Medical Device Qualified Supplier Directory
Borla Inc. Company Profile
Qualifications: ISO 13485, ISO 9001, FDA Registered, CGMP Certified, Supplier to Medical Manufacturers, Exhibitor in at least 2 MD&M and/or MEDTEC shows
Borla is the world leader in the design and manufacture of medical components and assemblies, with more than 40 years in business. ISO 9001 Certified, with facilities totaling 550,000 square feet, with 180,000 square feet of clean rooms Borla is vertically integrated from development and design through manufacturing.
Borla manufactures a wide variety of medical components at unsurpassed quality and unbeatable pricing.
- Air Vents
- IV Spikes and Drip Chambers (Gamma/Non DEHP)
- Blood Filter Assemblies
- Male Luer Connectors
- Y-Site – Injection Sites – Connectors
- Pinch Clamps – Roller Clamps – Slide Clamps
- Hemodialysis Components
- Female Luer Locks – Caps
- Burette Chamber Components
- Needlefree Systems
- Check Valves
- IV Filters
- Enteral Connectors – Dispensing Devices
Research & Development
- Cutting-edge technology
- Investment and implementation of projects with high scientific and technological content
- Development of advanced prototypes for custom solutions as well as standard production
- In-house high-standard mold design and production
- Rapid tooling and rapid prototyping systems for component and mold prototyping.
- New components research and testing in a dedicated clean room
Design & Molding
- Transition from mold prototyping to high volume production executed through the stages of mold sampling, mold flow and structural analysis.
- Extreme precision delivered at each stage of mold manufacturing through limited and high-cavitation mold design and construction
- Mold fabrication utilizes technologies that ensure compliance with total Quality
- Molding is executed in three clean rooms
- 100 fully automated high-tonnage injection molding presses are electronically controlled and continuously monitored for compliance with fixed parameters
- Continuous supervision of production systems in order to maintain uniformity of features compared with reference parameters
- Total output capacity exceeds 10 billion components per year
- Four clean rooms designed for specific product manufacturing maximize precision production processes
- 80 high-speed assembly machines operate simultaneously
- A direct connection between molding and assembly department achieves a collaborative and continuous flow of material
- Dedicated robotic workstations provide complete automation of production units
- Production monitoring systems provide real-time status of machinery and production lines
Packaging & Logistics
- Product packaging is performed in a controlled environment
- Dedicated handling and warehousing
- Completely automated warehouse optimized for "just in time” situations
A division of Borla, Yukon Medical is an ISO 13485 certified and leading developer of innovative pharmaceutical preparation and delivery devices, with a focus on reconstitution at the point of care and injectable drug delivery.
Yukon Medical designs innovative products that simplify drug reconstitution and medication delivery, increase caregiver safety, and address complex challenges using novel approaches. These include our ViaLok Non-Vented Vial Access devices, ViaLok Vented Vial Access devices, Arisure™ Closed Medication System, and our Advanced Reconstitution Systems. Additional products currently in development will expand our future offerings.
All Yukon Medical products are distinguished by the following features:
- Simple, easy-to-use designs
- Needle-free reconstitution
- Compatible with standard drug vials to avoid risk of failed stability studies
- High transfer rates and closed containment
- Optimized systems to minimize drug waste
- DEHP-free and latex-free
- Compliance with USP <797> and ASHP guidelines for reducing risks associated with compounded sterile preparations.
Yukon Medical possesses extensive experience in designing and commercializing novel pharmaceutical devices. If you require devices customized for specific delivery volumes, delivery methods or vial sizes, we will gladly accommodate your specifications. We will also work with our customers’ internal resources to provide any documentation and/or test data required for regulatory submissions.
For more information contact Borla Inc.
Brea, CA United States
2650 E. Imperial Hwy., Ste. #201