Clean Room Assembly, Inspection

As part of PassageMaker’s Precision Assembly / Inspection center, our ISO 13485 compliant clean room and medical grade production environment offers assembly, inspection and packaging capabilities for medical, electrical and other environment-sensitive products. Airborne particulate levels are kept low in order to meet the following certification requirements:

The clean room is divided into three areas:

1. Employee staging area: clean room gear is stored and air shower is conducted on all employees before entering clean room to remove outside particulates on employees.
2. Material staging area: materials to be inspected/assembled/packaged undergo an air bath at a pre-determined time period to remove outside particulates before entering the clean room core.
3. Clean room core: here products are inspected, assembled and packaged

A central computer controlled air filtration system ensure required temperature and humidity levels are maintained in the clean room and surrounding medical grade production environment (1000+ square meters)

Products made at this facility have been cleared for marketing by the US FDA (Food and Drug Administration). Additionally, ISO 13485  standards and internal SOPs ensure our clean room staff maintain strict levels of cleanliness.

To take a look at our clean room click here to take the virtual tour.

For more information and pricing structure visit Assembly / Inspection page and Assembly / Inspection Pricing page.