Pittsboro, NC (Manufacturing)
About 30 miles west from our headquarters is one of our manufacturing facilities located in Pittsboro, NC. This positioning allows our engineering teams to remain involved in the manufacturing transfer process as needed, ensuring product designs are correctly and efficiently transferred from design into manufacturing. Gilero’s medical device manufacturing services integrate years of design, engineering, and manufacturing expertise. With a proven capacity to innovate, scale and commercialize, our domestic and international facilities are equipped to develop unique manufacturing solutions and accelerate device commercialization timelines. Gilero is FDA registered, ISO 13485 certified and compliant with cGMPs.
Our manufacturing services through this location:
Design Transfer
- In- house design transfer team
Complex Assembly
- Manual, semi-automated, and fully automated assembly
- Solvent bonding and complex adhesive bonding
- Ultrasonic welding and ultrasonic and heat staking
- Gluing and curing
- Cannula bonding
- Plasma treating
- Ultrasonic wash, drying, and depyrogenation
- Electrostatic discharge (ESD) controlled assembly
- Catheter tip forming and skiving
- Propellant can filling
- Cold chain storage and monitoring
Packaging
- Packaging design and development
- Label design and printing
- Sterile and non-sterile packaging
- Sterilization management
- Drug handling, labeling, and kitting
- Drug-device combination product packaging
- Combination product convenience kitting
- Dedicated form, fill, and seal packaging lines
- Vertical fill and seal
- Pouch sealing
- Tray sealing and semi-rigid tray forming
- Vacuum or nitrogen purged sealing
- In-house package testing (dye penetration, bubble emission, burst, creep, thermal conditioning, ship testing, etc.)
- Cold chain storage and monitoring