Stericlean+ robots for highly aseptic pharmaceutical processes

Stericlean+ epitomizes cleanliness in critical environments designed to eradicate a wide spectrum of microbial threats in isolator and fill/finish processes. Its optimal hygienic configuration ensures precise, robust operation that’s easily cleaned and decontaminated. Each system is accompanied by a comprehensive validation and documentation package, upholding the highest sterility standards.

Hygienic design

FDA compliant coating for the entire arm
VHP compatible
Hygienic covers with FDA compliant static gaskets - USP Grade VI
NSF H1 oil
ISO 5 - Grade A

Improved tightness and cleanability

FDA compliant dynamic joint sealing on all axis - USP Grade VI
IP65

Smart design

Encapsulated 6-axis arm enabled by hollow shaft drives, no external cables
Vertical connection for integration through the base
Attachement methods: 360° mounting possibility
Patented JCS smart gearbox
Unique and modular SIL3 / PL e safety functionalities

Validation and documentation package relating to cleanliness, cleanability and decontamination

D-Value
Microbiological resistance
H2O2 Desorption / Absorption test
Cleanability Test with Riboflavin
Surface roughness
Chemical resistance with 13 cleaning agents

Validated robots for the pharma environment

To stay in line with the new requirements, Stäubli partnered with SKAN, the world leader in manufacturing isolator systems, and specialized in pharma 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 at SKAN.

The Stericlean+ is easily integrated in pharma automation thanks to its complete documentation, which supports the pharmaceutical industry in qualification of the entire machine. Stäubli offers a full range of validated robots including the documentation package required to ensure compatibility, safety and consistency and ease final acceptance of the entire machine.

Decontamination processes are key within the pharmaceutical sector, especially within an isolator environment. Stäubli and SKAN’s collaboration has resulted in the development of new features for the Stericlean+ package that ensure that the robots are suitable for aseptic manufacturing conditions.

Testing resulted in two major benefits. For Stäubli, greater progress in R&D design, and for clients, greater transparency about robot performance.

« 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 at SKAN

More about SKAN

Main applications

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

Contact our specialists or get more technical information

MyStäubli Portal

Technical specifications

6 axis robots Stericlean+
Model	TX2-40	TX2-60 / 60L	TX2-90
Degrees of freedom	6	6	6
Load capacity (kg)	2	4.5 / 3.7	14
Reach at wrist (mm)	515	670 / 920	1000
Repeatability (mm)	±0.02	±0.02 / ±0.03	±0.03
Cleanability	H202 35%, H202 50%, Isopropyl alcohol (IPA), Diethenyl Ether, Ethanol, Hydrochloric Acid, Sodium Hydroxide, Sulfuric Acid, Ammoniac, Cyclo-hexane, Formalin, Sodium hypochlorite, Peracetic Acid
Cleanroom standard: ISO 14644-1 FS 209E	Class 5 Class 100	Class 5 Class 100	Class 5 Class 100
GMP	Grade A	Grade A	Grade A
Protection class	IP65	IP65	IP65
Attachment methods	360° mounting possibility
Stäubli controller	CS9
Available options	Stericlean H₂O₂ harness