Injection molding has allowed many life-enhancing and life-saving medical devices to be within reach of millions of people, by making it possible to produce plastic medical products in large volumes and at competitive cost.Read More
Class I, II and III medical devices, which include products like medical device housings, surgical instruments, implantables, emergency room products, fluid delivery devices and containers,cardiac products, blood delivery products, pediatric devices, in vitro diagnostics, medical imaging, obesity treatment devices, opticRead More
Any company involved in the production and distribution of medical devices intended for commercial distribution in the United States is required to obtain a registration with the FDA.
Most companies who seek to produce medical devices are required to register and to list the devices and the activities performed on those devices at that establishment.
The registration is completed once the Quality Management System is in compliance with the rules established under FDA Quality System Regulation (QSR) as established under the 21 Code of Federal Regulation (CFR) Part 820 (Medical Devices).
Clean Room Injection Molding for the Medical Industry
A clean room is a location that maintains a controlled level of environmental pollutants - also known as contamination. These pollutants may include dust, chemical vapors, aerosol particles or airborne microbes.
Clean room areas require a steadily maintained level of control of these pollutants which lead to part contamination. These particles are measured as per the amount found within a specified area - which is measured by the cubic meter of air.
- A certified ISO 7 clean room is 10,000 particles of pollutants per cubic foot
- An ISO 8 certified clean room is 100,000 particles of pollutants per cubic foot
The specifics of clean room injection molding have intensified as the need for cleanliness has only increased with time. Regulating the levels of cleanliness continues to be an area of expanding focus.
Clean room areas require a steadily maintained level of control due to the effects of environmental pollution, which lead to part contamination. These pollutants include;
- Chemical vapors
- Aerosol particles
- Airborne microbes
These particles are measured as per the amount found within a specified size - which is by the cubic meter of air. Anytime plastic is injected into a steel or aluminum mold to form a needed part - no matter what device it may be for - clean room injection molding has been applied.
Clean Room injection molding has become irreplaceable for the medical and pharmaceutical industries. Cleanliness is not only essential but regulated very specifically. It must adhere to strict medical manufacturing protocols. These are mandated to operate under the ISO 13485:2003 certificated procedures for medical devices.
There are also several classifications of clean rooms. A fully certified ISO 7 clean room is 10,000 pollution particles per cubic meter, or foot. An ISO 8 certified clean room is 100,000 particles per cubic foot. The type of clean room needed for manufacturing depends on specific product requirements or on specific customer considerations.
Once again we are about to have the largest medical device manufacturer conference in our history.
- Exposition: June 10–12, 2014
- Conference: June 9–12, 2014
This event will be located at Jacob K. Javits Convention Center | New York, NY. This is the largest MedTech event happening on the East Coast.