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00254EN – Rev. 01 – 11/2012 – ORIGINAL INSTRUCTION

Commercial office:

Via Merendi, 22

20010 Cornaredo (MI)

Tel. +39.02.93.991.92

Fax. +39.02.93.991.608

E-mail: [email protected]

OPERATING AND

MAINTENANCE MANUAL

ASEPTIC

Summary of Contents for ASEPTIC

Page 1: ...54EN Rev 01 11 2012 ORIGINAL INSTRUCTION Commercial office Via Merendi 22 20010 Cornaredo MI Tel 39 02 93 991 92 Fax 39 02 93 991 608 E mail info faster dgroup it OPERATING AND MAINTENANCE MANUAL ASEP...

Page 2: ...ON 25 7 F HEPA FILTERS by technical assistance personnel 26 7 G REPLACEMENT OF MOTOR FANS by technical assistance personnel 30 7 H REPLACEMENT OF FLUORESCENT LAMPS by technical assistance personnel 32...

Page 3: ...lity testing Microbiology Preparation of culture media Preparation of ophtalmic solutions TPN Preparation The performances of the isolators are detailed in the TESTING CERTIFICATE Furthermore ASEPTIC...

Page 4: ...n a room sheltered from rain 2 B INSTALLATION REQUIREMENTS Install the isolator away from drafts and heat sources radiators ventilators convectors to ensure proper functioning Install the isolator in...

Page 5: ...If an electric valve is supplied then just standard electrical connection is needed For the installation of the work surface proceed as follows remove the protective paper from the work surface leant...

Page 6: ...D mm 2670x1500x880 Useful dimensions L x H x D mm 1200x700x600 Weigh Kg 330 Noise level dB A 51 Lighting level Lux 1000 Main voltage V 230V AC 2P T Frequency Hz 50 Power W 970 Current A 4 9 Electrica...

Page 7: ...s creates the positive pressure condition in the working area B to protect the products handled The the air is pushed by the main fan in laminar flow conditions into the work chamber B of the isolator...

Page 8: ...B REMOTE SIGNALS On the ceiling of the isolator a PVC box contains 3 terminal clamps with the following dry contacts A Ventilation status ON OFF It is possible to obtain a 12 Vdc output to connect a...

Page 9: ...ired time about 40 seconds for the laminar flow and the internal pressure to reach the pre set values In addition an audible alarm will sound intermittently during this stand by period alerting the op...

Page 10: ...his value is taken by an electron probe located inside the isolator U V Lamp Residual Lifetime Shows the operating time of the U V lamp pre set by the user with the appropriate keys The LCD will displ...

Page 11: ...LAF velocity and internal pressure are about 50 than their nominal values The light and the gas electro valve cannot be switched on If they are on they switch off automatically The following two mess...

Page 12: ...PERATOR MENU LANGUAGE OPERATOR MENU SET UP THE CLOCK OPERATOR MENU CHANGE PASSWORD OPERATOR MENU HISTORY VIEW ALARM CLOCK SET UP ENABLE YES NO SET ALARM CLOCK DATE TIME UV LIGHTING LENGTH DURATION hh...

Page 13: ...he display shows TIMER SET UP RESET YES press SET 10 to confirm press ESC 9 to exit the operator menu ALARM CLOCK use UP DOWN arrow keys 8 to scroll the operator menu select ALARM CLOCK SET UP and pre...

Page 14: ...roll the operator menu select U V LAMP RESIDUAL LIFETIME and press SET 10 key the display will show U V LAMP RESIDUAL LIFETIME set XXXX where XXXX shows the number of the hours set for lifetime of the...

Page 15: ...u select SET UP THE CLOCK and press SET 10 key the display will show SET UP THE CLOCK set XXXX Use the up and down arrow keys to change the hours minutes days month year weekday Then press the SET key...

Page 16: ...menu VHP MODE The VHP mode is used to seal compleately the cabinet when a disinfection by gas H2O2 or Formaldehyde is required use UP DOWN arrow keys 8 to scroll the operator menu select VHP MODE and...

Page 17: ...ons in accordance with the regulations in their own country INFORMATION FOR USERS OUTSIDE THE EUROPEAN UNION This symbol is valid only in the European Union If you want to dispose this product contact...

Page 18: ...painted Gasket polyurethane Keyboard PE graphite circuits in materials compatible with Rohs regulations Front window Laminated safety glass Wirings Wires according to Rohs regulations flame proof case...

Page 19: ...lator DO NOT use ethanol as a sterilizing substance if a heat source is used under the isolator DO NOT use cosmetic powders nail polish hairspray or cosmetics in general during work DO NOT eat drink o...

Page 20: ...velocity and work chamber pressure are displayed 5 wait for approx 5 minutes before starting work 6 during this period of time introduce into the internal work zone of the isolator only the materials...

Page 21: ...n the external door is open it is not possible to open the internal door 4 Introduce the material in the pass box 5 Close the external door 6 Wait till the green light is ON after a prestabilished tim...

Page 22: ...t cleaned zones do not put the cleaning agents on the HEPA filters to avoid damages Wipe carefully all the cleaned zones using clean blotting paper Be sure to remove any residual of the decontaminatin...

Page 23: ...zation on the display of the isolator are showed the different phases 8 When the Clarus L 2 finish the Sterilizarion cycle on the display of the isolator appears the following message PRESS SET TO OPE...

Page 24: ...of the isolator are showed the different phases 7 When the Steris VHP finish the Sterilizarion cycle on the display of the isolator appears the following message PRESS SET TO OPEN THE ATV 8 When the...

Page 25: ...panel to access the internal part of the cabinet 3 connect the earth conductor of the two motor blowers 4 reconnect the cabinet to the main supply 5 perform maintenance operations 6 disconnect the cab...

Page 26: ...commended as well as the collection of the replaced HEPA filters in polyethylene bags Pass box top HEPA filters F3 1 Remove the pre filter support frame 2 Unscrew the bolts 20 that fasten the top pass...

Page 27: ...a D GROUP Company 00254EN Rev 01 11 2012 27 LAF Filter F1 1 Switch off the isolator and disconnect it from the mains 2 Open the control board 1 turning the locks 2 with the proper exagonal key 2 1...

Page 28: ...e HEPA filter 6 Rear view 5 Remove the HEPA filter wearing PPD and put it in a hermetically sealed polythene bag 6 Place the additional gasket if it is not already present on the filter shoulder frame...

Page 29: ...ial fastening screws 13 Re close the control board 1 with care and lock it with the closures 2 14 Proceed with the necessary control calibration procedures of the laminar air flow isolator ATTENTION G...

Page 30: ...he environment the use of PVC gloves is recommended as well as the collection of the replaced materials in polyethylene bags Replacement of main motor fan 1 Proceed as indicated in sub section Replace...

Page 31: ...stirrup 12 6 Position the new motor fan after having mounted again the flow sensor group 15 and the relevant stirrup 7 Fasten the motor fan with the relevant screws and reconnect electrical connectors...

Page 32: ...t fasten the frontal panel of the exhaust plenum 4 Remove the screws 20 of the suction fan 13 and the electrical connection Place the new suction fan and set the wiring 5 Re place the textile plenum 7...

Page 33: ...motor fan 1 V50 000000910 LAF sensor fan diam 200 1 V50 000100360 LAF HEPA filter 1220 x 610 x 115 mm F1 with laminator sheet 1 V50 000100230 Suction HEPA filter 457 x 610 x 69mm F2 1 V50 000100120 Re...

Page 34: ...the fan anemometer installed in the suction duct Max LAF Alarm Airflow speed in the work chamber over maximum threshold value Front glass open The front window is not closed correctly Sensors failure...

Page 35: ...ves integrity Check F6 fuse on the power card Check that the suction duct is not clogged Check the suction motor fan HEPA filters are clogged Replace HEPA filters Alarm Minimum LAF alarm The main moto...

Page 36: ...d to keep the internal pressure constant and to create a protective barrier on the glove opening in case of glove brake Speed regulation Automatic regulation to keep constant air flow speed 0 45 m s a...

Page 37: ...t to ensure good stability and to protect the basin under the isolator and the front window against damage in transit Take care not to damage protruding parts e g suction duct when passing through doo...

Page 38: ...PTIC 2 4 2 2800 950 2100 120 Steel straps and clips During transport take care to maintain the package in a vertical position i e the pallet at the bottom The isolator with or without the package must...

Page 39: ...e instruction manual of which the most important are listed again below installation in a place which does not conform to the manufacturer s recommendations wrong power voltage poor earthing use of ch...

Page 40: ...dings lasts at least 1 minute The velocity is measured with a hot wire thermo anemometer with the following features Measure Range 0 2 m s Precision of the device including the probe 0 05 m s 5 Workin...

Page 41: ...st report 13 D MEASUREMENT OF LIGHTING Take the measure with a luxmeter placed inside the work chamber in the middle of the work surface Consider at least 4 readings points where the two side points s...

Page 42: ...hat the red light of the relevant alarm and the visual and sound buzzer signals start Furthermore check that when the glove is back in the correct position the alarm stops ALARM FOR OPENING OF THE FRO...

Page 43: ...exposure to aerosol TEST PROCEDURE The photometer must be used at a threshold sensitivity specific to the test aerosol of 0 0001 g l and capable of measuring aerosol concentrations up to about 80 g l...

Page 44: ...LAF HEPA Filter F1 5 Working Chamber 6 ATV 7 Screws 8 Front Window Screws 9 Front Window gas springs 10 Control Panel locks 11 Lamps 12 Control Panel 13 LAF Plenum 14 SUCTION motor fan 15 LAF Fan Scre...

Page 45: ...a D GROUP Company 00254EN Rev 01 11 2012 45 13 IDIAGRAM FOR MAINTENANCE OPERATIONS...

Page 46: ...a D GROUP Company 00254EN Rev 01 11 2012 46...

Page 47: ...a D GROUP Company 00254EN Rev 01 11 2012 47 13 J FRONTAL DIAGRAM...

Page 48: ...a D GROUP Company 00254EN Rev 01 11 2012 48 13 K SIDE DIAGRAM...

Page 49: ...a D GROUP Company 00254EN Rev 01 11 2012 49 14 SUPPORT TABLE...

Page 50: ...Check the tightening of all the screws and the firmness of the stand Lift the isolator with suitable equipment for example a forklift complying with the safety rules the weight of the isolator is sho...

Page 51: ...1 16 SENSORS LIST PCB PLUG SOFTWARE NAME OF THE SENSOR DESCRIPTION J9 S0 LAF J10 S1 not used J11 S2 not used J12 S3 not used J13 S4 Window closed J14 S5 Left footswitch J15 S6 Right footswitch J16 S7...

Page 52: ...a D GROUP Company 00254EN Rev 01 11 2012 52 17 WIRING DIAGRAM ASEPTIC EQUIPPED WITH CLARUS L 2...

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Page 60: ...a D GROUP Company 00254EN Rev 01 11 2012 60 18 WIRING DIAGRAM ASEPTIC EQUIPPED WITH STERIS VHP...

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Page 68: ...ouncil on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits and with the following standards EN 12469 Biotechnology perform...

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