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Cleanroom suitability qualification of a six axis robot system for aseptic processing

Presentation held at ISPE 2017 Europe Annual Conference, Lead and Manage Future Operations, 3-5 April 2017, Barcelona, Spain
 
: Keller, Markus

:
Präsentation urn:nbn:de:0011-n-4524276 (5.6 MByte PDF)
MD5 Fingerprint: c9c2a0520074222bd20e47722a24337c
Erstellt am: 13.6.2017


2017, 78 Folien
International Society for Pharmaceutical Engineering (ISPE Europe Annual Conference) <2017, Barcelona>
Englisch
Vortrag, Elektronische Publikation
Fraunhofer IPA ()
Reinraum; Reinraumtechnik; Roboter; Partikelemission; biologische Resistenz; chemische Resistenz; Good Manufacturing Practice (GMP); hygienic design; Fluoreszenztest; Sechs-Achs-Roboter

Abstract
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 and ab- and desorption behaviour of the exposed material in regards to hydrogen peroxide.
The most flexible pharmaceutical automation solution is the usage of a 6-axis robot system. But 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 manufacture of sterile products is subject to special requirements in order to minimise risks of microbiological contamination, and of particulate or pyrogen contamination, as stated in current GMP regulations. ISO 13408-6 states that the used surface materials 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 assessment, resistance against chemicals and microorganisms of exposed material and the absorption/desorption characteristics of the exposed material in regards to hydrogen peroxide. This paper details all the mentioned standardised test methods and outlines the benefit of such a holistic qualification for a later performed risk analysis.

: http://publica.fraunhofer.de/dokumente/N-452427.html