Facts on Clean Room Injection Molding for Your Medical Device
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;
• Dust
• 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.
Companies can take advantage of a clean room contract manufacturer's specialized skills like design-for-manufacturing which will help to build a more efficiently engineered and manufactured product. Â
Medical injection molding customers should expect ISO-13485 certification –– the standard for on-going suppliers. Accomplishing this quality-control system of compliance greatly enhances your ability to attract potential customers.
Quality control systems are required for medical device manufactures to achieve or exceed ISO 13485:2003 certification standards for quality
ISO 13485 achieves regulatory purposes by mandating that you maintain quality procedures. System ISO 13485 emphasizes documentation to verify procedures providing controlled conditions.
ISO 13485 implementation requirements involve work environment controls for clean room medical injection molding product safety. Risk management activities are required as well. Trace-ability requirements for implantable products are required also.
Anytime you find yourself needing a medical injection molder, Crescent Industries is 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 medical injection molding capabilities today.
