Quality control and testing of silicone products include various things, such as strict raw material inspection and testing, management of manufacturing processes, physical property testing, and compliance with industry regulations. By implementing these measures, plastics manufacturers can ensure that their silicone rubber products meet the highest quality standards and perform optimally in various applications. As a manufacturer of silicone products, Mitour Silicone is ISO9001, BSCI and FDA-certified to meet the needs of our customers. Our highest principle is a final product reject rate of less than 2%.
Raw Material Quality Control
Partner with trusted and reliable raw material suppliers to check the quality and characteristics of the raw materials used in the production of silicone rubber. Ask the supplier for the test reports of the silicone raw materials, such as FDA, LFGB, RoHS, REACH, SDS, etc. When the silicone rubber is shipped to our factory, the warehouse management will check it before storage.
Preparation And Color Comparison
When the mixing technicians are notified of the production schedule, they mix the silicone colors according to the material specifications. After the operator produces a test block, the inspector compares the color and hardness to ensure that the material is within the tolerance of the specification.
Process Quality Control
During production, IPQC personnel conduct regular inspections daily until the end of the product line process. If a product passes through the IPQC personnel and an abnormality is found, the supervisor will be notified immediately to adjust the machine. Once the product line process is completed, the process control personnel will schedule additional techniques such as deburring, printing, PU coating, cutting and gluing, followed by standard inspection procedures.
Silicone Product Quality Testing
At the end of the additional process, the QC personnel will inspect the product according to standard inspection procedures, limiting samples and spot checks. Each product will undergo a final quality control check before packaging.
Standard performance tests of silicone rubber products include the following:
1、Tension Test
Tensile force is the primary functional standard of silicone products. As silicone material has lost the effect of tensile force, then the product is equal to the product that has been aging and no longer has a meaningful role, so usually, we are tested through the finished product of silicone, whether it is to achieve the tensile range of 80.49N.
Silicone products tensile test method:
- Measuring tool: tensile testing machine
- Measuring speed: 450MM/MIN?
- Measuring specification: with tensile test special cutter (1 type), thickness 2.0±0.2MM
- Measurement method: in the middle of the parallel part of the specimen marked 2.5CM distance, this marking line (width ≤ 0.5MM).
The test results will not have an impact; open the tensile machine switch and test software, clamp the ends of the piece to be tested, fixture clamping specimen to make the longitudinal axis of the sample and the center of the upper and lower fixture line coincide; and to be suitable for tightening and loosening to prevent the specimen from slipping off and break in the fixture is appropriate; test is completed to save the results.
2、Elasticity Test
The elasticity test is usually applied to silicone keys more. This test method is mainly to achieve the product’s functionality, usually to press the key the number of times to reach how many times above the standard, the conventional silicone material in the 300,000-500,000 times or so. Still, they are also adjusted through the material to achieve more requirements.
Test method:
Silicone key elasticity tester
Silicone key elasticity testing machine specifications:
- Test load type; 2kgf, 500gf (choose 1)
- Minimum display load: 0.01gf
- Larger test stroke: 100mm
- Minimum display stroke: 0.01mm (0.001 optional)
- Measuring speed range: 1-100mm/min
- Transmission mechanism: ball screw
- Standard value: 50±(5-10)g, 70±(5-10)g, 90±(5-10)g, 100±(5-10)g, 120±(5-10)g, 150±(5-10)g 170±(5-10)g
3、Temperature Resistance Test
Temperature test is the silicone products used with high and low temperatures whether there will be cracking aging. Other phenomena of the main issues, and usually the silicone products temperature effect in -40 ℃ to 280 ℃ between the impact of the working temperature of the silicone material in the -15 ℃ to 100 ℃ between the storage is no problem. The test method can be tested by high-temperature baking or low-temperature refrigeration.
4、Size Test
Size affects the assembly of silicone products, so the size of the problem needs to be controlled in the silicone products manufacturers’ internal molds and the appearance of the design above. Usually, silicone materials have a certain degree of softness; it is impossible to do degrees, so there will be a 0.1mm-0.3mm size error. Want to control the large size of the silicone manufacturer fully can not guarantee that, so the test size of the silicone products is usually done to ± 0.3mm tolerance range, so the size of the silicone products can be tested to ensure the quality of the silicone products—tolerance range of about 0.3mm.
5, Hardness Test
Silicone product hardness is usually divided into 30-80, and the regular use of hardness of different products has a corresponding impact. Sealing high silicone ring hardness may lead to a lack of life, and hardness may be too low, leading to deterioration of sealing performance.
Test method:
According to the above conditions, a good hardness particle can not be immediately after the hardness test and needs to be placed at room temperature to be hardness particles naturally cooled before the hardness test. The specific test methods are as follows:
- The hardness of the grain is placed on the desktop to ensure that the surface is tested in a horizontal state;
- Take the Shore A hardness tester dial at the bottom of the needle vertically aligned with the back side of the hardness grain;
- Shore A hardness tester to apply 1kg of force and 150px / s speed pressure to the grain’s hardness to ensure the test’s accuracy. It is better to make a hardness tester test bracket. The hardness tester will be installed in the stand after the hardness of the test;
- To be a hardness tester, dial the pointer to stop reading. The information points to the value and record; at this time, the high-temperature vulcanized silica gel (HTV) hardness test is completed.
6、Appearance Test
- Test quantity: according to the prescribed ratio of three to one
- Test method: Under normal lighting conditions, visually inspect the appearance of the product’s quality and color. Measure according to the standard size of the drawing.
- Test standard: The products have no rupture, bubbles, impurities, lack of material, no burr phi phenomenon and have the unique luster of silicone products. The product surface does not appear to be a yellowing or whitening phenomenon. The color of the product appearance shall not have noticeable differences.
What certification does silicone products export need to do?
Silicone products’ standard certification reports are FDA, LFGB, ROHS, PAHS, REACH, MSDS, halogen, etc. The more authoritative certification bodies are SGS, TUV, CE and other organizations.
1, FDA / LFGB for non-food and drug testing is mainly food contact materials and other tests, FDA is the U.S. food certification report, LFGB is the EU’s food certification report, and FDA / LFGB are two completely different standards.
2, ROHS report is an environmental report, the primary test six heavy metals: lead (Pb), cadmium (Cd), mercury (Hg), hexavalent chromium (Cr (VI)), polybrominated biphenyls (PBBs), polybrominated diphenyl ethers (PBDEs).
3, PAHs The primary test is polycyclic aromatic hydrocarbons. PAHs (Polycyclic Aromatic Hydrocarbons PAHs) are volatile hydrocarbons produced by incomplete combustion of organic matter such as coal, petroleum, wood, tobacco, organic polymers, etc. They are significant environmental and food pollutants. So far, more than 200 kinds of PAHs have been found, some of which are carcinogenic, such as benzo α pyrene, benzo-α anthracene, etc. PAHs are mainly detected. PAHs are widely distributed in the environment and can be found in every corner of our life; any organic material processing, waste, combustion or use of the place are likely to produce PAHs.
4, REACH, and RoHS directive is different. REACH involves a much broader scope. Now increased to 168 tests, is the EU regulation “Registration, Evaluation, Authorization and Restriction of Chemicals” (REGULATION concerning the Registration, Evaluation, Authorization and Restriction of Chemicals) for short, is the establishment of the EU. REACH establishes that society should only introduce new materials, products or technologies if their potential hazards are known.
5, MSDS report refers to the chemical safety instructions, the material safety coefficient table, technical education and chemical safety data sheets.
6、Halogen testing includes (fluorine (F), chlorine (CI), bromine (Br), and iodine (I).
What are the contents of the FDA certification test?
Silicone products for U.S. FDA certification require tests and analyses to ensure that the product meets the relevant standards and requirements. The following is a detailed description of the content of silicone products for U.S. FDA certification testing.
1. Product composition analysis
First of all, we need to analyze the composition of silicone products. It includes testing the main components, additives and other chemicals of the silica gel material to determine whether the product meets the requirements of the US FDA. Standard silica gel components include silicates, silicone polymers and fillers.
2. Testing items
Silicone products for U.S. FDA certification need to carry out some testing programs to ensure the quality and safety of the product. The following are some everyday testing items:
Hazardous substance testing: Detect the presence of dangerous substances in the product, such as heavy metals, harmful gases, etc.
Safety testing: Evaluate the structure and electrical safety performance of the product, such as the risk of electric shock, electromagnetic compatibility, etc.
Environmental safety testing: Evaluate the performance and safety of products under environmental conditions.
Material Reliability and Failure Analysis: Analyze the reliability and failure of silicone materials to determine the service life of products.
Food contact material testing: testing whether the product meets the requirements for food contact materials.
3. Relevant Standards
Silicone products need to comply with specific standards for FDA certification. The following are some of the standards related to silicone products:
U.S. FDA 21 CFR 177.2600: Regulations for rubber and rubber products in contact with food.
U.S. FDA 21 CFR 175.105: Regulations for Rubber Products in Contact with Food.
US FDA 21 CFR 177.1210: Regulations for silicone rubber in contact with food.
U.S. FDA 21 CFR 178.3293: Regulations for Silane Crosslinked Rubber in Contact with Food.
These standards specify compositional limits, safety requirements, etc., for silicone products. To obtain FDA approval, you need to ensure that the product meets the requirements of these standards.
Mitour Silicone applies for ISO9001, BSCI, and FDA certificates to provide continuous and stable quality. Mitour Silicone develops product and process specifications, and the employees implement product quality control for each process according to company regulations. Through strict testing of silicone products, we can ensure the quality and safety of our products. Meanwhile, wholesalers should also pay attention to whether the products comply with these standards when purchasing silicone products to guarantee the security of the products. Complemented by the ISO quality system, we can improve quality and continuously provide better products to customers.