Contract Manufacturing

Gilero’s manufacturing expertise ranges from single-use medical devices to complex electromechanical systems.  We focus exclusively on the medical device and drug delivery/combination product markets. 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 cGMP.

Manufacturing Services

Plastic Injection Molding

  • In-house injection mold tool building
  • ISO certified cleanroom injection molding
  • Injection molding machines ranging from 30-Ton to 250-Ton
  • Single cavity, pre-production injection molds
  • High cavitation, engineered hot runner, insert and two-shot mold systems
  • First article inspection and capability analysis
  • Scientific molding process development
  • Process validations and real-time process monitoring

Complex Assembly

  • Manual assembly to high-speed robotics and automation
  • White space & 14 certified cleanrooms
  • Laminar Flow Hood assembly
  • Electromechanical medical device assembly
  • Silicone bonding equipment
  • Heat staking, ultrasonic welding and cleaning, gluing and curing
  • Assembly testing

Packaging

  • Primary packaging design & development
  • Secondary packaging design
  • Sterile and non-sterile packaging
  • Dedicated form, fill, seal and packaging lines
  • Semi-automated thermoforming and sealing equipment
  • Validated heat sealers, impulse bar sealers and continuous rotary sealer
  • Vision inspection equipment
  • In-house package testing

Kitting

  • Combination product convenience kitting
  • Kitting in packages or trays
  • Customized thermoformed trays
  • Ability to handle drugs in primary containers
  • Cold chain storage

Global Manufacturing Footprint

Pittsboro, NC, USA

40,000 square feet
9 certified cleanrooms (9,000+ square feet)
4,000+ square feet of white space assembly
Assembly, kitting & packaging
Manual to fully automated production lines
Clinical to high volume production

Morrisville, NC, USA

15,000 square feet
1,500+ square feet of certified cleanroom space
DV&V, pilot and clinical builds
Process development
Co-located with Design Center

Shenzhen, China

36,000 square feet
In-house mold tool making
Cleanroom injection molding
Gas-assist molding, two-shot, insert & overmolding
Manual to fully automated assembly production lines
High precision machining of tooling components
Rapid tool iterations and modifications

Ready to get your device in the market?