Pharmaceutical Technology - November 2018

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Pharmaceutical Technology LABORATORY BEST PRACTICES 2018 7 tailed risk analysis on the cobot project before it is deployed to determine if any additional steps need to be taken to ensure safe operation," he notes. Automation can provide reproducibility, tracking, information reporting on hardware performance, electronics documentation, audit trails, and user- access control, which are important for both R&D and regulated (GxP) environments, notes Biosero CEO Tom Gilman. The company announced com- pletion of FDA 21 Code of Federal Regulations Part 11 compliance certification for its Laboratory Au- tomation Software package, Green Button Go, in August 2018 (3). The compliance enabling process includes verification of system functionality, audit trails, electronic signatures, and other documenta- tion required when using electronic quality records. Considering automation? Pharma labs considering adding automation should look at how fast the return on investment would be, the f lexibility of an automation solution, and the option to change the application without expensive engineering help, suggests Hulgard. "Clearly defining the objectives for the project and the tasks for the robot/automation are key. Equally important is to think through how you want the humans to engage and interact with the equipment," says Garrett. In addition to defining the scientific process used in a new system, identifying the handling require- ments, such as how to move something from point A to point B and the sample loading characteristics of the instruments, is key, adds Ouren. "Once you have this information, find a scheduling software package that matches both the instruments and the process. We've seen a big improvement in the breadth of capabilities of software in recent years. Taking the time to find the right software simplifies training of operators, increases the number of users, and creates an opportunity for higher efficiency." References 1. J. Tilley, "Automation, Robotics, and the Factory of the Future," sights/automation-robotics-and-the-factory-of-the-future, ac- cessed Sept. 25, 2018. 2. Grand View Research, "Pharmaceutical Robots Market Analy- sis by Product (Traditional, Collaborative), By Application (Picking & Packaging, Inspection of Pharmaceutical Drugs, Laboratory Applications), By End Use, And Segment Forecasts, 2018 – 2025," (July 2017). 3. Biosero, "Biosero Receives FDA 21 CFR Part 11 Compliance Certification for Green Button Go Laboratory Automation Software," Press Release, Aug. 24, 2018. PT Lonza Announces Technology for Automated Endotoxin Testing Lonza exhibited its next-generation endotoxin automation solution, PyroTec Pro Robotic Solution, at the Parenteral Drug Association (PDA) Global Conference on Pharmaceutical Microbiology (October 15–16, 2018, Bethesda, MD). The company's instruments, reagents, and software are integrated into the robotic platform, providing a fully automated workflow solution, which will be available in 2019. The company is also adding features to its WinKQCL Endotoxin Detection Software. The automation module in version 6.0 simplifies the process of setting up an automated endotoxin testing run, and no programming or robotic scripting knowledge is required. The software can now generate robotic scripts and adapt to changing sample dilution requirements, as well as control the procedure from start to finish. The software can import sample test worklists from a sample management system and export the results back out to the same system, preventing transcription errors and saving time over manually entering data. Source: Lonza

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