Hear from Austin Roberts, Operations Manager, Sterile Fill-Finish, at PCI Pharma Services‘ facility in San Diego, as he shares valuable industry insights and how he sees robotic technology shaping the future of GMP aseptic manufacturing.
As Operations Manager, Sterile Fill-Finish, at PCI’s San Diego facility, my responsibilities include overseeing multiple areas of robotic aseptic filling, including inventory management, formulation, filling, visual inspection, and packaging and labeling of vials, prefilled syringes or cartridges.
Our GMP clinical sterile drug product manufacturing and packaging facility in San Diego features gloveless aseptic filling robotic technology. I supported the validation of the robotic filling isolators and other GMP equipment within the Grade C cleanroom. Through this experience, I have become the subject matter expert for the equipment and have established many of the standard operating procedures used throughout the facility. By working closely with the QA, Project Management, and Engineering teams, we ensure GMP compliance and successful operational delivery to meet our clients’ needs.
As I picture the future of Sterile manufacturing, I see robotic isolators leading the way. There are numerous benefits to using robotic isolators, and it makes sense for the industry to continue developing this technology, which ultimately benefits the patient.
Compared to conventional aseptic filling lines, robotic isolators offer many advantages. Operating in a sterile environment with no human intervention reduces the risk of introducing contaminants.
The interior of the isolators are decontaminated through vaporized hydrogen peroxide and are designed to supply Grade A laminar airflow, together with ready-to-use sterile components ensures sterility.
Drug product quality is enhanced with the use of plastic caps with integrated stoppers, which helps eliminate metal particle contamination.
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