China Xiamen Juguangli Import & Export Co., Ltd Company News

Screen printing belongs to stencil printing, which is known as one of the four major printing methods along with flat printing, embossed printing, and gravure printing. Perforated printing includes transfer plates, hollow pattern plates, spray printing, and screen printing. The principle of stencil printing is that during printing, the ink is transferred to the substrate (such as paper, ceramics, etc.) through the holes in the stencil (made on the substrate of a paper film or other plate) under a certain pressure, forming an image or text. Transliteration printing, the simplest form of stencil printing, began in the late 19th century. This type of printing is made on specially made wax paper using a typewriter or iron pen to create wax paper graphic plates. Ink rollers are used to print on the wax paper plates, resulting in ideal printing effects on the substrate. The most widely used method in stencil printing is screen printing. Screen printing is also the most common surface character process in our silicone products, among which silicone buttons and silicone toys use this process more widely. According to the character design, adjust the oil difference color, and then use the positioning fixture and screen to print the required characters. The silk screen part of silicone products may have a convex feeling when touched by hand, and it needs to be carefully understood. Silk screen is a very important process in the silicone product industry. During the operation, it is necessary to pay attention to whether the surface of the silicone product is clean, the baking temperature and time after silk screen printing, and especially not to use low-quality silk screen ink or other materials to replace silk screen ink in order to save costs. This will lead to the occurrence of batch defects. Strong printing adaptability, thick ink layer, strong three-dimensional sense, rich texture, strong light resistance, bright color, printing area, can be summarized as follows:1. Screen printing can use various types of ink. Namely: oil-based, water-based, synthetic resin emulsion type, powder and other types of inks.2. The layout is soft. The screen printing layout is soft and has a certain degree of elasticity, which is not only suitable for printing on soft items such as paper and fabric, but also suitable for printing on hard items such as glass, ceramics, etc.3. Screen printing has low embossing force. Due to the low pressure used during printing, it is also suitable for printing on fragile objects.4. The ink layer is thick and has strong coverage.5. Not limited by the surface shape and area size of the substrate. As mentioned above, screen printing can not only print on flat surfaces, but also on curved or spherical surfaces; It is not only suitable for printing on small objects, but also for printing on larger objects. This printing method has great flexibility and wide applicability.

Silicone suction cup is a common type of suction cup, which has high reliability and good durability. They are widely used in various fields such as medical devices, machinery manufacturing, and household appliances. Today, we will learn about the application areas of silicone suction cups. In the field of household appliancesThe home appliance industry is another application area of silicone suction cups. In smart home systems, silicone suction cups can be used for the manufacturing of robot cleaners, smartwatches, smartphones, game consoles, and various other consumer electronics products. In addition, silicone suction cups can also be used on auxiliary tools such as vacuum cleaners and cleaning equipment in home cleaners.Mechanical manufacturing fieldSilicone suction cups are also widely used in the mechanical manufacturing industry. The automotive industry is a good example, where silicone suction cups can be used to secure glass, metal, and plastic components. In addition, it can also be used on automated production lines, such as electronic production lines, pharmaceutical packaging production lines, and so on. Silicone suction cups can better grip product components without causing damage or loss, greatly improving the efficiency of automated production lines.Medical device fieldSilicone suction cups are widely used in the medical device industry, especially as auxiliary instruments in surgery. Silicone suction cups can help doctors better grasp surgical tools, thereby improving surgical accuracy and safety. In addition, silicone suction cups can also be used during tracheal intubation and gastric intubation to improve intubation accuracy and bring less pain to patients.SummaryAs mentioned above, silicone suction cups have a wide range of applications in many fields, from medical devices to mechanical manufacturing and household appliances. The high-quality characteristics of silicone suction cups bring efficiency and reliability to the production and operation of enterprises.

Service Life of Silicone Products (General Industry Reference)The service life of silicone products mainly depends on five factors: raw material grade, curing system, temperature, ultraviolet radiation, chemical media, and repeated compression & friction. The longest service life is achieved under static, room-temperature and light-shielded conditions.I. Reference by Application Scenarios1. Industrial static gaskets / O-rings (indoor room temperature, minimal disassembly, high-quality fumed silica silicone)Performance retention period: 8～12 years; General compound silicone: 3～5 years.2. Industrial dynamic parts, automotive silicone buttons, sealing gaskets (intermittent high temperature + repeated compression)Design service life: 3～6 years. Continuous working temperature above 120℃ shortens the lifespan to 1～3 years.3. Outdoor weather-resistant silicone (with UV-resistant formula)Under sunlight and ozone exposure: 3～8 years. Ordinary transparent silicone tends to turn yellow outdoors, with obvious aging within 1～2 years.4. Food-grade silicone kitchenware, baking trays, silicone molds (repeated high-temperature steaming/baking & cleaning)Material performance can be maintained for 5～8 years; Replacement is recommended after 2～5 years for hygiene safety. Baby silicone products are suggested to be replaced every 1～3 years.5. Electronic silicone keypads (indoor room temperature pressing)High-quality platinum-cured silicone: up to millions of keystrokes, 3～8 years. Ordinary peroxide-cured silicone has a shorter service life and is prone to yellowing and tackiness.II. Shelf Life (Unused products, stored at room temperature, dry and away from light)Qualified finished silicone: over 10 years. Premium formulations can even reach 20 years with slow elasticity degradation.III. Signs of Aging (Replace immediately if any occurs, regardless of service time)- Hardening, loss of elasticity, no rebound after compression- Surface cracking, fine crazing, chalking, tackiness or oil bleeding- Strong odor, easy to tearIV. Key Factors Affecting Service Life- Temperature: Thermal oxidative aging is the primary cause. Aging accelerates sharply at higher temperatures. Rule of thumb: service life roughly halves for every 10℃ temperature rise.- UV Radiation: Direct sunlight speeds up yellowing and surface cracking. Black silicone has better UV resistance than transparent or colored silicone.- Chemical Media: Engine oil, solvents, strong acids and alkalis accelerate swelling and degradation.- Mechanical Fatigue: Continuous repeated compression, bending and friction shorten service life. Static gaskets last much longer than dynamically moving parts.V. Tips to Extend Service Life- Avoid long-term direct sunlight and prolonged exposure to temperatures over 200℃- Clean with neutral detergents; avoid strong solvents- Prevent scratches from sharp objects; store in cool, dry and dark places when not in use

How to ensure details in customized silicone parts? Silicone parts are quietly integrated into daily scenarios such as medical devices, household small items, electronic devices, etc. due to their flexible touch, temperature resistance, and chemical stability. When standard components are difficult to fit unique structures or functions, customization becomes a natural choice. However, from a requirement description to the final product in hand, material selection, process refinement, and detail confirmation are interrelated. A slight negligence may affect the fit and service life of the parts. The starting point of customization is to clearly 'translate' the requirements into technical language. When communicating with suppliers, it is necessary to clarify the usage environment: whether it comes into contact with humans or food? How much pressure can you bear? What is the working temperature range? For example, baking molds need to withstand high temperatures of 230 ℃, while therapy equipment handles focus on softness and slip resistance. Attaching a diagram or physical reference can significantly reduce misunderstandings and pave the way for subsequent steps.Material selection is like "qualitative" analysis of a component. Silicone hardness is indicated by Shore A, and can be adjusted as needed, ranging from jelly like softness to slightly elastic solidity. Colors are not limited to basic colors, but can also be customized with textures such as matte and semi transparent. If there are special requirements involved, such as medical grade biocompatibility or food contact certification, they must be explained in advance. The supplier will provide samples of the corresponding materials for touch and confirmation, and it is safe to see them by hand.Design and molds are the soul of customization. Engineers will optimize the details of the drawings: adjust the demolding angle, ensure uniform wall thickness, and avoid shrinkage or burrs during production. The precision of the mold directly determines whether the contour of the part is smooth. The samples produced during the trial stage need to be personally inspected to ensure their size is accurate? Is the edge rounded? Is the assembly smooth? The patient confirmation in this step can effectively avoid regrets after mass production.The production process emphasizes the importance of heat and moderation. Liquid silicone injection is suitable for precision small parts, while solid-state molding is used for slightly larger structural parts. Temperature, pressure, and vulcanization time need to be strictly controlled. Quality control runs through the entire process: randomly check the size, carefully inspect the surface for bubbles, impurities, or color differences. The finished product is individually packaged after gentle cleaning, especially in areas with high cleanliness requirements, where every step shows respect for details.Occasional minor situations can also serve as opportunities for communication. If the edges of the sample are slightly rough, it may be due to mold trimming or fine-tuning of process parameters; Color deviation requires checking the color card and sampling records. Honest communication and joint analysis often lead to quick solutions. Choosing a partner who is patient in communication and has solid experience will make the customization process smoother and more secure.

As is well known, silicone has become the preferred material in fields such as kitchen and home furnishings, electronic appliances, and automotive vehicles due to its excellent properties of high temperature resistance, low temperature resistance, and chemical stability. Its key is its high temperature resistance performance. The high temperature resistance of silicone comes from its unique molecular structure of polydimethylsiloxane. The Si-O-Si bond energy of the main chain is much higher than that of the C-C bond of ordinary rubber, and its thermal stability is extremely strong. Secondly, the molecular chain has flexibility and forms a protective effect by connecting with organic side groups, making it difficult to decompose and deform in high temperature environments, and able to maintain good elasticity for a long time.From the perspective of temperature resistance, silicone can be divided into multiple grades. Conventional silicone can be used for a long time at temperatures ranging from -60 ° C to 200 ° C, and can withstand high temperatures of up to 250 ° C in the short term. Modified high-temperature silicone can meet the needs of general scenarios such as kitchen utensils and ordinary seals. Its long-term temperature resistance can be increased to 200 ° C to 250 ° C, and it can reach 300 ° C in the short term. It is suitable for industrial scenarios such as automotive engines and high-temperature steam equipment. Special high-temperature silicone can be modified with benzene, fluorosilicone, or filled with ceramics. Its long-term temperature resistance can reach 250 ° C to 300 ° C, and its short-term peak can even exceed 350 ° C. It can cope with extreme high-temperature conditions such as aerospace and firefighting equipment. In addition, the actual temperature resistance of silicone is also affected by the purity of raw materials, production process, and usage environment. It is worth mentioning that high-quality silicone can be further improved in temperature stability through secondary vulcanization process, reducing deformation and odor problems at high temperatures.

Staining is a common problem with silicone products, and we often encounter situations where the surface of silicone products is very dusty. So, how should we deal with this situation? The phenomenon of sticking to dust and debris is due to the inherent chemical properties of silica, and the phenomenon of adsorption force is an inevitable factor in raw materials. Therefore, for silicone products used in daily life and placed in textiles, plush, etc., adhesion will definitely occur. However, for such phenomena, they need to be processed and solved by silicone product manufacturers. It should be noted that adsorption force is the main reason for the accumulation of dust powder in silicone products. Therefore, the additives in organic silicon and inorganic silicon are different in the raw materials. Different adsorption methods can reduce the silicon chain structure units in silicone materials. Adding a large amount of water during raw material mixing can destroy the adsorption strength of silicon hydroxyl groups and reduce the active proportion in silicone adsorption. After molding, silicone products belong to the untreated process, so the surface will have the ability to automatically adsorb dust. However, static electricity can be covered by electrostatic oil surface spraying to prevent adsorption ability. There are two methods of treatment. Before processing and production by silicone product manufacturers, anti-static glue is used to control the adsorption energy and anodization of silicone in the raw materials. Another method is to spray oil on the generated silicone product surface to achieve a smooth and anti-static effect.

What are the coloring methods for silicone products? Silicone products are widely used in various fields such as kitchenware, toys, medical supplies, etc. due to their softness, high temperature resistance, non-toxic and odorless characteristics. In order to meet diverse market demands, the coloring process of silicone products is particularly important. 1, Solution coloring methodSolution coloring is an early coloring method used for silicone products. The basic principle is to dissolve silicone rubber in a good solvent to form a solution of a certain concentration, then add coloring agents and rubber compounding agents other than sulfur, and mix the components evenly by stirring. After drying and removing the solvent at a specific temperature, sulfur is added to the rubber mixing machine to complete the vulcanization process.However, this method has significant drawbacks: the operation process is complex and requires high control of parameters such as temperature and stirring speed; The uneven dispersion of colorants and complexing agents in solution can easily lead to color differences in the finished product; Solvent recovery is difficult and may cause environmental pollution. Therefore, with the emergence of more efficient and environmentally friendly coloring methods, solution coloring has gradually been eliminated from the market.2, Mixing method coloringMixing method coloring is currently the most commonly used method for coloring silicone products. Its core is to directly add the coloring agent or mix it with the carrier first, and then add it to the rubber material. Through a rubber mixing machine, it is thoroughly mixed to make the silicone rubber uniformly colored. According to the different forms of coloring agents, mixing coloring can be further divided into the following categories:1. Dry powder coloring methodThe dry powder coloring method is to add powdered coloring agents and small materials to silica gel and mix them on an open mill. This method is easy to operate and has a lower cost, but it has obvious shortcomings: dust flies during the mixing process, polluting the environment; Colorants are not easily dispersed evenly, which can lead to color differences in the finished product; If the coloring agent particles are too hard or coarse, it may also cause quality problems such as color spots, stripes, or chromatographic contamination. Therefore, the dry powder coloring method is currently less commonly used and is more commonly used as an auxiliary means or emergency plan in specific scenarios.2. Color paste coloring methodThe color paste coloring method is to mix coloring agents with liquid additives (such as plasticizers), grind them into a paste or slurry through a three roll machine, and then add them to silicone rubber in a certain proportion for mixing. This method can effectively prevent dust from flying and facilitate the uniform dispersion of colorants in rubber, resulting in bright and uniform colors in the finished product. However, the content of colorants in the color paste is relatively low, resulting in low coloring strength; Meanwhile, the transportation volume and loss of colorants are large, making it inconvenient for users to use. Therefore, the pigment coloring method is more suitable for scenes that require high color uniformity but not strict requirements for coloring intensity.3. Particle coloring methodThe granular coloring method is currently the most promising coloring method for silicone products. The preparation process mainly includes two types: one is to soak the powdered coloring agent with a surfactant, and then melt it with wax or melt it with resin to extrude and granulate it; The second method is to immerse the coloring agent in a surfactant, refine the particles through mechanical force, and make a dispersion of a certain concentration. Then, it is mixed with latex and co precipitated, dried, and rolled into granules. Granular coloring agents are easy to use, have good dispersibility, no dust flying, and do not pollute the environment; Bright color, uniform hair color, and no color difference. Although the preparation process of granular colorants is complex and costly, with the continuous advancement of technology and the gradual reduction of costs, their application prospects will become increasingly broad.4. Coloring method for masterbatchThe masterbatch coloring method is to mix coloring agents, some plasticizers, and other silicone rubber compounding agents with raw rubber through an open mill to produce a coloring agent rubber compound with a concentration of about 50%, and then add it to the silicone rubber in proportion for coloring. This method has a good coloring effect on dyes with small particles and difficult dispersion, with uniform coloring and no color difference. However, the preparation process of masterbatch is relatively complex and requires additional storage and transportation costs, so it is more commonly used in high-end products that require extremely high color consistency.3, Surface coloring methodSurface coloring method is to spray coloring agents onto the surface of silicone products to color them. This method has a certain effect on static products, such as silicone phone cases, silicone toys, etc. However, for dynamic products such as silicone seals, silicone tubes, etc., surface coloring agents are prone to peeling and fading, which affects the effectiveness and aesthetics of use. Therefore, surface coloring methods are more commonly used as auxiliary means or decorative treatments in specific scenes.4, Other innovative coloring methodsWith the advancement of technology and changes in market demand, the coloring methods of silicone products are constantly innovating. For example, some companies have begun to try using materials such as oil-based pens, acrylic pigments, AB glue, etc. to locally color or refine silicone products. Although these methods are flexible and colorful, they are more commonly used in personalized customization or artistic creation, making it difficult to achieve large-scale industrial production. There are various coloring methods for silicone products, each with its unique advantages, disadvantages, and scope of application. When choosing a coloring method, companies need to consider multiple factors such as product requirements, production costs, and environmental requirements.

Many consumers easily confuse silicone products with ordinary plastic products when purchasing daily necessities, thinking that the two are just different in softness and hardness. They spend a high price to buy products labeled as "silicone", but in reality, after using them for a short time, they experience problems such as releasing odors and severe deformation at high temperatures. They even buy inferior plastic products labeled as silicone, which not only have poor user experience but may also pose safety hazards. Many people have a vague understanding of the differences in core characteristics between two materials, and only make choices based on appearance and price, ignoring the differences in core dimensions such as raw material properties, temperature resistance range, and safety performance. It is easy to choose products that do not meet their own usage scenarios. By clarifying the material characteristics, advantages and disadvantages of silicone products and plastics, one can accurately choose the right material according to their own usage needs and avoid purchasing traps. The core material properties of the two are completely different, which also determines the essential difference in basic safety performance. Silicone is a highly active adsorbent material, belonging to the amorphous silicate class of substances. Its chemical properties are very stable, and qualified food grade silicone does not contain any toxic or harmful substances. Even if it is exposed to food or high temperature environments for a long time, harmful components will not precipitate, and the safety level is very high. The main raw material of ordinary plastics is polymer resin, and different types of plastics will add various chemical additives such as plasticizers and stabilizers. Some additives are easily precipitated in high temperature environments and can enter the human body after contact with food. Long term use poses certain safety hazards. You can quickly distinguish between the two based on their basic odor performance. The brand new high-quality silicone only has a very light raw material odor, which will completely dissipate after a short period of ventilation and heating, and there will be no pungent odor after heating; Most brand new plastic products have a distinct plastic odor, which will significantly intensify when exposed to high temperatures.The difference in temperature resistance and durability between the two is huge, and their adapted usage scenarios are completely different. The temperature resistance range of silica gel is very wide, and it can maintain a stable shape under the environment of minus 40 ℃ to more than 200 ℃. It will not deform when it is put into the refrigerator for freezing, or put into the oven for cooking. The anti-aging ability is extremely strong, and it can be used for many years under normal use, without obvious material aging problems. The temperature resistance range of ordinary plastics is very limited. The vast majority of common plastics will soften and deform beyond 100 degrees Celsius, and some categories may even release harmful substances at high temperatures. After long-term use, they are prone to yellowing, brittleness, and cracking, and their service life is much lower than that of silicone products. From the physical rebound characteristics, it is also possible to quickly distinguish between the two. Silicone has extremely strong resilience, and when pulled and released, it can quickly restore its original shape without leaving any deformation marks; However, most ordinary plastics are hard or semi-rigid, and after pulling, they either break directly or undergo irreversible permanent deformation, with extremely poor rebound performance.The daily user experience and adaptation scenarios of both have their own advantages and disadvantages, and there is no absolute distinction between good and bad. The choice should be based on the needs. Silicone products have a soft and warm touch, good anti slip performance, and can be firmly held even if the hands are stained with oil. They are not easy to slip off and are very suitable for making tableware handles, baking tools, and baby products that require high safety and anti slip properties. The disadvantage is that the price is higher than ordinary plastics for the same volume, and some soft silicone is prone to absorb small dust. Ordinary plastic products have low molding difficulty, low price, high hardness, and are not easily deformed. They are suitable for use in storage boxes, ordinary outer packaging, and other scenarios that do not require high safety and high hardness. The disadvantage is poor temperature resistance, and long-term use is prone to aging, making them unsuitable for direct contact with high-temperature food. There are significant differences between silicone products and ordinary plastics in terms of raw material nature and usage characteristics, and there is no situation where one completely replaces the other. According to one's own usage scenario, prioritizing the selection of suitable materials can balance user experience and safety, without paying a premium for unnecessary performance or choosing the wrong product with safety hazards.

Silicone O-ring is a common sealing component mainly used for sealing mechanical equipment. Considering that mechanical equipment needs to withstand the erosion of various lubricants and industrial lubricants during use, can silicone O-rings provide good sealing when facing these lubricants and oils? Let's analyze it below.Firstly, we need to understand the material characteristics of silicone O-rings. Silicone has excellent elasticity, high temperature resistance, and cold resistance, and can be used over a wide temperature range. Additionally, silicone has good oil resistance. However, the tolerance of different types of silicone materials to oily liquids varies. For the common lubricating oils and lubricants in mechanical equipment, we need to choose silicone O-rings with better oil resistance.Secondly, in addition to the material properties of silicone O-rings, the usage environment is another key factor affecting their oil resistance performance. If silicone O-rings are used in high-temperature environments, aging and hardening may occur over long-term use, thereby reducing oil resistance. So, for mechanical equipment in high-temperature environments, we need to choose silicone O-rings that have better high-temperature resistance characteristics.Finally, it is important to note the usage of silicone O-rings. If used improperly, silicone O-rings are easily damaged or aged. For example, when installing silicone O-rings, it is necessary to avoid scratches, clean the installation position before installation, and use the pressing method for installation. For long-term operating equipment, we also need to regularly inspect and replace silicone O-rings.In summary, silicone O-rings have good oil resistance to a certain extent, but in practical use, various factors such as material characteristics, usage environment, and application methods need to be considered. Therefore, when selecting and using silicone O-rings, it is recommended to choose according to the specific equipment situation and follow the correct installation and maintenance methods to ensure their good sealing effect. Silicone O-ring is a common sealing component mainly used for sealing mechanical equipment. Considering that mechanical equipment needs to withstand the erosion of various lubricants and industrial lubricants during use, can silicone O-rings provide good sealing when facing these lubricants and oils? Let's analyze it below.Firstly, we need to understand the material characteristics of silicone O-rings. Silicone has excellent elasticity, high temperature resistance, and cold resistance, and can be used over a wide temperature range. Additionally, silicone has good oil resistance. However, the tolerance of different types of silicone materials to oily liquids varies. For the common lubricating oils and lubricants in mechanical equipment, we need to choose silicone O-rings with better oil resistance.Secondly, in addition to the material properties of silicone O-rings, the usage environment is another key factor affecting their oil resistance performance. If silicone O-rings are used in high-temperature environments, aging and hardening may occur over long-term use, thereby reducing oil resistance. So, for mechanical equipment in high-temperature environments, we need to choose silicone O-rings that have better high-temperature resistance characteristics.Finally, it is important to note the usage of silicone O-rings. If used improperly, silicone O-rings are easily damaged or aged. For example, when installing silicone O-rings, it is necessary to avoid scratches, clean the installation position before installation, and use the pressing method for installation. For long-term operating equipment, we also need to regularly inspect and replace silicone O-rings.In summary, silicone O-rings have good oil resistance to a certain extent, but in practical use, various factors such as material characteristics, usage environment, and application methods need to be considered. Therefore, when selecting and using silicone O-rings, it is recommended to choose according to the specific equipment situation and follow the correct installation and maintenance methods to ensure their good sealing effect.

1. Raw material selection criteriaThe raw materials for medical silicone products must comply with biosafety requirements and pass internationally recognized biocompatibility tests, such as the ISO 10993 series standards. The raw materials must be high-purity medical grade silicone and must not contain harmful substances. At the same time, the raw materials need to have stable chemical properties, and when in contact with human tissues, blood, or body fluids, they will not degrade, dissolve harmful substances, or cause adverse reactions such as allergies and inflammation. For example, silicone raw materials used for heart stent coating need to undergo strict hemolysis and cytotoxicity tests to ensure that they have no destructive effect on blood components.2. Production environment standardsThe production of medical silicone products needs to be carried out in a clean workshop, and the cleanliness level is classified according to the product risk level. The production environment for Class III medical devices (such as implantable silicone products) must meet ISO level 8 (i.e., the number of particles ≥ 0.5 μ m per cubic meter of air ≤ 352000), and be equipped with high-efficiency particulate air filters (HEPA) to ensure extremely low levels of dust and microorganisms in the air. The workshop needs to adopt a fully enclosed design, and personnel entering must go through processes such as changing clothes, disinfection, and air shower to avoid introducing pollution sources. Production equipment needs to be regularly cleaned and disinfected, and tools that come into contact with the product should be made of corrosion-resistant and easy to clean materials such as stainless steel, and undergo high-temperature sterilization treatment (such as 121 ℃ high-pressure steam sterilization for 30 minutes).3. Production process standards(1) Molding process controlThe molding processes such as compression molding, extrusion, injection molding, etc. require strict control of parameters. Taking compression molding as an example, the temperature needs to be precisely controlled at 160-180 ℃, the pressure should be maintained at 10-20MPa, and the vulcanization time should be adjusted according to the thickness of the product (usually 2-10 minutes) to ensure that the silicone is fully vulcanized and avoid a decrease in the mechanical properties of the product or residual harmful substances due to insufficient vulcanization. The extruded medical catheter must ensure a diameter tolerance of ≤± 0.1mm, a smooth surface without burrs, and prevent scratching of human tissue.(2) Clean production processDuring the production process, the product should avoid contact with non clean surfaces and use automated production lines to reduce manual intervention. For example, in the production of medical silicone gloves, the entire process from raw material injection to finished product demolding is automated, and each step is carried out in a sterile environment. In addition, environmental parameters (temperature, humidity, pressure difference, etc.) need to be monitored in real time during the production process, and recorded and archived to ensure traceability.4. Testing and certification standards(1) Factory inspection itemsEach batch of medical silicone products needs to undergo visual inspection (no bubbles, cracks, impurities), dimensional accuracy testing (such as catheter inner diameter and wall thickness deviation that meet design requirements), and mechanical performance testing (tensile strength ≥ 7MPa, tear strength ≥ 20kN/m). At the same time, sterile testing (using membrane filtration method to ensure no viable bacteria) and pyrogen testing (rabbit method or horseshoe crab reagent method to avoid causing fever reactions) are required.(2) Industry certification requirementsMedical silicone products need to be certified by the National Medical Products Administration (NMPA), and Class III high-risk products also need to pass clinical trials. Export products must comply with target market standards, such as FDA certification in the United States and CE certification in the European Union. Detailed production process documents, testing reports, and biocompatibility data must be submitted to demonstrate product safety and effectiveness.