Simply put: quality matters most in silicone injection molding. Inconsistency and poor quality can lead to various negative outcomes such as slower time to market, customer complaints, tainted reputation, strained supplier-OEM relationship – and worst of all, customer loss or harm! OEMs that supply medical parts and devices to the healthcare industry simply cannot afford to cut corners when it comes to quality.

The key quality consideration for OEMs is your molding partner. Not all manufacturers produce quality products, and quality assurance and control are areas where excellent injection molders stand out from the competition! OEMs need an experienced molding partner that is familiar with the necessary production planning needed to meet all of the necessary regulatory and quality standards. Additionally, OEMs need to ensure a molding partner is providing them with a reliable and dependable process. An injection molder’s quality planning and assurance program is more than just meeting the requisite ISO and FDA requirements – it represents their proven way to ensure consistent quality silicone injection molded parts. A sound quality program demonstrates that the molder monitors the effectiveness of their supply chain and demonstrates traceability related to regulations of materials and finished goods – enabling the production of medical products with consistency and repeatability. When assessing a potential molding partner, OEMs should consider the following about their project and the supplier being evaluated:

  • What inspections and standards does my product have to meet?
  • What certifications and compliances such as ISO, FDA, and REACH does the supplier have?
  • Does the supplier have experience manufacturing products for my industry and have they been recognized?
  • Does the supplier utilize the latest quality software and automated machine technologies?
  • What is the supplier’s quality track record and the typical level of rework due to quality issues?
  • What is the supplier’s preventative maintenance plan for your injection mold?

Raw material selection is another quality consideration. Due to its chemical inertness, durability, stability, and low toxicity, medical grade silicone is an excellent raw material for implantable and other medical devices. Medical grade silicones are known for their quality and are often specified by OEMs.

Utilizing advanced technologies and cleanrooms are also quality considerations for medical silicone injection molding. Cleanrooms control contaminants and air quality, and are essential to manufacturing high quality medical products. Maintaining and operating a cleanroom environment to ISO standards requires excellent processes and procedures. Cleanroom processing includes raw material handling as well as packaging to avoid particulates and other forms of contamination during these steps. Use of advanced and automated technologies during processing can also enhance quality. For example, computer-controlled programs can automate various operations such as measuring, mixing, and sampling to improve batch consistency as well as repeatability from batch to batch.

ProMed’s Commitment to Quality

At ProMed, quality is not just a department, it is a cultural commitment. We understand the importance of quality to your success. That is why quality is embraced every step of the way to create a product that will assure confidence in your products.

Partnering with an experienced injection molder like ProMed allows for the necessary production planning needed to meet all of the necessary regulatory, quality, and commercial standards. Our work force is highly specialized in the manufacturing and quality requirements of medical products, much of which go into the long-term implantable market space. Every employee at ProMed is trained with the idea that quality is their most important responsibility.

Our equipment utilizes cost-effective, high-end molding technology to keep operating expenses down while producing parts with an extremely high level of precision and repeatability. Our tools are designed and manufactured to exacting tolerances. Expert toolmakers use high-tech design software and machining centers to produce molds that are durable and dimensionally repeatable from cavity-to-cavity, part-to-part!

We are an approved, certified supplier to many of the top medical device manufacturers in the world. All ProMed facilities go through routine audits by our ISO registrars and customers. Below is a sample of the standards we meet. Additionally, our products are wholly synthetic, not animal derived, and do not contain substances of very high concern or materials sourced from conflict regions.

  • ISO:13485 – 2016 certified
  • ISO:17025 certified
  • FDA 21 CFR 820, 210/211 and part 4 compliant
  • ISO Class 7 Clean Room
  • REACH and ROHS compliant

About ProMed

ProMed was founded in 1989 to address an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We have garnered a reputation as the world benchmark of implantable silicone components and assemblies – and are one of few companies in the world to provide contract manufacturing of drug-eluting products.

ProMed has expertise in working with the full spectrum of silicones covering a wide range of properties and characteristics. We will assist in your material selection to help ensure all design requirements are met. Our manufacturing facilities and equipment are designed for a single purpose—to mold medical and implantable silicone, combination components, and bio-material grade plastics with uncompromising quality and service. We currently have four divisions that are located within two manufacturing sites. All are certified class 10,000 / ISO Class 7 cleanrooms.

We can identify the right manufacturing solution for any project. We have extensive experience in a wide range of injection molding techniques including:

  • Automated Injection Molding
  • Multi-cavity tooling
  • Micro molds and micro molding
  • Servo-controlled de-molding capabilities
  • Insert molds, overmolds, and automation integration
  • Transfer molding
  • Compression molding

Contact ProMed today at 763-331-3800 to discuss how we can help with your next silicone injection molding project!

Quality Considerations for Medical Silicone Injection Molding
Article Name
Quality Considerations for Medical Silicone Injection Molding
Quality considerations for medical silicone injection molding such as vendor and raw material selection, and use of cleanrooms and advanced technology.
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ProMed Molding
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