Equipment List Equipment List Analytical Shimadzu HPLC

							Equipment List
Analytical
Shimadzu HPLC - LC-10           (2)                                             Photostability Chamber- SunTest
Shimadzu HPLC- 2010 AHT (4)                                                           - Fluorescent Light (-5000 lux)
UV/Vis, PDA, RI Detectors                                                             - UV Light
Varex Evaporative Light Scattering Detectors                                    Darwin Stability Chambers w/ Veriteq Data Logging Software
Scientific Software Class VP 7.4 SP1 Control and Data Acquisition                     - cGMP Stability Chambers (ICH Guidelines)
System (Isolated Network)                                                             - 25°C / 60%RH (ICH)
Shimadzu FTIR - 8400S                                                                 - 30°C / 65%RH (ICH)
Shimadzu LCMS - 2010 w/ PDA Detector                                                  - 45°C I 75%RH (ICH)
ShimadzuGC-17 w/FID Detector                                                          - 65°C 175%RH
Coulometric Karl Fisher Titrator                                                cGMP Storage Refrigerators
Accumet Model AB30 Conductivity Meter                                                 - Refrigerator 3°C - 8°C
Accumet Model AB15 pH Meter                                                           - Revco Freezers: -80°C, -30°C, -55°C
Rotary Evaporators (Impurity/Degradation Analysis) 5-Li, 1 O-Li, and 20-Li      Dissolution USP Apparatus I and Apparatus II            (2)
Labconco FreeZone 18 Stoppering Tray Dryer / Lyophilizer                              - vanKel VK8000 Dissolution Auto-Sampler Stations
Barnstead E-Pure Water System                                                         - vanKel Dissolution Baths
Fisher Scientific IsoTemp Oven                                                        - Apparatus I - Baskets
Precision Scientific Vacuum Oven                                                      - Apparatus 11- Paddles
Eppendorf Centrifuge 5415-C                                                           - vanKel 1 Disintegration Testers
Jouon Centrifuge RC-1 01 0
Tecan SpectraFlor Plate Reader




Formulation and cGMP Manufacturing
cGMP Cleanroom - Class 10000
EtQ cGMP Compliance Software System (SOPs, Electronic records and               vanKel disintegration Tester
forms, CAPA, Training)                                                          Varian Friabilator Testers

Granulation, Blending, and Milling                                              Branson 3510 Sonicator

      - Vector GMX Micro High Shear Granulator / Mixer                          Precision HDL-8 Sonicator

      - Vector VFC Lab Micro Fluid Bed                                          Corning PC-351 Hotplate Stirrer
      - Vector FloCoater VFC Lab-3 Fluid Bed                                    CAHN Orion CM-1 0 Moisture Balance

      - Vector GMX-25 High Shear Granulator                                     Mettler Toledo PB303 Electronic Balances
      - SCI 3-D 50-Li Blender                                                   Mettler Toledo SG32001 Electronic Balances
      - SCI CM150A Conical Mill                                                 Mettler Toledo AG245 Electronic Balances

      - Quadro Comil 197S Mill                                                  Mettler Toledo LC-P43 Balance Printer

      - Patterson-Kelly Blend Master V-Shell Blender (interchangeable shells)   Mettler Toledo MT5 Electronic Balances
      - K-A Planetary Mixer                                                     Mettler Toledo LC-P45 Balance Printer
      - Fisher Mixer SL2400                                                     Ohaus Navigator N08110 Electronic Balances

Tablet coating                                                                  Induction Sealer 500A

      - Vector Laboratory Development Coating System (LDCS) Tablet Coater       GoldStar Dehumidifier
Tabletting                                                                      Electronic Microscope with Digital Picture and Video Capabilities
      - SCI TPS-D25 Tri-Layer Tablet Press (cGMP)                               Associated Environmental Systems Stability Chamber (Configurable)
      - Dynamic Exim MC200 Tablet Press w/ Force Feeder (cGMP)                  Manufacturing and Packaging Support

      - Dynamic Exim MC200 Mini Press - 10 Station Tablet Press                       - Release Testing

      - Dynamic Exim Bi-Layer Tablet Press                                            - Post Packaging 10
      - Carver 3851-0 Tablet Press                                                    - Compendial testing

Torit 80-CAB Dust Collection System                                                   - In-Process Testing

Buchi Mini Spray dryer B-290                                                          - Formulation Support
FlowSciences Flow Hood                                                                - Cleaning Verification Analysis
Thermolyne SP46615 Hot/Stir Plate                                               Stability Testing and Support

Brookfield LVDV 11+ Pro Viscometer                                                    - Samples Storage- ICH Guidelines and Conditions

ATM Sonic Sifter                                                                      - Design Protocols per ICH for IND or NDA (API, Drug Product)

Omni GLH Homogenizers (various shafts and heads)                                      - Chemical Testing (Stability- Indicating Assay and Degradation

Mitutoyo Thickness Gauges                                                              Products, Chiral)

vanKel Tablet Hardness Testers                                                        - Drug Excipient Compatibility Studies

vanKel Tap Density Tester                                                             - Standard or Customized Stability Reports




                                                                                                                                                    rev. 10082008