Types of Medical Molding
Posted by Phineas Gray , on Jan, 2015
The majority of medical molds are made by plastics contracting manufacturers, who have specialized skill in producing repeatable, accurate, sterilized plastic materials. Advancements in the medical field have allowed for less invasive procedures. These procedures require smaller, more precise instruments. Medical molding companies construct these types of items, with features as small as two microns and parts weighing as little as .0001 grams.
Advancements in the Medical Field
The reason medical molding has become such a popular specialty in the plastic manufacturing area is the advancements in materials that can be used in the medical field. Strides have been taken to allow smaller, less invasive parts to be used. When made of plastic-based materials, these products become disposable after use.
Medical Molding Processes
The process for medical molding is precise and accurate. Sterile products must be produced in a cleanroom environment, meaning that the air in the room, the machinery, and all its related components must be held to the highest sterility standards. First, the material is thoroughly stirred with sterile material, to ensure consistency. This material is fed down a heated barrel into a mold. Once inside the mold, the material sits in a still environment until it is hardened. The hardened product is removed from the mold and then precision-machined to add any necessary features.
While the basic process of medical molding is the same, there are several techniques that must be used. Medical parts and products come in a wide range of shapes and sizes. The three types of molding most commonly used for medical parts are micro insert molding, micro molding, and insert molding. Most medical manufacturing companies also specialize in needs such as lab slides, luer connectors, assembly work, tight tolerances, and sealing surfaces. These techniques are used alone and combined to manufacture dental implants, tracheotomy tubes, catheter components, surgical instruments, bioresorbable implants and more. Whatever the customer needs, the company works closely with them to ensure the best standards.
While there are a variety of processes and machines that may be used for medical manufacturing, they all meet the stringent guidelines set by the FDA. There are several steps that a good medical molding company will take to ensure the compliance of its process. At the first stage of the process, all equipment is thoroughly tested for accuracy and repeatability, down to the micron. A good company will have a repeatability range of +/- .002 or .004mm, or two to four microns. At the next stage of the process, the quality of the manufacturing materials is checked. Medical manufacturing companies will often perform regular audits on their suppliers, to ensure quality and compliance of materials. Finally, all the components and the entire manufacturing process are documented to ensure regular compliance.