project

Industrial maintenance strategy for a biotechnology plant

Consulting Life Sciences Switzerland

Context and challenges

This client is a world-wide biotechnology company. One of its sites is a new biological manufacturing facility, located in Luterbach near Solothurn. Production is to start in 2019 to be fully operational in 2020.

This plant will support the manufacture of mammalian cell culture products in bio-manufacturing production units.

Firstly, two bio-manufacturing production units are planned to be built. The site Master Plan allows for up to seven units to be built. Each building has all the required equipment (upstream and downstream, support and utilities) for the production of biopharmaceutical drug substances.

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

During the construction phase, this client appointed Assystem Care to implement an industrial maintenance strategy, including a strategy for integrated facility management organisation.

Logo Assystem Care

Project scope

  • Support the Maintenance and Engineering Department Manager to define and implement maintenance organisation, covering all site equipment maintenance and utilities operations
  • Strategy definition (management processes, etc.) for the integrated facility management unit (which is managed by a third party and set up by client personnel)
  • Definition, implementation and monitoring of key maintenance processes until equipment handover to operations (documentation, procedures, work instructions, maintenance plans and contracts, spare parts, master data creation in CMMS [Computerized Maintenance Management System], training definition and management, tools, workshop, etc.)
  • Involvement in resources recruitment (resources need assessment, job descriptions, interviews)
  • Contribution to site operation readiness, reporting, management of multi-discipline projects
  • Setting up of processes compliant with regulatory requirements (quality and safety, predictive maintenance scheduling, spare parts management, etc.)
  • Proposition of proven solutions in order to increase awareness of potential hazards: definition of maintenance plans, maintenance management system, documentation structure, procedures

Client benefits

  • Time saving and optimised operations, through the definition of an overall maintenance organisation (procedures, tools, etc.), which is operational upstream of commissioning. In addition, the maintenance strategy has been tested upstream, which is also a prerequisite for production
  • Optimisation of mission timing, through the implementation of the maintenance strategy before the maintenance personnel are recruited
  • Qualification of more than 90 systems, without increasing internal personnel

In Figures

2

production buildings

1

utilities building

90

equipment

10

consultants

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