Eisai Manufacturing Ltd (EML)

Project 075 Packaging Line Facilities, Hatfield

The Opportunity

EML required High Potency Packaging (HPP) lines as part of their future production expansion strategy.

Austin were asked to undertake the design and construction for fit-out of new Good Manufacturing Practice (GMP) packaging lines at EML’s site in Hatfield. The site encompasses four main buildings: a Production Facility, Headquarters Office, R&D laboratories and Shared Facilities.

The EML production building is circa 8,000m². EML had added an extension to the production facility to accommodate a HPP line (Packaging Line 5). Part of this production building extension was left for future development. This project’s aim was to complete these areas with the detailed design and construction for Packaging Lines 7 and 8, one of which is for HPP products, and the other with the capability of being quickly adapted for HPP products.

The additional packaging lines and adaptation/remodelling of adjacent GMP areas, together with the construction of new shared support areas, included changing rooms and welfare facilities to be developed and provided within the scope of this project.

The requirements extended to include:

  • PL6 – Secondary Packaging room (+15Pa)
  • PL7 – Multi-product blister line (Primary +30Pa/Secondary +15Pa)
  • PL8 – High Potency Packaging rooms (Primary -30Pa 25% RH/Secondary -15Pa)
  • Changing rooms – Production facility
  • Changing rooms – High Potency Packaging (HPP) facility
  • General locker area – Controlled not classified (CNC)
  • Tearoom/Rest area
  • Accessible Lift
  • Link corridors (GF) between PL7 and Production Changing rooms to the Main Production building
  • Welfare facilities

The Solution

Austin developed the detailed design and implementation plan based on EML’s brief to meet their criteria and constraints of working in adjacent operational areas.

The design involved 3D modelling to integrate the new facility within the constraints of the existing building, with a complex link design to connect the two production facilities.

M&E services were designed to be installed within the existing operational plant room, adding more complexity. This included 3 No. AHUs, 2 No. 550kW LTHW Heat Exchangers, HW Storage Calorifiers with duty/standby, extending Chilled Water Systems, etc. within an existing congested plant room.

Work was undertaken alongside operational GMP facilities. This entailed planning critical works over weekends and evenings.

Groundworks commenced early to reduce overall timescales whilst internal designs were developing.

Working in a live manufacturing environment/ setting whilst maintaining services as well as working alongside EML to sustain operability.

Interfaces between construction and the end users required meticulous planning and coordination of activities. This was managed via an interface schedule agreed at the outset with EML.

The design had to be in keeping with the existing building, allowing for both buildings to operate as one.

Constructing 3 link buildings to connect to the existing Production Building with the new facility, whilst maintaining water tightness to the building and avoiding impacting adjacent operational GMP facilities.

Supporting early delivery and assembly of packaging equipment during construction and prioritisation of critical utilities to meet EML timelines for validation.

  • architecture
  • mechanical
  • electrical
  • structural
  • public health
  • construction
  • management