The current era in pharmaceutical manufacturing is defined by challenging market demands and stricter regulations, particularly with new, more comprehensive GMP standards codified in the EU’s revised Annex 1 and updated CGMP standards from the FDA. Industrial automation pioneer Stäubli Robotics, in a show of foresight, has entered it armed with solutions to bring the efficiency of robotics to more applications while assuring compliance – and delivering the documentation to prove it.
Regulations vary around the globe and are often a source of confusion. But their goals are both straightforward and universal: to avoid contamination, chiefly by minimising human intervention, and thus ensure the safety of products and patients. Separating operators from processes is the overriding theme of Annex 1, and any contamination control strategy (CCS) must make this its focus. From this unifying standpoint, Stäubli Robotics has developed a robust portfolio of pharma robots designed to reliably handle processes in aseptic areas and withstand rigorous cleaning procedures.
This mission started long before the EU or FDA set out to enact stricter requirements for aseptic processing. Stäubli Robotics is a pioneer in the field, having served the pharmaceutical industry for decades. In 2009, the company launched its groundbreaking Stericlean series, the world’s first robot specifically designed to operate inside isolators and RABS. Today these robots are used in pharmaceutical and biotech labs and production facilities worldwide for a range of tasks in material handling, filling and closing, as well as troubleshooting, inspections and packaging.
Joining Forces to Meet New Challenges
In the 15 years since Stericlean was launched, Stäubli has worked with its installed customer base to learn from their experiences and refine the robot’s design. The company has also cultivated partnerships with OEMs and integrators specialising in pharma to expand and adapt its portfolio of robots to handle more applications and meet the industry’s changing compliance and commercial needs. The pharma community witnessed the next leap forward at CPHI Frankfurt in 2022, when Stäubli launched its next-generation Stericlean+ series, designed exclusively for use in isolators, with the flagship TX2-60.
In many ways, this is a classic story of evolution through adaptation, specifically to GMP grades and ISO classes. It is also a story of partnership. To fine-tune its aseptic robot design and help end users meet the standards of Grades A/B through D/E and ISO Classes 1 through 8, Stäubli partnered with SKAN, the market leader in isolator systems. Stäubli also sought to proactively provide customers with the validation and documentation packages they would need to prove that their equipment is compliant. SKAN proved an ideal partner for this purpose as well. Through its SKANalytix service, the company conducts comprehensive third-party testing and analysis of isolator and cleanroom technologies.