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Expert View: Standardisation through automation
29 February 2016 • Author(s): SOTAX Group
As Symonds and Elder mentioned in their article, ‘Dissolution Testing in the Modern World’, there are several sources of variability in the “inherently poor design” of compendial dissolution apparatus types. Nevertheless, dissolution testing is a QC requirement for many products, and so the industry faces the challenge of implementing and managing fleets of dissolution equipment. However, through instrument and process design and automation, managing the products, equipment, and personnel associated with routine QC testing can be streamlined.
It is abundantly clear to those experienced in routine QC dissolution testing that the assembly of the apparatus, checks to assure proper assembly, execution of the test including manual sampling, and cleaning after the run completion, all introduce opportunities for variability to arise. When moving from manual to semi- and fully automated systems, at each step automation has been and continues to be a way to reduce some of these inherent sources of variability.
Automation of instrument qualification
First, consider the assembly and the checking of the dissolution system post assembly, to assure that the assembly was properly executed. For years, there have been both compendial and regulatory recommendations on how to best accomplish this task, and what the acceptance criteria should be for each parameter. Both mechanical and chemical tests have been used over the years and the relative merits of each have been argued exhaustively. The debate has gone on for several years and the current state of affairs is a mismatch between compendial and regulatory agency recommendations.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Butterworth Laboratories Ltd CAPSUGEL NV Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) Eurofins BioPharma Product Testing EUROGENTEC F.P.S. Food and Pharma Systems Srl GE Analytical Instruments IDBS JEOL Europe Kaiser Optical Systems Inc. L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Lonza MA Business Metrohm Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Ocean Optics Panasonic Biomedical Sales Europe B.V. Peak Scientific PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Viavi Solutions, Inc Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics