Positive construction

Published: 16-Oct-2003

Working on a pharmaceutical production site has proved both a challenge and a success for Wates Group


Since February 1995, construction and development company, Wates Group, has been working for a pharmaceutical client at one of its production plants. Wates' involvement has been in constructing a number of cleanroom and production facilities (this particular site housed inhaler device production facilities). Besides complex construction issues, the various projects were all positive examples of how an open, working relationship can have a positive impact upon the construction process – something that is especially important when construction involves pharmaceutical production facilities. A number of the facilities were live while construction took place, so the financial implications of any delay in the building process were extremely onerous.

Building begins The first scheme was a new building to house a tablet research laboratory and offices. The works involved demolition of existing buildings, followed by construction of a steel-framed two-storey extension to an existing complex. The project potentially could have had a major impact on the client's business if it did not remain within the project controls. The new building also abutted the client's current facility, necessitating careful planning when it came to the breakthroughs. As part of the project, the existing ground floor had to be stripped out and reinstated, all while the building was being occupied over and around the construction area. The mechanical and electrical plant was housed within the site area and demolition and reconstruction had to be carried out without disturbing the functioning systems. The building's internal finish, which was commensurate with laboratory functions, had to be done according to the client's high specification. The project entailed a full service installation including medical gases, laboratory benches, quality water, Afos tables, fume cupboards and solvent distribution. Due to the proximity of the works to the plantroom, and its shared use with the existing and new systems, in-depth surveys of the systems had to be carried out to establish a project control plan for the installation section of the project. The control plan addressed the client's change control procedure. This consisted of: schedules of work to be carried out on each system; timings for the shutdowns required; health and safety risk and method statements to cover the works; in-depth activity programmes for all activities on the system; liaison with the user teams; validation/testing actions; and finally contingency planning in the event of the unforeseen. The teamwork ethic and the complementary strengths of individuals were evident from the start. Accordingly, the project was completed on time, within budget and to a high standard of quality. The success of the project led onto further works with the client in the same building almost prior to completion. Wates was contracted to create a new microbiology area within part of the complex to centralize this support facility within the production site. The support services were brought in from the newly completed laboratory area. All connections, therefore, needed careful planning to allow completion without disturbing the users.

High profile project Following this project, Wates was then contracted to carry out a series of jobs of varying sizes within the same production site. One in particular was the tablet production suite (TPS) extension, which was the highest profile project due to its impact on the local skyline and the effect on the production floor. Additional space within the main tablet production facility was needed to consolidate the support staff and locate two new blister-packing machines. An important feature of this new facility was the ventilation system that was designed to keep the different areas clean. Two separate plants were required to achieve this and both were located on the second floor of the building. The first, designed to deliver Grade B air to the filling line area, was a re-circulating air handling plant using HEPA filters. The packing and assembly hall required Grade C air and this was also delivered via HEPA filters from a modulating fresh air plant. Chemical dehumidification facilities were also needed for the filling area and these were incorporated into the appropriate section. The ability to maintain such ventilation systems is vital to any cleanroom, so both these plants were fitted with run and standby coils, and supply and extract fans.

Operations continue Extending the building while in occupation was a major structural, safety and logistical undertaking. The main portal rafter, required to support the roof span into the new extension, had to be slotted into the existing structure without allowing any water or dust to enter – all while live production continued some 2m away. The lift of the rafter was further complicated by the fact that the height to ridge was 18m and the site was very restricted in terms of access. The work on the production floor involved detailed and structured programme and method statements to reflect the complexity of the work. There were several enabling moves required to achieve the final objectives, which all involved moving equipment and services critical to the production floor. Testing, method statements and validation were of utmost importance to ensure that quality assurance for the systems was maintained. With the ever-changing demands of the business it was essential that close liaison was maintained with the production floor staff and that the construction process remained flexible. On several occasions the works had to be re-programmed or interrupted within the seven day a week, twenty-four hour a day production cycle, due to external demands. So the pressure was still on to achieve the moves to the original outline programme, as the blister lines were pre-booked and the overriding business drivers meant that any delays encountered by production-related issues had to be absorbed. The final outcome was that the extension and the internal works were completed on programme and without any delays to the production facility. While the works on TPS were on going, Wates also undertook the design and construction of several other projects within the site, including the TPS over-roofing project, extension of the laboratories, the reconfiguration of NPI, extension to TPS office areas and some re-structuring works in microbiology. Although these contracts only equated to £1.5m, small in construction terms, all areas were extremely sensitive to the client for differing business needs, such as the need to install prototype filling and packaging machinery at very short notice.

Developing success As a reaction to the success of the device produced at this site, the pharmaceutical client then embarked on a radical development plan to increase production throughout its core business facilities. This culminated in the decision to increase the number of production lines abroad and in the UK. The client's emerging business strategy was that to achieve improvement in production output and quality, the activities of filling, assembly and packing must be grouped together in one single production facility. While this was not a radical idea, it was a relatively new concept for this sort of facility design and was the first to be put into practice at this particular production site. The market demanded a fast action response and almost before the design started, the production machines were ordered by the client for delivery in June 2002. The design development meetings began in early September 2001 with the objective of starting on site in January 2002 for an effective start.

Team involvement The involvement of the complete team at the outset was critical to the success of the project. An innovative approach needed to be adopted to solve the requirements of the design, while satisfying the restrictive nature of the site and reflecting the need for methods and materials that were suitable for the speed of construction. The final solution contained ideas such as:

  •  pre-fabricated pre-finished wall panels with integrated service positions
  •  walk-on ceilings to heavily serviced areas
  •  a lightweight, removable maintenance floor at mezzanine level to speed the first fix service installation and offer full future maintenance access
  •  adaptability in the design to allow for future conversion to tablet manufacture
  •  use of pre-fabricated services and connections. The site boundaries and the proximity to the adjoining highway further affected the complexity of the construction task. Because of these factors, there were prolonged negotiations with local agencies to obtain limited road closures so that larger components could be delivered and then erected on site. Despite potential obstacles and the complexities involved, the project was a resounding success, with some areas being handed over ahead of schedule.

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