Maximum safety is therefore guaranteed for the operators. Two MSD employees and a project engineer from project partner DHV talk about the custom-made Booth Unit Concept / DENIOS delivered to MSD Oss.
“As internal project manager, I was involved in the technical set-up and arrangement of the laminar downflow booth unit. This contains the weighing area, where products, which are sitting dry on a plate, are emptied into barrels.
This releases a lot of dust. The ‘downflow’ ensures that this dust cannot reach the operator, who can therefore work safely. Merck set the bar higher — we already satisfied the Dutch standard — and wanted to reduce the amount of active substances to zero. We achieve this among other things with the CCD/DENIOS booth unit custom-made for MSD!”
“During the tender process, everything was discussed down to the last detail and a suitable bid was made incorporating all the requirements and wishes of MSD. Advice was also given on the maximum height in relation to the air flow to prevent unnecessary vortices between the CG Cloth and the ceiling of the unit!” says Mark.
He continues: “The difficulty lay in the fact that the entire installation had to be installed in low rooms that are also hard to access. Concept / DENIOS knew what to do, and constructed the whole thing carefully to create a completely workable situation!”
Finally, Mark points out: “We’re extremely satisfied with Concept / DENIOS and its products. But above all with the fact that we were assigned a permanent coordinator from DENIOS who was at our side with advice and expertise for the entire project.
We’ve not yet had and experience with aftersales, because everything is working well. We were even supplied with extra filters without being charged by DENIOS!”
Containment systems, such as laminar downflow booth units and laminar downflow bench units, protect operators from hazardous substances that may escape during manual product operations. Various ventilation technologies are available with a very high level of protection, with the operator retaining complete freedom of movement. Laminar downflow booth units are mainly used in the pharmaceutical, chemical, cosmetic and food industries. They offer extremely good protection from exposure to hazardous substances. The user has complete freedom of movement. The work can be carried out under the best conditions.
This leads to a significant increase in productivity. The booths are available with recirculation or single-pass technology; in a design that complies with Good Manufacturing Practices (GMP) and meets the requirements of the Food and Drug Administration (FDA); with personal protection, with product protection and with personal and product protection. Agreements are made with the client beforehand on the objectives to be achieved. In recent years CCD/DENIOS has implemented various projects for producers in the pharmaceutical and fine chemicals industry.
Fred Bongers was section leader of the sampling group at MSD in Oss. This group is the user of the booth unit in relation to the sampling of non-active raw materials (excipients). “The reason for MSD to install the booth unit was to meet the new requirements in terms of GMP regulations. Concept / DENIOS understood what requirements the booth unit had to meet and had a mock-up constructed at Concept in England on the basis of the URS (trial model 1:1).
They even took account of possible stricter regulations. The new installation consists of a laminar downflow booth unit supplied with class A air and a personnel / goods airlock with class C air. DENIOS delivered the entire installation, including the necessary overpressure and underpressure spaces, cooling and heating systems, air treatment cabinets, filters, interlocks and control systems”.
“During the development period of the booth unit we travelled to England on two occasions. The first time, the booth unit, as I’ve already said, was put together as a true-size trial model in wood. We had ample opportunity to make changes to the design, which ultimately were all approved. The second time, the booth unit was already in the form that would be delivered to MSD, in accordance with requirements and wishes. The FAT (Factory Acceptance Test) was passed well.
During installation in situ, everything within our power was done to stick to the plans. When the SAT (Site Acceptance Test) was also successful, delivery was made!” says Fred Bongers. Fred continues: “From the outset, MSD was assigned a permanent coordinator from CCD/DENIOS. We liked this a lot, because it means the communication lines are short and there’s no unnecessary noise”.
DHV as the designer and Concept / DENIOS as the supplier.
“Since 2007 I’ve been working constantly on a project basis at MSD from DHV Eindhoven. This means I’m very familiar with the internal guidelines and standard documents. In the preliminary stage, the relevant division within MSD, in collaboration with a third party, produced a URS for a booth unit.
A design was then produced, and based on this an invitation to tender was issued to a number of parties, with DENIOS coming positively to the fore with a total solution. Within MSD, Concept / DENIOS is a familiar supplier of booth units and was able to satisfy all the conditions at a competitive price. From that moment the remainder of the project was implemented by DENIOS under the leadership of DHV”.
“The main reasons for buying such a booth unit were product protection and personal protection. A ‘mock-up’, a life-size wooden model, was produced so that the customer could see and experience what would be delivered. This resulted in a number of optimisations in terms of installation heights and design of a number of components. The complete installation was put together at the manufacturer so that it could be fully tested and checked during the FAT.
This was done to avoid disrupting the process at MSD and reduce the lead time. The installation was then dismantled and assembled in Oss, after which the SAT and then qualification were successfully performed. For product protection and personal protection, the booth had to deliver a downflow of 0.45 m/s and an air quality of class C. However, the air quality in the booth even complies with class A!”
“The lead time from the ‘mock-up’ to delivery was around 4 months. It was a complex project because there was little space available for the installation.
DENIOS implemented the project professionally and flexibly together with Concept from England!” concludes Gerard.>
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