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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Dette er et success story-highlight, hvor vi giver dig et indblik i inspirerende kundeprojekter for at styrke din laboratorietransformation. Så LabX-platformen, når den køres i et 21 CFR Part 11-miljø, som er FDA-koden, de europæiske koder, Annex 11 i PIC/S, Pharmaceutical Operation noget-ordningen. Så når du kører softwaren LabX i compliance-tilstand, bliver alt sporet. Så der er elektroniske signaturer for alt. Du kan spærre folk ude fra ting, de ikke er trænet til at gøre. Du kan ikke validere metoder. Du kan frigive metoder til visse. Visse personer, efter at de er trænet, der følger alt dette 21-data med, det kaldes data-integritet. Så LabX har det i back enden. Du kan slå det til eller lade det være slået fra. I en ikke-farmaceutisk verden lader du det være slået fra. Det er frustrerende, det dræner livet ud af dig at prøve at sætte det op. Al software er sådan. Når du først har fået en fungerende valideret compliance, er det fantastisk, fordi du kun kan gøre det, du har lov til at gøre, det, der er valideret, og det. det, du er trænet til at gøre, og vi samarbejdede med virksomheder, da vi etablerede Pharmalytics, hvor den ene var Agilent Technologies til alt kromatografiudstyret og den anden var Labix til alt det andet, så Vi købte vægte, viskositet, titratorer, power fisher, pH, ledningsevne, densitet ved UV. Det kører på én softwareplatform. Så der er Det er fantastisk. én platform at validere. Det er det. Ja, alt det kræver validering. Det er en del af den smerte, man skal igennem. Men hvad angår at gemme dataene i en database, er der kun én platform, jeg skal validere. Nu, hvis jeg købte de syv eller otte ting fra otte forskellige leverandører, Mm-hmm. skal jeg køre otte servere, validere otte platforme, have oplæring i otte platforme, al vedligeholdelsen, driften. Der er simpelthen ingen anden løsning på markedet, der tilbyder det. Og jeg ville ønske, at du havde flere instrumenter. Det første er, at det er Metler-vanen. Okay, de behøver ikke at gå ud og købe en andens. Så det går jo ganske godt. Vi er oppe på fem databaser for et helt laboratorium. En af dem er et LIMS. En er Agilent. én er Metla, så der er kun to andre, så det er godt, og det skyldes især, at Agilent har et enormt udvalg af kromatografiudstyr, der fungerer sammen med deres, og så valgte vi Metla, et enormt udvalg af alt det andet, som fungerer sammen med deres; det er ikke perfekt, men tæt på, virkelig tæt på, det er rigtig godt
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.
