Bioprocessing Validation Service

Bioprocessing Validation Service

Bioprocessing Validation Service

Validation Technical Support

Bio-Link 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.

Available Validation Service at Bio-Link

Bioprocess Research

Extractables/Leachables Research(E&L)

  • BPOG & USP Standard Method Extractables Study

  • Leachable study of customer feed

  • Risk assessment

  • 1500+ E&L-related databases

Bioprocess Microbial Detection

Microbial Detection (BSL2)

  • Bacterial viability experiments

  • Bacterial challenge experiments with sterilizing filters

  • Microbial limit check

  • Sterility testing

Bioprocess Filter Validation

Filter validation

  • Chemical compatibility studies

  • Product wetting integrity testing

  • Adsorption studies

  • Integrity testing

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Want to know more about Bio-Link bioprocessing products? Feel free to contact Bio-Link now!