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ACHEMA

PHARMA OFFERING

Pharma Offering

Unrivalled expertise for every pharma environment

We kept the trends in mind for our new Pharma Offering

  1. Stay aligned with the new regulations
  2. Increase performance in cleanability
  3. More agility to answer new automation trends
  4. More flexibility for intermediate cleaning applications

The right product for the right environment

Choose your dedicated robot for each pharma grade

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 

Different grades of pharma environment

“The trustful partnership between Stäubli and SKAN enabled to build robots that are in line with the current standards and highest expectations. These modifications were driven by combining the openness to challenge current systems and the expertise in asesptic processing.”

Maximilian Mittelviefhaus | Research Manager at SKAN AG

An Opportunity for a more complete Validation and Documentation Package

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.

For more information click here

Throwback Pharma Impulses Episode 4

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