Cartridge
biosurfit’s ISO 13485:2016 certified facilities allow our manufacturing services for pre-production (Pilot Line) up to large scale production (Automated Line) for accurate, reliable and cost-effective cartridges.
Our operating space for manufacturing processes includes:
- Pilot line
- Fully automated line:
o Clean room Class ISO 7 and Class ISO 8 (ISO 14644)o One- piece flowo 5-10s cycle timeo Continuous mode 24/7o Multiple dispensing station for reagents: >> Up to 8 reagents application
>> Correct height dispensing (50 µm precision)
>> Correct dispensing trajectory points (±25 µm)
- Validation area
- Labelling and Packaging
- Robust Quality Management Systems
Equipment
Our expertise also covers automated diagnostic instruments designed to deliver quantitative measurement of blood parameters to physicians in minutes. We are specialized in medical devices with electronics and plastic injection moulded enclosures. We provide troubleshooting support of manufacturing, assembly and testing.
Our manufacturing capabilities include:
- Low-cost instruments with high precision optical setups
o Optical microscopy module
o Surface Plasmon Resonance module
o Spectrophotometry module
- Standard components purchasing
- Quality Control
o In-Line
o Final
- Testing and Validation
- Labeling and packaging
- Robust Quality Management Systems
