Plastic injection molding of medical parts
Are you in need of a specific medical part? Idea Stampi can manage the whole production injection molding process, from the mold prototype to the finished product.
Everything related to the medical sector must comply with specific rules dictated by the FDA. This means that any tool, or part of it, used in the medical sector must be approved. Idea Stampi is able to carry out injection molding of medical parts, from prototyping to the finished product, in absolute compliance with the law.
On this page:
- Prototyping the mold
- Testing phase
- Injection molding process
- The suitable materials
- The requirements
Our area of expertise lies in constructing suitable molds for plastic injection molding. This process involves injecting the mold prototype into a mold cavity, where it cools and solidifies into the desired shape. In the medical sector, injection molding is used to manufacture a wide range of products, from syringes and IV tubing to surgical instruments and medical device components.
To create a mold prototype for medical injection molding, several factors must be taken into consideration. These include the material to be used, the design of the part to be molded, and the production volume required. The first step in creating a mold prototype is to design the mold itself. This typically involves using computer-aided design (CAD) software to create a three-dimensional model of the mold. The mold design must take into account factors such as part geometry, parting line placement, gate location, and cooling channel placement.
Once the medical mold prototype is completed, the test phase begins. The mold is put in place and produced some test pieces to understand if they meet the defined needs of the customer. Eventually, adjustments are made and we return to the design phase. Once the final result is obtained, the customer can choose whether to buy the mold and include it in their production line, or whether to entrust the entire production process to us. In fact, we are able to supply both semifinished medical parts and finished products ready for use in the construction of purchased instruments or directly in medical facilities.
Managing medical injection molding requires strict adherence to quality control measures and industry regulations. Here are some key steps to consider:
- Choose the right materials: select materials that meet the requirements for the specific medical application, including biocompatibility, durability, and sterility.
- Optimize the mold design: the mold design should be optimized for the specific medical part to ensure consistent production and quality.
- Implement process validation: the injection molding process should be validated to ensure that the parts produced meet the required specifications and quality standards. This involves testing and analyzing samples from the production process to ensure that they meet the required specifications.
- Establish quality control measures: implement quality control measures to ensure that each part meets the required standards. This includes monitoring the process, performing quality checks, and documenting the results.
Overall, managing the plastic injection molding process for medical parts requires a focus on quality control and compliance with industry regulations to ensure that the final product is safe and effective for its intended use.
Idea Stampi recognizes the significance of materials in medical plastic molding, as the end products must adhere to FDA regulations. To ensure compliance, we utilize medical-grade plastics that possess high molecular weight and exhibit chemical and heat-resistant properties. For injection molding in the medical industry, the most appropriate materials are:
- polycarbonate PC
- polyether ether ketone PEEK
Polycarbonate PC is widely used for medical tubing due to its remarkable tensile, flexural, and shear strength, as well as its resistance to heat and low moisture absorption. PEEK, a plastic resin that is highly resistant to chemicals, fatigue, and cracking, is suitable for food contact, and medical devices made from PEEK can be sterilized by an autoclave. Ultem, on the other hand, is an ideal plastic material to use in medical devices because of its resistance to environmental stress and high temperatures, as well as its exceptional dimensional stability.
As mentioned, the medical sector applies strict controls at all levels, including medical and orthodontic instruments used in public and private facilities. The Food and Drug Administration is the controlling body, and its laws must be subject to the companies operating in producing injection molding of medical parts. Thanks to its many years of experience, Idea Stampi guarantees an absolute level of safety, in compliance with US and European laws in manufacturing molds and finished products for the medical sector.
Contact us for a quote