Faster GLOVEFAST ASEPTIC Operating And Maintenance Manual
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Faster GLOVEFAST ASEPTIC Operating And Maintenance Manual

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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
GloveFAST Aseptic
0254EN – Rev. 06 – 09/2019

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  • Page 1 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 GloveFAST Aseptic 0254EN – Rev. 06 – 09/2019...

  • Page 2: Table Of Contents

    DISPOSAL OF WASTES AND CONTAMINATED MATERIALS MATERIALS, WHICH THE ISOLATOR IS MADE OF ERGONOMICS LIMITATIONS OPERATING PROCEDURES PRELIMINARY CHECKS SWITCHING ON the GLOVEFAST ASEPTIC isolator SWITCHING OFF THE GLOVEFAST ASEPTIC ISOLATOR HOW INTRODUCE MATERIAL MAINTENANCE INSTRUCTIONS FOR DAILY CLEANING OF ISOLATORS (by users) GLASS CLEANING...

  • Page 3: General

    All Faster’s isolators are provided with low pressure drop filters. Faster s.r.l. cannot be held responsible for malfunctions, damage to people or property due to non- compliance, poor or no maintenance, or improper use of the isolator.

  • Page 4: Installation

    2 INSTALLATION 2.A INSTRUCTIONS AND CHECKS ON DELIVERY Considering the critical nature of the use of the GLOVEFAST ASEPTIC isolator and the need to keep it in optimum condition, installation is very important. GLOVEFAST ASEPTIC isolator are positioned on a pallet wrapped in an extensible film and contained in a package of multi-layer strapped cardboard or a wooden cage.
  • Page 5 This heat value must be added to the heat generated by any instrument (e.g. connected to internal socket or tap) used by the client in the work chamber. ATTENTION: the installation must be done by technicians authorized by Faster S.r.l. or by the official distributor.

  • Page 6: Celectric Connections And Installation Of The Work Surface

    30 mA. The GLOVEFAST ASEPTIC is supplied with an electric Air Tight Valve (ATV) to close and seal the isolator during sterilization phase or pressure decay test.

  • Page 7: Technical Features Table

    a D:GROUP Company 3 TECHNICAL FEATURES TABLE GLOVEFAST GLOVEFAST GLOVEFAST Description Unit ASEPTIC 2-4-2 ASEPTIC 2-5-4 ASEPTIC 2-6-4 Overall Dimensions (L x H x D) 2510 x 2300 x 870 2815 x 2300 x 870 3120 x 2300 x 870 Useful dimensions (L x H x D) 1192 x 740 x 580 1497 x 740 x 580...

  • Page 8: Operation Principles

    D:GROUP Company 4 OPERATION PRINCIPLES The following are the working principles of the GLOVEFAST ASEPTIC isolators. The air (A) is sucked by the blower is firstly pulled through the inlet positioned on top of the cabinet and then pushed by main blower through the H14 HEPA filter bank providing laminar flow conditions in the work chamber and protecting the products handled.
  • Page 9 a D:GROUP Company 0254EN – Rev. 06 – 09/2019 Page 9 of 65...

  • Page 10: Operation

    D:GROUP Company 5 OPERATION 5.A SYSTEM AND PERFORMANCES CONTROLS The GLOVEFAST ASEPTIC isolator is provided with an automatic regulation system to keep the unidirectional down flow air speed and the negative pressure in the work chamber constant even with the progressive clogging of the HEPA filters up to the maximum pressure supported by the motor-fans.

  • Page 11: Csymbols Of The Control Panel

    "0" position, the green light of the mains voltage is on (3); the LCD displays the model name "GLOVEFAST ASEPTIC ". In this position the operator can activate only the lighting system (7), the optional U.V. lamp (14) and the power outlet (6) (with plug installed) and can see the data stored in the microprocessor by pressing the “STATUS”...
  • Page 12 a D:GROUP Company isolator – 2) to enter the operator menu – 3) to enter the main menu to change the data input (allowed only to authorized technical staff – service – because unsuitable interventions can cause troubles and incorrect operation of the isolator).
  • Page 13 a D:GROUP Company REDUCED AIRFLOW >>>DO NOT WORK<<< The “SPEED REDUCTION” function can be enabled only when the isolator is ON. 13 U.V. TIMER Not activated 14 U.V. Not activated 15 MUTE The red alarm LED lights up when an alarm condition occurs, which is shown also by the message appearing on the LCD.

  • Page 14: Dmanagement And Programming

    a D:GROUP Company 5.D MANAGEMENT AND PROGRAMMING Get access to operator menu when the isolator is in stand-by pressing “ESC” [9] together with “UP arrow” [8] keys (password). The following diagram shows the organization of the OPERATOR MENU By pressing “SET” [10] you can either go to the highlighted entry or confirm data entry. By pressing “ESC” [9] you go back 1 menu level. VENTILATION OFF PASSWORD ESC+UP...
  • Page 15 a D:GROUP Company TIMER (countdown): use "UP/DOWN arrows"[8] to scroll the operator menu select “TIMER SET UP.” and press "SET" [10]; the display will show: TIMER SET UP SET UP hh:mm input the desired time and press SET [10] to confirm press “ESC”...
  • Page 16 a D:GROUP Company UV PROGRAMMING: use "UP/DOWN arrow" [8] to scroll the operator menu select “UV PROGRAMMING” press "SET" [10]; and the display shows: UV LIGHTING LENGTH SET UP hh:mm input the desired time for the UV cycle and press SET [10] to confirm the display shows: .UV PROGRAMMING DATE &...
  • Page 17 a D:GROUP Company LANGUAGE SELECTION use "UP/DOWN arrow" [8] to scroll the operator menu select “LANGUAGE” and press "SET" [10]; the display will show: LANGUAGE English With the “UP/DOWN arrow” [8] select the desired language (Italian, English, French, German, Spanish). Press the “SET” [10] to confirm and exit the “LANGUAGE” menu. Press the “SET”...
  • Page 18 a D:GROUP Company DISPLAY OF HISTORICAL FILES use "UP/DOWN arrow" [8] to scroll the operator menu select “HISTORY VIEW” and press "SET" [10]; the display will show: use "UP/DOWN arrow" [8] to scroll through the list of the possible troubles happened. The list is in chronological order and contains up to 64 voices.

  • Page 19: Edisposal Of Wastes And Contaminated Materials

    a D:GROUP Company 5.E DISPOSAL OF WASTES AND CONTAMINATED MATERIALS DISPOSAL OF ELECTRIC AND ELETTRONIC DEVICES (AEE) NFORMATION FOR UROPEAN NION USER This symbol on the device means that when it needs to be disposed, it must be handled separately from urban waste. At the moment of the disposal, contact the dealer, to receive information about the collect and disposal in accordance with the laws in force in the country.

  • Page 20: Fmaterials, Which The Isolator Is Made Of

    a D:GROUP Company 5.F MATERIALS, WHICH THE ISOLATOR IS MADE OF PARTS OF THE ISOLATOR MATERIALS External structure Epoxy painted steel Inside work chamber AISI 304 stainless steel Work surface AISI 316L stainless steel Motor-fans Galvanized steel Filters Frame: aluminium alloy Filtration media: glass fibre Protection: aluminium grid/epoxy powder painted Gasket: polyurethane...

  • Page 21: Limitations

    Listed below are the most important guidelines to be followed and the main substances to be avoided to ensure the correct use of the GLOVEFAST ASEPTIC isolator: NEVER USE chlorine-based substances (e.g. sodium hypochlorite) as they are corrosive for the metal structure of the isolator, and in particular for stainless steel parts.

  • Page 22: Operating Procedures

    – the isolator has been sterilized in case of change in the nature of work to be carried out 7.B SWITCHING ON the GLOVEFAST ASEPTIC isolator To start the isolator, proceed as indicated below: turn on the light by pushing the button [7] be sure that the frontal window is closed press the main key I/0 [1] (see chapter 5C) and enter the password to switch on the ventilation.

  • Page 23: Dhow Introduce Material

    a D:GROUP Company 7.D HOW INTRODUCE MATERIAL To introduce material in the isolator, it is necessary use the pass boxes mounted on both sides of the isolator. The pass boxes have two timed doors electrical interlocked. To open the external doors you have to push the button installed on the control panel: To introduce material in the isolator follow this steps: 1.

  • Page 24: Maintenance

    D:GROUP Company 8 MAINTENANCE IMPORTANT: Faster recommend to perform the standard tests and maintenance once per year by specially trained and authorized service personnel according to the standards, in order to ensure the efficiency and safety of the (microbiological safety/laminar flow/cytotoxic safety/chemical fume hood) isolator.

  • Page 25: Bglass Cleaning

    a D:GROUP Company WARNING: Never use solutions containing free chlorine (for instance, sodium hypochlorite), which cause corrosion to steel and stainless steel, resulting in irreparable damage to the isolator structure. 8.B GLASS CLEANING For the internal cleaning of the glass proceed as follows: 1.
  • Page 26 a D:GROUP Company 0254EN – Rev. 06 – 09/2019 Page 26 of 65...
  • Page 27 a D:GROUP Company 11. Remove the internal panel [3] unscrewing the relevant fastening screws. 12. Rotate the threaded bars [4] to release the HEPA filter [6]. (Rear view) 13. Remove the HEPA filter wearing PPD and put it in a hermetically sealed polythene bag. 14.
  • Page 28 a D:GROUP Company Exhaust Filter (F2) 17. Rotate the fastening threaded bars [7] to lift down the plenum group [8] and to release the HEPA filter. (Rear view) 18. Proceed as indicated in above 6, 7 points. 19. Lock the HEPA filter by rotating the fastening threaded bars [7]. 20.

  • Page 29: Dreplacement Of Motor-Fans (By Technical Assistance Personnel)

    a D:GROUP Company 8.D REPLACEMENT OF MOTOR-FANS (by technical assistance personnel) ATTENTION: before replacing the motor-fans, the isolator must be decontaminated and a sterilization certificate must be issued to the technicians before starting the operation (see par. 7D). For the safety of the personnel and the environment, the use of PVC gloves is recommended as well as the collection of the replaced materials in polyethylene bags.
  • Page 30 a D:GROUP Company Remove the main motor-fan [11] including the side stirrup [12]. Position the new motor-fan after having mounted again the flow sensor group [15] and the relevant stirrup. Fasten the motor-fan with the relevant screws and reconnect electrical connectors. Proceed as indicated in the sub section "Replacement of HEPA filters", points 12 and 13.

  • Page 31: Ereplacement Of Lighting System (By Technical Assistance Personnel)

    a D:GROUP Company Replacement of exhaust motor-fan. Proceed as indicated in sub-section "Replacement of HEPA filters", from 1 to 3 points and remove the exhaust HEPA filter. Remove the textile plenum Remove the screws [17] of the exhaust fan [13] and the electrical connection. Place the new exhaust fan and set the wiring.

  • Page 32: Spare Parts List

    a D:GROUP Company 9 SPARE PARTS LIST GloveFAST GloveFAST GloveFAST CODE DESCRIPTION Aseptic 2-4-2 Aseptic 2-5-4 Aseptic 2-6-4 V01000019500 Pressure transmitter V30000101200 Light led module V20000006900 Power line filter V20000006880 Magnetic sensor V30000000010 Shielded Proximity V30000000090 Proximity V30000000790 Interface board BHX_MIX V30000007410 BHCPU_128 board V30000006400...
  • Page 33 a D:GROUP Company V50000604500 O-ring 300mm V50000604240 O-ring 250mm V50000604200 O-ring 100mm V40000003890 Magnetic doors lock V50000604000 pair of neoprene gloves th=4/10 V50000604100 Gloves cuff ring L=110 V50000604300 Textile sleeve 100-300 mm L=550mm V50000604810 Textile sleeve 100-250 mm L=570mm K60025430000 Textile Bag Plenum K60021530000 Textile Bag Plenum...

  • Page 34: Monitoring System

    a D:GROUP Company 10 MONITORING SYSTEM ALARM OR ERROR MESSAGE DESCRIPTION Min. LAF Alarm Airflow speed in the work chamber under minimum threshold value Min Pressure Alarm The pressure of the work chamber is raised under the minimum alarm value. It can be due to a hole in the gloves or to the opening of a door.

  • Page 35: A Alarm List

    a D:GROUP Company 10.A Alarm List English alarm message German alarm message Description Setpoint Tolerance Alarm limit Time delay Minimum LAF alarm Alarm Minimum LAF Airflow speed in the work chamber under minimum threshold value 0.45 m/s +20% -0,04 m/s from set point 1 sec Maximum LAF alarm Alarm max.

  • Page 36: Troubleshooting - Probable Causes Of Malfunctions

    a D:GROUP Company 11 TROUBLESHOOTING - Probable causes of malfunctions PROBLEM CAUSE REMEDY – – Isolator does not work the electricity supply has check the voltage input to been cut off at the mains the isolator – – Electronic board out of order Replace PCB –...

  • Page 37: Technical Specifications

    a D:GROUP Company 12 TECHNICAL SPECIFICATIONS AISI 304 stainless steel. Perfectly air-tight structure with work External structure area under negative pressure. Made from glazed AISI-304 stainless steel with radiussed Work chamber angles AISI 316L stainless steel sheet (removable). Work surface AISI 304 stainless steel, located under the work surface Spillage tray Filtration (Main, LAF, Exhaust...

  • Page 38: Transport, Packing And Storage Instructions

    Packaging characteristics: Wooden pallets of the following dimensions: 270 x 100 x 12 cm for GLOVEFAST ASEPTIC 2-4-2 300 x 100 x 12 cm for GLOVEFAST ASEPTIC 2-5-4 330 x 100 x 12 cm for GLOVEFAST ASEPTIC 2-6-4 Pluriball to wrap and protect the isolator from dust 0254EN –...
  • Page 39 D:GROUP Company Cardboard outer package of the following dimension: Isolator model GLOVEFAST ASEPTIC 2700 1000 1750 2-4-2 GLOVEFAST ASEPTIC 3000 1000 1750 2-5-4 GLOVEFAST ASEPTIC 3300 1000 1750 2-6-4 Steel straps and clips During transport take care to maintain the package in a vertical position (i.e. the pallet at the bottom)

  • Page 40: Additional Information

    14 ADDITIONAL INFORMATION 14.A WARRANTY The warranty for GLOVEFAST ASEPTIC isolators is 12 months from date of invoice on spare parts only. In addition to those cases specifically indicated in Chapter 6 relating to improper use of the isolator, the warranty offered by Faster S.r.l., also excludes certain improper uses described in the instruction manual, of...

  • Page 41: Tests Performed According To En 14644-3 Standard

    a D:GROUP Company 15 TESTS PERFORMED ACCORDING TO EN 14644-3 STANDARD 15.A MEASUREMENT OF LAMINAR AIRFLOW VELOCITY The LAF velocity is measured at 250 mm under the HEPA filter taking the reading in at least 8 points: In our tests the readings are taken in 12 points as above-diagrammed. Each one of the 12 readings lasts at least 1 minute.

  • Page 42: Bmeasurement Of The Internal Pressure

    a D:GROUP Company 15.B MEASUREMENT OF THE INTERNAL PRESSURE Check the internal pressure by connecting a calibrated manometer to the transparent pipe in the front control panel. Use a 3 ways “T” connector to allow the pressure transmitter and the calibrate manometer to be connected together.

  • Page 43: Fcontrol Of Alarms

    OTHER ALARMS With the help of FASTER’s technicians also the alarms for LAF and protection barrier velocity below the minimum threshold or over the maximum threshold can be checked 0254EN – Rev. 06 – 09/2019...

  • Page 44: Gdop Test For Hepa Filters

    a D:GROUP Company 15.G DOP TEST FOR HEPA FILTERS OBJECT AND PRINCIPLE OF THE TEST: Check of the integrity of the HEPA filters through an analysis of the filtering system, able to find out possible small leaks and/or defects altering the efficiency of the filters and at the same time to test leaks around gaskets.

  • Page 45: Hhepa Filters Testing Method

    a D:GROUP Company 15.H HEPA FILTERS TESTING METHOD green the filter that can be scanned. blue the filters that must be tested by integral measuring 0254EN – Rev. 06 – 09/2019 Page 45 of 65...
  • Page 46 a D:GROUP Company 0254EN – Rev. 06 – 09/2019 Page 46 of 65...

  • Page 47: Idrawings And Diagrams

    a D:GROUP Company 15.I DRAWINGS AND DIAGRAMS LEGENDA Ref. Description Front panel Locks Internal panel Knobs fastening LAF HEPA filter Fastening screws LAF HEPA filter Threaded bars of exhaust plenum Exhaust plenum Main HEPA filter (under the work surface) Screws fastening the main motor blower Main motor blower Main motor blower brackets Exhaust motor blower...

  • Page 48: Jdiagram For Maintenance Operations

    a D:GROUP Company 15.J DIAGRAM FOR MAINTENANCE OPERATIONS 0254EN – Rev. 06 – 09/2019 Page 48 of 65...

  • Page 49: Frontal Diagram

    a D:GROUP Company 16 FRONTAL DIAGRAM 0254EN – Rev. 06 – 09/2019 Page 49 of 65...

  • Page 50: Aside Diagram

    a D:GROUP Company 16.A SIDE DIAGRAM 0254EN – Rev. 06 – 09/2019 Page 50 of 65...

  • Page 51: Assemby Of The Isolator On The Supporting Stand

    a D:GROUP Company ASSEMBY OF THE ISOLATOR ON THE SUPPORTING STAND When the stand has been assembled the isolator can be installed following this procedure : Check the correct levelling of the stand and in case adjust the height of the feet [3] 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 shown in the “table of technical features”...
  • Page 52 a D:GROUP Company The two eyebolts positioned on top of the isolator can be used to lift the isolator  0254EN – Rev. 06 – 09/2019 Page 52 of 65...

  • Page 53: Sensors List

    a D:GROUP Company 17 SENSORS LIST SOFTWARE NAME PCB PLUG OF THE SENSOR DESCRIPTION not used not used not used Window closed not used not used not used not used not used 0254EN – Rev. 06 – 09/2019 Page 53 of 65...

  • Page 54: Wiring Diagram

    a D:GROUP Company 18 WIRING DIAGRAM 0254EN – Rev. 06 – 09/2019 Page 54 of 65...
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  • Page 65: Declaration Of Conformity

    D:GROUP Company 19 DECLARATION OF CONFORMITY The undersigned legal representative of the company Faster S.r.l. hereby declares that the following products: GLOVEFAST ASEPTIC are in compliance with the following directives: 2006/42/EC Directive of the European Parliament and of the Council on machinery...

This manual is also suitable for:

Glovefast aseptic 2-4-2Glovefast aseptic 2-5-4Glovefast aseptic 2-6-4

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