Validation Services

Category:Outsourcing Contract, Custom service, Consultation > service > Analysis and Validation
Product Name:Validation Services
CAS No.:/
Standard:ChP, USP, EP
Price(USD):Negotiable
Company:Hangzhou Cobetter Filtration Equipment Co.,Ltd.

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Basic Info
  • Grade: Food Grade, Pharmaceutical Grade, Injection Grade and Sterile Grade

    Factory Location: HANGZHOU, ZHEJIANG, CHINA

    Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Asia,Middle East

  • Sample Provided: no

    Payment Terms: T/T

    Founded in 2007 with a 70 million RMB investment, Cobetter Filtration Validation Center has been accredited by China National Accreditation Service for Conformity Assessment (CNAS). Our Validation Center Team includes 10+ international experts and 80+ lab technicians. We provide over 1,200 technical validation reports annually to customers in the pharmaceutical industry and 1,300 technical validation reports annually to customer in the electronics, chemical, and life sciences (excluding pharmaceutical) industries.

     

    · Bacteria Challenge Test

    With our technical experience and deep understanding of the sterilization process, our Validation Center can provide validation services to global customers in the Life Sciences Industries so that they comply with GMP standards regarding Data Integrity.

     

    Validation Services include Bacterial Challenge Test (BCT), Extractable Test, Chemical Compatibility, Integrity Test, and Adsorption Test.

     

    By following both PDA TR26 and ASTM F838 standards, Cobetter Validation Center providers her customers with customized filtration solutions and technical support.

     

    Process Validation

    Sterilized Pre-filters

    Sterilized Final Filters

    Bacteria Challenge Test

    Required

    Optional

    Extractable Test

    Required

    Required

    Chemical Compatibility

    Required

    Required

    Integrity Test

    Optional

    Optional

    Absorption Test

    Evaluate and Perform if Necessary

    Evaluate and Perform if Necessary

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