- Europe
- Americas
- Asia and Middle East
- Africa and Oceania
We kept the trends in mind for our new Pharma Offering
Market Requirements:
Level 1: Highly aseptic, isolator, ISO 5 (A/B)
Highest hygienic standards in design, material and components. Highly monitored and regular VHP cleaning High potent and toxix drugs Isolated fill/finish process line
Level 2: Highly aseptic, RABS and Freeze Dryer, ISO 5 (A/B)
Lower VHP contamination rates, liquid H2O2 cleaning tissue or punctual; Sterilization and decontamination by alcohol; Media with different properties; Auxiliary process around isolator, freeze dryers or autoclaves
Level 3: Inspection and secondary packaging, ISO 7 (C/D)
Ponctual need to be alcohol disinfected; Handling in secondary packaging processes like inspection and individual packaging
Level 4: Final packaging, ISO 7 (C/D)
No cleaning requirement. Lower standard, loading and unloading, final packaging, cartooning and palletizing
To stay in line with these new requirements, Stäubli partnered with SKAN, the world leader in manufacturing isolator systems, and specialized in pharma and aseptic environments, in August 2021. SKAN’s analytical services (SKANalytix) helped Stäubli improve its aseptic robot design.
How to validate robotics equipment for Pharma to stay aligned with guidelines?
The pharmaceutical industry has been slowly but steadily shifting from a human-centric environment to a closed and fully automated industry. Hygiene, safety, and productivity are all pushing the industry away from manual production.
The requirements just got even more restrictive with the GMP Annex 1 revision and FDA regulations.
Putting Aseptic Robots to the Test
Stäubli and SKAN’s collaboration involved putting Stäubli’s then-current offering of Stericlean robots through intensive tests for cleanability, resistance, and movement. The object was to determine what improvements could be made to make the high-performance robots even more fit for use in cleanrooms and isolators. These tests, including actual cleaning processes, helped define the R&D roadmap for the new design, which also benefited from testing and validation by a neutral third party.
Watch the Recording
