Medical contract manufacturing creates medical devices and components in sterile environments. Companies can outsource production and design to specialized manufacturers with certifications for compliance with regulations and standards. Sterilization methods include gamma rays, electronic beam processing, and ethylene oxide.
Medical contract manufacturing is a highly specialized industry that focuses on the design, prototyping, construction and packaging of devices in controlled, sterile environments. Companies that do contract medical manufacturing can often create any type of device or component for use in the medical industry. They are also generally well versed in all applicable laws, regulations and standards. In many cases, companies or their manufacturing facilities will have government or international certifications verifying the integrity of their processes.
All contract manufacturers offer some type of outsourcing service that can allow a company to have components or devices built to specification. This process typically consists of a company approaching the contract manufacturer with a design, concept, or formula. The contract manufacturer can then provide an estimate for what the entire process will cost. Medical contract manufacturing is an example of this practice which is specifically used to create items that will be used in healthcare and related fields.
If a company has designs for a medical device but does not have the facilities or knowledge to produce the items, it will typically retain the services of a medical contract manufacturing company. In this way it is possible to outsource the entire production phase, including sterile packaging compliant with current regulations and tests. In other cases, a company may have a concept but lack the means to design or prototype it. Medical contract companies can often assist with this stage as well and then bring it into production if the prototype device is acceptable.
A company that provides contract medical manufacturing services may specialize in small disposable sterile items, large equipment, or anything in between. Facilities are typically tightly controlled and often include certified cleanrooms to build and package sterilized items. In many cases, the facility or cleanrooms may be certified by governmental or international organizations. These certifications can help ensure that manufacturing processes meet stringent specifications and that all appropriate sterilization methods are employed.
Medical contract manufacturing can make use of a variety of sterilization methods. Depending on the situation and customer requests, gamma rays, electronic beam processing, ethylene oxide and other methods can be used to sterilize both the artifacts and the working environment. Workers typically wear sterilized gowns, hairnets and other gear to ensure that the medical equipment they produce also remains sterile. Sterile clothing and robe rooms are often provided so that workers do not bring external contaminants into the facility.
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