Validated robots for the pharma environment

Product catalog summary

Validation & Documentation Package
Robots used in pharmaceutical environments must be validated to ensure they meet specific requirements for cleaning processes and particle emissions. Stäubli provides a comprehensive validation and documentation package to ensure compatibility, safety, and consistency, facilitating the final acceptance of the robots.

Pharmaceutical Environment Requirements
The pharmaceutical factory is divided into several areas, each with different specifications. Stäubli defines four levels of requirements, from the most restrictive Grade A Isolator subjected to aggressive H2O2, to logistic areas. Intermediate levels include inspection, RABs, Freeze Dryer, crimping, inspection, and secondary packaging, where equipment is cleaned with alcoholic wipes.

Stericlean+ for Aseptic Production
Stericlean+ is highlighted as the ideal robot for aseptic production within isolators. Decontamination processes are crucial, and Stäubli has conducted tests to validate the robot's performance with various cleaning media. These results are included in the documentation package.

Cleanroom Compatibility
Stäubli robots are designed to be compatible with cleanroom environments, meeting ISO 5 standards and resisting alcoholic wipes. They offer solutions that consider payload, reach, speed, and environmental cleaning processes.

Key Features and Compliance

VHP compatibility
Biological resistance
Resistance to various cleaning media
Grade A compatibility
FDA compliant materials
Hygienic design

Certification and Norms
Robots must comply with ISO 14644-1 cleanroom requirements and be tested for pharmaceutical environments. Materials in contact with external environments must be compliant, and robots must be manufactured and checked according to specifications.

Customer Benefits

Increased transparency
Proof of compatibility
Support for risk assessment
Time-saving in machine qualification documentation
Greater acceptance

Global Presence
Stäubli has a global presence, with units and representatives worldwide, ensuring support and service for their robotic solutions.

Catalog excerpts

Validated robots for the pharma environment-1

Validated robots for the pharma environment Robotics | Experts in Man and Machine

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Validated robots for the pharma environment-2

VALIDATION & DOCUMENTATION PACKAGE Robots must be valided A third party as witness Pharma factory is divided in several areas Decontamination processus is key in phar- that raise different specification in term of ma especially within isolator. Stäubli perfor- cleaning process and particule emission. med the main tests to validate the robot and Stäubli defines 4 levels of requirement, material used and evaluate performance from the most restrictive Isolator in Grade with various cleaning media. Results of the- A subjected to agressive H2O2, to logistic se tests are part of this package. Stäubli...

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Stäubli Units Global presence of the Stäubli Group www.staubli.com Staubli is a trademark of Stäubli International AG, registered in Switzerland and other countries. © Stäubli 05/2023. V2. We reserve the right to modify product specifications without prior notice. [email protected]

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