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Plant Catalonia; Spain


Key Data

Vilassar supports customers within Fresenius Kabi as a complete service provider and is therefore a crucial part of the global Fresenius Kabi supply chain, delivering products like standard infusion solutions (NaCl, glucose, Ringer lactate etc), irrigation solutions and Luer-lock PE ampoules to international markets, mainly European countries like Spain, UK, Germany, Italy, Poland, Netherlands, Denmark ans Austria. And of course the plant also works for business-to-business customers, who include both domestic and international pharmaceutical companies. Processes and services are usually tailor made to meet the client’s needs. You could be next.

 

  1. Markets
    • International scope

  2. Technologies:

    • Blow fill seal – bottles

    • Blow fill seal – ampoules

    • Customized BFS Containers (e.g. Drainjet Solutions)

    • QTerminal sterilization

  3. Batch-Sizes:

    • Bottles - Infusion: max. 29.000 L

    • Bottles - Irrigation: max. 29.000 L

    • Ampoules: max. 4.000 L

  4. Containers:

    • Bottles - Infusion: 100 & 500 ml

    • Bottles - Irrigation: 60, 100, 120 & 500 ml

    • Ampoules: 5, 10 & 20 ml

  5. Certifications:

    • EU GMP

    • ISO 9001 (Quality)

    • ISO 14001 (Environment)

    • CE Mark (for Irrigation Solutions) /MDD

  6. Services:

    • QC Support

    • Stability Studies

    • Warehousing and Shipping

    • Regulatory Support


 

In the Spotlight

The production site of Fresenius Kabi’s Spanish affiliate, Fresenius Kabi España S.A., is located in Vilassar de Dalt, 25 km outside of Barcelona. Operations began here in 1964 in the form of a pilot plant for standard solutions in glass bottles and ampoules, in a building of just 264 square meters. Today, the plant houses a cutting-edge blow-fill-seal (BFS) facility, with about 140 employees working in 5 shifts to keep the production running 24/7. The site has its own quality, logistics and administration departments and a warehouse.

 

Top quality

The quality unit has outstanding analytical competence – beginning with analysis of the starting materials, continuing with IPC production surveillance and finally in the release of the finished products. There are climate chambers where stability studies can be done in accordance with ICH requirements.

 

Blow-fill-seal

The plant produces a huge variety of sizes. A recent extension of the BFS capability in the last years added new state-of-the-art bottelpack machine dedicated to 5 mL & 10 mL and 20mL polyethylene (PE) Luer-lock ampoules. A new state-of-the-art polyethylene luer-lock ampoule design has started to be produces in 2014.

 

Ampoules take heat

The Luer-lock PE ampoules are simple to use; maximum safety with needle-free handling and sound performance are guaranteed. The easy-opening twist-off cap and the highly collapsible shape give these ampoules a clear competitive advantage. The new ampoule design has an improved grip of the break-off part to prevent contamination during ampoule opening. Also, they can be sterilized at 112°C to achieve an FO value of higher than 9, which eliminates microbiological risks. The ampoules are 100% free of PVC, latex, DEHP and plasticizer.

Drainjet

Another type of container produced in Vilassar is the Drainjet irrigation bottles. These are squeezable bellows bottles that allow precise manual irrigation. They have a thermo-finished nozzle for easy connection to flexible tubing, and are available in 60 mL and 120 mL sizes.