ThomasNet News Logo
Sign Up | Log In | ThomasNet Home | Promote Your Business

Facts on Clean Room Injection Molding for Your Medical Device

Print | 
Email |  Comment   Share  

Facts on Clean Room Injection Molding for Your Medical Device
Facts on Clean Room Injection Molding for Your Medical Device
Click Here to Enlarge Picture

Crescent Industries, Inc.
70 East High St.
New Freedom, PA, 17349

Press release date: July 22, 2014

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.  

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.

Print | 
Email |  Comment   Share  
Contacts: View detailed contact information.


Post a comment about this story

(your e-mail address will not be posted)
Comment title:
To submit comment, enter the security code shown below and press 'Post Comment'.

 See related product stories
 See more product news in:
Laboratory and Research Supplies and Equipment
| Featured Manufacturing Jobs
 Other News from this company:
Crescent Industries is Now FDA Registerd
Tips to Consider When Selecting a Contract Manufacturer
What is Antimicrobial Materials for Plastic Injection Molding
What Is Standard Set-Up Data for Revalidation of Injection Molding Processes?
More ....
 Tools for you
Watch Company 
View Company Profile
Company web site
More news from this company
E-mail this story to a friend
Save Story
Search for suppliers of
Medical Injection Molding
Join the forum discussion at:
The Machine Shop
Wired In

Home  |  My ThomasNet News®  |  Industry Market Trends®  |  Submit Release  |  Advertise  |  Contact News  |  About Us
Brought to you by        Browse ThomasNet Directory

Copyright © 2014 Thomas Publishing Company. All Rights Reserved.
Terms of Use - Privacy Policy

Error close

Please enter a valid email address