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High-Quality Manufacturing for Diagnostic Solutions

At biosurfit, we provide ISO 13485:2016-certified contract manufacturing services, covering the full production cycle—from pilot-scale prototyping to fully automated large-scale production. Our expertise ensures accuracy, reliability, and cost-efficiency in both diagnostic cartridges and medical equipment.


Cartridge


Our state-of-the-art manufacturing facilities are designed to meet the highest industry standards, offering scalable solutions for small-batch pilot production and high-volume automated production.

Our manufacturing capabilities include:

✔ Pilot Line for flexible production and testing
✔ Fully Automated Line with:
Clean rooms (Class ISO 7 & ISO 8) ensuring contamination-free environments
One-piece flow production for streamlined manufacturing
5-10s cycle time, optimizing efficiency
24/7 continuous operation, maximizing output
Advanced reagent dispensing technology:
o Up to 8 reagents applied per cartridge
o Precision dispensing (50 µm accuracy)
o Trajectory control (±25 µm precision)
✔ Validation Area to ensure compliance with performance standards
✔ Labelling and Packaging for market-ready products
✔ Robust Quality Management System ensuring full regulatory compliance

Cartridge

Equipment

We specialize in the production of automated diagnostic instruments, delivering rapid and accurate quantitative blood parameter measurements. Our expertise spans across electronics, optical systems, and plastic injection-moulded enclosures, ensuring high-quality manufacturing.

Our manufacturing capabilities include: 

✔ Precision optical systems for diagnostics, including:

•  Optical Microscopy Modules

•  Surface Plasmon Resonance Modules

•  Spectrophotometry Modules

✔ Standard component procurement to ensure supply chain efficiency

✔ Comprehensive Quality Control at every stage:

•  Incoming Material Inspection

•  In-Line Quality Checks

•  Final Product Testing

 ✔ Testing and validation to meet regulatory and performance requirements

✔ Labelling and Packaging for product finalization

✔ Robust Quality Management System ensuring compliance with medical device regulations


Equipment
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