Biocoat - Innovation unbound

Biocoat - your trusted partner for biocompatible coatings on catheters, guide wires, introducer sheaths, balloons and IOL cartridges.

Biocoat, Inc. is an ISO 13485: 2003 certified manufacturer of coating reagents and a research facility dedicated to meeting client needs. Biocoat scientists are keen to assist clients through all aspects of regulatory compliance. Biocoat is a private firm that is financially strong and keeps long-term clients. Located in two facilities in Horsham, Pennsylvania, US, Biocoat maintains redundancy in manufacturing to ensure constant delivery.

Management is focused on maintaining an active quality management system that is in a state of control of procedures. Ongoing employee training and safety programmes are robust.

The HYDAK hydrophilic coating process

HYDAK® is Biocoat's registered trademark for its immobilised hyaluronan coatings technology. Application of the HYDAK Coatings is a process that uses conventional coating equipment and curing ovens - coatings are applied by dip-coating. HYDAK Coatings can be used on both inside and outside surfaces, and on most commonly used polymers and metals.

HYDAK advantages

  • exceptionally hydrophilic
  • lubricious when wet, preventing trauma and tissue abrasion
  • abrasion resistant
  • very thin, flexible coatings can be applied
  • biocompatible
  • non-thrombogenic
  • prevents adhesion of platelets, proteins, and microorganisms.

Why choose Biocoat?

The choice of a coatings vendor is influenced by several important factors:

  • technical expertise of the vendor staff
  • accessibility of vendor management to make decisions for you
  • an active and ongoing research effort to improve coating performance, address customer and regulatory inquiries, and characterise in-depth multiple aspects of a coating common to inquiries from the FDA
  • response time for coatings inquiries
  • coating performance: durability, lubricity, documented low particle counts and an extensive biocompatibility profile
  • cost - set up, per piece coatings contribution, licence fee, royalties, reagent costs, manufacturing through-put and percentage of coating disposed of as waste
  • safety record of vendor
  • on-time supply record of vendor
  • establishment and maintenance of a robust quality management system
  • technical services staff ready to assist in all aspects of coating application: test facilities, validation and verification support, experience is a variety of coating methods such as dip or cup coating, and selection of equipment such as ovens, shelf life determination, etc.
  • back-up facilities: if one lab has a fire or spill, does the vendor have dedicated secondary facilities to ensure your supply?
  • financial strength.

At Biocoat, we pride ourselves as chemists, and experts on coatings, substrates and adhesion. Biocoat clients enjoy an industry-leading level of support and often realise long-term savings from getting the Biocoat team on board early in the device development process.

Biocoat services include development, verification, validation and support. To seek an independent evaluation on how Biocoat coatings can be implemented to your project, or to learn more, please contact: Keith Edwards, president, using the contact details below.

Products and Services

Contact Details

Biocoat
211 Witmer Road
Horsham
PA 19044
Pennsylvania
United States of America
Tel: 215-734-0888 x106
Email: sales@biocoat.com
URL: www.biocoat.com

Hydak® Coating Schematic - The coating is bilaminar with an acrylic-based primer material and a top coat based on a naturally occurring polysaccharide, hyaluronan (HA), made from certified non-animal sources.
The HYDAK® Process - Depending on your device, a typical base coat cure time of 20 minutes is followed by a top coat cure of about 120 minutes at 60°C.
Roadmap to success - A successful launch of your medical device starts with getting the Biocoat team engaged early in the development process. Key achievements are listed in the Roadmap.
Process validation for medical device coatings - Once a manufacturing process is designed and built, it must be validated in order to meet good manufacturing process (GMP) standards. Biocoat has access to experts in the area of process validation and can help you along your pathway towards commercialisation of a coated product.
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