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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 our recent filling line upgrade, we can fill at 7,200 vials per hour using our automatic filling line, offering liquid fill batch sizes of up to 30,000 DIN 2R vials, perfect for Phase I/II clinical trials and beyond.

We also offer manual filling options for bespoke requirements and difficult to handle products.

Vibalogics’ liquid fill and finish operation:

  • Experienced fill and finish team dealing with virus and live bacterial products
  • Liquid and lyophilized products up to BSL-2
  • Grade A/B clean room for manual and automatic operations
  • Liquid fills with 0.2mL to 1.5mL volume
  • 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.

All of our operators are gowning qualified according to our SOPs prior to being allowed to work in the facility with an individual competence matrix and documented training record for each member of staff to ensure that individuals are qualified to perform the tasks required.

The facility is monitored at rest and during operations to ensure that the environment meets specification during critical manufacturing operations.

We welcome you to visit us and see our operation for yourself.

For more information regarding our Fill & Finish Manufacturing Suite, contact us today on +49 4721 565 400 or email contact@vibalogics.com

Liquid Fill Finish

Aseptic fill and finish of biopharmaceuticals…

…in a Grade A/B environment