Clean Room Manufacturing

Clean Room Injection Molding/LIM Clean Room Molding
Our injection molding machines that are used for medical parts only are located in our class 8 clean rooms, this keeps out any dust, germs or other contaminates.

Clean Room Assembly Area
Our assembly area for medical devices is located in our class 7 clean room in order to keep dust, germs and any other contaminants out.

Clean Room Regulations:

ISO 14644-1 (Title: Classification of air cleanliness by particle concentration)
ISO 14644-2 (Title: Clean room performance monitoring related to air cleanliness by particle concentration)
ISO 14644-3 (Title: Test methods)
ISO 14644-4 (Title: Design, construction and start-up)
ISO 14644-5 (Title: Operations)
ISO 14644-7 (Title: Separative devices (clean air hoods, glove boxes, isolators, mini-environments)
ISO 14644-9 (Title: Classification of surface particle cleanliness)

Medical Assembly
Clean Room Capabilities Presentation (PowerPoint)

class 7 clean room

ISO 8 clean room

FDA

ISO 13485

ISO 9001

Our Daily/Monthly Monitoring of the Clean Room Environment:

Daily:
1. Atmospheric Pressure
2. Temperature and Humidity
clean room molding
Monthly:
3. Particle Counts
4. Air Velocity

If you have any questions please
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