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.

 

 

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

 

 

Follow AIP Precision Machining on Linkedin

linkedin logo

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

 

For 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?

 

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.

 

Get a Consultation
 

Follow AIP Precision Machining on Linkedin

linkedin logo

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

 

 

CUSTOMIZED FOR YOUR APPLICATION

Schedule a Consultation.

Follow AIP Precision Machining on Linkedin

linkedin logo