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Validation

Listening to customers and following strict rules
helps us track processes, offering reliable,
tailored solutions for development and validation studies

Center Overview

Advanced hardware, reliable validation services

300+㎡

  • Featuring a 300+㎡ professional validation laboratory, with cleanrooms classified at both ISO 7 and ISO 8 levels.

Standardized Management

  • Adhering to standardized management procedures to ensure the sufficiency, validity, and traceability of data

50+ Types

  • Develop over 50 validation and application experimental methods to meet regulatory validation requirements and filtration process development needs.

Testing Subjects

More than 50 methods

Methods for validation and testing, fulfilling regulatory needs and process development for filtration.Including, but not limited to:

  • Microbial challenges
  • Extractables and leachables
  • Chemical compatibility
  • Product integrity
  • Product adsorption analysis
  • Filtration performance analysis
  • Filter selection
  • Material selection
  • ...

Testing Subjects

Microbial challenges

Extractables and leachables

Chemical compatibility

Product integrity

Product adsorption analysis

Filtration performance analysis

Filter selection

Material selection

Validation Services

We offer clients:

sterile filtration validation, virus clearance validation, filtration performance validation, and filtration process development, etc.

TEL

0571-86707870

Consultation

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