Begin Your Tour of our State-of-the-Art Facilities
- 1. Entrance
- 2. Basecoat
- 3. Topcoat
- 4. Applications Development
- 5. Contract Coating Services
- 6. Quality Control
- 7. R&D Lab
Welcome to Biocoat!
Biocoat is a global leader in the development of hydrophilic coatings for medical devices. Take a virtual tour through our facilities to learn more about the following areas:
- Quality Control
- Applications Development
- Contract Coating Services
- Research, Development & Innovation
Our coatings use a two-coat application process. The first coat is our basecoat, which is used to “normalize” the substrate and prepare it to bond with the hydrophilic topcoat.
Our Basecoat area is:
- A purpose built, eight room, production area that supports Manufacturing, Chemical Storage, Equipment Preparation / Cleaning, and Finished Goods Storage.
- Specifically built with different reactors and bulk blending vessels to support the creation of the materials for our Thermal and UV coatings.
Our coatings use a two-coat application process, with the second coat being our Topcoat. The Topcoat enables the high levels of lubricity. The Topcoat and Basecoat are covalently bonded, which is what enables excellent coating durability and low particulate counts.
Our Topcoat area is:
- Specifically built with class 7 cleanrooms that contain six reactors and three dialysis vessels to produce any of our various products.
- Built with five rooms each for a specific task. These areas are Manufacturing, Finished Goods Preparation, Equipment Preparation and Cleaning, and Finished Goods Storage.
Our Applications Development team consists of Scientists and Engineers who support the development of our coatings for the device requiring the hydrophilic coating.
Our Applications Development technical team:
- Uses several analytical test methods available to understand the substrate and to match the best coating option.
- Works on dedicated, fully automated, Thermal Heat and UV cure coating machines that are used to support the testing process and to characterize the coating using frictional analysis, thickness measurements and coating integrity analysis.
- Is readily available to help troubleshoot any issues you may have during the development process.
Contract Coating Services
Our turnkey Contract Coating Services Unit is used by our customers to coat their products to complete the manufacturing process using our in-house machinery and expertise. Our Coating Services is ISO 13485:2016 certified and designed to expertly coat our customers devices to ensure maximum safety, maneuverability, and patient comfort.
Our Contract Coating Service allows for:
- Seamless application of our industry-leading hydrophilic formula on your device.
- Devices to be cured using either a UV or thermal cure process.
- A stable and repeatable application process.
- Customizable fulfillment to support your product’s unique needs.
- Rapid and efficient turnaround times to meet your production schedule.
Quality Control Lab
Our Quality Control Team has developed and follows our certified ISO 13485:2016 Quality Management System to ensure that our coatings meet our expected results in every batch.
Our quality system offers:
- Complete material, product history and traceability from design through manufacturing and shipment.
- A dedicated laboratory with analytical and wet chemistry, physical testing, biological analysis, lubricity, and durability testing capabilities.
- Specifically dedicated areas for the visual and equipment aided process used for coated and uncoated device inspections.
- Full quality testing, inspection, release, and certification of all products and services per internal and external requirements.
- Access to our FDA Master Files for reference in regulatory filings.
Research, Development and Innovation Laboratory
Our Global Research and Development team works out of our Witmer Road facility, which is also our backup production facility. Our R&D team’s primary responsibility is the development of new coatings that best match the expected criteria as identified by global regulatory agencies. The R&D team is also tasked with:
- Working with analytical chemistry models to improve our coatings and to troubleshoot any unique development projects
- Developing coating processes to support new materials or device capabilities
- Testing and analyzing coating characterization to evaluate the coatings performance
The Leading Full-Service Hydrophilic Coating Solutions Provider
INDUSTRY-LEADING PERFORMANCE IN CURING:
- Thermal Heat
- Ultraviolet light (UV)
- Peripheral Vascular
ABILITY TO COAT NEARLY ALL SUBSTRATE MATERIALS:
- Hydrophilic Films
FLEXIBILITY IN COATING DELIVERY:
- Contract Coating services at our state-of-the-art facilities
- Licensing and reagent delivery to meet your requirements
Do you require a hydrophilic coating for a medical device? We can help!
Tell us about your project and our team will respond within two business days.