PMB 301
200 Ave. Rafael Cordero Ste 140
Caguas, PR 00725
ph: (787) 745-0318
fax: (787) 745-0028
more
· Creation and Revision Standard Operating Procedures for Laboratory Equipment
· Laboratory Deviation Investigations
· Revision of Laboratory Test Methods
· Validation/Qualification studies on new transferred methods of new products.
· Method Development, Optimization and Validation of Active Trace Determinations, Detergent Determinations, and Cleaning Validation Samples
· Quality Assessments for Quality Systems, Computer System Validation and 21 CFR 11 Compliance
· Beckman P/ACE MDQ Capillary Electrophoresis
· Celsis Advanced Luminometer
· ChemStation for UV-Vis and ChemServer for GC/LC
· Coulter Counter LS230
· Custom Spreadsheets using MS-Excel
· DataPro/DataGuard for Sievers 800AS TOC Analyzer
· Global Vision Scan TVS Proofreader
· Haake RotoVisco 1 with Rheowin Pro Software
· Hitachi, 32 Karat
· KAYE Validator 2000
· Lab-X Titrator System
· Malvern Mastersizer 2000 with Scirocco 2000, Hydro 2000G, and Hydro 2000SM accesories
· Multidose G3 Automatic Dissolution System
· PerkinElmer UV WinLab ES V4.2
· Primus Bio-Pharma Sterilizer
· Shimadzu Class-VP Chromatographic Software
· Shimadzu TOC-V with ASI-V
· TPW II Tablet Processing Workstation
· Vitek Senior Microorganism Identification System
· Waters Millennium32 4.0 Chromatography Manager
· Waters Empower Chromatography System
· Weight Variation System withLV-11 Feeder & SQC-14
Air Sieve Shakers, Analytical Balances, Auto Analyzers, Autoclaves, Automatic Titrators, Biolog Colony Identification Systems, Buchi Digester, Capillary Electrophoresis (Beckman), Centrifuges, Computrac, Conductivity Meters, Coulometer KF Titrator, Coulter Particle Size, Diffusion Cell Systems, Diluters, Disintegration Testers, Dissolution Baths, Diffusion Baths, Elix 70 Purified Water System with Recirculation Tank, Freezers, FTIR, Fume Hoods, GC (HP, Shimadzu & PE), Gas Generators, Glovebox Isolators, Headspace, HPLC’s (Waters, Hitachi, HP, Shimadzu & PE), Hydrogen Generators, Incubators, Karl Fisher Titrators, Label Readers, Malvern Mastersizer, Melt-Temp Apparatus, Micro Balances, Microscope, Milli RX 45, Milli-Q, Mixers, Moisture Analyzers, Nitrogen Generators, Osmometer, Ovens (conventional, depirogenization, vacuum, glassware), Pantone Color System, pH Meters, Plastograph, Polarimeters, Refractometers, Refrigerators, Room Incubators, Rotovapor, Shakers, Sieve Shakers, Temperature Baths, TOC Analyzers, Top Loading Balances, Ultrasonic Baths, UV-Vis Spectrophotometers, Viscometers, Vitek Identification System, Water Baths, Washers, Zero-Air Generators, Thermal Mapping (using Kaye Validator 2000) of Stability Rooms, environmental Chambers, Ovens, Sterilizers and Freezers.
· Analytical Techniques and Instrumentation
· Basic Operation and Infrastructure of Waters Empower and Millennium 32
· Cleaning & Process Validation Basic Concepts
· Computer System Validation for Lab Systems
· Good Documentation Practices
· Laboratory Equipment & Method Validation
· Laboratory Investigation Reports
· Thermal Mapping (using Kaye Validator 2000) of Stability Rooms, Environmental Chambers, Ovens, Sterilizers, and Freezers

Our Expertise on Laboratory Systems grew at the QC Laboratory. Chemists with extensive exposure to laboratory equipment troubleshooting and complex data acquisition software systems were skilled in the Validation fundamentals based on current regulations. The result is a Validation Specialist with strong hands on experience on Laboratory Systems and Quality Focused Validation Expertise.
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©2007 EB Validation Services, Inc.. All rights reserved.
PMB 301
200 Ave. Rafael Cordero Ste 140
Caguas, PR 00725
ph: (787) 745-0318
fax: (787) 745-0028
more