It is no revelation to say that the age of robotics and automation is underway, as many assembly line industries have utilized production robots in one form or another for several decades. Yet pharma manufacturing remains heavily human. Robotic systems, however, can offer solutions to problems caused by the human element, such as the problem of microbial contamination in aseptic processes.
In a presentation at the Nov. 2014 PDA Parenterals conference in Munich, Germany, Sergio Mauri, Manager, Integrated Projects Business Unit, Fedegari Autoclavi, showcased his company’s gloveless, fully sealed isolator that uses a robotic, GMP-compliant arm. This solution is currently in an advanced development phase and the company hopes to market it for small-scale manufacturing of personalized, cytotoxic materials used for clinical trials.
“If we are able to take personnel out from our process, then we will really reach the goal to have an advanced aseptic process,” he said. “The isolator with the GMP robot can give a flexible and modular solution.”
He added, “Our system is based on a batch system and it is completely sealed.”
With no operator required, the isolator supports a completely automated fill/finish process. Without the need for gloves and the resulting glove ports and gauntlets, a greater level of sterility assurance is assured.
The equipment includes Wash in Place (WIP) capability to clean the contamination generated by the process. It also uses single-use material such as ready-to-use primary containers and closures, beta bags and disposal waste bags.
To ensure airtight construction, Fedegari’s seven-axis robot arm—built by robotics manufacturer Kawasaki—is stainless steel and designed to be low particle shedding. It is also resistant to high pressures and temperature wash downs, fully compatible for decontamination using H2O2 vapors. The system can also support both positive and negative pressures. An electronic motor controls the strength of the arm’s grip.
“This is really a breakthrough,” emphasized Mauri.
External parts are decontaminated with steam sterilization. The tubs inside the isolator are decontaminated with H2O2 through a vaporizer that controls a dosing pump and heater for compressed air by means of saturated steam within the material transfer autoclave before entering the isolator.
Human Element Still a Factor
Fedegari, according to Mauri, is currently wrapping up development of the isolator. One company has already signed on to purchase the isolator and Mauri expects others to look into the system.
He stressed that “nothing is advanced with human intervention,” and the company seeks to remove the human element from the aseptic environment except for loading and unloading the isolator.
Yet other industries have seen issues—and even crises—arise from becoming fully reliant on automation. In fact, overreliance on automated systems has been cited as a major factor in the 2009 crash of an Air France flight (1). In a separate interview with the PDA Letter, Mauri acknowledged this could be a potential risk. He said he would encourage a customer to use the Quality by Design approach to build a risk assessment regarding an operator’s ability to correctly respond to the equipment.
“It’s part of training, part of making all the safety requirements in devices in order to avoid problems due to a lack of control by the operator,” he said.
While the isolator system is currently configured just for small-scale production, Mauri does see the potential for use in larger-scale manufacturing, particularly if manufacturers move to using smaller, parallel systems.
“We have to take an example from semiconductor manufacturing where they have a huge manufacturing output by adding in parallel, smaller clusters. So, even if one of these clusters is running out of operation there are another 50 working giving out all the outputs. While in pharmaceutical manufacturing, with big-scale manufacturing we have a line, and if the line is jammed and it stops for two or three hours, you are losing the production of two or three hours,” he explained. “We have to learn from other businesses how to manage the efficiency of the pharmaceutical industry.”
- Langewiesche, W. October 2014. The Human Factor. Vanity Fair. www.vanityfair.com/news/business/2014/10/air-france-flight-447-crash
About the Expert
Sergio Mauri is a chemical engineer involved in contamination control technologies of viable and nonviable particles in cleanrooms and clean air devices since the early ‘80s. At present, he is in charge of the Integrated Projects Business Unit at Fedegari Group.