FORMULATION & MECHANICAL PIPING INSTALLATION, Broadmeadows
CSL Biotechnology Manufacturing Facility

Client: CSL Behring
Year: 2017
Industry: Pharmaceutical
Location: Victoria

  • PROJECT SCOPE
  • SPECIALIST INSTALLATION
  • QUALITY ASSURANCE
  • INNOVATION & COMPETITIVE SOLUTIONS

TFG Group was engaged to complete the pipework and mechanical installation to increase production of the formulation area in the existing CSL plant. The Biotechnology manufacturing facility required substantial upgrades to all clean rooms and due to the increased demand for plasma, the project was expedited from the original timeline. TFG upgraded the process piping and process service piping to the formulation, bulk purification, sterile filtration and sub fraction sterile plants to ensure the plant was efficient with production.

A 14-strong specialised welding team ensured the project was completed in the very tight timeframe. All pre-spooling fabrication was carried out prior to the 2-week shutdown where final ties-ins to existing process and service pipework was completed. Orbital welding was performed to an exceptionally high standard together with borescoping to inspect all internal welds. All tradesman completed and passed daily weld tests inclusive of all NDT competencies. 

Full traceability was mandatory for all fittings and weld maps, coupled with qualifications and drawing updates to CSL standards and QA requirements. TFG complied and submitted a Quality Assurance Manual including quality plan, material and test certificates, welding procedures and qualifications, weld mapping, as-built isometric drawings and installation checklists. All welds were documented to ASME BPE 2014 Bioprocessing Equipment Standard.

TFG personnel have been highly commended on the installation of the addition of the new IgLAB IV Bulk Formulation and Ultra filtration which forms part of the overall bulk process of the CSL Broadmeadows facility. The timeline and scope of works required TFG to meet and achieve stringent deadlines within the production schedules. TFG supplied orbital welders and an onsite qualified QA personnel throughout the project to ensure all aspects were successfully achieved with a 100% safety record.