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.

Replacement of Substations C & D, Elstree

The Opportunity

BPL identified a need to replace 2 No. substations on the service floor of Building 27, on their Dagger Lane site.

This is the first phase of a planned upgrade for the rest of the HV/LV systems serving the building. The two substations are critical to the production and research operations within Building 27.

Substation C supplies power and lighting to the Aseptic Filling Suite (AFS) via the existing 500kVA UPS and six associated Air Handling Units. In addition, it also supplies Autoclaves, Freezedriers, Oversealer and Depyrogenation Tunnels for Filling lines 1 and 2.

Substation D supplies critical refrigeration equipment, AHUs, process equipment, power and lighting for all other production areas.

Both substations are approx. 35 years old with switchgear that is approaching obsolescence.

The existing substations are installed in a multi-use plant room area with complex ductwork and piped services. This location is challenging due to the presence of high voltage switchgear in addition to constraints on space availability internally and externally at ground level.

BPL’s URS noted the following key requirements for the design:

• Detailed understanding of the existing substations’ maximum demand and allowances for future loading.
• Address status monitoring and control of switchgear and safety during operation and maintenance particularly at HV.
• Integration of the new substations and the transfer of existing loads during planned shutdown(s).

The Solution

The technical solution included:

• Replacement substations C & D in weather resistant enclosures for location on the roof of the building.
• New SCADA expandable power management and operation software.
• Assessment of existing building for a new structural steel platform on the roof to accommodate the proposed plant with walkway for maintenance access.
• Extension of the high voltage ring.
• New outgoing cables on the roof structure with allowance on the new platform to accommodate the substations.
• Existing load centres with new sections of cables jointed to existing cables at strategic locations.

The overall approach involved:

• Assessment of existing and future electrical load demands.
• Survey and assessment of the existing area for crane requirements to allow lifting of the substation components to the roof due to limited space.
• Surveys of existing switchgear, routes of existing HV and LV cables.
• Development of phasing sequences for the works to minimise disruption to business.

Austin, in coordination with BPL, developed techniques for implementing the works followed by procurement, engineering support, construction and managing the works on site within BPL’s shutdown periods to successfully implement the requirements on site.

Medical Research Council (MRC) is active in The Gambia as the UK’s single largest investor in medical research in a developing country. The growing demands placed on the MRC’s operations in The Gambia focusing on infectious diseases highlighted the need to review and update the facilities in various locations and make provision for the extended scientific needs of the organisation.
The MRC’s main Unit in The Gambia is situated in Fajara, approximately nine miles from the capital Banjul. The Unit operates over a 100 acre site which consists of research and clinical laboratory facilities (up to ACDP containment level 3). The Unit is also home to the busy clinical services department, the Unit’s biobank, as well as approximately 40 residential units of various sizes.
As well as maintaining existing site services, there is a requirement to add new facilities to continue the MRC’s commitment to leading scientific research. These new facilities will introduce a greater demand on the site utilities, specifically the electrical infrastructure which is the Unit’s primary energy source. The anticipated new facilities are:

• New molecular laboratory (1000m²);
• Biobank extension (160m²);
• New lecture theatre (600m²);
• Accommodation for academy (Two 10 bedroom blocks – 800m²); and
• A Training centre (approximately 1000m²)

Following a number of commissions for the MRC in The Gambia including a review of energy consumption across its sites Austin were commissioned to undertake a survey of the site electrical infrastructure across the unit in Fajara.
MRC approached Austin as they required a survey to be undertaken on their infrastructure in The Gambia.

Austin approached the requirements by undertaking a detailed survey to establish the current electricity demand including identification of peak times in consumption with potential causes. This included:

• Provide a replacement schedule for equipment associated with the electrical infrastructure including respective time frames
• Identify installations which are deemed unsafe or not in accordance with current standards; and
• Identify the required power capacity for the site in order to future proof and ensure reliable power provision for current and planned activities

The survey was carried out over five days with its extent and recommendations limited to the low voltage infrastructure, culminating at the point of isolation within each building.
Detailed recommendations were provided in a report that addressed current and future needs for the unit and the required upgrades. This included the recommendation for installation of new substations that allows connectivity of the proposed developments onto the upgraded infrastructure. This extended to provision of an additional standby generator to overcome manual intervention and reduction in available capacity during periods of simultaneous standby and further upgrades to problematic generators.
Austin subsequently oversaw the implementation phase on site by supporting MRC with procurement, monitoring installation through to final commissioning and into operation.

A time-lapse video showing progress of a typical large scale project, from ground clearance to completion.

Click here to view the video.

For more information call Austin on Tel: +44 (0) 1923 432 658
or Email: enquiries@austin.co.uk

A new 10,000m² Pharmaceutical Manufacturing Facility, which centralises European operations on one site, has more than doubled the size of 3M’s existing plant.
The new facility incorporates clean rooms for liquid and creams production and packaging areas together with solid dose packaging lines. In addition a 6,000 pallet narrow aisle warehouse and low bay warehouse were part of this contract.
The building also accommodates distribution support offices, a marshalling area, flammable liquids storage and a low bay warehouse with picking and packing areas.
Features include six end-loading truck docks; two enclosed docks; full sprinkler protection to NFPA requirements with in-rack sprinklers; high efficiency lighting systems; non-stratified temperature control and the ability to contain contaminated sprinkler water in the depressed dock area.
Existing lines were upgraded and vessels relocated to the new single facility whilst maintaining production throughout.
During the course of the work the existing Aerosol Packaging Areas were remodelled, placing great emphasis on safe working and special precautions were taken to minimise the impact of the construction work on the adjacent clean room areas.
Austin provided preliminary engineering, detailed engineering, procurement, project management and construction services.
Process services and clean rooms were commissioned, qualified and validated to meet FDA requirements.

Over the past few years Austin has developed a relationship with 3M Health Care which has resulted in a number of varied design studies in the UK, France and USA such as:-

• Site master planning and development strategies
• Concept design studies to upgrade process manufacturing
• Design studies for extending / stand alone manufacturing and research facilities
• cGMP audits and engineering reviews
• Preparing global facility world wide standards

As a result Austin has undertaken a number of key design, manage, construct and validate.

• Upgrade of Metered Dose Inhaler (MDI) Packaging Line
• Modifications to Liquids and Creams process areas
• Modifications to cold Fill MDI Line
• New boilers and transformers
• Upgrade of main circulation corridor to meet cGMP and regulatory authorities standards
• Strip-out and refurbishment of Pharmaceutics Pilot Plant

All the above projects were carefully planned and undertaken to allow 3M Health Care to maintain operations.

This project is a 12,000m² facility providing four floors of research laboratories and associated offices, write up areas, meeting rooms and interaction areas.

Each floor operates independently via a dedicated plantroom per floor. Both offices and research laboratories have prefabricated service supply modules.

The voids act as a supply air plenum to the open plan areas.

The meeting rooms were designed for prefabrication off site and are fully demountable for easy relocation.

A “No Ceiling” philosophy has been adopted to allow easy access for flexibility and maintenance.

The open plan laboratories accommodate 260 fume cupboards. A full height atrium fronts the office and serves to connect existing buildings on both sides providing a casual meeting space on the ground floor, a refreshment hub and direct access to a library and meeting rooms.

Austin was commissioned to replace existing buildings to provide increased capacity and an enhanced facility, to develop a design to respond to an extremely constrained site adjacent to a cliff face and to create a solution that addresses the unique position facing the sea. This posed a challenge as we had to respond to the Planning and Conservation Area requirements of the high visibility site.

The building design has been developed using a functionality zoned approach which also responds to the exceptional site constraints. Plant rooms have been positioned to the rear of the site addressing the cliff face. The highly serviced laboratories are adjacent to the plant rooms to minimise service runs. Write-up and office accommodation is positioned along the front of the building to take advantage of the sea views.

The laboratories and offices are designed with flexibility and adaptability as a major requirement.
The interior design philosophy is an innovative and fairly radical approach to meet both functional and financial objectives by providing a combination of high performance elements with basic factory finished building components.

Sea views offer a dramatic outlook which have been fully utilised in the building design. This has been enthusiastically supported by the Local Authority.

Austin provided Architectural, Structural and Drainage design services design with on site quality support.

The completed project achieved a BREEAM Rating of Very Good.

Austin was given the opportunity to develop concept and preliminary study for user and management approval.  The project included refurbishment of existing HVAC plant, resetting of pressure regimes, addition of new HVAC plant, installation of secondary packing machines, provision of new finishes, air locks, redesign of change areas and product of dispensary.

Subsequently Austin were asked to take the project to the next stage which entailed the management and execution of the detailed design, procurement, programming, construction, installation, cost reporting, commissioning, DQ, IQ and OQ qualification through to handover of GMP upgraded solid dose manufacturing areas.

At the heart of this project was an extremely complex phasing strategy.  Hence, the work was divided into 30 separate phases to match the works with production down times within a constantly changing production schedule.

Each phase was independently validated to allow continuous production. Areas in which work was to take place had to be formally handed over to Austin before any work could commence. Work was subsequently carried out and the areas cleaned, works validated and then formally handed back to Novartis with all completed documentation in place, for them to begin production.

Much of this work was out of necessity, undertaken outside of normal working hours due to site manufacturing schedules. Work was often carried out in the evenings or at the weekend with release to Austin at lunch time on Friday and handed back to Novartis for production at lunch time on Mondays.

Flexible attitude, teamwork and quick response required by Austin and their subcontractors to accommodate changing scope and program. Procurement and installation of new plant and equipment was carried out within very short timescales as performance testing of existing systems to establish relevant criteria was not possible before commencement of the project on site. All work was carried out in strict observance of cGMP.

In addition using the Austin Total Air System the high bay warehouse was temperature controlled not to exceed 24ºC with a temperature difference between floor and roof of 1ºC.

The challenge was to centralise research activities at Alderley Park into a new facility which when combined with existing facilities, would provide improved support for AstraZeneca’s candidate drugs programme.

We were commissioned to replace the existing laboratories with a new facility on the same foot print due to “Green Belt” restrictions. In addition The Austin Company was to maintain the existing plant which serves adjacent buildings in the sub-basement of the existing laboratory.

We had to meet the following critical success factors:

• Conform to regulatory requirements.
• Provide improved functionality and
• efficiencies in the areas of:
  • Communication
  • Interfaces between functions
  • Co-location of staff
• Flexibility/adaptability (accommodate new technology).
• Project a “World Class” image and environment to retain and attract staff.
• Design a new facility compatible with long-term site vision.
• Maintain ongoing operations in adjacent facilities throughout the construction period.

The Austin Company performed a feasibility study with options that identified a solution which was developed for implementation.

The demolition of one floor and a roof plant area of an existing reinforced concrete building, left the lower floor level in place over an existing plant area serving adjacent buildings.

We strengthened the remaining structure and foundations within an operational plant room, before constructing a four-storey research facility totalling 11,400m², on top of the existing building.

The new facility is connected on three sides to existing units. Great care and planning had to be taken during the demolition and rebuilding to minimise disruption to these sensitive areas.

Team working created a positive `can do’ attitude and eliminated traditional adversarial arrangements through the AstraZeneca “Alliance Team” approach to project implementation.

This complex project met the client’s brief for purpose, safety, quality, time and cost.