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:

• Basecoat
• Topcoat
• Quality Control Lab
• Applications Development
• Contract Coating Services
• Research, Development & Innovation

Basecoat

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.

Topcoat

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.

Applications Development

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 customer’s 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 Assurance & Regulatory Affairs Team ensures compliance with all internal and external requirements and standards in accordance with our ISO 13485:2016 Quality Management System.

Our quality system offers:

• Complete material, product history and traceability from design through manufacturing and shipment.
• A dedicated Quality Control Laboratory with analytical and wet chemistry, physical testing, biological analysis, lubricity, and durability testing capabilities.
• Specifically dedicated quality areas for visual and equipment-aided inspections of coated and uncoated devices.
• Full quality testing, inspection, release, and certification of all products and services per controlled specifications and applicable regulatory and customer requirements.
• Access to our FDA Master File Authorization for reference in regulatory submissions.

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