Stericlean, the result of a three-way collaboration between robotics specialist Staubli, factory automation firm ATS and pharmaceutical manufacturer Sanofi-Aventis, was introduced at Interphex with the claim that it is the only robot arm on the market that can be used in barrier isolation systems.
The shift towards the use of isolators - in which process machinery no longer stands in a sterile room, but in a sterile chamber within a regular cleanroom - is gaining pace across the pharmaceutical industry because it saves on space and offers more reliable containment and contamination protection.
The key to the robot's use in that environment is its resistance to vaporous hydrogen peroxide (VHP), the gaseous sterilizing agent of choice in isolator systems with a use rate of around 80 per cent.
Sanofi-Aventis was a key player in the collaboration as it had a very specific objective - overcoming a major production bottleneck in syringe filling.
The company had previously relied on an operator carrying out repetitive tasks - taking lids off containers, loading a filling machine one syringe at a time etc - all within a glove box.
The three partners have come up with a robot that has the same operation as a human arm, is resistant to harsh chemicals such as VHP, and is compact enough to fit in an isolator.
Earlier robots were unable to withstand that type of sterilization, but also have not offered the flexibility of motion that makes it possible to carry out such a complex series of manoeuvres.
" Until now, we thought it was impossible to put a robot into this type of harsh environment ," commented Ronan Le Floc'h, industrial director at Sanofi-Aventis.
"
Stericlean has replaced manual processes and given us a significant increase in productivity ."
" During testing, the robot has already demonstrated its ability to simulate human motion and meet productivity goals, raising the rate at which syringes can be filled on a high-speed line significantly ," he added.
In an interview, Laurence Oldacre of ATS, which handled the integration of the system into Sanofi's workflow, said there are around 300-350 isolators in use in facilities around the world, and more and more are being set up every year.
This is largely thanks to the endorsement of the technology by the European Medicines Agency in May 2003, and the US Food and Drug Administration (FDA) in September 2004, as a suitable technology for use in aseptic manufacturing. "
The trend towards the development of highly active and potent compounds in pharmaceutical development means that there is a growing need to protect production personnel from the risk of exposure to actives, as well the potential health consequences of repetitive manual movements ," he said.
An allied consideration is that there is a real value in isolating these sensitive materials from human operators, the greatest source of contamination. "
Eliminating the presence of human operators is key to maintaining product protection ," said Oldacre. "
In addition, operators will not be as consistent and repeatable in their process steps as an automated system ," he added.
The technology underlying the Stericlean robot can be applied across Staubli's robotic arm range, and work is underway on adapting some smaller robots for use in applications such as automated pharmacies, pharmaceutical compounding and cell culturing.
" The only real limitation on the robot's use in pharmaceutical production is the creativity of the end-user ," said Oldacre.