Bassaire K-Range Laminar Flow Cabinet

Transcription

1 Bassaire K-Range Laminar Flow Cabinet Operating and Maintenance Instructions Rev B Bassaire Limited Duncan Road - Park Gate Southampton - SO31 1Zs Tel: +44 (0) Fax: +44 (0) sales@bassaire.co.uk Registered in England:

2 Contents 2. Standard Specification 4. Description K Range Cabinet 5. K Range Control Panel Control Panel Wiring Diagram 6. Membrane Control Panel 8. Calibration Procedure 12. Membrane Control Panel Wiring Diagram 13. Optional Accessories 15. Testing 17. Installation 19. Operation 20. Maintenance Air Velocity Adjustment Pre Filter Replacement HEPA Filter Replacement Lamp Replacement Cleaning Spares 29. Troubleshooting 30. Service Record 31. Other Products and Services 33. Copy of Certificate of Conformity 1

3 Description Standard Model The K Range cabinet is an extension of the Bassaire S-range module. This comprises a white powder coated carbon steel carcase fan/filter unit which houses a pre filtered grille, HEPA filter and fan(s). The module sits upon an aluminium tubular framework, the sides and rear of which are fitted with clear acrylic screens. The standard control panel includes green illuminated power on indicator, fuse and switch for fan(s) and a variable fan speed controller. Five standard sizes are available in both horizontal and vertical flow models. The vertical flow unit can also be supplied in a reverse flow mode (See table and drawing for dimensions). Units can be supplied complete with support stands manufactured from white powder coated mild steel box section mounted on either adjustable levelling feet or castors. MODEL DIMENSIONS (Width x depth x height) Vertical Flow Cabinet K2VB 660 x 660 x 1115mm MODEL DIMENSIONS (Width x depth x height) Horizontal Flow Cabinet K2HB 660 x 1115 x 660mm K3VB 965 x 660 x 1115mm K3HB 965 x 1115 x 660mm K4VB 1220 x 660 x 1115mm K4HB 1270 x 1115 x 660mm K5VB 1575 x 660 x 1115mm K5HB 1575 x 1115 x 660mm K6VB 1880 x 660 x 1115mm K6HB 1880 x 1115 x 660mm Other sizes can be designed and constructed to comply with customer specifications & requirements. Bassaire also undertake the design and manufacture of specialised units for specific applications and are always available to discuss options for any project. Every unit carries a one year guarantee which covers both parts and labour. 2

4 K-Range Vertical Flow Cabinet General Arrangement 3

5 K-Range Horizontal Flow Cabinet General Arrangement 4

6 Standard Bassaire Module Specification BS EN ISO CLASS 4 FILTER FACE AIR VELOCITY 0.45ms ¹ NOISE < 65dB(A) (1m) HEPA FILTER EFFICIENCY H14 MPPS HEPA FILTER OPERATING 230Pa max PRESSURE PRE FILTER EFFICIENCY 5µ (EU4) ELECTRICAL SUPPLY 230V, 50/60Hz, 1ph Note - BS EN ISO has superseded all National and European Standards. It has also superseded Fed Std 209. This standard will eventually be complete in nine sections: The sections so far;- BS EN ISO (1999) BS EN ISO (2000) ISO/DIS (Feb 2003) BS EN ISO (2000) ISO/DIS ISO/DIS ISO/DIS ISO/CD Classification of Air Cleanliness Specifications for Testing & Monitoring Metrology & Test Methods Design, Construction & Start Up Operations Terms & Definitions Separative Devices Classification of Airborne Molecular Contamination We include overleaf a comparison sheet of classifications for information showing relevant past and present standards. 5

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8 Module Description S range clean air modules consist of a pre-filter protected by a grille, fan(s) and a HEPA filter, housed in either a non shedding laminated plywood, white painted mild steel or stainless steel carcase, with an acoustic foam backed fan board. The filter face air velocity can be set by adjustment of the fan speed controller. The speed controller and fan on/off switch are protected by a removable fuse. The module is supplied with a 2m cable and plug, ready for connection to the mains supply. Five standard sizes are available, see table below. Optional extras include higher classification filtration, filter differential pressure gauge, stainless steel HEPA filter protection mesh, remote control and digital display control panel. MODE L WIDTH (DIM X) (mm) AIR FLOW RATE (m 3 s -1 V=0.45ms -1 RUNNING CURRENT Amps@230 volts RATED POWER (Watts) S S S S S The normal power supply requirement is 230V, 50/60Hz, 1ph. 7

9 Testing Each unit is provided with Certificate of Conformity. The tests listed below are carried out to ensure the product complies with the relevant tests and standards. Portable Appliance (PAT) TEST The PAT equipment tests for earth continuity, earth leakage, and insulation resistance and correct fusing. It also records the running load, which is engraved on the data label. Filter Leak Test (PD6609) Each unit is tested for filter integrity. A measured concentration of smoke/aerosol is added to the supply air, a photometer is then used to detect for any leakage through or around the HEPA filter face and filter seal. Testing complies with PD6609. Filter Face Air Velocity Air velocity is set to 0.45ms -1 by adjusting the fan speed while measuring the air velocity with an anemometer in front of the filter face. The fan speed controller setting is recorded and shown on the certificate of conformity. Particle Count The particle measurement probe is positioned within the cabinet in accordance with BS EN ISO Five separate timed runs are recorded at particle sizes of 0.3µ, 0.5µ, 1µ, 3µ. 5µ and 10µ. The highest counts for each particle size are noted and these values must be within the limits set by BS EN ISO The 0.5µ result is shown on the certificate of conformity. Other - Lighting, Noise and Visual The lighting (where appropriate) and noise levels are measured and recorded on the certificate. Prior to packing and despatch a general visual check is carried out. 8

10 Other testing e.g. such as microbiological counts, can be undertaken by customers at Bassaire premises by arrangement. Revalidation It is recommended that revalidation of Bassaire clean air cabinets is carried out every six months. Bassaire offer and undertake maintenance and validation services on all clean aor products and clean rooms. 9

11 Installation Site Requirements Laminar flow cabinets should be placed away from open windows, doors and other sources of draughts, which may disturb the clean air, flow pattern, and allow foreign particles to penetrate the enclosure. All cabinets will generate a small heat load. Rooms will normally be large enough to dissipate this heat load and avoid a rise in temperature. If several units are located in a restricted space, Bassaire should be consulted. Where there is a choice of site, the cleaner operating environment will reduce pre-filter maintenance costs. Access is needed to the pre-filter grille on a regular basis, access to the instrumentation should also be allowed. Note, the pre-filter should never be obstructed. Unpacking and Inspection Units are normally delivered in wooden framed crates, mounted on skids. Export units are packed in accordance with shipping conditions. Inspect the unit carefully after unpacking. Any damage should be reported immediately to Bassaire or your shippers, as appropriate. Handle with care. The HEPA filter is vulnerable to shock and easily damaged. As well as your cabinet, make sure your package includes an owner s manual and certificate of conformity. Under benches and under cupboards may be packed separately. Installation Except where specified by the customer, cabinets are delivered fully assembled. Where an electrical plug is not supplied connect the power cable as shown: Cable Colour Brown Blue Green/Yellow Terminal Live Neutral Earth 10

12 Site Requirements The normal power supply requirement is 230V, 50/60Hz, 1ph. The running current and power ratings are as indicated on the table shown on page 7: A suitably qualified person should connect any special services, such as gas or vacuum taps. 11

13 Operation Ensure unit is installed correctly and connected to the electrical supply. Check power on indicator is illuminated Switch on fan(s). Check fan switch illuminates. Check correct filter face air velocity as shown on the certificate of conformity, either with an anemometer or by confirming the fan speed controller is set to that shown on the certificate (Variac setting). The unit should be allowed to run for 1 hour before being used, unless the clean air classification can be verified by checking with a particle counter. 12

14 Maintenance Regular maintenance is essential to the proper functioning of any clean air facility. We, therefore, strongly advise that these maintenance instructions are adhered to. Air Velocity Adjustment Standard Controls To compensate for the gradual increase in resistance of the HEPA filter, the fan speed will need to be progressively increased. At six monthly intervals, the HEPA filter face air velocity should be checked and the fan speed controller adjusted to give the required average air velocity (usually 0.45ms -1 ). Always check the condition of the pre-filter before adjusting the air velocity. The fan speed controller is accessed by removing the pre-filter adjacent to the module controls. An adjustment knob is located just under the pre-filter grille. Membrane Control Panel The membrane control panel incorporates a digital display providing a continuous air velocity reading. Visible and audible alarms are triggered when the air velocity falls below the value 0.36ms -1. Pressing the mute button can silence the audible alarm. 13

15 Pre-Filter Replacement To ensure proper airflow and extend the life of the HEPA filter, the pre-filter should be changed as soon as it becomes clogged, denoted by a darkening of the fibres. The frequency of change is usually between two weeks and six months, depending on the environment. Never run without a pre-filter, as this will shorten the life of the HEPA filter. To replace, remove the grille core by pushing up against the spring, until it clears the frame, then pull down and away, as illustrated below. Pull out and dispose of the used pre-filter. Clean the grille frame, if necessary. Lay in a new pre-filter. Replace grille core. 14

16 HEPA Filter Replacement The HEPA filter will need changing when the desired filter face air velocity cannot be achieved, with the fan speed controller set at 100% and clean prefilters installed. The frequency of change is usually about five years, depending on the environment and regularity of pre-filter change. A good indication that the HEPA filter is approaching the end of its life, is when the filter differential pressure gauge (where installed), rises to approximately 230 Pa, with a clean pre-filter. We recommend that HEPA filters only be changed by Bassaire s Service Department or by a qualified service engineer. Isolate mains power supply. Remove pre filter grille c/ pre- filter. Remove lid. Disconnect fan supply cable at terminals. Release filter clamping angles by removing M8 fixings. Remove fan board and adaptor. Withdraw and dispose of used HEPA filter. Clean sealing surface. Insert new HEPA filter, ensuring it is positioned centrally. Tighten filter clamps progressively in clockwise rotation. Reassemble the unit in accordance with BS EN ISO We recommend that HEPA filters only be changed by a qualified service engineer that can complete an insitu aerosol filter test. Bassaire s Service Department undertake all filter change and testing. 15

17 Maintenance Cleaning Laminar flow cabinets should be cleaned (and disinfected if applicable) at regular intervals, typically weekly depending upon the cabinets use. Before cleaning, allow the cabinet to purge by running for at least one hour, preferably overnight. Clean the cabinet while it is running. Clean hard surfaces using damp wipes, this should remove most of 5µ and larger particles. Wipes should be of high quality and of non-shedding type suitable for clean room use. Regularly vacuum the filter face, taking care not to damage the filter medium. If the cabinet is used for any purpose where microbiological contamination is a consideration, the surface must be disinfected in accordance with established procedures. Note that alcohol based disinfectants will cloud and craze acrylic panels over a period. 16

18 Guidance notes for Cleaning of Isolators and Laminar Flow Cabinets These notes are prepared for guidance only and should not replace internal SOP s. This guidance should be used in conjunction with the instructions supplied by the equipment supplier. Specific requirements of EC GMP Annexe 1 Manufacture of Sterile Medicinal Products. 1. All disinfectants used in a Grade A or B zone should be sterile prior to use. 2. If disinfectants are used consideration should be given to rotation to prevent microbial resistance. Cleaning Techniques 1. Use spray and wipe for best results. Studies carried out have shown that spraying and wiping is the most effective way of removing contamination. Spraying alone does not disturb a potential biofilm, which may exist. Cleaning and disinfecting should be carried out by wiping from:- a) Top to bottom b) Back to front c) Cleanest to dirtiest Wiping should be carried out in straight lines, each wipe overlapping the last by 10-25%. 2. Use cleaning tools to reach difficult areas. Tools should be considered where reach is an issue, eg Klercide Isolator Cleaning Tool. The pads used on tham should be sterile, single useand minimise the generation of particulates. 17

19 3. Wipe difficult areas Where there is potential for fluid to run into areas where it cannot evaporate or be reached to wipe dry, the fluid should be sprayed onto the wipe or pad and then applied to the surface. Consideration should also be given to the use of pre-impregnated wipes. This prevents areas of pooled liquid, which cannot be removed and become a potential source of corrosion. Areas to be particular aware of are:- Around the doors, behind seals etc Around fixings, catches, screws, hanging rails Around fitted equipment, sockets, sterility test systems, centrifuges, dose calibrators, vacuum pumps etc. Underneath any fitted trays. Also be aware of any areas which are scratched especially paint or coatings where the biocide maybe able to seep underneath the coating. 4. Use only for specified contact time All disinfectants should be removed after the specified contact time. One of the greatest causes of corrosion is the disinfectant being left in contact with a surface for too long. This contact time will always be available from the disinfectant manufacturer. In some instances the effectiveness of the disinfectant will decrease with time. 5. Remove residues by wiping Many disinfectants leave a residue, which should be removed in product contact areas by spraying and wiping with either sterile 70% alcohol or Water for Injection. All surfaces should be left dry. However the disinfectant should not be left to dry since this can increase the risk of residues, e.g. Quaternary Ammonium Compounds once out of solution are difficult to re-solubilise. 6. Check datasheets before use and train staff on correct application. Consult the Material Safety Datasheet for each product to be used. Some biocides, especially sporicides are listed as corrosive and will damage the components of an Isolator even when used correctly. This also applies to products used on the floor around the Isolator where they can have a detrimental effect on the wheels, frame and footrest of the Isolator. (Reproduced by permission of Shield Medicare) 18

20 Electrical Maintenance All cabinet ranges have been certified in accordance with the requirements of the EC directive concerning electromagnetic computability (EMC). All standard units are designed to be connected to a conventional 13A socket outlet. For current and power ratings, see section 6. Wiring Diagram Warning All standard Bassaire clean air cabinets operate on a 230Vac supply. Normal safe techniques applicable to hazardous voltages should be observed when connecting and servicing the units. 19

21 Spares All listed items can be obtained from Bassaire. Item No. Fitted Recommended Min. Holding Pre-filter Eff. 5µ (EU4) 1 1 pack of 6 per cabinet HEPA Filter MPPS <.0005% penetration Fan 500W Fuse 3.15A 5x20 Eff. H14 Models K2, K3, K4 Models K5, K6 Models K2, K3, K4 1 1 per 5 cabinets per 10 cabinets 1 per 5 cabinets 1 per cabinet Fuse 5A Models K5, K6 1 1 per cabinet 5x20 Fan Speed Controller 1 1 per 5 cabinets 20

22 Optional Accessories Non standard sizes All ranges of Bassaire clean air cabinets can be manufactured to customer specified sizes. Contact our sales department for details. Front Screens To reduce the number of particles entering the cabinet during non-working times, clear acrylic night doors can be attached. Alternatively, if the cabinet has a hinged front half screen, a lower half screen can be fitted. Roller blinds can also be provided for the same purpose. Service Outlets Socket outlets, diaphragm valves, gas cocks and needle valves can all be installed in the cabinets. Lighting This consists of a single tube fluorescent light complete with diffuser. UV Lighting All models can be supplied with ultraviolet lighting (wavelength 253.7nm) installed. However, due to the damaging effects of radiation, protective measures are necessary. Warning Bassaire does not advocate the use of UV germicidal/biocidal lamps (defined output of radiation wavelength at 253.7nm) due to the health and safety hazards they impose on operators and those in the vicinity. The manufacturers recommendations state that these units should not be used in manned areas as the UV emissions are harmful to skin and eyes and reflective capabilities are high. Customers who use this type of unit should ensure that their operators and Health and Safety officers are aware of the potential problems. Work Surfaces The K range cabinet comes as standard without a worktop. However, laminated, stainless steel and static dissipative work surfaces can all be supplied. 21

23 Controls The standard unit is supplied with a variable fan speed controller located inside the fan/filter module. Alternative power supplies (e.g. 110V) are available. Filter differential pressure gauges, switches and low air alarms can be provided. There is also the option of a digital display LCD membrane control panel which self regulates and displays the airflow and is equipped with low air alarms. 22

24 Optional Accessories K RANGE Special sizes Roller blind Night door Half screen Removable bottom half screen Socket outlet Service Outlets Lighting UV lighting Laminated work surface Stainless steel work surface Anti-static work surface Conductive work surface Filter differential pressure gauge Filter differential pressure switch Alternative power supply Under bench Under cupboard Castors Class 10 ULPA filtration Static eliminators Stainless steel filter mesh Pressure gauge calibration port 23

25 MEBRANE LCD AIRFLOW CONTROL PANEL General Description The LCD Monitair system monitors and maintains the filter face velocity via an input from an anemometer. It displays the airflow velocity in real time The control panel not only displays the air velocity it maintains the airflow at the calibrated velocity, thus once set no further manual adjustment of airspeed is required. The panel also incorporates an airflow failed alarm, and a UV light option On system start 3 screens are displayed in turn: Screen 1: Screen 1: Screen 2: Screen 3: Displays company logos or text or both for a preset time e.g. Displays company logos or text or both for a preset time e.g. 5 seconds Displays the Data Screen with details of elapsed time, alarm set time and filter ID for a preset period of time e.g. 10seconds If an elapsed time alarm is present the alarm screen will be displayed on acknowledgement the Normal Run screen will be displayed. The systems calibration of airflow is carried out from the front membrane using easy to follow on screen instructions. The filter face velocity is variable on calibration from 0.25m/s to 0.80 m/s. The airflow failed alarm point is software set and is adjusted incrementally from the target face velocity set point. At 0.45 m/sec this is 0.35m/sec. 24

26 An elapsed time display and alarm is incorporated in the Menu section, the alarm point is in hours is user select. Operation On initial start up and subsequent times after power has been removed from the unit the following procedure is undertaken following the instructions displayed on the LCD display 25

27 Initial Start Up Calibration 1. Hold in CAL whilst applying mains power to the unit. 2. Release CAL when two audible beeps are observed. 3. After second audible beep is observed a SET FAN SPEED prompt message will appear on the LCD display. 4.The system must be now be left for a minimum of 15 minutes to allow the Figaro sensor (if fitted) to reach operating temperature. 5. Using a calibrated handheld anemometer set the face airflow velocity to the required value using the FAN UP and FAN DOWN switches to alter the fan speed. 6. When the required face velocity has been set and allowed to stabilise, press the CAL switch again. An airflow display reading in m/s will appear on the LCD. 7. After the airflow reading has stabilised use the FAN UP and FAN DOWN switches to set the displayed airflow to match the reading shown by the calibrated handheld ananometer. 26

28 Inputs X1 X1 Aemometer Data connect cable Outputs X1 X1 X1 White light 2.5 amp max 230VAC or 115VAC Spare or UV toggle (interlocked with cabinet light) Variable AC output6 amps max (cont) for fan supply Wiring Diagram Power Board to Fan Torin Fan Configuration (Standard Fan) Ziehl Fan Configuration (Special Units Only) 27

29 LCD Membrane Control Panel Wiring Diagram 28

30 MAINS J1 N L E J3 MEMBRANE PANEL PL3 L N C POWER PCB ASSEMBLY PL4 J5 DISPLAY PCB ASSEMBLY J9 L PL2 N L PL1 N 9 0 J1 9 J6 J8 EXHAUST FAN CAPACITOR LIGHT BALLAST UV SEC TRANS PRIM OPTIONAL ANENMOMETER NB 1) BLACK WIRE FROM FAN MUST NOT BE LINKED TO MAINS IN NEUTRAL 2) PCB SIDE OF CAPACITOR CANNOT BE WIRED TO FAN NEUTRAL MAINS GAS SENSOR 29

31 Others Other optional extras include, laminated chipboard under cupboard, castors, class 10 filtration, flexible PVC curtain, static eliminators and stainless steel mesh protecting the HEPA filter face. For these or any special requirement please contact our sales department. 30

32 Troubleshooting Problem Remedial Action Unit does not start Check power supply: Plug is firmly in socket outlet Check fan fuse has not failed Cable correctly connected Plug fuse has not failed Ensure fan speed controller is not set at zero If unit still does not start call Bassaire s Service Department HEPA filter face air velocity incorrect Check pre-filter state, change if necessary Adjust fan speed controller to give desired velocity (with clean pre-filter If the desired velocity still cannot be achieved the HEPA filter needs replacing. Call Bassaire s Service Department Fan runs at full speed Fan speed controller cannot be adjusted Unit vibrates or is excessively noisy Fan speed controller is faulty Call Bassaire s Service Department Isolate mains supply and remove pre-filter grille Check inside unit for foreign objects in fan air intake(s) If problem still exists call Bassaire s Service Department Lights not working Check lighting fuse has not failed Replace starter Replace tube If problem still exists call Bassaire s Service Department 31

33 Service Record Model: Serial No Date delivered Commissioned by: Date Commissioning comments: Date Service Engineer Action Comments 32

34 Other Products and Services Positive and negative pressure isolators Radiopharmaceutical isolators Glove boxes Purpose built clean rooms and clean working areas Mobile clean air enclosures Clean air tents Microbiological safety cabinets Class I, II and III Chemical work stations and fumes cupboards Portable filter cubes Document workstations Air showers Transfer Hatches Barrier Stools 33

35 This manual contains proprietary information that is protected by copyright. No part may be reproduced in any form without the express consent of Bassaire. 34