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