GSK Receives FDA Approval to use ChemScanRDI for Routine Microbiological Water Analysis
Chemunex have announced that GlaxoSmithKline has received approval from the FDA to use the Chemunex system, ChemScanRDI (ScanRDI in the USA) for the microbiological analysis of their pharmaceutical grade water.
Recent work with ChemScanRDI has delivered confidence in the speed and sensitivity of the system to give accurate and early counts for the waters used in manufacturing. As part of the Process Analytical Technology (PAT) initiative, the early detection of organism levels is seen to contribute to improved process control. The sensitivity of ChemScanRDI will be utilized to deliver "real-time" microbiological trending of pharmaceutical waters.
The ChemScanRDI system delivers counts of viable microorganisms without the requirement for a growth phase. Laser scanning of a filter membrane supporting labeled organisms delivers sensitivity to a single cell within two hours from sampling. Internal requirements and external regulatory bodies increasingly monitor the absolute requirement for water quality control in all aspects of production and cleaning processes. The introduction of the specific elements of speed and sensitivity, inherent in the ChemScanRDI protocol, will offer further confidence and control for the pharmaceutical microbiologist.
Typically the standard growth plate method takes between 48 to 72 hours (TSA) or 5 to 14 days (R2A) allowing counts of culturable organisms. Such methods do not allow early detection of, or response to, excursions from approved limits within the water system, any such response being retrospective to the production process.
The ChemScanRDI protocol enables real time counting and the consequent ability to react to any out-of-specification excursion, to then take early and remedial steps to return the water system to production, the plant to profitability, and to reduce the expensive risk of contaminated product.
Recent multi-site studies have shown ChemScanRDI to offer further scientific, production and commercial benefits in the introduction of new water systems, biofilm characterization, water-system trending and rapid microbiological environmental monitoring.