Your clean room manufacturer
Clean room production
In order to deliver medical grade plastic parts and tubing without contamination, all manufacturing, assembling, testing and packaging activities are performed within our large controlled ISO Class 8 clean room. This clean room is newly built in 2011 and tailored for medical device manufacturing.
The J&J production area is over 650 square meters of ISO-7 and ISO-8 certified clean room area.
The assembling area is a certified ISO-7 environment and the manufacturing area for extrusion and molding is a certified ISO-8 environment. The cleanroom facility houses equipment for performing several assembling operations, suitable for the production of Plastic Medical Devices such as catheters, syringes and other medical products.
For instance: Double bagged packaging is a standard procedure for us.
US FED STD 209E cleanroom standards
| Class | maximum particles/ft³ | ISO equivalent |
||||
|---|---|---|---|---|---|---|
| ≥0.1 µm | ≥0.2 µm | ≥0.3 µm | ≥0.5 µm | ≥5 µm | ||
| 1 | 35 | 7 | 3 | 1 | ISO 3 | |
| 10 | 350 | 75 | 30 | 10 | ISO 4 | |
| 100 | 750 | 300 | 100 | ISO 5 | ||
| 1,000 | 1,000 | 7 | ISO 6 | |||
| 10,000 | 10,000 | 70 | ISO 7 | |||
| 100,000 | 100,000 | 700 | ISO 8 | |||
