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SERVICES

Manufacturing

 
 
 
 
•A 6500 m2 facility, encompassing 1250m2 clean room
•Clean room with GMP ISO 8 (Class 100000), production room with GMP ISO 7 (Class 10000) and GMP ISO 8 (Class 100000), and a product assembly room
•Obtain multiple production lines, with annual capability to 50 million reagents
•Complete storage space, equipped with raw materials, packaging materials, intermediate products, semifinished and finished products

•Well-designed plant layout, prevents cross-contamination, site features are complete

Key Equipment and utility services
•Janus automated liquid handling work station: Flexible and scalable at any range or throughput
•Automated reagents loading system: Involves canning, capping, printing and labeling
•Efficient drying system: Humidity level to as low as 10 %
•Purified water system: Double RO + EDI, complies with GMP standard

Licenses

•ISO13485 certified
•Cleaning room inspection qualification report