CleanPlus fast-track

The cleanroom facilities for laboratories and the production of Nexium Intravenous (IV) at AstraZeneca's Gärtuna site, near Södertälje, Sweden are due to be completed by the end of March.

The 2000m² CleanPlus fast-track cleanroom project is a key part of AstraZeneca's investment of €66 million in a new plant at one of its major production sites. As well as providing a "state-of-the-art facility" for production of Nexium, a proton pump inhibitor used in the treatment of heartburn and associated symptoms, the project also incorporates essential infrastructure to support the manufacturing operations.

Completed in record time With a cleanroom start date of October 2002, the CleanPlus phase of the project will be completed in record time – approximately half the time it would normally be expected to take. The facility will have an estimated production capacity of 30 million freeze-dried Nexium IV vials a year. Bulk vials produced in the plant will be transferred to facilities within AstraZeneca for final packaging. The building framework allows installation of a second production unit at a later date, without need to impact upon established operations. The manufacturing plant is scheduled for completion in early 2004 and will be fully validated for the manufacture of stability batches by the beginning of June 2004. This is an aggressive and challenging time scale with the aim of enabling the US market to be supplied from the new facility Q2 2005. "AstraZeneca is striving to achieve a shorter lead time between the strategic decision to invest and the start of production at any new plants", says Marcus Törnlund, engineering manager at AstraZeneca. "At the feasibility study stage for this project, the original overall build and commissioning time for the Nexium IV plant was estimated at 3.5 years. However, when the investment decision was approved it was decided that the project could only take 2 years. "In order to meet these strict timeline demands, we have had much earlier and closer liaison with all contractors, signed contracts with them and in close co-operation with the project managers carried out the works in about 12 months". The main contractor is Skanska, which has the responsibility for the prefabrication elements of the contract in which Carmetec CleanPlus is a key player. The main criteria for planning and contracting were time, quality and cost and, as far as possible, all the key sub-contractors signed incentive agreements with Skanska. In the final analysis, the choice of all the sub-contractors and materials used was said to be primarily based on speed of build and quality achieved. Carmetec was appointed at an early stage as the cleanroom supplier and together with the team responsible for process engineering and other services, a design based on the flexible CleanPlus system was developed last Spring.

Series of projects carried out Work on the outer structure commenced in May 2002 and topping out took place as early as October 2002. Good fortune did prevail upon the project as the Swedish Summer weather proved to be extremely dry, which meant that all building disciplines could work flat out during the work on the foundations, ground and first floors and external structural envelope. This is the most recent in a series of cleanroom projects Carmetec has carried out for AstraZeneca. In the past few years, the company has provided in excess of 15000m² CleanPlus cleanrooms for the drug major in production units making liquid and bulk products, as well as tablets.