Astra Zeneca’s global packing centre delivers GMP compliant infrastructure for growth capacity
AstraZeneca’s Macclesfield, U.K., advanced manufacturing and medicines development campus employs more than 3,000 people and accounts for 1 percent of total U.K. goods exports. From their packing facility, AstraZeneca produces 100 million packs annually for 130 markets. The 21 products they pack provide life-changing treatments for a broad range of therapeutic areas including oncology, diabetes and heart disease and neurological conditions.
The company is constantly evolving to keep pace with scientific advances, manufacturing best practices and the need to provide reliable supply for patients around the world. On the Macclesfield site, AstraZeneca has invested in new manufacturing, packaging and infrastructure to develop a new facility to make a prostate and breast cancer treatment used by patients in more than 80 countries; packing and warehousing facilities; a new packing line; and new uses for artificial intelligence in medicines development and manufacture.
A part of this investment and the recent major development at the site is the Packing and Logistics project, comprising a new, fully-automated 30 metre High Bay Warehouse, refurbishment of the existing Low Bay Warehouse and delivery of a new Global Packing Centre (GPC) – a GMP Grade D clean-classified environment with nine packing lines.
This complex capital project, consisting of more than 225,000 square feet of total site development, was delivered in a live pharmaceutical environment, while enabling business as usual operations throughout. The utilised sustainable design and construction solutions and the exceptional collaborative efforts led to completing this time-critical project on time and within the budget, with safety performance five times safer than industry average. The new facilities incorporate technological innovations, which benefit productivity, enable collaborative ways of working and ensure the security of supply of essential medicines for global distribution.
AstraZeneca engaged BES to design and build the facility much earlier in the project process than normal practice. This approach helped to ensure that the whole team bought-in to the project’s key success factors at the earliest opportunity, ensuring that cost, time, SHE and constructability were fully considered from the outset. Filling the role of principal designer and principal contractor, BES worked as an integral part of AstraZeneca’s team to develop the initial scheme into fully-commissioned facilities.
Phased Project Delivery
The project required intricate planning to allow refurbishment of discrete areas while maintaining business as usual in adjacent highly-serviced and controlled environments. The development of new facilities was split into three distinct and functional stages – each enabling the following phase of work. Phases were coordinated with the design to maintain clear demarcation between construction sites and operational areas, with consideration given for material and personnel flows, segregation, containment and access.
Controlling the High Bay Environment
Phase 1 involved provision of the fully-automated High Bay Warehouse to enable increased pharmaceutical stock holding, with a loading capacity in excess of 12,500 pallets. In order to ensure the integrity of stored products, the VNA (very narrow aisle) facility incorporates complex air handling engineering to maintain mission-critical temperature and humidity throughout its 18,000m2 floorplate and 30m height.
The design parameters for the building services installation included controlling the temperature between 16°C and 25°C, while ensuring relative humidity of less than 60 percent at all times. In a building of this height, the temperature gradient presents significant challenges in this regard and excellent circulation of airflow around all stock within the warehouse was also a key requirement. The solution was to provide HVAC system capable of delivering air supply at high level (30m) and air extract at low level, providing a natural airflow around all stock within the controlled environment. The distribution ductwork was precisely coordinated to ensure the services were outside the working zones of the automated loading cranes.
Design and construction of the warehouse also had to take into account the sensitive robotic picking equipment used to pick orders and manage stock. Robotic operation of the warehouse has allowed a hypoxic fire suppressant system to be installed, safeguarding valuable stock from fire and potential damage from more conventional fire suppressants, such as water or foam. This system limits oxygen levels within the building so that fire is prevented from taking hold.
The same ducting used to maintain temperature and humidity control through the HVAC system is also used to deliver the hypoxic fire suppressant functionality, using N2 generated on site by specialist plant housed within a Pre-Fabricated Plantroom.
The supply ductwork for both the HVAC and hypoxic fire suppression system was installed within the steelwork and, to minimise working at height and the associated risks, this was fabricated into the modular structure prior to erection on site. Trained climbers were then used to commission the system.
Low Bay Refurbishment
Phase 2 work was carried out concurrently with the construction of the High Bay. The aim was to revamp the existing Low Bay Warehouse areas to provide 1,500 pallet spaces and 9,200m2 of shelving. Works were undertaken sequentially throughout the facility, utilising full height temporary partitions together with airlocks and change areas to safely segregate the adjacent spaces and maintain cleanliness and environmental conditions. All new HVAC services were installed and commissioned without interrupting the smooth operation of existing service. The fully GMP compliant facility was completed and refurbished to exacting standards.
Global Packing Centre
For the final phase, the project team designed and delivered a Global Packing Centre, which was constructed within an existing warehouse – in an area cleared following completion of stages 1 and 2.
The new 8,130m2 facility comprises nine Grade D packing cells adjoining a common secondary packing space, along with wash bay, tool store and associated office accommodation. The critical areas maintain stringent air pressure regimes ensuring microbiological and particulate contamination is kept strictly within compliant limits. Air locks are employed throughout, and temperature, humidity and pressure are all independently monitored by the facility’s Environmental Monitoring System. With complete segregation between primary and secondary packing areas, The GPC delivers a standard of product containment that minimises the potential for cross-contamination when product is exposed.
The inter-disciplinary team at BES developed a bespoke solution for this complex clean environment, combining both architectural and building services design while delivering key operational, people and commercial aspects of the client brief. For example, an innovative acoustic ceiling construction combines hygienic, wipeable, sound absorbing materials and cleanroom-grade Norwood metal-faced partitions, which not only reduce environmental noise levels but also provide cleanable airtight surfaces. This allows for improved acoustic properties whilst providing surfaces suitable for a GMP environment.
Alongside the hygienic finish of the partition panels, cleanability has been ensured by recessed radiused coving at ceiling to wall joints to provide a smooth clean finish. All partitioning and ceilings were fully co-ordinated with the associated electrical and mechanical services and integration of the technically complex packing equipment.
To deliver all environmental requirements, the HVAC system uses primary and secondary air handling units, in conjunction with modularised service distribution systems delivering high-quality, closely-controlled air to the individual areas. Service modules also carry the critical utilities which will ultimately be used to provide compressed air, power, data and extract to the installed packing equipment.
This plant and equipment is housed on a purpose-built mezzanine plant deck, which necessitated the installation of a new structural steel frame. To accommodate the associated increased structural loading, the slab beneath was replaced and fully tied into the existing structure.
Against the backdrop of the project’s technically complex brief and operationally challenging build requirements, there was also a need to incorporate AstraZeneca’s environmental goals. This was integral to all elements of the design and construction, including architectural, HVAC, energy saving and electrical.
The key sustainability benefits from the architectural design centre around the re-use of existing built assets for phases 2 and 3 of the project. The fabric of an existing building was improved to reduce heat loss and weather resistance, and the Grade D GPC facility was constructed within the existing building envelope with additional steelwork to allow a mezzanine plant deck in preference to constructing an external plant room.
Meanwhile, the airtightness of the High Bay Warehouse constructed in phase 1 reduces the heat loss and gain of this building. The use of a hypoxic fire system avoids the need for a sprinkler system and the associated additional building height, water storage and plant.
Off-site fabrication of service modules for the HVAC system provided wide-ranging SHEQ benefits, which aided the environmental profile of the project along with programming and site safety. This included reduced waste and reduced deliveries. The cleanroom areas were designed to a strict sustainability matrix with a focus on minimising air change rates and adjusting them in line with operational requirements on a zone-by-zone basis in real time. The BMS ensures that air change rates remain compliant for each Grade D packing cell, while maintaining pressurisation at all times to maintain cleanliness. At night, the air change rate is reduced for all cells while the building is unoccupied.
While it is not possible to re-use the air extract from the GPC, a run-around coil has been incorporated into the HVAC system to enable pre-heating of the fresh air in-take, reducing the heating/cooling load required by the system. A heat recovery cassette system has also been included in the project for the office areas.
Multiple high efficiency fans have been used in preference to a central centrifugal fan to increase the flexibility and efficiency of the HVAC system, allowing it to operate at varying volumes depending on the capacity required. Similarly, the water system has been designed with variable speed pumps that can be operated using less power when lower volumes are needed. As the Macclesfield site is operated using energy from a central CHP, all reduction in demand from the new facilities makes a positive contribution to the overall energy capacity and efficiency of the entire campus.
Technically Advanced, People Focused
The project also focused on the human elements of the facilities, both during the design and construction process and as a workplace following commissioning and validation.
Collaboration was central to the project design and delivery, with complete transparency and visibility between all delivery partners. Budget information was shared from the outset and options were quickly budgeted to allow informed decisions early in the design process. Any savings on the final account were then shared as part of a gain-share element of the contract. All team members were encouraged to see the success of the project from the ultimate customer’s point of view – meaning the patient’s perspective, rather than just to satisfy the project manager signing the final account.
The finished GPC has been designed to ensure the cleanroom environments provide opportunities for human interaction within the GMP compliant areas. For example, flush mounting of vision panels has enhanced the work environment by enabling colleagues to see each other without compromising room cleanliness and qualification. In the open-plan secondary area, meanwhile, partial height glazed partitioning, designed specifically for this project, provides the necessary segregation of the operational packing lines without reducing the open feel of the area.
Controlled Environment Throughout the Product Journey
The GPC project may be on a pharmaceutical manufacturing site but it highlights that cleanroom environments are required for a much broader range of functions than lab production and testing alone. A controlled environment is critical to the integrity and efficacy of medical treatments throughout the product’s journey to the patient, including storage, packing and dispatch.
This project demonstrates that major improvements in packing and storage infrastructure can be delivered to a high level of technical specification and cleanroom compliance without compromising business continuity, operational efficiency or the work environment. Moreover, with a creative, collaborative and outcome-focused design process, GMP clean-classified facilities can be delivered within a framework of achievable sustainability goals.