project

Qualification and validation of equipment for a biotechnology plant

Compliance / Security Life Sciences Switzerland

Context and challenges

This client is a world-scale company specialized in biotechnology. One of its new sites, located in Luterbach near Solothurn is a new biological manufacturing plant. Start up of the plant is scheduled for 2019 and will be fully operational in 2020.

This plant will be specialized to support the manufacture of mammalian cell culture products within the bio-pharmaceutical production units.

First of all, it is planned to build two bio-manufacturing production entities. Afterwards, according to the site Master Plan, seven additional units are planned to be built. Each building is comprised of all the necessary equipment (upstream and downstream, utilities and support) for the production of biopharmaceutical substances for drugs.

Additional facilities located at Solothurn will include a warehouse with manufacturing support, administration facilities, a Central Utilities Building (CUB), QC (Qualification and Commissioning) laboratory and a tank farm.

This client has appointed Assystem Care, during the construction phase to perform qualification and validation of systems, using the Atlas methodology.

Logo Assystem Care

Project scope

The mission consists of delivering qualification, including temperature mapping services related to support equipment (manufacturing equipment). The mission covers autoclaves, washing machines, cold rooms, storage areas, incubators, freezers, biosafety cabinets, etc. Sensors are placed inside the equipment to check the temperature stability. The equipment is used for production quality control (local freezers, temperature incubators, etc.).

Assystem Care teams applied the Atlas methodology, including:

  • The writing of qualification protocols (IC [Installation Confirmation], FC [Functional Confirmation]), using a “1st of a kind, subsequent of the kind” approach (checking whether specifications are met and checking functional tests)
  • Protocol execution (thermal mapping, coverage testing, etc.) and organisation of workshops with the customer’s personnel
  • Review of protocol executed and drafting of report

Tasks and deliverables are performed in close cooperation with customer engineering, and validation and quality representatives.

Client benefits

  • Improved activity coordination, through the reviewing of methods and qualification processes in the project management phase
  • Fewer errors during the execution phase, through the drafting of improved protocols
  • Efficient equipment qualification, following feedback from the support equipment, which was qualified first
  • Lower potential risk of delays related to equipment, qualification and production startup, due to the Atlas qualification method adopted. This method prevented any negative effect on production and provided a smooth transition from theory to practice

In figures

2

production buildings

1

utilities building

90

equipment

20

improvements for basic protocols

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