QHSES & Compliance Bulk vaccine production building

Project

  • Modification of the general layout of a bulk production building: removal of production equipment followed by total dismantling of the interior of the building (networks, partitions, AHU, etc.) before reconstruction and reintegration of the production tool
  • Qualification of fully automated USP and DSP production equipment under an EMERSON control system (Delta V)

Challenges

  • Quality : 5/5
  • Cost : 3/5
  • Deadlines : 5/5
  • Security : 3/5

Services provided

  • Integrated qualification strategy (from the commissioning phases)
  • Monitoring implementation,
  • FAT tests,
  • Receipt of equipment,
  • SAT (process),
  • QI/QO/QP
  • DOE
  • Management of non-compliance
  • Proposal for technical improvements
  • Priority management and planning for integration of production test batches

Summary

Study duration

5-6

months

Project duration

24

months

Building

4200m²

3 on 3 levels

Expertise

Sheet metalwork, piping

Commissioning / Qualification

Automated system (functional analysis)

Process / CIP

QHSES & Compliance

Fabrication shop risk assessment

16/12/2021

Julia Moynier

QHSES & Compliance

Fabrication shop risk assessment

06/12/2021

Julia Moynier

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