Design, Construct, Validate and Maintain

Cleanroom Facility

SAFC Biosciences (Irvine) are manufacturers of cell culture products, reagents and Down Stream Purification (DSP) buffers.

Background to the project

SAFC required a full strip out of an existing production area, to be replaced with the construction of a new cleanroom facility with two mixing rooms and two fill rooms, as well as an adjacent WFI plantroom. T-SQUARED successfully tendered against three other companies to be appointed as the specialist design and build contractor. T-SQUARED worked with the client’s design brief to develop the design of the cleanroom production suite.

The scope of works also included the process design involved with the production machinery with all the Validation involvement from the Medicines and Healthcare Products Regulatory Agency (MHRA) and Food and Drugs Administration (FDA).

Scope of the project

T-SQUARED, working alongside SAFC Biosciences, created the cleanroom facility which included the following works:

  • Full strip out of existing production area
  • Design and build of two cleanrooms
  • Design and build of two mixing areas
  • Design and build of two fill rooms
  • Design and build of WFI Plantroom
  • Process design for production machinery
  • Validation involvement from the MHRA and FDA

Timescales

The project was completed on time and to budget.