Preassembled Vial
- Sterile and depyrogenated
- Ready to use
- Neutral Type I glass tubing
- CE Marked(upon request)
- ISO 13485：2016 Certified
- DMFs filed with US FDA
- Manufactured per cGMP standards
Process
Sterile open vial
- Sterile and depyrogenated(upon request)
- Ready to use
- Neutral Type I glass tubing
- ISO 13485：2016 Certified
- Manufactured per cGMP standards
Process
Quality Assurance
Our staff are specially trained with an emphasis on adherence to work instructions and the utmost attention to quality.
All aspects, including material control, manufacturing process, quality control, supplier administration, etc. are defined in a set of Standard Operation Procedures.
A complete GMP quality system has been established.The system has been certified by the US Food and Drug Administration (FDA) (cGMP). It also holds ISO13485 and CE certificate issued by global qualification organizations.
