BioLink Validation Analysis Center (Agilent co-constructed laboratory) covers an area of about 1400 square meters, equipped with various large-scale precision instruments, including Inductively Coupled Plasma Mass Spectrometer (ICP-MS), Ultra High Performance Liquid Mass Spectrometer (LC-MS), Gas Mass Spectrometer (GCMS), TOC Detector, Automatic Microplate Reader, Infrared detector (FTIR), etc.
The platform is operated and managed according to the CMA and CNAS(CNAS[ISO17025]) quality systems. Committed to the daily quality control and verification analysis solutions of biopharmaceutical consumables.
Extractables/Leachables Research(E&L)
BPOG & USP Standard Method Extractables Study
Leachable study of customer feed
Risk assessment
1500+ E&L-related databases
Microbial Detection (BSL2)
Bacterial viability experiments
Bacterial challenge experiments with sterilizing filters
Microbial limit check
Sterility testing
Filter validation
Chemical compatibility studies
Product wetting integrity testing
Adsorption studies
Integrity testing
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