Stericlean+ robots for highly aseptic pharmaceutical environments

Stericlean+ epitomizes cleanliness in critical areas, developed to eliminate a wide range of microbiological risks in isolator and fill/finish operations. Its excellent sanitary setup ensures precise and reliable functioning that is simple to clean and disinfect. Each system is backed by a thorough validation and documentation package to ensure the highest sterility standards.

Hygienic design

• Hygienic coverings with FDA-compliant static gaskets (USP Grade VI)
• Optimize hygiene with the hollow wrist option
• FDA-compliant coating for the entire arm
• Compatible with VHP
• ISO 5 - Grade A
• NSF H1 oil

Improved tightness and ability to clean

• FDA-compliant dynamic joint sealing on all axes (USP Grade VI)
• IP65 (and IP67 for pressurized versions)

Smart design

• Hollow shaft drives facilitate the encapsulated six-axis arm, eliminating the need for external connection cables
• Integrated via the base using a vertical connector
• Attachment options include 360° mounting
• Patented JCS smart gearbox
• Unique and modular SIL3/ PLe safety features

Validation and documentation package relating to cleanliness, cleanability, and decontamination

• Proven chemical resistance to 13 cleaning chemicals
• Test for H₂O₂ desorption/ absorption
• Riboflavin-Based Cleanability Test
• Microbiological resistance
• Surface roughness
• D-Value

Get in touch

Validated robots for the pharma environment

To meet the new criteria, Stäubli worked with SKAN, the world’s leading manufacturer of isolator systems specializing in pharmaceutical and aseptic environments.

Through our SKANalytix service, we provide our customers with analytical support for their questions and concerns around aseptic processing.

Gregor Hommes, Head of Research and Strategic Business Development, SKAN

The Stericlean+ can be easily integrated into pharma automation due to its comprehensive documentation, which helps the pharmaceutical industry qualify the entire system.

Stäubli provides a complete variety of verified robots, including the documentation bundle required to ensure compatibility, safety, and consistency, and facilitate the final acceptance of the entire machine.

Decontamination techniques are critical in the pharmaceutical industry, especially in an isolator setting. Stäubli and SKAN collaborated to develop new features for the Stericlean+ package, ensuring that the robots are suited for aseptic manufacturing environments.

Testing yielded two key benefits. Stäubli expects further advances in R&D design, while clients expect greater transparency about robot performance.

Image Credit: Stäubli Robotics

We offer studies around all aspects of isolators, and run tests regarding product, process and operator safety with regard to isolator and cleanroom technology.

Gregor Hommes, Head of Research and Strategic Business Development, SKAN

Stericlean+ Hollow Wrist option

Stäubli Robotics’ Stericlean+ Hollow Wrist option maximizes cleanliness by encapsulating electrical wires and pneumatic lines inside the robot arm, reducing external contamination concerns and improving machine interaction.

This arrangement enhances cleanability and decontamination processes by leveraging FDA-compliant materials and design, ensuring the high standards needed in aseptic environments. Additionally, the Stericlean+ Hollow Wrist has been verified for cleanability and decontamination, giving complete documentation to support pharmaceutical automation operations.

Main applications

• Bag and TUBs opening
• Stopper handling
• Transferring
• Denesting
• Renesting
• Weighing
• Capping
• Filling

Image Credit: Stäubli Robotics

Technical specifications

6-axis robots Stericlean+. Source: Stäubli Robotics