![zetasizer nano series basic guide zetasizer nano series basic guide](https://postfiles.pstatic.net/20121025_260/malvern_kor_1351143229755YqQiy_JPEG/MRK1839K-01_%C6%E4%C0%CC%C1%F6_04.jpg)
The system incorporates a two angle particle and molecular size analyzer for the enhanced detection of aggregates and measurement of samples at very low or high concentration usingĭynamic light scattering with ‘NIBS’ (Non-Invasive backscatter optics).
#Zetasizer nano series basic guide software
This information from correlator is then passed to computer where a specialized Zetasizer software will analyse the data and derive the required results. An Avalanche photodiode acts as detector that measures the intensity of this scattered light and passes it to a digital signal processing board called correlator. Most of the laser beam passes straight through the sample cell but some is scattered by the particles in all directions. Then a light source like laser beam is used to illuminate the particles within the sample. The sample is prepared, filled in appropriate cells and placed in the cell chamber area. The instrument also measures the electrophoretic mobility of the proteins using a improvised laser Doppler velocimetry method (M3) with Phase Ananysis Light Scattering (PALS). In addition, the system can also be used in a flow configuration to operate as a size detector for Size Exclusion Chromatography (SEC) or Field Flow Fractionation (FFF). The ZSP also incorporates a zeta potential analyzer that uses electrophoretic light scattering for particle and a molecular weight analyzer using static light scattering for the measurement of Zeta potential and molecular weight respectively. The system incorporates a two angle particle and molecular size analyzer for the enhanced detection of aggregates and measurement of samples at very low or high concentration using dynamic light scattering with ‘NIBS’ (NonInvasive backscatter optics) technique. The system also has the ability to perform Trend (tendency) measurements and enables in determination of microrheology of protein and polymer solutions, Protein melting point etc. The software controls the system during the measurement and then analyses the data from the instrument to give particle size, molecular weight or zeta potential for the sample measure. This system consists of optical unit, sample dispersion units like MPT-2 Titrator, vacuum degasser and a computer with zetasizer software installed. Ensure all activities are being performed in a manner consistent with applicable regulatory guidance documents and XYZ policies and procedures. Review and approve documents listed in section 6. Reviewing and approving of applicable discrepancies observed during the execution of this protocol. Develop, review and approve documents listed in section 6.Ĥ.4.1. Assist in sorting out discrepancies found during the execution of GAP IOQ protocols. Assist in the execution of GAP IOQ protocols. Assisting and collaborating with QC validation in the development of GAP IOQ protocols. Develop, review and approve documents listed in section 6. Provide IT impact assessment details in the change control and complete any change action items. Assist with the drafting of the GAP IOQ, primarily the sections on installation qualification, configuration verification. System Design and Configuration SpecificationĤ.1.1. Installation and Operational Qualification ReportĪ document that should be assessed for changes when specification, design, or testing documents are created or revised or when business processes and practices change.Ī document written to support validation project activities that a typically not revised after the system is released to production use. Installation and Operational Qualification ACRONYMS, TERMS AND DEFINITIONS Acronym/Term The scope of validation will be limited to the one (1) Zetasizer nano ZSP (System ID: ZEN 5600) at XYZ’s Quality Control (QC) laboratory located at 300 XYZ Way, Lexington MA.Ģ. The Zetasizer Nano ZSP will be validated in accordance with SOP, “Analytical Instrument Qualification Procedure”( USP1058) Scopeġ.2.1. The purpose of this Validation Project Plan (VPP) is to outline the validation approach, strategy, and deliverables required for the validation of Zetasizer Nano ZSP model ZEN 5600). VALIDATION STRATEGY.6ĭELIVERABLES, RESPONSIBILITIES AND APPROVAL MATRIX.10ĭEPENDENCIES.13 INTRODUCTION.2ĪCRONYMS, TERMS AND DEFINITIONS.3 VALIDATION PROJECT PLAN FOR THE ZETASIZER NANO ZSP Doc # :