BIO 2024: Robotics in Sterile Processing

Using robotics in sterile fill/finish operations provides “hands-off” aseptic manufacturing, says Jeff Clement, executive director of Technical Sales for Development and Manufacturing Group at PCI Pharma Services, in an interview with BioPharm International® “Most of the robotic instruments don't even have a glove board. So, there's no human interaction with the equipment, which is great for contamination. You know, one source of contamination for a RABs [restricted access barriers] type of line would be the human operators, and with a robotic manufacturing system that takes that completely out of the equation.”

Companies already performing aseptic fill/finish are doing environmental monitoring and therefore have ISO 5 suites, according to Clement. “But with an isolator technology or a robotic system, which would incorporate isolator technology, basically, you can do that in an ISO 7 suite. So, actually, your classification is a little bit lower, so your environmental monitoring is lower. And basically, you can validate that the lower classification, which could be a quicker way to put in aseptic manufacturing.”

When adding robotic isolator technology to a new facility, modular systems are available that would require supporting services, such as HVAC systems, says Clement, “but with the lower classification required for your operating space for isolator and robotic technology,” he adds. “A lot of times, you can do that a little bit quicker and more economically than perhaps you could in the past [in comparison to] setting up a RAB system in an ISO 5 environment.”

PCI Pharma Services will be showcasing its products and services at the 2024 BIO International Convention in San Diego, Calif., from June 3–6.