pharmaceuticals
26 Issue 6 2018
The importance of data integrity in a GXP regulated laboratory DATA integrity is a critical component of pharmaceutical product quality and the information submitted to regulatory agencies. However, in recent years an increasing number of inspections have revealed incomplete data, the lack of audit trails, and falsification of results. In July 2014, United States Food and Drug Administration (FDA) issued a stern warning that data integrity was a key focus of its enforcement efforts. The UK Medicines and Healthcare Products Agency (MHRA) went further and issued GMP data integrity definitions and guidance for industry in January 2015. As regulators continue to tighten their inspection approaches, it is critical for
Stevia
SWEETENERS are often used in diet products. MCP polarimeters can be used to determine the quality of optically active sweeteners like stevia. The specific and optical rotation of single, purified steviol glycosides, extracted from stevia plants, can also be measured. Stevia - sweeter than sugar, 100% organic, no calories Stevia sweetener is prepared from the leaves of the plant Stevia rebaudiana. The stevia leaf is up to 30 times sweeter than conventional sucrose but has no calories. This makes stevia plants an ideal source for the process of low-calorie sweeteners,
managers and scientists in regulated GXP laboratories to understand the key issues surrounding data integrity and be able to demonstrate compliance. Mettler Toledo’s LabX 2019 laboratory system can connect a variety of laboratory instruments and meets all data integrity criteria and requirements regarding 21 CFR 11, EU Annex 11 and ISO 17025. LabX 2019 software comprises several modules designed to accompany Mettler Toledo’s 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. LabX 2019 thus allows one to fully control measurements from anywhere in the laboratory or office. LabX 2019 brings power to the laboratory bench with automatic data handling, high process security and full SOP user guidance. To ensure data integrity with LabX 2019 in the laboratory, controls can be put into place so that SOPs are followed according to ALCOA (Attributable, Legible, Contemporaneous/Complete, Original, Accurate) guidelines. Automatic data transfer ensures all sample information entered travels along with the sample, from
one instrument to another, eliminating any calculation and transcription errors.
e.g. in diet food and diet drinks. The major components in stevia powder or liquids are called steviol glycosides. The sweetest steviol glycosides is stevioside, which can be 300 times sweeter, and rebaudioside A, which can be up to 450 times sweeter than sucrose. The exact composition of the steviol glycosides in stevia can vary and contain impurities. Therefore, the verification of the equality of the stevia powders and liquids is necessary to ensure the high quality of the product batch. Moreover, single purified steviol glycosides can be measured to validate purity and concentration.
steviol glycoside can be measured. Thereby, a concentration determination of single steviol glycosides is possible. Depending on the required measurement conditions and the accuracy, MCP 100, 150, 200, 300 or 500 can be used. MCP polarimeters allow a precise analysis of stevia compounds in the milligram range due to the high resolution of up to ± 0.0001° optical rotation. As the optical rotation is temperaturedependent, the MCP polarimeters have a built-in Peltier temperature control with an accuracy of up to ± 0.03°C.
Depending on the type of instrument, a FillingCheck camera system is available which helps to verify the correct filling of the sample cell to avoid air bubbles or streaks that can lead to data falsification. Detailed information is given in the stevia application report.
MCP polarimeters are ideal for the quality control of sweeteners The MCP polarimeters from Anton Paar are ideal for quality control of stevia extracts by measuring optical rotation. Further, the optical and the specific rotation of any single purified
THE Sterisart NF System is a completely closed system for the sterility testing of pharmaceutical products. It is based on the membrane filter method. However, it eliminates the procedure of manipulating the filters. By this means, the main risk of a secondary contamination and false positive results is eliminated. The Sterisart NF System is a completely disposable technology based on the membrane filtration method, for the sterility testing of pharmaceutical products. By providing more than 20 different types of units, technicians can selectively choose which adapter or system best fits their application. The Sterisart Universal Pump transfers the sample into the filtration units. After rinsing, the filtration units are then filled with culture media and used for incubation of the filters without any contact to the environment. After 14 days of incubation, a visible result is available (turbidity/no turbidity). The unique Sterisart Septum version makes aseptic sampling easy, during or after incubation that is required for dilution or
Maximising throughput on the titration bench Breaking the limits of all existing automation solutions: The Omnis Sample Robot addresses the need of large QC laboratories in the manufacturing industries, as well as contract laboratories, for an efficient solution to cope with high sample loads at the lowest possible cost per sample. Entirely modular by design, the Omnis Sample Robot benefits users with unique flexibility and unmatched performance - for a whole new level of productivity. Walk-away automation for up to 175 samples Modular automation with Omnis means users may start with the Omnis Sample Robot S (two racks, up to 50 samples), scale it up to a Sample Robot M (five racks, up to 125 Samples) and ultimately analyse up to 175 samples completely unattended on seven racks with the Omnis Sample Robot L.
BIOTECH SOLUTIONS (PTY) LTD Tel: (011) 315 5444 sales@biotechsolutions.co.za www.biotechsolutions.co.za
Good to know The MCP polarimeters measure the optical rotation of stevia and single, purified steviol glycosides with high accuracies. Sample cell volumes are available from 0.05 to 20ml.
Tel: (011) 021 5165/6/7 Fax: 086 610 3908 info.za@anton-paar.com www.anton-paar.com
Omnis Sample Robot
Features include: • High retention of microbes • Low adsorption • High mechanical stability • Sharp metal needle for easy penetration • Pre-installed color-coded tube clamps • Easy-to-read graduated marks
Rudy Maliepaard Tel: (011) 553 2300 Fax: (011) 553 2400 rudy.maliepaard@microsep.co.za www.microsep.co.za
ANTON PAAR SOUTHERN AFRICA (PTY) LTD
Sterisart - sterility test consumables rapid detection, or for the supplement of additives for inactivation of antibiotics (penicillinase). The Sterisart NF System is available with different types of adapters. Depending on the application, Ethyleneoxide (EO) and Gamma-irradiated Systems are available. The latter have been specially developed to enable the transfer into clean rooms and isolators, thanks to their packaging.
MICROSEP (PTY) LTD
Time savings of up to 60% The Omnis Sample Robot can accommodate up to four workstations.
They can be used to perform up to four titrations in parallel, saving 60% in time compared to performing the same application on a stand-alone system. With Omnis, users can consolidate and automate all their titration applications on a single platform. Hot-swapping sample racks for continuous reloading Users can assign their routine applications to dedicated workstations on the Omnis Sample Robot to keep a perfect overview. When the Omnis Sample Robot has finished analysing the samples on a particular rack, it can be simply exchanged while the system keeps working uninterrupted. METROHM SA (PTY) LTD Tel: (011) 656 1918 CPT: (021) 852 0213 DBN: (031) 265 0067 Fax: (011) 656 2698 078 643 7113 info@metrohm.co.za www.metrohm.co.za
