FFuzkk Atlas of China
#12Official Top 100

Kelun Pharma

四川科伦药业股份有限公司

#12

Sterile productsChemical medicines and finished dosage formsOncology, ADC and high-potency

Manufacturing profile

Sterile products
Chemical medicines and finished dosage forms
Oncology, ADC and high-potency

Region: Sichuan

Selection basis

The company is included in the official 2024 ranking of the 100 largest Chinese pharmaceutical-industry enterprises by main-business revenue.

The FUZKK fit shows potential applicability of existing utilities. It does not claim actual use of FUZKK, specific installed equipment models or a product not confirmed by the public company profile.

Representative manufacturing and QC chain

  1. 1WFI, clean steam and cleanroom HVAC
  2. 2Solution preparation and bioburden control
  3. 3Sterile filtration
  4. 4Isolator/RABS filling or lyophilisation
  5. 5Sterility, endotoxin, particles and container-closure QC
  6. 6Raw-material receipt and identification
  7. 7Dispensing, blending and granulation
  8. 8Tableting, encapsulation or solution preparation
  9. 9Packaging and labelling

Relevant FUZKK packages

LabEx QC SuiteSterile Medical Devices SuiteGlobal API & Biosimilars QC SuiteChina: national essential medicines QC packageADC / Conjugated Biologics QC SuiteLumex QC Suite

Product/API utilities

Water For Injections Quality CheckerFill Volume & Container Closure CheckerAssay & Impurities Result ReviewerADC Aggregation MonitorADC Drug Antibody Ratio AnalyzerADC Free Payload QuantifierADC Linker Stability ProfilerADCRelease Readiness Checker

Lumex — instrumental QC

AAS Glass Leachables TestCE Inorganic Ions AnalyzerLabWare CDS Bridge ConnectorGenotoxic Impurity Screener M7Content Uniformity Acceptance ValueDissolution Profile f2 CalculatorCE Chiral Separation CheckerAAS Elemental Impurities Class1CE mAb Aggregates FragmentsCE mAb Charge Variant Checker

LabEx — laboratory QC

Sterility Test Membrane Filtration Quality CheckerBacterial Endotoxins LAL Quality CheckerParticle Count Injection USP <788> Quality CheckerFilter Integrity Test Quality CheckerPackage Integrity & Leak Test Quality CheckerOsmolality Quality CheckerEnvironmental Monitoring Cleanroom Quality CheckerAssay & Impurity HPLC Quality CheckerResidual Solvents GC Quality CheckerWater Content KF Quality Checker

Medical Devices — equipment and software lifecycle

Process Validation CheckerData Integrity Security CheckerRelease Readiness CheckerSupplier Evaluation CheckerCalibration Status CheckerChange Control Impact CheckerRequirement Traceability Checker

Suggested first pilot

  1. Confirm one real product, method or recurring QC review.
  2. Record the instrument, export format and current specification.
  3. Select 3–7 utilities from the map above.
  4. Run a PASS/FAIL sample and agree the expected output.
  5. After user validation, expand the scope.

Mapping boundary

The FUZKK fit shows potential applicability of existing utilities. It does not claim actual use of FUZKK, specific installed equipment models or a product not confirmed by the public company profile.

Methodology