pharmaceuticals
22 Issue 6 2020
Intelligent flash purification using TLC and mass spectrometry
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he combination of the Advion expression Compact Mass Spectrometer and Interchim puriFlash flash chromatography technologies speeds up the synthesis, purification and characterisation of a compound. The integrated use of Advion expression CMS, the Plate Express TLC Plate reader, the ASAP Atmospheric Solids Analysis Probe and the Interchim puriFlash XS 520 allows for an execution of fast, user-friendly workflow to run TLC whilst harnessing the power of your mobile phone to develop a flash method and finally utilising a simple dipping probe to confirm fractions within seconds. With easy sampling techniques, intuitive software and advanced detection technology, you can simply and confidently synthesise, purify and characterise your compound, in a flash. BRUNO STEINER LAB CONSULTANCY Tel: (011) 804 3503 Fax: 086 719 2778 Mobile: 078 342 3354 bruno@bslc.co.za www.bslc.co.za Bruno Steiner Lab Consultancy SA is a Level 2 BBBEE contributor
LabX ensures data integrity in pharmaceutical labs
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ata integrity is a critical component of pharmaceutical product quality and the information submitted to regulatory agencies. As regulators continue to tighten their inspection approaches, it is critical for managers and scientists in regulated GXP (Good Practice) laboratories to understand the key issues surrounding data integrity and compliance. Mettler Toledo’s LabX laboratory software connects to a variety of laboratory instruments and meets all data integrity criteria and requirements regarding 21 CFR 11, EU Annex 11 and ISO 17025. Multiple instruments, one software LabX software comprises several modules designed to accompany Mettler Toledo instrumentation, such as precision and analytical balances, density meters, refractometers, autotitrators, Karl Fisher titrators, melting point instruments, Quantos dosing systems, pH meters and UV/VIS (Ultraviolet-Visible Spectroscopy) systems, and offers complete instrument control, user friendly data management (network, processing and reporting capabilities), and integration into LIMS.
Increased workflow efficiency LabX brings power to the laboratory bench with automatic data handling, high process security and full SOP user guidance. To ensure data integrity with LabX in the laboratory, controls can be put into place so that SOPs are followed according to ALCOA+ framework throughout workflows. Automatic data transfer ensures all sample information entered travels along with the sample, from one instrument to another, eliminating any calculation and transcription errors. Ensure only adjusted and calibrated resources are in use with LabX asset management. Compliance made easy Auditors focus on the raw data and the metadata and the electronic records are the primary interest. With its powerful search capability, relevant data can be easily retrieved from the secure database and presented to an auditor where necessary. Data of results, measurements, tests, audit trail entries and metadata are saved, and the necessary documentation of a fully controlled and accurate process is readily available. Data integrity throughout the whole SOP process is simplified and achieved with LabX. MICROSEP (PTY) LTD Rudy Maliepaard Tel: (011) 553 2300 Fax: (011) 553 2400 rudy.maliepaard@microsep.co.za www.microsep.co.za
Mira P for the pharmaceutical industry: Instant onsite verification of raw materials
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etrohm is pleased to present the latest compliant handheld Raman solution for the pharmaceutical industry. Mira P offers enhanced resolution, new immersion sampling and validation accessories, and ergonomic features that improve user experience. Mira P is fast, easy, and accurate, helping users optimise the inspection of incoming goods, formulation verification and process monitoring. Mira P and its dedicated software, MiraCal P was developed in collaboration with some of the world’s leading pharmaceutical companies. New features streamline verification routines and include an automated training set builder and improved model analysis tools. Soft- and firmware improvements, like a colour-coded audit trail with advanced management features, ensure that users can easily reference samples even in massive databases. FDA compliance is met with customisable reports, automated report generation and export, as well as in-software viewing and printing. Following USP and EP guidelines has never been easier with the new CVA (Calibrate/Verify Accessory). This new attachment ensures accurate performance of Mira P and the quality of results with a thorough calibration and
verification routine. Mira P is IP67 rated and MILSPEC 810G tested, as expected from Metrohm’s rugged handheld analysers. In combination with the new guided workflow, this makes Mira P a perfect solution for the demanding pharmaceutical environment. From verification of morning deliveries to reviewing a day’s audit trail, Mira P helps in increasing the efficiency of the typical workflow in the pharmaceutical manufacturing industry.
METROHM SA (PTY) LTD Tel: (011) 656 1918 CPT: (021) 852 0213 DBN: (031) 265 0067 Fax: (011) 656 2698 076 643 7113 info@metrohm.co.za www.metrohm.co.za
