Design & DevelopmentCleanroom EnvironmentThermoformingAssembly & Contract packaging Complementary ProcessLaboratory & ValidationHeat Sealing Machines

Laboratory & Validation

Quality Assurance & Regulatory Affairs

Experienced–continuous
training–customer focus culture

People

continuous improvement–Lean

System

reliable–High technology–scalable

Equipment

traceability, SPC, capa pk, cpk
Change Control & risk analysis (FMEA product & process)

Control

Technical Files management, regulatory
compliance, normative forecasting

Regulatory Affairs

Packaging Validation

  • Laboratory

    The group invests relentlessly in equipments for its Quality Laboratory, where all control measures and tests are done. Some examples in two different application fields:

    Control of microbial contamination in ISO 7 & ISO5

    ●Microbiological contamination control of our ISO 7 & ISO5 clearnroom:
    ●Bacteriological controls,
    ●Biodurden testing,
    ●Control of air cleanliness (YY0033),
    ●Microbiological samples of air and surface areas (GB16293),
    ●Test reports on cleanroom performances etc.
    ●Micro insoluble particle inspection GB8368

    ●“Dimensional Laboratory” for the product control:
    ●Control during the manufacture,
    ●Batch Release

    Pull Strength

    Dye penetration test

    DYE test

    Cleanroom control

    Micro insoluble particle inspection

    x

    Under Construction

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