Facts On Clean Room Injection Molding For Your Medical Device

Crescent Industries is a FDA registered employee-owned custom injection molder providing an integrated single source solution for your custom plastic injection molded components.

Crescent injection molds a comprehensive range of engineering and commodity resins for the medical, pharmaceutical, dental, defense, safety, electrical/electronic, aerospace, OEM/Industrial and consumer industries.

Companies that are involved in the production and distribution of medical devices intended for commercial distribution in the US are required to obtain a registration with the FDA. Most companies are required to register are also required to list the devices and the activities performed on those devices at the company. This registration requires the Quality Management System to be 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).

• Dust• Chemical vapors• Aerosol particles• Airborne microbes

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;

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.

Crescent’s Quality Management System is not only in compliance with European Standards like ISO 9001 and ISO 13485 (Medical Devices) but with the FDA. With this FDA registration we can manufacture not only components that are distributed to a

finished device manufacturer; but to manufacture Finish Good devices or a component/accessory that are packaged or labeled

for commercial distribution for health-related purposes to an end user.

Class I, II, III medical devices and components such as medical device housings, pediatric devices, in vitro diagnostics, medical imaging,

obesity treatment devices, surgical instruments, implantables, emergency room products, fluid delivery devices, fluid delivery

containers, cardiac products, science & research devices and dental products.

Crescent offers several clean room assembly and packaging services in an ISO 7 clean room (10K) to complete your project.

Assembly operations can be simple to complex. Clean room packaging services include a wide variety of products, kits,

security and tamper evident seals etc.

Quality Engineering tools help to achieve product specifications from design through final production. These include IQ,OQ &

PQ, Control Plans, Capability studies and Gage R&R.

At Crescent we have a validated ERP System which means the system has been certified by a third party and complies with FDA mandates including cGMP and 21CFR Part 11. This system is used to track orders from incoming raw materials through production

for full lot traceability.

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.

Business Development Manager

Email: [email protected]

Sales Engineer(Eastern PA, NJ, NY, MA)

Email: [email protected]

Sales Engineer(MD, VA, DE)

Email: [email protected]