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Medical Equipment and Specialty Devices

Medical Equipment and Specialty Devices

Spartech has 50 years of proven expertise producing plastic products used in medical equipment and specialty devices. As a result, we are able to provide industry-leading proprietary plastic sheets for medical equipment enclosures as well as wall coverings in hospital clean rooms, patient rooms, drug testing and packaging facilities.and cell cast acrylic sheets, tubes and rods for medical devices, fluidic manifolds, and diagnostic fabricated parts.

Our custom processes, proprietary formulations, quality focus and collaborative approach to solving your problems make us the industry leader. The result is that we can help you achieve the required outcomes for any project.

To learn more about how we can deliver a healthy amount of innovative solutions to your next medical equipment or specialty device project, contact us.

MEDICAL DEVICE HOUSINGS

Medical device housings must meet rigorous testing

The Royalite® line of product materials remains the most trusted and reliable brand of rigid thermoplastic sheets available. The proprietary formulation produces thermoplastic sheets that are extruded, then vacuum formed or pressure formed into housings for a growing number of medical device applications, especially those which operate at high temperatures. Royalite Sheet is formed into medical device enclosures that protect medical device electronics and other components that operate critical medical equipment.

The sheet is typically vacuum formed or pressure formed into a housing panel for medical equipment. Royalite performance grade plastic sheets are an alternative to injection molding, where increased size can sometimes equal higher costs due to large, costly custom molds and extended molding cycles as well as longer lead times. Royalite materials are available in a wide range of colors and surface textures.

Royalite materials for medical equipment and specialty devices meet rigorous UL safety certification requirements (including UL 94 HB, UL 94 v-0, and UL 94 5VB). From a sustainability perspective, up to 100% recycled materials are available as well.

Royalite Sheet is also used for wall coverings in hospital corridors, surgical rooms, patient rooms, and pharmaceutical clean rooms requiring ASTM E84 class 1/A thermoplastic sheet.

SPECIALTY DEVICES

Polycast medical grade acrylic rods and sheet are USP Class VI approved for biocompatibility, including extensive testing and application history for systemic toxicity requirements, intracutaneous reactivity tests, and long-term implantable medical devices.

Optically clear materials like Polycast acrylic offers advantages such as being radiolucent. This is an advantage over PEEK, which is another implantable grade thermoplastic that is opaque.Sometimes Polycast’s clarity is easier for surgeons to use.

Biocompatibility (USP Class VI)*

TEST

METHOD

RESULT

1. Cytocompatibility Study

  • Extract
  • Direct Contact Saline-blood Mixture
  • Cell Attachment

(MEM) (L-929) / 72 Hrs.

(SC) (AS) + (cso) / 24Hrs.

(SC) (AS) (CSO0 + extracts for Acute systemic toxicity

Direct Contact with Lysis

L-929

No Lysis or Cytotoxicity Effect

No Cell Lysis

No Toxicity

No Blood Cell

Non Toxic

2. Mutagenicity

AMES (Vitro)

Not Mutagenic

3. Systemic Toxicity Extract in Mouse

USP-TUO12-500

No Considerable

Toxicity

4. Rabbit IntradermalInjection of Extract

Erythmea

Edema

None

None

5. Sensitization

By DNCB

Good Sensitization

6. Implantation Test

  • Intramuscular
  • Implantation Test 4-Week
 

No Reaction

7. Equivalence Evaluation and Toxicological Risk Assessment

USP and ISO 10993

Guidelines

Demonstrated chemical and

Toxicological equivalence among all UVA 400 materials

The Polycast offerings include medical-grade acrylic tubes used in medical equipment fluid reservoirs such as surgical irrigation/waste management systems machines used for endoscopic and orthopedic procedures.

QUALITY & EXPERTISE

Quality and expertise that you cannot find anywhere else.

Spartech is a custom medical sheet extruder and works directly with you to deliver the appropriate compound for each application. The variety of plastic substrates lets us offer many options for your medical device enclosure design. Plus, our experienced material scientists and staff professionals use their extensive knowledge of plastic materials to help designers and fabricators make the right material decision for each application, whether that involves an entirely new product or an enhancement to an existing one. These materials are available in a wide variety of quantities, colors, textures and sheet sizes.

Expertise and quality are some of the essential differences that Spartech provides. As a custom medical grade plastic extruder, our teams are experts in working with our production lines to adjust to our customers’ expectations, but quality is never compromised when one product run is finished and another begins. In addition, our materials are designed to meet custom specifications.

We control the material that goes into every formulation. During production the materials are tested to all required specifications. Whatever your requirements might be, Spartech assures that any product going out the door meets all required specifications and is delivered on-time and on-budget.

COLLABORATION

Collaboration leads to innovation

At Spartech, our team is constantly searching for the next generation of materials for medical equipment and specialty devices. We focus on developing eco-friendly plastics, products with greater heat dispersion capability and new color/texture combinations.

Often a new product cycle involves collaboration with customers like you. That collaboration frequently leads to innovation since customers with new ideas are invited to bring them to Spartech’s experienced team. Our proprietary plastics formulations contain built-in flexibility that lend themselves to be modified for new product development, while maintaining important certifications. The result can be an entirely new product without lengthy certification timelines. Spartech also has the capability to engineer entirely new formulations and our knowledge of the safety certification processes can expedite new product launches.

SERVICE

Service. On-time delivery. And supply chain continuity.

We realize the importance of on-time delivery of critical materials for medical equipment and specialty devices. Spartech’s flexibility in manufacturing locations ensures business and supply chain continuity advantages for your project. For example, the Royalite brand is produced at multiple plants across the United States. And our other facilities can be quickly converted to provide a stable supply chain. Most competitors have a single manufacturing site for each plastic material, and sometimes just one site for all materials.

Spartech - Contact Us

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