Medical & Disposable
Device Injection Molding

It’s important to partner with a trusted medical device injection molding provider who has extensive experience in medical and surgical device injection molding. Empire Precision works as  surgical device and single use plastic medical product manufacturer to bring customers all around the globe high-quality drug-device injection molding. As an established top vendor for bioabsorbable materials, we strive to redefine and develop a process that ensures the durability, sustainability, and safety of every product we design.

Our surgical and disposable injection molding manufacturing experts not only deliver exceptional products but also offer clear feedback and consultative design services before the disposable device injection molding process beings. In each phase of our validation molding process, all details even the smallest are documented to obtain exceptional quality products and the ability to replicate accurately with every mold.

Drug Device Injection Mold Performance

Once everything is documented and tested, the surgical device injection molding is placed in the performance qualifications (PQ) phase. Our operators run the test on the medical device injection mold to verify it collaborates with the OQ range and meets all customer requirements. The phase also includes:

  • Recording parameters
  • Ensure accurate measurements for dimensional requirements
  • Durability and strength under various conditions
  • Approval of all devices that meet customer standards


Medical device injection molding requires the right materials for the devices to function properly. At Empire Precisions, we use a validation checklist for medical device injection molding, more than 200 checkboxes. Our team is equipped with the latest state-of-the-art technology to ensure the process delivers your desired results. Contact us today to speak with one of our operators who will assist you with your drug-device injection mold.

The Steps of Validation Injection Molding Process

Before the validation injection molding process begins, Empire Precision experts begin with the design qualification (DQ) and customer collaboration. Communication is vital to making an exceptional drug-device injection mold. Our operators collaborate with you to ensure all required standards meet your requirements and expectations. In this phase, our operator’s review:

  • Tight tolerance
  • Non-uniform wall thickness
  • Heavy wall thickness
  • Overall mold design

Establishing the Most Effective Process

Validation injection molding begins with the qualification (IQ) phase. During this phase, our team focuses on the equipment and systems necessary for the production of a product. During IQ, our techs carefully monitor the assembly of the product according to OEM’s instructions, and all the required equipment is calibrated appropriately.  Lastly, a thorough check of the environmental conditions is suitable and all equipment documentation is compiled correctly.

Test, Test, and Test Again in OQ

After the IQ confirms that the equipment is correctly installed and meets all the requirements, the process moves to the operational qualifications phase (OQ). The OQ phase is the most important part of the process because it ensures the equipment is capable of maintaining performance over a specified range. Our operators perform test runs by recording the machine’s operating settings when adjusting controls, including pressure, temperature, speed, and more. Other data parameters that are collected include:

  • Mold cavity balance
  • Rheology curve
  • Gate seal
  • Cooling time optimization
  • Packing pressure latitude study