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Cleanroom suitability qualification of a six axis robot system for sterile pharmaceutical manufacturing: Holistic approach

: Keller, Markus; Boos, Stefan; Baum, Gabriela; Schweizer, Marion; Bürger, Frank; Gommel, Udo

Volltext urn:nbn:de:0011-n-4415708 (1.1 MByte PDF)
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Erstellt am: 14.4.2017

International Confederation of Contamination Control Societies -ICCCS-; Sociedade Brasileira de Controle de Contaminação:
ISCC 2016, 23rd International Symposium on Contamination Control : 20th to 23rd September 2016, São Paulo, Brazil
São Paulo, 2016
17 S.
International Symposium on Contamination Control (ISCC) <23, 2016, São Paulo>
Konferenzbeitrag, Elektronische Publikation
Fraunhofer IPA ()
Reinraum; Reinraumtechnik; Roboter; Partikelemission; biologische Resistenz; chemische Resistenz; Good Manufacturing Practice (GMP); hygienic design; Fluoreszenztest

In such fields as cleanroom technology for sterile pharmaceutical production, more and more processes are automated and placed into isolators in order to fulfil the requirements defined by the Good Manufacturing Practice guidelines (GMP). The most flexible automation solution is the usage of a 6 axis robot system. There are plenty industrial 6 axis robot systems on the market, but they are mainly built for normal handling operations for example in car manufacturing. Only a few robot systems are adapted in order to fulfil the GMP requirements regarding the defined cleanliness level for sterile manufacturing processes for particles and microbiological contamination.
The current GMP guidelines state further, that “…in clean areas, all surfaces should be smooth, imperious and unbroken in order to minimize 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 in order to minimize risks of microbiological contamination, and of particulate or pyrogen contamination. ISO 13408-6 states that the used surface materials should be evaluated in regards to the absorption and outgas behaviour of decontamination agents such as hydrogen peroxide.
Based on these requirements, a six axis robot system for pharmaceutical usage was modified and improved regarding principal hygienic design recommendations. For the Tested-Device certification, the following parameters were tested:
- Particle emission
- Hygienic Design and Cleanability as weak point assessment
- Chemical and biological resistance of exposed material
- Ab- and desorption behaviour of the exposed material in regards to hydrogen peroxide.
The talk will detail all the mentioned standardized test methods and outline the benefit of such a holistic qualification for a later performed risk analysis.