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

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

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

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

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