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 the 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 type of cleanroom needed for manufacturing depends on specific product requirements or on specific customer considerations which include Class I, II, and III medical devices. Some of these types of products include medical device housings, surgical instruments, implantables, emergency room products, fluid delivery devices and containers, cardiac products, blood delivery housings, optical grade lenses, and pharmaceutical and dental products.
The Quality control systems for FDA-registered and ISO 13485:2003 certification standards include raw material and lot number controls, process parameter controls, record keeping, and environmental controls.
Contract Manufacturing Solutions for Medical Components
Safe, sterile, pristine medical equipment and components are vital for certain medical devices to meet approval. Clean room molding, assembly, and packaging are all aspects of facility operations that can be outsourced.
To gain the full benefit of using contract manufacturing, it is best to focus on a few key items:
- Cost savings
- Mutual partnership
- Advanced skills
- Quality control
- Positive communication
For a medical device manufacturer, a clean room contractor could be an ideal outsourcing option. Companies that specialize in clean room injection molding, assembly, and packaging can produce the various components in a certified ISO clean room so that the medical device manufacturer can avoid the expenses of a clean room facility, equipment, and trained personnel.
Most contract manufacturers have relationships with vendors and a logistics supply chain for their industry that provides quality materials and resources at reduced rates.
Companies can take advantage of the contract manufacturer’s specialized skills like design-for-manufacturing which will help to build a more efficiently engineered and manufactured product. This is increasingly important when you are making products for the medical industry and utilizing a clean room facility for manufacturing.
Crescent Industries is FDA Registered and ISO 13485:2003 certified. We operate a Class 100K clean room for injection molding and a Class 10K for assembly and packaging operations. Learn more about Crescent Industries' clean room injection molding capabilities today.