Medical Device Injection Molds and Cleanroom Manufacturing

Our 75,000 sq. ft. (7,000 sq. meter) manufacturing complex in China houses a 32,000 sq. ft. (3,000 sq. meter) class 100,000 clean room assembly facility. This highly sophisticated facility is available for the contract manufacturing and assembly of medical devices. Products are manufactured and assembled by highly skilled and disciplined workers using techniques such as adhesive bonding, and radio frequency welding, ultrasound welding, etc.

To save costs for the customer in the long run, Globe can customize sections of the clean-room facility in a semi-automation or full automation setup. Another advantage of our facility is that your company can eliminate the need for a registration with China MOH and the local government to establish a new manufacturing facility for your organization. 

Globe has partnered and invested with several medical device contract manufacturing facilities in China since 1992. Our two major partnership facilities are located in Shandong Province and Shenzhen city. Each facility is in a clean room environment and contains a parts injection machine shop, a tubing extrusion shop, a sterilization shop, and assembly lines.

All these manufacturing facilities are ISO 13485 certified. Globe develops a quality assurance program for every product by validating the quality, manufacturing, and in-house ETO Gas sterilization.  We also provide solutions for Gamma-ray sterilization in the US or China.  In addition, we identify material stable for either Eto gas sterilization or Gamma-ray sterilization.

Advantages:

  1. Integrated parts and product design, molds design, and injection machine process (cycle time) evaluation.
  2. Cost effective materials selection during the design phase per FDA and ISO guidelines.
  3. Integrated Turnkey service provides “design for manufacturability" (DFM) – this means the parts design and molds design are optimum for achieving the best per–unit cost.
  4. Provide Injection Molds Flow Computer Simulation to obtain optimum runner size, cavity fill time, and gate location.
  5. High demanding tolerances with an advanced CNC machine through an experienced engineering team. This process is especially critical for sophisticated design parts.
  6. High volume molds: multi-cavity hot runner molds and stack molds.
  7. Over-molding injection machine to save assembly costs.
  8. Low cost, one cavity sample injection molds to make an assembled, functional samples.
  9. Quick turnaround time for Injection Molds:
  • Sample Injection Molds: 15 days (compared to 30 days or more from competitors)
  • Production Injection Molds: 45 days (compared to 3 months from competitors)
  • CNC MachinedPrototypes: 1 week

 Plastic Parts Manufacturability Analysis:

Part Analysis: We help identify problems early on, so that design changes can be completed early with minimal cost variance, while the flexibility to establish the best solution is at its highest.

Injection Mold Flow Analysis: At this stage, Globe's troubleshoot techniques help determine the optimal gate size and location, help balance the hot and cold runner designs, help ensure that the runner system is designed to fill all cavities at the same time, help minimize stress levels, and help identify warpage potential.

Injection Mold Cooling Analysis: When used in conjunction with mold flow analysis, this process helps to provide the cooling effects on flow, thus, minimizing cycle time, reducing warpage, and help determining uniform part cooling. 

 

Advantages of Integrating Parts Design and Molds Design

  1. High quality US FDA medical grade plastic component manufacturing and assembly.
  2. Reduces trial and error in the design phase.
  3. Better injection mold design, consistent quality, and shorter production cycles.
  4. Increased materials savings by reducing scrap rates and optimizing materials usage.
  5. Reduced product and process development times.
  6. Consistent part quality and structural performance.
  7. Greatly enhanced manufacturing efficiency through continuious manufacturing process analysis.
  8. Efficient production controls and detailed training programs ensure consistant final product assembly.

 

Computer Simulation with Mold Flow:

IV Administration Set - Spike Injection Mold Cavity Fill Simulation

 

Multiple Cavities Injection Mold Fill Runner Simulation

 

Roller Clamp Injection Mold Single Cavity Fill Simulation

     
 

 

Inside Class 100,000 Clean Room

 

Class 100,000 Clean Room

 

Injection Molding Machines Inside Clean Room

Tube Extrusion Machine inside Clean Room    

 

Injection Machine Inside Clean Room

 

Quality Control Laboratory  

 

 

All of our quality control inspections and testing are done by fully trained and qualified technicians. Our tests include physical, chemical, & biological testing procedures that adhere to FDA's Quality System Regulation.   

 

Machineries

Injection Molding Factory

Injection Molding Factory Building

 

Road Sign & Directions

 

CNC Machinery

 

 

Injection Molding Machinery (inside clean room)

Injection Machine

 

Extrusion Machine

 

 Injection Mold Technology

 Specialty one cavity sample molds and multi-cavity hot runner molds

 

   

 

 

 Over Molding

Over Molding Injection Machine

 

Over Molding Product