FFuzkk Atlas of China
#89Official Top 100

Tofflon Science

东富龙科技集团股份有限公司

#89

Pharmaceutical equipment and engineeringMedical devices

Manufacturing profile

Pharmaceutical equipment and engineering
Medical devices

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. 1Raw-material receipt and identification
  2. 2Dispensing, blending and granulation
  3. 3Tableting, encapsulation or solution preparation
  4. 4Packaging and labelling
  5. 5HPLC, GC, KF, ICP/AAS, dissolution and stability QC
  6. 6Design inputs and risk management
  7. 7Supplier and incoming controls
  8. 8Assembly and process validation
  9. 9Software, electrical safety, EMC and usability

Relevant FUZKK packages

Medical Devices Standards & Lifecycle QC SuiteMedical Device Software SuiteMedical Device Risk Management SuiteElectrical Safety & EMC SuiteUDI & Labeling SuiteMedical Device QMS Suite

Product/API utilities

Companion Diagnostic Report Checker

Lumex — instrumental QC

AAS Glass Leachables TestCE Inorganic Ions AnalyzerLabWare CDS Bridge Connector

LabEx — laboratory QC

Environmental Monitoring Cleanroom Quality CheckerTOC Water Quality CheckerpH & Conductivity Water Quality CheckerWater Microbiology Quality CheckerFilter Integrity Test Quality CheckerPackage Integrity & Leak Test Quality CheckerSterility Test Membrane Filtration Quality CheckerBacterial Endotoxins LAL Quality CheckerMicrobial Enumeration (TAMC/TYMC) Quality CheckerElemental Impurities ICP Quality Checker

Medical Devices — equipment and software lifecycle

Design Control Compliance CheckerSupplier Evaluation CheckerCalibration Schedule CheckerCalibration Status CheckerProcess Validation CheckerRequirement Traceability CheckerConfiguration Baseline CheckerIntegration Test Coverage CheckerData Integrity Security CheckerCybersecurity Risk Assessment CheckerRisk Management Report Completeness CheckerRisk Control 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