Custom Silicone CPAP Nasal Mask Mold Injection

Custom silicone CPAP nasal mask mold injection molding is a specialized manufacturing process designed to produce high-quality, comfortable, and biocompatible nasal masks for sleep apnea therapy. These masks must provide a secure yet gentle seal to ensure effective airflow while maximizing patient comfort.

Material Selection

Liquid Silicone Rubber (LSR) is the ideal material for CPAP nasal masks due to its flexibility, softness, and durability. LSR is medical-grade, hypoallergenic, and resistant to bacteria, making it suitable for prolonged skin contact. Additionally, it maintains elasticity over time and can withstand frequent cleaning and sterilization.

Mold Design and Tooling

Designing a mold for a custom CPAP nasal mask requires precision engineering. The process starts with 3D CAD modeling to ensure the mask conforms to various facial structures. The mold is then manufactured using high-precision CNC machining or EDM (Electrical Discharge Machining) to create smooth, detailed cavities. Venting and gating systems are carefully designed to allow uniform material flow, preventing defects such as air pockets or warping.

Injection Molding Process

The silicone injection molding process for CPAP nasal masks involves several key steps:

1. Material Preparation: We get the medical grade liquid silicone rubber from supplier in 40kgs or 400kgs.

2. Injection & Molding: The liquid silicone is injected into the preheated mold cavity under controlled pressure and temperature.

3. Curing & Solidification: The silicone cures rapidly in the heated mold, taking on the precise shape of the nasal mask.

4. Demolding & Trimming: The formed mask is removing from the mold, and excess material (flash) is trimming.

5. Post-Processing & Quality Control: Masks undergo sterilization, surface finishing, and rigorous quality checks for fit, flexibility, and air leakage.

Customization & Design Features

Key features include:

• Custom Fit: 3D scanning and modeling enable personalized designs for a better seal.

• Adjustable Cushioning: Varying silicone thickness enhances comfort and minimizes pressure points.

• Integrated Exhalation Ports: Allows efficient CO₂ release to enhance breathing comfort.

• Ergonomic Shape: Optimized for minimal skin contact to reduce irritation.

Regulatory Compliance & Quality Assurance

CPAP nasal masks must meet strict medical standards such as:

• FDA (Food and Drug Administration) Approval for biocompatibility.

• ISO 10993 Compliance for skin safety and toxicity.

• Leak & Durability Testing to ensure long-term performance and reliability