Fill & Finish
Close attention must be paid to the final steps of the manufacture of the drug product as this is the last opportunity to ensure product integrity.
Vibalogics tries to achieve an optimal product yield by continuously attempting to keep product loss during filling operations to a minimum. Usually a product-fill simulation is carried out prior to final product filling.
Vibalogics also sets very high standards regarding vial cleaning, sterilization and depyrogenization. Effective cleaning procedures such as fumigation are established to prevent cross-contamination. Regular media-fill simulations according to cGMP guidelines for standard formats are performed. For customer-specific needs such as different batch or vial sizes we swiftly validate and establish any requested process, assuring the highest standards of product quality.
We offer fill & finish also as stand-alone service.
Vibalogics assists their partners in their choice of vials, stoppers and seals to meet European compendial requirements.
- Filling using disposable and conventional systems/units
- Vial filling (per cycle)
- up to 10,000 2R vials
- up to 8,000 6R vials
- up to 5,000 10R vials
- Labeling of primary packaging (only non-blinded batches)
- Labeling of secondary packaging