John Challenger, WH Partnership, emphasises the importance of integrating process plant and cleanrooms for successful pharmaceutical production
John Challenger, WH Partnership
The devil is in the detail
One of the deeply worrying aspects of modern design for the pharmaceutical industry is how far designers are becoming removed from the reality of construction. As a design and build contractor that employs its own construction teams for both process plant and cleanrooms installation, WH Partnership is often required to tender for the detailed design, supply and construction of facilities based on designs and specifications developed by third parties. We are seeing an increasing number of enquiry documents, which include preliminary design information that is either incorrect or not practical from a constructability point of view.
Designs can often include plant and services that cannot physically be installed in the space available, have not been thoroughly planned or ignore the requirements of installation, commissioning, validation and maintenance activities. The causes of such errors include poor quality of training, lack of spatial awareness, inadequate design time, inappropriate experience and poor checking procedures. It is likely that many modern designers have only limited exposure to and experience of practical aspects of manufacturing or construction and therefore, unlike designers of the past, do not bring to the process that essential understanding of how a complex facility is built or operated.
Considerable pressure is placed on companies bidding for pharmaceutical projects as they often have incredibly short tender periods. As a result, the contractor then has a choice to make, he either tenders for what is issued to him or he takes the view that he has a duty of care to inform the client of the shortcomings of the information provided. The former approach is a gamble and could well lead to high numbers of variations, claims and potentially costly disputes. Opting for the latter approach and informing clients of any potential issues with the data they provide and then trying to adopt practical and cost-effective solutions makes far more sense, since the time taken to resolve such matters at the early project stages pays massive dividends in the end.
An inside-out design
When the issues of clean or aseptic standards are added to the design mix, the need for thoroughly integrated design and construction becomes obvious. From small start-up enterprises to major international pharmaceutical companies, researchers and manufacturers alike require facilities that will meet the expectations of the regulatory bodies, yet are value for money. Clients also expect facilities to be designed and built in extremely short timescales. Integrating the operation plant, utilities and equipment into a cleanroom is key to meeting client expectations regarding capital and operating costs as well as timescales. This calls for an inside-out approach, starting with the process and treating cleanrooms and any associated building as part of the production plant.
Few companies combine the full design and construction capabilities for both process plant and cleanrooms in a single organisation. This is surprising since integration of the two essential facets of pharmaceutical production is paramount in the successful outcome of projects for the clean industry sector as a whole.
The development of a process-led user requirement brief or specification that fully covers the manufacturing plant and the building is essential to achieving a successful project. So often, building designs are developed separately from process plant and often by companies with little true understanding of the operations that are to take place within, which inevitably leads to failures in quality, purchaser disappointment and sometimes dispute.
Design and construction — an integrated approach
It is for the reasons stated above that WH Partnership seeks to persuade clients of the need to fully integrate the design, procurement and construction process as a combined activity. Generally speaking, clients and their operating staff working in manufacturing facilities know what they need but often do not have the time to establish a reliable brief or consider how that brief is to be achieved. The contractor’s job is to listen to and interpret what is required, then advise on a range of possible technical and commercial solutions. This proactive approach, when linked to a stage gate project management approach, provides the purchaser with access to, and control of, both design and commercial information at appropriate times throughout the project.