What are the details of the processing technology for medical silicone products? 润色译文 笔记

Raw material preparation

The main raw materials for medical silicone products include silicone rubber and vulcanizing agents, which are the basis and key to making silicone. As the main material, silicone rubber needs to have high purity and low impurities to ensure the biocompatibility and stability of the final product. Vulcanizing agents are important substances that promote the vulcanization reaction of silicone rubber, and their types and amounts directly affect the physical and chemical properties of the product. In addition, it is necessary to add appropriate amounts of additives and fillers, such as plasticizers, reinforcing agents, coloring agents, etc., to improve the processing performance, mechanical strength, and reduce costs of silicone gel.
In the stage of raw material preparation, it is necessary to strictly control the quality of raw materials, conduct detailed quality inspection and control, including appearance inspection, performance testing, and batch management, to ensure that all raw materials meet medical grade standards. At the same time, the storage environment for raw materials is also crucial, avoiding issues such as moisture, pollution, and expiration to ensure that the raw materials are used in their optimal condition.

blend

Mixing is the process of uniformly mixing silicone rubber, vulcanizing agents, additives, and fillers in a certain proportion. At this stage, it is necessary to strictly control the mixing temperature and time to prevent excessive temperature from causing premature sulfurization of raw materials or insufficient temperature from causing uneven mixing. During the mixing process, attention should also be paid to the stirring speed and direction to ensure that all materials are thoroughly mixed and to avoid the formation of bubbles and impurities. The mixed material should present a smooth, delicate, and uniformly colored appearance.
vulcanization
Sulfurization is a crucial step in the processing of medical silicone products. Put the mixed materials into a vulcanizing machine and carry out vulcanization reaction at a certain temperature and pressure. The vulcanization temperature and time need to be precisely adjusted according to the specific material formula and type of vulcanizing agent to ensure that the vulcanization reaction proceeds fully and not excessively. During the vulcanization process, it is also necessary to closely monitor the operating status and vulcanization effect of the vulcanizing machine, adjust process parameters in a timely manner, and avoid performance problems caused by insufficient or excessive vulcanization.

forming

After vulcanization is completed, the vulcanized silicone needs to be subjected to molding treatment. There are various molding methods, including compression molding, injection molding, extrusion molding, etc. The specific method needs to be selected according to the shape and size of the product. Compression molding is suitable for products with complex shapes and precise size requirements; Injection molding can produce products with high flexibility and precision; Extrusion molding is suitable for producing long or tubular products. During the molding process, temperature and pressure must be strictly controlled to ensure that the product’s dimensional accuracy and appearance quality meet the requirements.

Post processing

After molding, silicone products need to undergo post-processing, including trimming, polishing, cleaning, and other steps. Trimming mainly involves removing excess scraps and burrs; Polishing is to make the surface of the product smoother and more delicate; Cleaning is the process of removing stains and impurities from the surface of a product. During the post-processing process, attention should be paid to operational skills and safety to avoid damage or contamination to the product. At the same time, strict quality inspection of products is required to ensure that all products meet medical grade standards.

quality testing

Quality inspection is an important step in the processing of medical silicone products. The inspection covers multiple aspects such as appearance quality, dimensional accuracy, physical properties, chemical properties, etc. The appearance quality needs to be checked whether the surface of the product is smooth and flawless, and whether the color is uniform; The dimensional accuracy needs to be checked through precision measuring tools; Testing of physical properties including hardness, tensile strength, tear strength, and other indicators; Chemical performance requires testing of key indicators such as biocompatibility and toxicity of the product. Only products that have undergone strict quality inspection and meet standard requirements can be used in the medical field.
Packaging and Storage

After completing the quality inspection, medical silicone products need to be packaged and stored. The packaging materials must meet the requirements of the medical field, have good sealing and hygiene to ensure that the products are not contaminated during storage and transportation. The storage environment should be kept dry, ventilated, away from light, and at low temperatures to avoid damage to the product caused by high temperatures, humidity, and pollution. At the same time, it is necessary to establish a sound inventory management system, regularly inspect and maintain inventory products, and ensure product quality and supply stability.
In summary, the processing technology of medical silicone products involves multiple links and details, and each link requires strict control of quality and technical parameters. Only through precise processing techniques and strict quality management can high-quality silicone products that meet medical grade standards be produced,