In pharmaceutical manufacturing, cleanrooms are designed to minimise the risk of contamination from microorganisms, biomolecules, or anything else that might affect the safety and efficacy of the final product.
In the radiopharmaceuticals field, when drugs contain radioactive forms of chemical elements called radioisotopes, the environment is hazardous. Because of the additional challenges when human intervention is required, these rooms are precisely controlled.
Any time a person enters a cleanroom to repair, maintain, or perform other tasks, they disrupt the sterile environment and increase the risk to the person.
Telemanipulation is a compelling solution, especially as Europe’s EU GMP Annex 1 and US FDA regulations become law. Soon, pharmaceutical companies will be required to minimise human presence during the manufacturing process to reduce the risk of contamination and harm.
Telemanipulation enables people to perform tasks from outside of the sterile or hazardous environment
"We expect that robot telemanipulation will play a vital role in ensuring precision, efficiency, and safety in pharmaceutical manufacturing. By allowing people to manage issues without requiring proximity to the process, this technology would help aligning with the new EU GMP Annex 1 revision through contamination risk mitigation, in addition to decreasing operational costs," said Jean-Maxime Guay, Senior Manager, Manufacturing Intelligence at Pfizer.
Telemanipulation enables people to perform tasks from outside of the sterile or hazardous environment, protecting contamination. SRI’s XRGo system allows operators to remotely control the movements of a robotic arm to, for example, adjust misaligned or broken parts, or perform routine maintenance, without ever needing a person to enter the room.
XRGo opens many possibilities for high-risk situations where there could be a robot on standby inside of the room so that the environment can remain closed, the more hazardous the environment, the more useful this will be. Remote telemanipulation can help protect people from potential interactions with hazardous products while allowing the type of human control that is required for many operations such as repair, cleanup, and maintenance.
XRGo was originally created for periodic use cases such as bomb disposal and field medical assistance
"XRGo’s foundational technology was developed by SRI for surgical robotics and bomb disposal so the system has decades of development,” Bill Rusitzky, said SRI’s Managing Director. "The pharmaceutical companies that we’re working with agree that this is something that the industry needs, especially as ANNEX1 compliances becomes critical. Overall, the industry, is excited about the potential of this kind of system."
Because the use cases for robot telemanipulation occur periodically and may be operated by anyone on duty, it is critical that the system be intuitive and easy to use. XRGo was originally created for this type of periodic use cases such as bomb disposal and field medical assistance. As a result, XRGo requires very minimal training and is elegant to use.
Over 100 people have used the XRGo system to move items around, picking them up and putting them in the required place in under a minute. At the recent PackExpo in Las Vegas the system was on display where people were able to use the system to move dice and stack them or place them in a box.
People who visited SRI put on the VR headset (many using VR for the first time) and remotely moved XRGo to move the dice. People who used the system took less than a minute to grab and move the first dice. The second dice move was even faster.
A key value of robot telemanipulation is its ability to capture data
The XRGo software streams live 3D stereoscopic video to the headset. This precise video is critical for a successful telemanipulation system that can be easily operated remotely. The interface allows operators to switch between multiple views, create a 3D model of the arm’s orientation, and access information such repair manuals.
The movements of the robotic arm are seamlessly linked to the movements of the handheld controller, which provide haptic feedback to the operator, buzzing the hand controllers to signal that the system has reached some limited range area.
Important in most use cases, the system can be restricted to ensure that no damage is done to existing environments, such as pharma manufacturing equipment or other pharmaceuticals nearby. The result is a system that pairs gracefully with existing robot arms that are rated to function in sterile environments and is easy for anyone to operate.
Robotics are indispensable in cleanroom environments, where precision and reliability are paramount
SRI’s XRGo team is working with industrial robot arms manufacturers that are already working with companies such as Stäubli. “Robotics are indispensable in cleanroom environments, where precision and reliability are paramount.
Stäubli has been working in the field of robotics for decades where we enable manufacturers to ensure the safety and integrity of sensitive processes in industries such as pharmaceuticals, biotechnology, food, electronics, and others." said Rudolf M Weiss, Global Head of Life Sciences & Food, Stäubli Robotics.
A key value of robot telemanipulation is its ability to capture data. Today, interventions are manually documented in a logbook with the possible addition of a remote video. Robot telemanipulation will allow for a 3D video recording as well as specific data so that the exact motion of the robot can be replicated by a robot or as a 3D model. This provides the manufacturing and compliance teams with better records than manual processes.
We have been looking for a telemanipulation solution that can minimise human contact with sterile areas of pharmaceutical manufacturing
"We have been looking for a telemanipulation solution that can minimise human contact with sterile areas of pharmaceutical manufacturing," said Charly Coulon, Head of Future Manufacturing Concepts at INVITE, a joint research venture with Bayer Pharmaceutical and other companies. "With SRI’s software, we found a great system with unmatched technical readiness and demonstrated compatibility with pharmaceutical robotics."
SRI is working with INVITE to accelerate the use of telemanipulation in the pharmaceutical industry.
XRGo is available now to test various use cases in pharmaceutical labs. SRI is exploring use in food processing, other types of cleanrooms, bomb disposal, dangerous industrial environments, maintenance in the energy sector, and others. "XRGo opens many possibilities of remote repair work for offshore oil or other high-risk situations where we might have a robot on standby," Rusitzky said.
SRI’s telemanipulation software is being integrated with 3rd party robot arms so that pharmaceutical companies can test many use cases and proof-of-concepts with their existing systems.