Neoka Group

Pharmaceutical plant, R22, Professional services for various sterile sites, Canada

Delpharm
1
year per mandate
> 4
M $ CAD
Engineering
Project management

Main tasks performed

Consultant placement :

  • CAPEX Project management in sterile and OSD plants;
  • Commissioning and validation;
  • CAPA management;
    Technical studies to ensure compliance with GMP, regulations and best practices;
  • Plant health and safety assessments and machine safety assessments.

Replacement of rooftop ventilation units for a site :

  • Completion of feasibility study and detailed cost estimate for projects;
  • Development of detailed design for MEP systems, to ensure compliance with applicable codes and standards;
  • Development of plans and specifications for MEP systems, enabling efficient integration of other project components.
  • Analysis of a site’s fire protection system for retrofit;
  • Upgrade of a site’s fire alarm system;
  • Bringing a site’s crawl spaces up to standard;
  • Design study of WFI network points of use for two buildings on the same site;
  • Analysis of gas and ventilation system compliance;
  • Drafting of operating procedures (SOP).
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