There are many different grades of plastics available for Syringe Mold and each one has strengths and weaknesses that need to be considered. Below are a couple factors that need to be top of mind when choosing a plastic material for your medical device.
When choosing a medical grade plastic for injection molding, it is important to select one that has the proper strength. Plastic resins come in many different strengths, so it is important that you choose one that fits the specification of your medical device. Choosing a material that is not strong enough can result in the medical device failing during use.
Resistance to Chemicals and Heat
One of the most important aspects to consider is the type of heat and/or chemicals is your medical device going to have to endure. Will your medical device be subject to standard sterilization methods, or will it have to endure more harsh cleaning methods? Such harsher cleaning methods are high-heat and water pressure (like an autoclave), radiation, chemicals and high intensity ultra violet light. Failing to take these conditions into account can dramatically reduce the life of your medical device.
Fungus, algae and other microbes can grow on untreated plastics. This can lead to unsightly discoloration, unpleasant odor and plastic degradation. If you know your medical device will be subject to an environment where these might be a concern, then an anti-microbial additive can be mixed into the plastic resin. Anti-microbial additives can be added during the injection molding process. This can reduce or inhibit microbial growths when a microbe touches the surface. A medical device that promotes microbial growth will require more frequent sanitation. This can lead to more down time and possible shorter device life.
The conditions that your medical device will be exposed to will determine the requirements of your medical grade plastic material. Some conditions that need to be considered are chemical resistance, corrosion resistance and exposure to radiation and temperature. Failing to take your operating environment into consideration can cause faster degradation of your medical device.
The FDA has different requirements for plastic materials based on how much contact with the human body the device has. These can be divided into 3 broad categories. The category with the most regulations are plastics used in medical devices that are implanted into the human body. These medical devices have a long list of requirements, such as certified non-toxic and materials proven not to break down over the lifetime of the implant. These parts must also be manufactured in a certified clean room.