CE for the largest automated hospital pharmacy in the Benelux
Machine safety
Prohead Engineering specialises in conformity processes for assemblies of complex industrial installations. Our knowledge, experience and methodology ensure that the conformity process, including the engineering of the required measures, is completed efficiently and to a high standard.
About the case
Context:
A high-tech automated tote warehouse was installed in the largest hospital pharmacy in Belgium. The system combines several storage robots with conveyors and lifts spread over different floors. Because this configuration constitutes an assembly of machinery, the installation fell under Machinery Directive 2006/42/EC and a CE assembly process was mandatory.
Approach:
Prohead Engineering guided the entire conformity process from study to CE marking:
- Defining the CE assembly: analysis of the various sub-assemblies, their individual conformity and the interfaces between the machines.
- Risk assessment: application of EN ISO 12100 and the Essential Health and Safety Requirements (EHSR). Risks identified included crushing, trapping and manual interactions.
- Safety measures:
- extension of the tunnels at the robots' entrances and exits to eliminate trapping risks,
- linking the emergency stop functions between robots and conveyors so that the whole system stops safely,
- providing illuminated emergency stops on mobile conveyors, in accordance with EN ISO 13850.
- Documentation & manuals: compiling the overarching instructions for use and the technical file. For the sub-assemblies, the manufacturers' original manuals remained valid, supplemented with specific instructions for the assembly.
Result:
The project resulted in an EC declaration of conformity for the assembled machine. The hospital pharmacy now has a fully CE-compliant system that:
- stores and transports pharmaceutical products safely and efficiently,
- demonstrably complies with the Machinery Directive,
- and, thanks to the integration of collective safety functions, is future-proof and easy to maintain.
Added value:
With our guidance, the operator could rely on a practically feasible conformity process that guaranteed not only the safety of the installation but also the continuity of operations.