Product Protection by Implementation of Improved Hygiene Zones
GMP in View - Within two years, Chemgineering - as general planner and contractor - converted a bottling plant at DSM to comply with current standards. The efficient collaboration of the project team and client guaranteed success of the ambitious multi-million-euro project.
Royal DSM, a global science-based company active in health, nutrition and materials, delivers innovative solutions that nourish, protect and improve performance in global markets such as food and dietary supplements, personal care, feed, pharmaceuticals, medical devices, automotive, paints, electrical and electronics, life protection, alternative energy and bio-based materials. DSM's 22,000 employees deliver annual net sales of around € 9 billion.
With about 900 staff members and an annual production volume of 40,000 tons, the plant in Sisseln (Switzerland) as a branch of DSM Nutritional Products AG is one of the most important production facilities of DSM's life sciences division.
From planner to general contractor
Planning activities with DSM began with a conceptual design phase in 2009. In Building 320 of the DSM plant in Sisseln an existing process was to be optimized during ongoing production: The solid and liquid intermediate products, delivered as bulkware, were to be packaged in commercially available packages in a GMP-compliant environment using the existing filling technology.
Chemgineering was initially assigned to develop various versions of the GUPAS+ project both technically and commercially. This involved, in addition to a range of remodeling work, setting up new and optimizing existing hygiene zones (clean rooms).
Following the conceptual design phase in 2010, Chemgineering was appointed as the general planner for the entire project to produce the basic design; in 2011, to be entrusted with the implementation of the project as the general contractor with full responsibility for costs, scheduling and quality.
The implementation involved the fulfillment of numerous and diverse requirements as well as compliance with statutory regulations. The primary objectives of the project included:
- cGMP-compliant implementation of DSM's internal guidelines for the filling of powder and liquid products in Building 320
- assessment and comparison of different process versions
- planning and implementation of a hygiene concept according to DSM's internal guidelines for personnel, material and production units
- planning and implementation of a pressure rating system for room ventilation
- adaptation of the new apparatus technologies (e.g. material handling) as well as the infrastructure to the existing process and safety requirements
- timely implementation of the project without affecting other projects, departments or the ongoing production in Building 320
Conversion during ongoing operations
Because all measures had to be implemented during ongoing production with only a few exceptions for complete stoppages, the remodeling and new construction had to be done in several phases.
Thus, existing building sections and systems were dismantled in multiple phases in order to facilitate the installation of a pallet transfer system with vertical pallet handling technology. The existing bottling system was also converted.
New clean rooms (hygiene zones) were integrated on three floors of the building. During this process, 1800 m2 of new clean room flooring was laid. To create space for a new ventilation system, old ventilation components (ducts, monoblocks, etc.) were dismantled.
Moreover, a new infrastructure and power supply system (e.g. heat recovery system, cold sink) was installed and connected. Finally, the new systems and hygiene zones were put into operation and qualified.
During planning, compliance with the current cGMP standards was taken into account and implemented jointly with the client. During the implementation and construction phase, elements including process optimization, automation and EMSR technology, building site management, ventilation technology, clean room installation and qualification support were implemented and optimized in close collaboration with DSM.
The complete conversion of the bottling plant was successfully accomplished during ongoing production. The tough requirements for product quality and occupational health and safety (accident-free construction site) were met to the fullest satisfaction of the client.
After a two year planning and remodeling phase, Chemgineering successfully completed the project in January 2012 and handed the building over to the DSM operators.
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