Quality System

High-Quality Liquid Silicone Rubber (LSR) Parts

SIMTEC has delivered billions of LSR parts to customers around the globe, and our excellent customer quality ratings speak for themselves. We understand that good quality planning begins early at the very start of a project and continues throughout the entire process. We assure all of our fully-automated manufacturing processes (molds, manufacturing cells, and post molding operations) are optimized to deliver high-output, consistent high quality parts resulting in a smooth supply chain and product launch for our customers.

Early Involvement
At SIMTEC our project launch team, including engineering and quality engineering team members, work closely with our customers’ teams to establish a good understanding of the part, its function, expectations, and project timeline. An understanding of the part’s function and features such as critical dimensions, durometer, and surface finish, as well as the quality expectations provide insight into the tolerance window, control plans, and functional tests and fixtures that will be required.

Quality Tools & Best Practices

At SIMTEC, we view quality as a scientific business approach applying a collection of problem-solving tools used to assure we deliver consistent high quality parts to our customers. This begins with a sound quality plan, a stable and controlled molding process, and the utilization of quality tools and best practices to meet our customers’ specific requirements.

With a wide variety of quality tools available, SIMTEC views the following to be essential:

  • Advanced Quality Planning
  • Custom Validations and Qualifications
  • Control Plans
  • Customized Procedures
  • A Wide Array of Metrology Capabilities
  • Technical Problem Solving Methods

Visual InspectionQuality System

Optical equipment such as  magnifiers, stereoscopes and microscopes are used for visual inspections. Specialized high-powered 10-300x magnification microscopes are used for measuring intricate micro molded LSR components.

Quality System

Dimensional Measurements

For dimensional measurement of LSR parts, SIMTEC’s QA lab has a wide array of metrology equipment, from traditional to the latest technology. We design and fabricate customized fixtures to secure parts for accurate and repeatable measurement. Optical CMM (Coordinate Measuring Machines) equipment for example often times use mirrors and custom fixtures for accurate intricate measurements.

Functional Testing Metrology

Quality System

Functional testing simulates application-specific, in-the-field conditions to test performance. These may include shore hardness and tensile testing, or leak and pressure testing important for seals and diaphragms. LSRs flexibility and compression set characteristics are very different from thermoplastics and other rigid polymers and require special methodologies. Accurately measuring LSR molded parts requires specific work instructions and training to ensure accuracy. For example, when measuring shore hardness with hard gages, the proper pressure must be applied for accurate and consistent measurements.

Quality Solutions

Industries and applications also dictate the manufacturing processes, ISO certification requirements and the overall quality plan.

Medical components for example undergo stringent testing and evaluation for purity and part quality as specified by our customers. In addition to our exceptionally clean facility with fully-automated production, inline value-added processes and packaging, SIMTEC also offers Class 8 clean room molding for its customers with hygienic requirements for their medical devices.

In addition to medical and healthcare products, infant products and food and beverage products may also require post curing. In the post-curing process, the LSR molded parts are placed in a post-curing oven where heat is applied to immediately drive out gases and volatiles, a process that happens naturally over time. SIMTEC provides full traceability and documentation of the post curing history for each lot that is post cured. The emergence of special, low-volatile grades of LSR provide another option for minimizing volatile content in the molded components.

SIMTEC ISO Certifications

 

SIMTEC is proud to be an ISO 9001, ISO 13485, and IATF 16949 certified manufacturer. We have maintained these quality certifications for many years.

 

SIMTEC’S Quality Assurance

At SIMTEC Silicone Parts, we understand that the foundation of our business comes from an uncompromising commitment to provide high quality custom injection molding solutions. Our early quality planning and aggressive quality systems ensure adherence to tight tolerances, maintaining thin, delicate part geometries, and intricate micro-molding requirements. We tailor our quality processes to meet the specifications of each of our customers.

Here are just a few of the SIMTEC quality control systems:

  • Process control: SIMTEC achieves the highest level of process control by combining rigorous tooling standards, robust IQ/OQ/PQ validations, control plans, and a best-of-class approach to silicone molding. Our extensive use of automation to drive our processes helps us achieve the highest quality levels for your parts and products.
  • Investment in the latest technology: To improve process stability and quality, we make ongoing investments in the best metrology technology available for material testing, part inspection and functional testing. Quality tools and equipment include visions systems, leak and pressure testing, and automated optical coordinate measuring equipment.
  • Workforce skill development and training: Both our hourly and salaried team members are provided with visual standards and guides, receive extensive training on cutting-edge technology and methodology, the latest manufacturing methods, and customer requirements.
  • Certifications: We are ISO 9001, ISO 13485 and IATF 16949 certified.

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