cGMP Modular Clean Room Fit-out

Overview:

Concept Projects Group were appointed to manage a compliance-driven upgrade project on behalf of a biotechnology manufacturer. Following the release of updated Annex 1 regulatory requirements, the client’s current sampling facilities were identified as non-compliant with cGMP due to the absence of a Grade D environment. To address this, we oversaw the implementation of a cGMP modular clean room fit-out, including the transfer of the existing Biological Safety Cabinet.

Scope Deliverables:

  • Project management
  • Feasibility study
  • Scope definition
  • URS generation
  • Tender management
  • Spatial coordination & visual layouts
  • Area assessment – civils, utilities, & power
  • Installation management of a standalone modular clean room to support QC sampling activities
  • GMP Cleancube Mini+ supplied, designed, installed, cleaned and commissioned in collaboration with
  • Guardtech Group (Clean Cube)
  • 1st and 2nd fix utilities including electrics, water, and nitrogen feed
  • CDM management – risk assessments, method statements, permit coordination, and health & safety file
  • Personnel Airlock fit-out: vinyl flooring, gown hangers, mirror, overshoes, face mask and hair net dispensers along with step over bench
  • Material Access Hatch fit-out: unidirectional airflow, vinyl flooring and stainless steel 316 transport trolley
  • QC Sampling Area fit-out: oxygen depletion sensors, Facility Monitoring System (FMS), COSHH cabinet, workbench, and biological safety cabinet
  • Snagging & sign-off
  • Handover package

Result:

The project was delivered on time and within budget, and achieved zero lost time accidents. The modular clean room was installed with minimal disruption, allowing warehousing operations to continue as normal. Using FAT & SAT protocols, the facility now meets Grade D requirements, ensuring cGMP compliance and reinforcing the client’s commitment to regulatory standards.

“Concept Projects Group (CPG) proved to be an excellent main contractor, demonstrating exemplary communication skills, strong leadership and impeccable standards on and off site. We worked together to install a Cleancube Mini+ portable cleanroom facility in an extremely tight space. What could’ve been a challenging project was made infinitely more achievable due to the fantastic collaborative relationship we formed. The Guardtech Group would highly recommend utilising CPG’s services for similar projects in the future.”

Elliott Pearce
Project Manager at Guardtech Group

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