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GMP Manufacturing

Aseptic manufacture of drug products in a Grade A environment with Grade B background ensures that the products we manufacture are of the highest quality for administration to the patient.

Vibalogics specialises in aseptic drug product manufacturing and has a spaciously designed fill and finish suite with Grade A/B classification.

With a maximum lyophilization capability of 3,000 DIN 2R vials, our services are perfect for customers who require material for Phase I/II clinical trials.

Vibalogics’ fill and finish and lyophilization operation:

  • Experienced fill and finish team dealing with virus and live bacterial products
  • Lyophilized products up to BSL-2
  • Process Development lyophilizer for non-GMP batches and formulation/ lyo. cycle development
  • Grade A/B clean room for manual and automatic operations
  • 100% semi-automatic visual inspection
  • 100% IPC weight check with automatic adjustment
  • Filling of DIN 2R, DIN 6R, 10R vials etc. corresponding to 4 ml, 10 ml, 13.5 ml brimful volume
  • Packaging material suppliers, all inspected and qualified
  • Validated processes (media fills) in place for standard fills
  • Room disinfection by vaporous hydrogen peroxide fumigation

To remain up to date with the latest interpretation of GMP, key personnel of our company is a member of the Parenteral Drugs Association (PDA), the International Society for Pharmaceutical Engineering (ISPE) and the International Association for Pharmaceutical Technology (APV).

Call us today to discuss your fill and finish requirements ether as an independent service, or as part of a full manufacturing project.

For more information regarding Lyophilization GMP Manufacturing, contact us today on +49 4721 565 400 or email contact@vibalogics.com

Lypho

A comprehensive service to companies requiring…

…virus and live bacterial products filled for clinical trials