Strict Hygienic Procedures for Precision Machining

 

It’s no secret that cleanliness and sterilization are crucial for applications in the medical industry. Any manufacturer you hire for machining your plastic component should be aware of this, and taking actions to prevent any contamination from taking place.

 

Here are three ways you can ensure that your medical application is being precision machined by a manufacturer committed to following strict hygienic procedures.

 

1) Check Industry Standards

 

Ensuring sterilization starts with picking the right manufacturing company, and you’ll want to be sure they take the matter of contamination seriously. To start, check their commitment to quality management and industry standards.

 

All product manufacturing companies must follow industry standards like International Organization for Standardization (ISO) and Food and Drug Administration (FDA). Before you work with a manufacturing company for your medical application, look at their certifications.

 

For example, ISO 13485 specifies requirements for a quality management system where a company demonstrates it can provide medical devices and related services to consistently meet customer and regulatory requirements. ISO 9001 focuses on meeting customer expectations and continually delivering satisfaction, plus reflects constant improvement from the company.

 

If the manufacturer you are interested in using does not have any of the above standards, then you may want to ask them why.

 

Here at AIP Precision Machining, we have been successfully audited by some of the most stringent OEMs in the orthopedic and medical device industries, and are ISO 13485:2016., ISO 9001:2015 , and FDA registered.

 

2) Plastic Machining isn’t Metal MachiningMetal vs Plastic Machining

 

Be wary of any manufacturer who machines both plastics and metals in the same facility. The tiniest sliver of metal embedded in a plastic part can have widespread ramifications, such as an unexpected electrical problem in the medical device.

Additionally, it’s common for metal machining companies to use oil-based cutting fluids. Any equipment that machines metal, then, can contaminate your plastic parts with those fluids. Many plastic materials are especially sensitive to those petroleum-based liquids, and they can degrade when in contact with them; others are hydroscopic and will absorb the oils.

 

It should be noted that plastic parts manufactured using equipment that machines metal parts will not meet FDA-approval, or the other industry standards mentioned above. The safest way to avoid this is to hire a plastics expert, not a metal machining company.

 

AIP takes the matter of sterilization seriously, and ensures the highest level of sanitation down to the sub-molecular level for its products. By designing, stress relieving and machining only plastics, AIP significantly reduces the threat of metallic cross contamination and therefore allows for the highest hygienic products possible.

 

3) Look for Experience

 

The most important factor to take into account overall is experience. Your supplier should be familiar with the types of polymers and composites you need machined, and should additionally know the best machining process for your application.

 

For the medical industry, you want to know that your manufacturer is experienced with the complex needs of your applications. For example, if your components are going to come into contact with body tissue or fluids, then they must be biocompatible per ISO 10993.

 

Which is to say: If you’re machining implants, your plastics will require different needs than if you’re machining reusable surgical instruments. Both require, however, careful attention to detail. A surgical instrument must be designed with sterilization compatibility for regular cycles in mind, while an implant requires biocompatibility to be safe for use.

 

Be sure that your manufacturer is familiar with the processes that come with your application, and check that they’ve done it before.

With 35+ years of experience, AIP is well acquainted with precision machining for the medical industry and guarantees careful material selection and processing for your medical applications.

 

The #1 Best Way to Avoid Contamination?

Overall, the best thing you can do to avoid contamination is to hire a plastic manufacturer with the experience and the credentials to complete your project to the highest standards of quality possible. Keeping the above three factors in mind will help you do just that.

 

To ask about AIP Precision Machining’s capabilities for precision machining medical applications, please contact us.

Follow AIP Precision Machining on Linkedin

linkedin logo

Thermoplastics in Medical ApplicationsWhen it comes to choosing a thermoplastic material for your medical applications, product durability, agency approval, biocompatibility and cleanliness aren’t just desirable—they’re essential. Beyond even that, though, a host of other factors must be considered when determining which high-performance plastic or composite material to use for an implant, orthopedic surgical guides, body fluid contact components, spinal devices, or surgical instruments. Medical product applications are becoming more and more advanced due to critical performance and alignment requirements as well as the need for radiolucency to support minimally invasive procedures. Therefore, the choice of plastic material specified for a given application as well as a manufacturer with battle-hardened experience is the critical first step in your decision process.

 

AIP has well over three decades of expertise with thermoplastic materials, and understands how plastics react when machined. We are one of a very select few companies able to hold incredibly tight tolerances in plastic parts. AIP has been successfully audited by some of the most stringent OEMs in the orthopedic and medical device industries, and are ISO 13485:2016, ISO 9001:2015 and FDA registered.

 

Here are just a few initial, yet critical considerations that take place when we determine the thermoplastic to best suit your particular medical or life science application.

 

Biocompatibility

 

If your components are going to come into contact with body tissue or fluids, then those components must be biocompatible per ISO 10993; if the manufacturer you are working with is not familiar with this standard and cannot provide you with this certification for the material, then move on to a manufacturer with medical industry knowledge. This is especially true if the polymers will undergo long-term contact with body tissues and fluid, such as when used as an implant. Polymers can undergo degradation due to biochemical and mechanical factors in the body, which results in ionic attack and formation of hydroxyl ions and dissolved oxygen. In turn, this can lead to tissue irritation, inflammation, and other reactions with body-like corrosion, wear and potential death. Due to this, very few polymers are available as medical grade for medical application, with an even smaller amount considered a candidate for implants.

 

AIP Precision Machining includes machined PEEK implants among its many capabilities for custom medical applications precisely due to PEEK’s biocompatibility. PEEK is also inert to body fluids, making it exceptional for bone surgery as well as areas of traumatology and orthopaedics. Another valuable trait of PEEK is that this material has a very similar modulus to that of human bone. The similar modulus to bone reduces the potential for stress shielding. Stress shielding is common with metallic implants whereby the metal implant and bone do not become one nor work in unison to form a single construct. By using Invibio’s PEEK Optima or Solvay’s Zeniva PEEK as an implant material, the bone and PEEK will grow into a single construct mimicking the bone’s natural tendency to repair the fracture or fusion.

 

Sterilization Compatibility

 

Plastics react differently to various sterilization methods, and if a product is not a single-use device and involves body tissue and fluid contact, then it may regularly undergo sterilization. The usual sterilization methods are radiation (gamma/e-beam), chemical (ETO), or autoclave (steam). ETO is rarely a concern, but radiation and autoclaving both require resistance from plastics. Several radiation resistant thermoplastics are:

 

 

When it comes to autoclaving, the best polymers for resistance are PPSU and PEEK, with both capable of handling exposure to thousands of cycles.

 

AIP takes the matter of sterilization seriously and ensures the highest level of sanitation down to the sub-molecular level for its products. By designing, stress relieving and machining only plastics, AIP significantly reduces the threat of metallic cross-contamination and therefore allows for the highest hygienic products possible.

 

Chemical Resistance

 

A polymer can be exposed to plenty of disinfection chemicals in a hospital. That exposure can deteriorate plastics, and negatively affect part performance. Polymer chains can be affected by isopropyl alcohol, bleaches, and peroxides. Semi-crystalline polymers like PP, PE, PTFE and PEEK can be expected to have better chemical resistance than amorphous polymers like ABS and PC. However, it’s important to check the performance to be certain of resistances, as exceptions can take place.

 

With decades of experience working with thermoplastics, AIP guarantees extreme chemical resistance in its material selection for your medical applications.

 

Electrical & Thermal Properties

 

Dielectric strength and thermal resistance are necessary for medical devices enclosed in areas that require high heat resistance. Thermoplastics such as PC (Polycarbonate), PC blends, PPS (polyphenylene sulfide), PEI and PS (polystyrene) blends have electrical properties that perform well, some even at elevated temperatures.

 

AIP’s material library includes thermoplastics that exhibit extreme thermal performance, and we are familiar with machining them in applications for medical life & sciences.

 

Mechanical Properties

 

Properties such as tensile and compressive strength, wear resistance, impact strength, and bending stiffness also must be considered when choosing your thermoplastic. Engineered thermoplastics such as PC, PEEK, PPSU, POM, PEI and reinforced grades of these same materials (glass, aramid and carbon fillers) perform very well in this respect, making them ideal for a variety of climate conditions, such as during transportation.

 

AIP provides thermoplastics that show extreme wear resistance, x-ray visibility or invisibility and high structural performance.

 

These are just a few of the many considerations that take place when choosing the right plastic for your medical applications. AIP offers you our full material consultancy from concept to completion, so that together, we find the right thermoplastic for your projects.

 

 

Explore Materials Inventory

or request a quote here.




Follow AIP Precision Machining on Linkedin

linkedin logo

We can’t wait for the biggest Medtech event on the East coast: MD&M East! We’ll be there, ready to talk about implantable devices, medical material components and more. Visit us at our Booth #2370 to learn about our unmatched precision in plastics manufacturing.

Follow AIP Precision Machining on Linkedin

linkedin logo

AIP Precision Machining recently attended the 2017 American Academy of Orthopedic Surgeons (AAOS) Conference in San Diego, California, and had a blast reconnecting with old friends and getting to know new members within the orthopedic field.

 

The AAOS sets out to bring together medical professionals and exhibitors, allowing attendees to meet with their peers and have the opportunity to learn about the latest in medical trends and advancements. It provides a venue for all members of the orthopedic community to gather: attendees range from basic component suppliers to implant designers, surgeons and even patients.

 

AIP has been attending the AAOS for over a decade now and every year we bring technically advanced products to the show. This year, we showcased our new PREFORM technology, which was a huge hit as trends are moving more and more toward production efficiency and cost reduction.

 

PREFORM technology weaves PEEK plastic fibers together, molding trauma guides and reusable nailing instruments together to form a one-piece, complex instrument. Combining creative radiolucent guide design with added strength and cost-efficiency, many new and existing OEMs were very excited by the range of opportunities this machinery presents.

 

Another impressive theme that kept popping up during the show was a major push to move the surgery market towards robotic control. Several new OEM projects already have projects in development that rely solely on robots to prevent human error and increase surgery success rates.

 

Looking to 2018, we can’t wait for another successful AAOS Meeting—New Orleans, here we come!

 

If you’d like more information about the creative manufacturing and materials solutions AIP can provide you, give us a call at 386-274-5335.

Follow AIP Precision Machining on Linkedin

linkedin logo