Medical-grade TPE Soft Rubber Molding Tool - Fanstar Empowers Medical Injection Molding

In the field of high-end medical devices and health care equipment, the medical-grade TPE soft rubber molding molds not only need to ensure a firm bond between the soft and hard rubber, but also must meet strict standards such as biocompatibility, no cytotoxicity, and sterilizability. As a manufacturer specializing in export-grade precision molds, Fanstar strictly follows the ISO 13485 quality system and has successfully delivered multiple sets of medical-grade TPE soft rubber molding molds for products such as handheld diagnostic instrument handles, infusion interface seals, and respiratory mask cushion pads. These molds support high-reliability secondary injection molding with PP, PC, or ABS and medical TPE (such as SEBS base).

The manufacturing challenges of the medical-grade TPE soft rubber molding tool include: the low viscosity of the TPE material, which makes it prone to overflow, and the strict prohibition of the use of release agents. The requirements for the sealing accuracy and surface treatment of the mold are extremely high. Fanstar uses S136 or 420 stainless steel mirror finish steel. The key sealing areas are polished to Ra ≤ 0.2 μm, and through five-axis precision processing, the sealing gap is ensured to be ≤ 0.02mm. The mold integrates an independent temperature-controlled hot runner system, precisely controlling the TPE melt temperature (±2℃) to avoid material degradation; at the same time, the depth and position of the exhaust groove are optimized to eliminate bubbles and scorching. All molds are assembled and tested in a cleanroom with a cleanliness level of 10,000 or higher, and support EO or gamma ray sterilization verification.

In addition to the medical-grade TPE soft rubber molding molds, Fanstar also has rich experience in areas such as 64-hole high-gloss molds for pens, PEEK molds for aviation interior components, and complex structure molds for mechanical and electrical enclosures. They offer a one-stop service ranging from material compatibility assessment, Moldflow dual-color simulation to compliance pilot production.

Choosing Fanstar means choosing a medical-grade TPE soft rubber molding tooling technology partner who truly understands medical regulations and dual-color processes. With our clean manufacturing and engineering precision, we create a safe, comfortable and reliable touch experience for global medical customers. Welcome to contact us and embark on a high-quality medical injection molding cooperation together!