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Plant Isola; Italy


Key Data

The plant is a crucial part of the global Fresenius Kabi supply chain, delivering infusion solutions to many European countries, some countries in South America and North Africa. And of course the plant also works for business-to-business customers, who include both domestic and international pharmaceutical companies. The client’s expectations are, as always, the driver for our processes and services.

 

  1. Markets:
    • International scope
  2. Technologies:
    • Glass -bottles
    • BFS PE bottles

    • Sterile product with terminal sterilization

  3. Containers:
    • Glass Bottles: (also as single pack): 100 ml, 250 ml, 500 ml and 1000 ml
    • PE Bottles: 100 ml, 250 ml, 500 ml

  4. Certifications:
    • EU GMP for Human and Veterinary products
    • ISO 9001 (Quality)

    • ISO 13485 (Medical Devices)

    • ISO 18001

    • ISO 14001 (Environment)

  5. Services:
    • Supply Chain
    • QC Support
    • Stability Studies
    • Warehousing and Shipping
    • Regulatory Support    

 

In the Spotlight

The production site of Fresenius Kabi Italy is located in Isola della Scala, 20 km south of Verona (100 km from Venice), perfectly served by motorway and an international airport. For nearly four decades, standard solutions are manufactured at this plant. Operations began with glass production in 1972.

 

In 40 years, many different sterile, injectable products (ampoules, bags, glass bottles, PE bottles) have been manufactured here, building a strong competence in sterile production for standard solutions.

 

At the same time, continuous improvement efforts and technological innovation based on Operational Excelence approach, generated the current plant where, in a site of 33,500 square meter, you can find the latest technology for production of PE BFS bottles on highly automatic and efficient lines. The facility is ISO 9001 and GMP certified. In the plant, all the departments are organized to support the goal of producing products with the highest standard of quality.

 

Production, engineering, maintenance, quality control laboratories, quality assurance, planning, logistics, purchasing and controlling departments work every day with professionalism and passion to ensure that patients receive the best possible product.

 

All the processes are managed by people trained in their job and continuously updated about client expectations.

 

The quality of the product and of the containers is checked before, during and after production, by IPC and automated inspection machines.

 

But more important is, that the quality is assured by a plant highly aware of the importance of the people knowledge and training, about the appropriate level of maintenance of the equipment and utilities, and about the effort in investment in new technology.

 

The facility manufactures a wide range of standard solutions in glass and in PE plastic bottles with the Blow-Fill-Seal technique.

 

The PE bottle production was set up 4 years ago creating, in the plant, a new dedicated and highly automated department.

 

There are two lines for glass bottles (100 ml, 250 ml, 500 ml, 1000 ml) and three lines  for PE bottles (100 ml, 250 ml, 500 ml), working 24 hours a day, 7 days a week.

 

New climate chambers are available for stability studies according to the ICH requirements.