INSIGHTS ON REGULATORY COMPLIANCE

REGULATORY COMPLIANCE SOLUTIONS

  • STELLARIS is a completely re-imagined confocal microscope platform.

    STELLARIS confocal microscopes can be combined with all Leica modalities, including FLIM, STED, DLS, and CRS. With the STELLARIS confocal platform, we have re-imagined confocal microscopy to get you closer to the truth.

  • The Class 2, Type A2 Laminar Flow Biosafety Cabinet provides a high degree of localized protection from particulate and aerosol hazards. The work area of the biological safety cabinet is continuously bathed with laminar flow ISO 5 HEPA-filtered air to protect the product from contamination while an inward airflow protects the user. Approximately 70% of the air from each cycle is recirculated through the supply HEPA filter while the remaining air is discharged from the biosafety cabinet through the exhaust HEPA filter. These biosafety cabinets eliminate cross-contamination and the accidental release of carcinogenic aerosols and drugs to the outside environment.

  • The out-of-specification (OOS) product in the MasterControl Quality Management System (QMS) allows for seamless compliance.

  • Therapies are more complex, tailored, and varied than ever, and the associated amount of data is growing – which requires a new level of attention to detail.

  • Examine how sterilizing-grade filters with high flux and broad compatibility support efficient bioprocessing across mAbs, vaccines, and viral vectors.