lxcelllnci I HROUGH II,NOVAIIOII Unused Dry Powder Injectable Line - 150VPM YOM 2008 / Imported in Jaunary 2009 1.1. Base Machine WM8200 Automatic intermittent motion washing machine suitable to wash new cylindrical containers like vials, unstable vials and ampoules as DIN specs for "C" body Loading of the containers from customer's trays or cartons. The containers are washed in upside-down position. Mechanical speed up to max. 12.000 washed containers/hour (Note: manifolds and needles not included, item 044 or 045 must be added) Including one set of change parts for 10 mi. vials dimensions to be confirmed [MAC6601001) 1 1.2. Options Connection and automatic control of containers accumulation at the entrance to the sterilizing tunnel [MAC6601030) 1 Kit of standard manifold and needles [MAC6601044) 1 Additional set of change parts for 20 ml vial [MAC6601040) 1 Recycled hot water washing station [MAC6601050) 1 100 liters tank for WFI [MAC6601777) 1 Filtration unit complete with 2,5 micron PALL filter, for recycled hot watercircuit and TRI-CLOVER connections [MAC6601060) 1 Filtration unit complete with 0,45 micron PALL filter, for distilled or demineralized water circuit and TRI-CLOVER connections [MAC6601062) 1 Filtration unit complete with 0,20 micron PALL filter, for sterile compressed air circuit and TRI-CLOVER connections [MAC6601064) 1 Aspirator for fumes extraction. The unit is separate from the machine. 11.2007 1/5
EXCllltHCI I H ROUGH llonovaiio I (Exhausting ducts not included) for machine connected with T600 tunnelseries 1 [MAC6601120] Recommended spare parts for 2 years' service [MAC6601200] 1 Profibus card [MAC6601250] 1 [MAC6601400] 1 1.3. Base Machine MACOFAR Mod. T 600/H2/C2 Laminar flow sterlizing tunnel to sterilize and depyrogenize glass-vials at a temperature of 320 C. Class 100 is assured above the openings of the vials. Vials dimensions: Dia. min. 8 mm.; H. max. 180mm. [MAC5102001] 1 1.4. Options Mechanical connection to the turn-table complete with stainless steel table and micro switches for max. loading. [MAC5102010] 1 Sterilizable cooling zone [MAC5102777] 1 Recommended spare parts for 2 years' service without spare filters [MAC5102777] 1 Profibus card [MAC5102250] 1 [MAC5102400] 1 11.2007 2 /5
[XCHLlHC!1HP.OUGIIIhNOVA11011 1.5. Base Machine MACOFAR Mod. TR 12 Intermediate turntable complete with guide for vials 10 ml [MAC7703001) 1 1.6. Options Additional change parts for 20 ml vial [MAC7703010) 1 Additional price for motor speed adjustment by INVERTER [MAC7703015) 1 Safety protection hood [MAC7703025) 1 Vertical laminar flow cabinet with connection to the microdosing machine, consisting of: Centrifugal fan; Aspiration pre-filter Absolute HEPA filter, efficiency 99,997% DOP test Mod. CAMFIL; Differential pressure gauges, to check absolute filter efficiency [MAC7703045] 1 [MAC7703400) 1 1.7. Base Machine MACOFAR Mod. MICRO 9 Fully automatic microdosing machine for antibiotic powders (Output up to 9.000 vials/h with 1 dos., 4.500 vials/h with 2 dos., 3.000 vials/h with 3 dos., etc.), complete with powder dosing unit, rubber stopper unit, change part for vials. The machine can perform an illimited number of dosages. Standard dosing range: For single dose: 80 mg.- 300 mg. with pistons diameter 6 mm. 250 mg.- 700 mg. with pistons diameter 8 mm. 500 mg.- 1,5 g. with pistons diameter 10 mm. For multiple doses: depending on the max W of dosages to be confirmed after communication of specific weight and tests on samples. Vials dimensions: Dia. min. 15 mm max. 52 mm; H. min. 35 mm max. 120 mm. 11.2007 3 I 5
lxcullncl I ROUGit lfo <OVAIIO I Including: one set of change for 10 mi. vials one set of change parts for one size of rubber stopper diameter 20 mm. one dosing disc with pistons diameter 10 mm. [MAC7601001] 1 1.8. Options Additional set of change parts for 20 ml vials [MAC7601777] 1 Additional dosing disc with pistons diameter to be defined [MAC7601050] 1 Nitrogen flushing unit, after filling. [MAC7601100] 1 Nitrogen flushing unit before and during filling (having purchased the system for nitrogen after filling) [MAC7601777] 1 Vial sampling unit without stopping the machine. [MAC7601105] 1 Liquid filling unit for validation purposes with needle, pipes and peristaltic pump. Fill accuracy +/- 0,5 %. Filling dosing range from 4 to 20 cc. (Max. output 2.000 vials/h). [MAC7601135] 1 Vertical laminar flow cabinet, for dosing and plugging station. [MAC7601145] 1 Self-assisted simultaneous adjustment of 12 dosing disc chambers from control panel with +/- button or from Control Weight unit [MAC7601160] 1 PROFIBUS card Recommended spare parts for 2 years' service [MAC7601200] 1 [MAC7601250] 1 Validation package for the SW system with reference to the MACOFAR DPIVZFEB99 documents Available in Italian, English language 11.2007 4 I 5
fxceihhci l"p.ougi!iio OVAHON Control Weight Unit statistic, complete with change parts 1 [MAC7601115] Additional set of change parts for SW system 1 [MAC7601116] [MAC7601400] 1 1.9. Base Machine MACOFAR Mod.TR12 Intermediate turntable complete with adjustable guides for 10 ml and 20 ml vials [MAC7703001] 1.10. Options Additional price for motor speed adjustment by INVERTER [MAC7703015) 1 [MAC7703400] 1 1.11. Base Machine MACOFAR Mod. NTA Swing way connecting conveyor belt for vials transport. Length 1.000 mm. [MAC3701002] 1 1.12. Options Laminar flow on upstream TR12 turntable + swing conveyor NTA [MAC3701777] 1 [MAC3701400) 1 1.13. Base Machine Capping machine model - MC 24 - blade sealing with pressure control including one set of change parts for 10 ml vial, one set of 20 mm alu-cap [MAC777] 1 11.2007 5 I 5