Facility
Located in the Kunshan Medical Device High-Tech Industrial Park, Sinova’s manufacturing facility is conveniently located within 60km of both Shanghai and Suzhou city centers.
Factory Building
Location: Kunshan Medical Device High-Tech Park
- Qiandeng Town, Kunshan County, Jiangsu Province
Total Space: 3,400 sq. meters
- 1st Floor:
- Production, Packaging
- 2nd Floor:
- Offices, Product Development, Testing Lab, Warehouse
Cleanroom
4 Separate Cleanrooms
– Cleanroom 1
- Area: 217 sq. meters
- Class: 10,000
- China GMP Certified?: Yes
- Purpose: Assembly & Packaging
– Cleanroom 2
- Area: 266 sq. meters
- Class: 10,000
- China GMP Certified?: Yes
- Purpose: Assembly & Coating
– Cleanroom 3
- Area: 258 sq. meters
- Class: 10,000
- China GMP Certified?: Yes
- Purpose: Extrusion & Grinding
– Cleanroom 4
- Area: 27 sq. meters
- Class: 10,000
- China GMP Certified?: Yes
- Purpose: Intermediate processing
Testing Lab
Capabilities:
- Accelerated Aging
- Bacteria Detection
- Aseptic Test
- Bacterial Endotoxin Test
- Chemical Tests For Product
- Acidity & Alkalinity
- Heavy Metal Content
- Potassium permanganate reducing substances
- Ultraviolet Absorbance (UVA)
- Evaporative Residue
- Discoloration Tests
- Residual Ethylene Oxide & 2-Chloroethanol
- Size measurements
- Laser Micrometer
- Secondary Image detector
- Pull test
Testing Equipment:
- Force Gauges
- Vision System
- Temperature & Humidity Controlled Environment
- Sterilizer
- Ultrasonic Cleaner
- UV-Vis Spectrometer
- Aging Ovens
Office Space
Total Area: 550 sq. meters
Cubicles: 14
Office Rooms: 11
Meeting Rooms: 2
Warehouse
Total Area: 564 sq. meters
Water Filtration
Multiple-Effect Water Distillation (MED) System