PHARMACEUTICAL Aurora 1030W TOC Validation Package Complete IQ, OQ, PQ Documentation with On-Site Support Deliverables & Support The Aurora 1030W Validation Package provides complete documentation for validating a 1030W TOC (Total Organic Carbon) instrument for use in pharmaceutical and biotechnology GLP/GMP applications. The Aurora 1030W Validation Package consists of instrument validation protocols for installation qualications (IQ), operation qualications (OQ), and performance qualications (PQ) and matching certication documents to record successful completion of each step with a signature and date. Aurora 1030W TOC Analyzers employ heated persulfate wet oxidation to perform the high sensitivity measurements required in Cleaning Validation (CV), Puried Water (PW), and Water for Injection (WFI) applications. The 21 CFR Part II compliant software and Aurora 1030W validation package ensure the instrument meets all requirements for operation in GLP and GMP environments. Installation Validation Package Installation Qualications Operation Qualications Performance Qualications Standard Operating Procedures OI Analytical PO Box 9010 College Station, TX An OI Analytical technician is available to install the Aurora 1030W TOC analyzer and perform the IQ, OQ, PQ validations, providing certications to be maintained with instrument records for inspections or audits. Organizations that use in-house personnel to conduct instrument validations may obtain the validation package separately. The validation package and on-site installation ensure the Aurora 1030W is properly installed, verify operation of all critical sub-components using NIST-certied meters, and conrm system performance to manufacturer specications, including accuracy and reproducibility, using a test standard supplied by OI Analytical. The validation documents support the initial validation of an Aurora 1030W instrument and continuing validations over the lifetime of the instrument. Principal Application Protocols & Documentation Validation of Aurora 1030W TOC Analyzers for GLP/GMP compliance supporting: • Cleaning Validation (CV) • Puried Water (PW) • Water for Injection (WFI) • Operation Qualications (OQ) • Performance Qualications (PQ) • Standard Operating Procedures (SOPs) • Certication Documentation PO Box 9010 College Station, Texas 77842 Tel (800) 653-1711 • Fax (979) 690-0440 www.oico.com • E-mail [email protected]