Validation Service
Since 2013, Celltricks, along with Cobetter, has been providing customers with validation services that comply with regulatory requirements and quality standards. With 20 years of rich experience and expertise in biopharma, we offer a wide range of tests for filters, single-use bags, and assemblies.
Our Validation Center, established over an area of 7,000㎡, is approved and validated by CNAS. Currently, we have more than 8 foreign laboratory experts and deliver over 6,200 validation reports annually to biopharmaceutical customers.
Sterile Filtration Validation
Bacterial challenge test is a critical step for drug manufacturing and processing to validate final sterilizing-grade filters. Cobetter have 20 years of experience and technical expertise in sterile filtration validation.
- Bacterial challenge test
- Chemical compatibility test
- Extractables and Leachables test
- Binding study
- Integrity test
Extractables and Leachables Study
With the wide use of single-use systems in the biopharmaceutical industry, extractable and leachables (E&L) testing become very important.
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TYPE
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Testing Methods
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Target
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Organic
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HS-GC-MS
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Volatile Substances
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DI-GC-MS
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Volatile and Semi-Volatile Substances
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UPLC-UV-MS
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Semi-Volatile, Non-Volatile Substances
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HPLC
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Semi-Volatile, Non-Volatile Substances
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TOC
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Total Organic Carbon
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FTIR
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Non-Volatile Residue
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Inorganic
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ICP-MS
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Inorganic Elements
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Organic/Inorganic
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NVR
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Non-Volatile Substances
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UV
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UV-Absorbing Substances
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pH
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Acidic or Alkaline Substances
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Conductivity
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Conductive Lons
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Virus Clearance Services
Virus clearance study is the most important step of a biopharmaceutical manufacturer’s strategy to ensure drug product safety. Virus clearance is the only way to prevent unexpected virus contamination, therefore, reliable virus clearance validation is crucial to ensuring patient safety. Cobetter provide sufficient virus clearance data, as well as expert consultation on virus clearance process design and optimization.
- Official origin of cells and virus ensure traceablity of data
- From process development to VC validation
- Customizable services with high purity virus
- High purity virus
- Compliant with GLP management
- Compliant with FDA/EMA/NMPA audit standards