Qualification of a 6-axis robot system for hygienic processes

In such fields as cleanroom technology for sterile pharmaceutical production, more and more processes are automated and placed into isolators to fulfil the requirements defined by Good Manufacturing Practice (GMP) guidelines. The most flexible automation solution is the usage of a 6-axis robot system. There are many industrial 6-axis robot systems on the market, but they are built primarily for handling operations such as in car manufacturing. Only a few robot systems are adapted to fulfil the GMP requirements regarding the defined cleanliness level for sterile manufacturing processes for particles and microbiological contamination. The current GMP guidelines state that ‘in clean areas, all surfaces should be smooth, imperious and unbroken to minimise the shredding or accumulation of particles or microorganisms and to permit repeated application of cleaning agents and disinfectants where used.’ The manufacture of sterile products is subject to special requirements to minimise the risks of microbiological, particulate or pyrogen contamination. ISO 13408-6 states that the surface materials used should be evaluated with regard to the absorption and outgas behaviour of decontamination agents such as hydrogen peroxide. Based on these requirements, a 6-axis robot system for pharmaceutical usage was modified and improved by applying principal hygienic design recommendations. For the Fraunhofer TESTED DEVICE® certification, the following parameters were tested: particle emission, hygienic design and cleanability as weak point assessments, material resistance against chemicals and microorganisms and material absorption/desorption characteristics with regards to hydrogen peroxide. This paper details the benefit of such a holistic qualification for a subsequent risk analysis. Whilst designed as an assessment for the pharmaceutical sector, the assessment techniques used may also be of interest to high hygiene applications in the food industry