DiaSorin S.p.A. – Manufacturing Liaison Products

Create a new 1,050m2 manufacturing facility within an existing operational area on the ground floor for the production of In-vitro Diagnostic Products (IVDs).

A preliminary design study, using our in-house multidisciplinary team was undertaken to provide an outline programme and ±10% estimate. This was to follow the conceptual layout produced by DiaSorin SpA UK.

The preliminary design study was undertaken to ascertain the most appropriate way of accommodating the user requirements including additional manufacturing areas with support and ancillary facilities.

The facility was to be a ‘standalone’ FDA/CBER compliant with manufacturing undertaken in an ISO 8 low bio-burden environment.

The HVAC solution included the provision of two dedicated ventilation systems and associated air handling plant. ISO 8 areas were to include terminal HEPA filtration including on-site integrity testing.

Space constraints necessitated the construction of a new mezzanine deck within the ceiling void to accommodate the HVAC plant.

Design proposals included structural, mechanical, public health, and electrical engineering to confirm compliance to FDA/CBER and user requirements

This Preliminary Design was followed by detail design, competitive procurement, construction, commissioning and validation of the IVD manufacturing facility.

The developed layout satisfied key adjacency requirements, grouping ISO 8 classification areas and less critical ISO operations with non-classified spaces, providing separation whilst considering an optimal solution for the ventilation and services distribution.

Personnel access to the new facility is provided via a single access through the existing building with a new change facility. Access thereafter to either the corridor leading to ISO 8 classification areas, or to the returns corridor are segregated. Further change facilities are provided to divide the critical and noncritical spaces.

The returns corridor running along the length of the north side of the building can be accessed without compromising classified/clean areas; and fire egress from the new facility can be made via the returns corridor rather than via a clean corridor area.

A new plantroom area within the facility accommodates two dedicated AHUs located internally, with the chiller and condensers located externally. To overcome space restrictions, this extended to plant and equipment located within the ceiling space with adequate access.

The air handling solution was designed as bespoke, as standard units could not be accommodated.

Austin undertook the complete design, engineering and construction management of this challenging project, including HVAC validation to the Client’s satisfaction.