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capabilities

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strategy

Medical Device Strategy

Patient Safety

Patient Safety

Account Spotlight

Account Spotlight

Precision Medical Injection Molding Services at Plastikos

As the healthcare industry evolves, Plastikos is at the cutting edge, producing critical injection molded components for medical devices that meet today’s challenges and anticipate tomorrow’s needs. Our commitment to innovation and quality in our state-of-the-art facilities ensures we remain at the forefront of the injection molding industry. Everything we produce can be defined as “Patient Critical” devices ranging from insulin pumps, surgical eye care, respiratory equipment, enteral feeding devices, and much more. We are solely focused and committed to ensuring you produce life-saving devices that help patients get back to their everyday lives.

We employ a standardized approach when investing in new equipment such as: machines, software, auxiliary equipment, robotics, etc. We remain privately owned and operated and continue to reinvest in the future of our business to ensure long-term success for both our customers and employees. Furthermore, we remain completely dept-free, allowing us to quickly respond to growth opportunities with our clients, especially with new technologies or equipment.

ISO 7 (CLASS 10,000) CLEAN ROOMS

ISO 7 CLEANROOMS

Two separate, state-of-the-art facilities with more than 50,000 square feet of combined cleanroom infrastructure with press tonnages ranging from 66T to 350T. All cleanroom machines are equipped with 3-Axis robotics to enable part handling and cavity separation.

ISO 8 CLeanroom

ISO 8 CLEANROOM

One stand-alone cleanroom with 8 medical molding machines ranging from 88T – 220T. Each ISO 8 cleanroom machine is equipped with its own 3-axis robot.

ENGINEERING EXPERTISE

IQ/OQ/PQ Validation

Experienced Quality Engineering staff is trained on the latest IQ/OQ/PQ mold validation protocols consisting of: First Article Inspection, process DOE, Gauge R&R, CpK Analysis, etc.

ISO 13485 CERTIFICATION

ISO 13485 certification

As an ISO 13485 certified facility, we continue to deliver the internationally recognized quality standard for the manufacture of Medical Devices. We are also ISO 14698 compliant and conduct routine bio-burden testing throughout the facilities.

INTEGRATED ROBOTICS

INTEGRATED ROBOTICS

Each medical molding machine is equipped with its own multi-axis robotics system. Part handling and cavity separation are achieved utilizing integrated robotics. These systems are also tied into our process monitoring system to discard product that may drift outside our molding parameters, which are establish during our rigorous mold validation.

ADVANCED PROCESS MONITORING

Advanced Process Monitoring

Process Engineers are trained at Multiple RJG Master Molder Levels through their rigorous standards. Also, we routinely utilize cavity pressure sensors with process monitoring technology to achieve 100% monitoring and traceability on patient-critical-applications

OUR STRATEGIC APPROACH TO LAUNCH YOUR MEDICAL DEVICE

Our approach includes detailed planning and oversight at every stage, ensuring seamless execution and exceptional quality.

We strategically go-to-market as both a toolmaker, and precision molder. Our philosophy is that we design a mold around the product, whereby we consider critical items such as gating, maximum cooling, venting, wear & replacement components, and tool longevity. This customized approach to tool design and fabrication can often be overlooked unless your supplier has both tooling and molding capabilities.

Furthermore, our Project Engineering team each holds a Plastics Engineering Degree and will help our clients to optimize their product design for manufacturing, material selection, process optimization, and on-going production support. Our clients are supported through weekly updates on the progress of the mold build through production approval.

This holistic support system ensures that every project we undertake is positioned for success, with a focus on innovation, quality, and patient safety.

Patient Safety and Product Efficacy for MEDICAL MOLD VALIDATION

Navigating the regulatory landscape for medical devices is complex, and at Plastikos, we pride ourselves on our rigorous compliance with specific regulations and industry standards. Our commitment ensures that the medical components we produce meet the highest levels of safety and quality.

As an ISO 13485 certified facility, we continue to deliver the internationally recognized quality standard for the design and manufacture of Medical Devices. We are also ISO 14698 compliant and conduct routine bio-burden testing throughout the facilities.

Furthermore, our team of expert quality engineers will lead your IQ/OQ/PQ mold validation strategy whereby we conduct the following:

White icon of a paper with a check list with green background

Step 1: Installation Qualification (IQ)

An Installation qualification is essentially a documented Bill of Materials of all the intended equipment that will be needed to mold a product (i.e.: Machine type / tonnage, Robotics, dryer(s), chillers, eDART equipment, etc.).

operational qualification white icon with a green background

Step 2: Operational Qualification (OQ)

This is where much of the mold validation work / time is spent. Our process engineering team will develop a scientific molding process to target several key process variables. From there, a DOE is performed to test high / low limits of the process. During this time, extensive metrology work is performed on all key print variables. Measurement technique / correlation with our client is crucial during this stage.

White icon of a microscope with a green background

Step 3: Performance Qualification (PQ)

A PQ is the final phase in the process development cycle. This is where an extended 8-24 hour production simulation run will occur on the mold to ensure we can move into full scale production. A metrology report on the critical dimensions is also performed as the last piece of confirmation with our clients.

Account Spotlight
OPERATION WARP SPEED

THE INITIAL CHALLENGE

During the peak of the COVID-19 pandemic, a prominent OEM specializing in fluid handling and liquid cooling for vaccine production partnered with Plastikos to help rapidly scale their growing Bio division. This initiative was driven by the urgent demand for COVID-19 vaccines in the United States and the broader pharmaceutical space. Plastikos, in collaboration with Micro Mold and several other reputable mold suppliers, spearheaded the project to meet the rigorous timelines to build and qualify more than 25 multi-cavity tools.

In conjunction, Plastikos Medical was already expanding our ISO 7 cleanroom, a process that would take another year to complete. To expedite our customer’s urgent capacity needs, our leadership team devised a plan to address the immediate cleanroom molding requirements while accommodating long-term growth:

  • Invested over One Million dollars to convert half of our whiteroom into an ISO 8 cleanroom within six months, while ensuring that existing production remained uninterrupted.
  • Utilized Micro Mold's R&D to further expedite initial mold samples during the initial debug stages of the project.
  • Executed our robust IQ/OQ/PQ validation strategy on numerous tools concurrently while maintaining weekly communication with our client with our dedicated project & quality engineering team.
  • Obtained our ISO 14698 Bio-Burden compliance which is a standard used to assess biocontamination control within our facility.

Today, Plastikos has become one of the largest suppliers to our pharmaceutical customer and continue to grow in other strategic markets they serve. Our debt-free, privately owned structure enabled our leadership team to make swift decisions and proactively invest in our customer’s rapid growth demands.

STRATEGIC SUPPLIER PERFORMANCE

  • INCREASED ANNUAL REVENUE BY MORE THAN 400% IN A SINGLE YEAR.
  • SHIPPED OVER 10 MILLION PARTS DURING OUR FIRST YEAR OF PRODUCTION.
  • MAINTAINED 100% YEAR-OVER-YEAR ON-TIME DELIVERY

CUSTOMER RESPONSE

We have great confidence in Plastikos as a supplier and regard them as industry leaders in injection molding. Our confidence is so great that we trialed a supplier data program with Plastikos before any other supplier, relying on their measurement data to streamline the receiving inspection process on our end.

—Eric M. Supplier Quality Manager

MEDICAL MOLDING EQUIPMENT

Max. Press Tonnage Quantity Max. Barrel Size (oz.) Tie Bar Height (in.) Tie Bar Width (in.) eDart Equipped
66 2 1.4 14.5″ 14.5″
88 4 3.9 18.5″ 18.5″
220 4 8.2 22.4″ 22.4″
Max. Press Tonnage Quantity Max. Barrel Size (oz.) Tie Bar Height (in.) Tie Bar Width (in.) eDart Equipped
66 1 1.4 14.5″ 14.5″  
110 6 3.9 18.5″ 18.5″  
220 8 8.2 22.4″ 22.4″  
350 3 12.7 28.3″ 28.3″  
Max. Press Tonnage Quantity Max. Barrel Size (oz.) Tie Bar Height (in.) Tie Bar Width (in.) eDart Equipped
66 2 3.9 18.5″ 18.5″
220 6 8.2 22.4″ 22.4″
Equipment Manufacturer Quantity
Multi-Axis Robotic Centers Arburg 35
Vision System / CMM OGP SmartScope Flash 250 1
Vision System / CMM OGP SmartScope Flash 302 1

Pioneering the future of medical device manufacturing with precision, care, and innovation

If you’re ready to elevate your project with top-tier injection molding services, contact us today.

LET’S MAKE THE IMPOSSIBLE TOGETHER.
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