Today’s pharmaceutical landscape demands rigorous data integrity and streamlined workflows—especially for critical therapies that prevent post-chemotherapy infections. In this spotlight, we explore how a global pharma site in Australia modernized its UV/Vis spectroscopy operations to align with tighter regulations. Leveraging METTLER TOLEDO’s UV7 Excellence Spectrophotometer and LabX™ software, the lab adopted a secure, automated system that reduces human error, simplifies SOPs, and ensures every measurement meets demanding compliance standards.
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Today’s pharmaceutical regulatory environment is exceptionally demanding. Whether the focus is on oncology support drugs or infectious disease therapies, QC must be comprehensive. In Australia, a branch of a global pharma leader was producing a medication aimed at lowering infection risk post-chemotherapy. The process required UV/Vis spectroscopy within a strictly documented framework
However, changing regulations exposed gaps in their setup: they lacked workflow security, thorough documentation, and guaranteed measurement accuracy. Realizing that manually maintaining multiple SOPs would risk errors and non-compliance, the QC manager sought a single, fully validated solution. They chose METTLER TOLEDO’s UV7 Excellence Spectrophotometer—aligned with the latest United States Pharmacopeia (USP) updates—and LabX™ software to address these needs.
Building a Secure UV/Vis Workflow
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Figure 1: METTLER TOLEDO's performance verification modules can remain mounted on a UV7 Excellence Spectrophotometer during sample measurements. |
This combined system enabled the QC team to surpass existing SOP requirements for sample preparation, absorbance measurements, and traceability. Thanks to step-by-step prompts on the instrument’s terminal, operators could follow each protocol precisely, minimizing the possibility of missteps. This daily guidance not only upheld compliance but also instilled confidence in the staff that every sample was handled with consistent rigor.
Instrument Performance, Compliance, and Traceability
METTLER TOLEDO’s UV7 Excellence Spectrophotometer and LabX™ software work in tandem to ensure data integrity and high performance:
- CertiRef™ and LinSet™ Performance Verification Modules: Automate optical checks, in line with the 43rd edition of the USP, allowing the lab to confirm up to 10 optical parameters with certified references.
- Single-Workstation Control: One PC running LabX software can govern two spectrophotometers, standardizing workflows and easing instrument management.
- Real-Time Prompts: Operators are guided through tasks such as sample insertion, measurement selection, and result logging, significantly reducing user errors.
Mounting the Modules
- The UV7 covers are removed from the spectrophotometer.
- The CertiRef™ and LinSet™ modules are easily attached, remaining in place during routine measurements.
Integrated Equipment, Software, and Workflows
The Australian lab quickly discovered that when it comes to dilution, absorbance measurements, and data security, METTLER TOLEDO’s UV7 Excellence Spectrophotometer paired with LabX software is a robust choice for modern pharma environments. Complex SOPs become more manageable under a unified platform, ensuring comprehensive audit trails and regulatory compliance. From basic QC checks to highly specialized testing, the system delivers consistency, reliability, and the flexibility to adapt to evolving standards.
In short, this integrated approach simplified day-to-day operations and minimized the risk of non-compliance—essential when patients’ health depends on accurate, reproducible results. QC managers now have confidence that each step meets the toughest demands, from sample preparation through to final documentation and data storage.
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Anika Adams is Senior Product Manager for UV/Vis Spectrophotometers at METTLER TOLEDO, where she focuses on driving innovation and optimizing customer workflows.
With a degree in business administration and experience spanning software development, mechanical engineering, and production, Anika brings a multidisciplinary perspective to the laboratory business. Her expertise lies in automating and enhancing customer processes, ensuring both product excellence and customer satisfaction.
