VIVUNT PHARMA

VIVUNT is a pharmaceutical company with over 30-years’ experience specialized in manufacturing drugs. We have 3 manufacturing sites and this year we are launching new state-of-the-art facility for sterile oncology drugs both in liquid and lyophilized vials.

From this new facility we offer CMO services to other pharma companies for the manufacturing of these dosage form and therapeutic area. Our facility incorporates state-of-art technology and fully complies with the Annex 1 EU GMP and US FDA standards.
We also have a Quality Control laboratory for both API and FDF batch release and stability testing.

Technology:

- Dosage forms: Liquid vials and lyophilized vials.
- Isolators for raw materials sampling and dispensing and product manufacturing.
- 3 compounding vessels: 5, 20, and 300 liters.
- Batch sizes ranging from 3 to 1,200 liters, working under campaigns.
- Automated product filtration system with CIP, DIP & SIP. Filter integrity test incorporated.
- High-speed filling line:
- 100 vials per minute / 6.000 vials per hour.
- Full range of ISO formats from 4R to 100R.
- Automated vial stoppering system under nitrogen atmosphere.
- Lyophilizer with loading and unloading automated system, under Class A.
- Maximum lyophilization capacity: 240 liters / 10 m² surface.
- Automated vial stoppering system inside the lyophilizer chamber under nitrogen atmosphere.
- Automated in-process control (IPC).
- Class A & B continuous monitoring.
- Filling volume control by dynamic scale (100%).
- Leakage test by oxygen or electric arc determination (100%).
- Vial optical inspection (100%).
- Manufacturing batches video recorded (100%).
- Quality Control laboratory for API & FDF batch release and stability testing.
- CCTV and interlocked doors security system with face recognition.

Type of Drugs Manufactured:

Small Molecule

CDMO Services:

Drug Product Formulation (FDF)

No. of Manufacturing Facilities:

3-5

High Potent Products capabilities:

OEB 3;OEB 4-5;OEB >5

Facilities Locations:

Europe

Regulatory Approvals for facilities:

EMA (Europe)

Manufacturing Technologies:

Liquids;Lyophilized amps/vials;Sterile Vials

Current Capacity:

Vivunt Pharma is committed to delivering high-quality services to meet the diverse needs of their clients in the pharmaceutical sector. For more information, please visit vivunt.es.