane applications due to its separation, permeance and biocompatible properties.

 

WHAT CAN ULTEM DO FOR SPECIALIZED INDUSTRIAL Sectors?

 

At AIP, we precision machine ULTEM for many specialized industrial applications as well: automotive, electrical and metal replacement, to name a few.  Despite the diversity of these industrial applications, we have the inventory and machining capabilities to provide solutions for any project specifications.

 

PEI is most often used in electrical and lighting systems in the automotive market for its high heat resistance, mechanical integrity and strength.  Principal automotive applications include: transmission parts, throttle bodies, ignition components, thermostat housings, bezels, reflectors, lamp sockets and electromechanical systems.

 

The electrical and electronic markets demand high heat resistant materials.  ULTEM is an excellent choice for applications such as electrical circuit boards, switches, connectors, electronic chips and capacitors.

 

As discussed previously, thermoplastics like ULTEM often replace metal parts in industrial applications.  For this reason, it’s often used in housewares, especially fluid handling systems.  Some of these applications are: HVAC equipment, microwave cookware, steam and curling irons, dual-ovenable trays for food packaging that meets FDA food packaging requirements.

 

What can AIP Precision Machining do for you?

 

From concept to completion, our team of engineers will work with you to realize the final product.  With some of the fastest lead times in the industry, our unrivaled technical experts we can tackle your polymer challenges.

 

What Can This Polymer Do? Supportive Information

 

Medical Sector Biomaterials Guide

Energy Sector Materials Guide

Aerospace Sector Materials Guide

Amorphous Materials

Aerospace Case Study: Weight-saving Polymers

 

 

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