User Information. BERNER FlowSafe. Safety Cabinet for Cytostatics C-[MaxPro]³-130 and -190

Transcription

1 User Information BERNER FlowSafe Safety Cabinet for Cytostatics C-[MaxPro]³-130 and -190 Class II Microbiological Safety Cabinet B-[MaxPro]²-130 and -190 B-[MaxPro]³-130 and -190 Read the user information carefully before using the safety cabinet! Keep the document near the safety cabinet. Ignoring the user information can affect the performance of the safety cabinet or cause faults, damage the health of the user and put the environment at risk.

2 - leere Seite - info@berner-international.de Page 2 of 75

3 Chapter 1: Contents 1 Contents 1 Contents Pictograms Important Information Short operating instructions Identification Manufacturer Sales Partners Description EC declaration of conformity Test marks and monitoring Quality assurance Copyright and industrial property rights Description Function Technical Data Accessories Area of application Storage and Transport Packaging Storage Transport Environmental conditions Position Exhaust air flow operation Recirculation process Laboratory Surfaces Power requirements and supply connections Safety instructions Assembly filter system: B-[MaxPro]² filter system: B- and C-[MaxPro]³ Height adjustable base frame BEM BERNER ErgoMove Safety instructions Operation Bringing the SC into operation Checklist for setting up operations Trouble shooting checklist...42 info@berner-international.de Page 3 of 75

4 Chapter 1: Contents 10.4 Sitting position Safety instructions Inspection Types of tests Procedures and equipment Range Documentation Safety instructions Repairs Replacement parts Repair service Safety instructions Cleaning and care Disinfectants Cleaning and disinfectant intervals Room fumigation Brushed and polished stainless steel Replacing preliminary filter Safety instructions Waste removal Waste code Safety instructions...58 I Appendix I.I Declaration of conformity...59 I.II Type testing certificate...61 I.III Quality assurance certificate...67 I.IV Glossary...68 I.V Index...70 I.VI Literature review...73 info@berner-international.de Page 4 of 75

5 Chapter 2: Pictograms 2 Pictograms The pictograms highlight information and indicate important points. Table 2-1: Pictograms and their meaning Pictogram Meaning Hazards and safety advice Important information Problems and frequent errors Further information CE ("Communauté Européenne") - symbols: indication of conformity to European Community guidelines GS (tested for safety) indicates the product has been tested for safety in accordance with German laws on the safety of equipment and products TÜV-quality management symbol in accordance DIN EN ISO 9001:2008 Note user information Warning of poisonous substances. Warning sign W003 in accordance with DIN Warning of biological threat. Warning sign W016 in accordance with DIN Warning of explosive atmosphere. Warning sign W024 in accordance with DIN Protect from dampness! Fragile. Handle with care! Temperature limit! Keep upright! Indirect exhaust air system connection info@berner-international.de Page 5 of 75

6 Safety cabinet BERNER FlowSafe, C- and. B-[MaxPro] x -130 and -190 Chapter 3: Important Information 3 Important Information Read the user information carefully before commencing any activities. Take special note of the safety advice specific to each chapter. All staff who use the safety cabinet must receive instruction every year. The instruction should be documented in writing. Keep the user information near the safety cabinet. Ignoring the user information can affect the performance of the safety cabinet or cause faults, damage the health of the user and put the environment at risk. BERNER INTERNATIONAL GMBH does not accept any liability or responsibility for safety cabinets that have been used for any purpose other than that for which it has been designed. The information in this user information has been carefully checked and comes from reliable sources. In view of the possibility of human or technical error, BERNER INTERNATIONAL GMBH does not accept any liability for mistakes, omissions or inaccuracies in this user information or for results arising from these errors, omissions or inaccuracies. With regard to translations into foreign languages, it is the German version of the user information that is definitive. The contents of the user information may be changed at any time without notice. info@berner-international.de Page 6 of 75

7 Chapter 4: Short operating instructions 4 Short operating instructions Adhere to the user information. Only authorised personnel who have received instruction may use the safety cabinet. Safety cabinet: individual work station. Use personal protection equipment. Safe: green control light. Unsafe: red control light and acoustic warning signal. Only carry out critical activities when the front window is in the working position. Do not block the air intake apertures in the work area. Do not block the air outflow apertures. Safe area: closed work surface. Work area: do not leave about or store items. No strong sources of heat (e.g. gas burners) in the work area. Organise the transport of materials properly. Clean and disinfect material before bringing it in or removing it. Clean and disinfect the work area daily. Follow the rules for good microbiological and/or aseptic techniques. Avoid using rapid arm movements in the work area. Avoid disruptive air movement in the surrounding area caused by people moving about, open windows and doors, etc. Only particles and not gases are normally released in the work area. Regular inspection by authorised, specially trained service staff in accordance with the state of the art. info@berner-international.de Page 7 of 75

8 Chapter 5: Identification 5 Identification 5.1 Manufacturer BERNER INTERNATIONAL GMBH Tel.: +49/(0)4121/ Fax: +49/(0)4121/ info@berner-international.de 5.2 Sales Partners Austria Fa. MTG Römergasse 27 A-1160 Wien Austria Tel: Fax: mtg-wien@aon.at Denmark Holm & Halby Vallensbaekvej 35 DK 2605 Brondby Denmark Tel: Fax: info@holm-halby.dk Greece E & E Medical SA 64 L. Riankur St. Apollon Tower 15 A3 GR Athens Greece Tel: / 92 Fax: info@eemed.gr Hungary Premier G Med Oko KFt Hidász u. 1. H-1026 Budapest Hungary Tel: Fax: premiergmed@premiergmed.hu Luxemburg Hospilux S. A. 1, rue des Chaux L-5324 Contern Luxemburg Tel: Fax: hospilux@hospilux.lu Poland SELMA IMPORT-EXPORT ul. Cieszynska 4/85 PL Warschau / Warszawa Poland Tel: Fax: selma@post.home.pl Switzerland Skan AG Binnigerstr. 116 CH 4123 Allschwil Switzerland Tel: Fax: info@skan.ch info@berner-international.de Page 8 of 75

9 Chapter 5: Identification 5.3 Description The safety cabinet models C-[MaxPro]³ and B-[MaxPro]³ have the same constructions and identical safety functions. The only distinctions are the primary area of application (pharmaceutics or biotechnology) and the model designations and the number of HEPA filters. Table 5-1: Safety cabinet names, models and item numbers Device name Product group Model Item number Cytostatic safety cabinet C-[MaxPro]³ Cytostatic safety cabinet C-[MaxPro]³ Class II microbiological safety cabinet B-[MaxPro]³ BERNER FlowSafe Class II microbiological safety cabinet B-[MaxPro]³ Class II microbiological safety cabinet B-[MaxPro]² Class II microbiological safety cabinet B-[MaxPro]² Primary field of application: C = Cytotoxic drugs B = Biological agents Diagram 5-1: Model designations and their significance X-[MaxPro] y -ZZZ Number of HEPA-Filters: 1-Filter system 2-Filter system 3-Filter system Maximum Protection for Personnel Product Cross contamination Approx.overall width in [cm]: info@berner-international.de Page 9 of 75

10 Chapter 5: Identification 5.4 EC declaration of conformity The machine described in this document corresponds, in its design and construction as well as in the model marketed by us, with the relevant basic health and safety requirements of the following EC directives: EC Machinery Directive (2006/42/EC) EC Low Voltage Directive (2006/95/EC) EC Electromagnetic Compatibility Directive (2004/108/EC). This is documented by the EC Declaration of Conformity (see appendix) in accordance with the EC Machinery Directive 2006/42/EC, Appendix II 1 A. The CE mark is displayed on the name plate. 5.5 Test marks and monitoring The safety cabinets (sc) were type tested and certified as cytostatic safety cabinets and class 2 microbiological safety cabinets on the basis of basic regulations such as DIN (06/05) and DIN EN (09/00) in accordance with the German Device Safety Act (GPSG). This is demonstrated by the GS certificate (see appendix) and documented by "TÜV NORD CERT GMBH", a neutral and approved test centre. The "GS mark" is displayed on the safety cabinet to confirm this. Production of the safety cabinets is checked regularly (usually once a year) by neutral TÜV experts on the basis of the GPSG in order to guarantee safety, functionality and quality. 5.6 Quality assurance The quality assurance system implemented in accordance with DIN EN ISO 9001:2008 ensures that our products and services are of a consistent and high quality. The quality assurance system is certified by TÜV Management Service GmbH. Independent TÜV auditors regularly (usually once a year) check the requirements of the quality assurance system, such as development and design, procurement, production, testing, training, customer service and evaluation of complaints, to name but a few. This is documented by a neutral TÜV certificate (see appendix). 5.7 Copyright and industrial property rights The BERNER FlowSafe product group name is a registered and protected trademark. Infringement of industrial property rights will be prosecuted. The Spill-Liquid-Guard is a registered and protected trademark. Infringement of industrial property rights (e.g. copying, reproduction) will be prosecuted. The main filter level below the work surface with the HEPA cartridge filters Best-Filter-Protection is a patented system. Infringement of patent (copying, reproduction, etc) will be prosecuted. This user information is the property of BERNER INTERNATIONAL GMBH and may not be forwarded to third parties, copied, photocopied or used for promotional purposes, either wholly or in part, without written consent! Copyright BERNER INTERNATIONAL GMBH info@berner-international.de Page 10 of 75

11 Chapter 6: Description 6 Description The SC in the BERNER FlowSafe product group guarantees maximum personal, product and cross contamination protection. In line with the design process special attention was paid to the ergonomic requirements (interface man-machine ) and the Ergonomic-Advantage-System enabled these conditions to be met. The Ergonomic Advantage System incorporates the ergonomic principles of safety cabinet design, increases safety, improves working conditions and counteracts detrimental effects on health (forced posture) and performance. A good ergonomic design has a positive influence on the entire operating system as well as the reliability of human performance. In our opinion, safety cabinets with a good ergonomic design have the following features: Significantly more legroom with "three-filter systems": Room to extend the legs + minimum angle between the thigh and lower leg of 90 A work area that is reasonably deep in terms of the area of reach and can be accessed from a sitting position A work surface that is at the correct height They deliberately avoid the use of armrests, i.e. the armrest points are at the same height as the work surface: minimum angle between the upper and lower arm of 90 The display and control elements can be easily recognised (field of vision) and operated by the user from a central and sitting position. They facilitate an ergonomically integrated EDP workstation (optional). An integrated footrest (optional) should be available. The ideal operating parameters, such as sound pressure level, vibration, lighting, temperature, humidity, etc., for the user. A front window that is inclined at an angle of 10 for relaxed and natural upper body posture A high work area inside the cabinet as standard Overall, the Ergonomic Advantage System enables you to work for long periods without stress and prevents illnesses triggered by forced posture, such as RSI (repetitive strain injury). info@berner-international.de Page 11 of 75

12 Chapter 6: Description 6.1 Function Two-filter system The BERNER FlowSafe Control microprocessor-controlled ventilator(s) [1] draw(s) the total air flow through the rear channel [2] into the negative pressure plenum [3]. In the Best-Pressure-Plenum the air flow is divided into recirculation and exhaust air, in a ratio of approximately 70/30. Around 70% of the total air flow enters the work area through the HEPA-recirculation air filter [4] as a lowturbulence displacement flow [5]. All particles are transported directly and without any backflow towards the intake ports [6]: Uniform-Downflow. The exhaust air [7], approx. 30% of the total air flow, flows through the HEPA exhaust filter [8] and into the Inflow-Downflow-Regulator [9] into the laboratory or exhaust system (optional). The IDR, which is fitted on the clean air side, simultaneously protects the exhaust air flow from obstruction or disruption caused by mechanical objects: Block-Guard-Plus. The air inflow [10] forms a stable and safe air barrier within the work opening, which is bordered at the top by a window, inclined by 10 and made out of MSG (multi-layer safety glass). The workspace, up to 755 mm high, consists of easy to clean V2A stainless steel. The sidewalls being made out of MSG, ensure the best lighting conditions and a comfortable working environment. The segmented worktops [11] are easily taken up for cleaning and can be disinfected by e.g. autoclaving. The lower situated intake ports safeguard optimal air circulation across the complete work opening. Figure 6-1: Side view of construction and operating principles of the 2-filter system [9] [7] [8] [1] [4] [3] [5] [2] [10] [6] [11] info@berner-international.de Page 12 of 75

13 Chapter 6: Description Three-filter system The BERNER FlowSafe Control microprocessor-controlled ventilator(s) [1] draw(s) the total air flow through the rear channel [2] into the negative pressure plenum [3]. In the Best-Pressure-Plenum the air flow is divided into recirculation and exhaust air, in a ration of approximately 70/30. Around 70% of the total air flow enters the work area through the HEPA-recirculation air filter [4] as a lowturbulence displacement flow [5]. All particles are transported directly and without any backflow towards the intake ports [6]: Uniform-Downflow. The exhaust air [7], approx. 30% of the total air flow, flows through the HEPA exhaust filter [8] and into the Inflow- Downflow-Regulator [9] into the laboratory or exhaust system (optional). The IDR, which is fitted on the clean air side, simultaneously protects the exhaust air flow from obstruction or disruption caused by mechanical objects: Block-Guard-Plus. The air inflow [10] forms a stable and safe air barrier within the work opening, which is bordered at the top by a window, inclined by 10 and made out of multi-layer safety glass. The workspace, up to 755 mm high, consists of easy to clean V2A-stainless steel. The sidewalls safeguard the best lighting conditions and a comfortable working environment. Immediately below the work surface the circulated air flows into the newly developed main filter: Best-Filter-Protection [11]. Figure 6-2: Side view of operation and operating principles of 3-filter system [9] [7] [8] [1] [4] [3] [5] [2] [10] [6] [12] [11] The segmented work tops [12] are easy to clean and are fitted with a Spill-Liquid-Guard. In this way damages to filters below the segmented worktops by spilt liquids are effectively prevented. The lower situated intake ports safeguard the optimal air circulation across the complete work opening. All particle sized contamination is filtered safely over the shortest distance by the cartridge filters Best-Filter- Protection below the worksurfaces. All cartridge filters are easily replaced in the workspace, safely and low in contamination. This safety cabinet offers with the newly designed 3-filter system maximum protection for your safety. info@berner-international.de Page 13 of 75

14 Chapter 6: Description 6.2 Technical Data Table 6-1: Safety cabinet data: 2-filter system General data Manufacturer BERNER INTERNATIONAL GMBH Product group BERNER FlowSafe Device Laboratory device Type of device Class II microbiological safety cabinet Type of construction DIN EN 12469; NSF 49 Year of construction Please see model label (outside right) Certificate TÜV GS-certificate Marking CE Production DIN EN ISO 9001 Model B-[MaxPro]²-130 B-[MaxPro]²-190 Item number General technical data Sound pressure level pusuant to ISO ,3 db(a) 53,4 db(a) Nominal illuminance 1200 lx 1400 lx Vibration (RMS) on the work tops 5 µm Drip tray volume 48,9 l 72,5 l Material-specific data: Casing Work area material 1,5 mm thick V2A stainless steel, material no.: Work area surface quality 320 grit fine finissh, mean roughness value R a 1,6 µm Casing material Powder-coated 1,5 thick Zincor sheet steel, material no.: Colour of paint coating White RAL 9002 matt; blue RAL 5024 matt Front, side and back panel Multi-layer safety glass with UV-ray absorbing PVB interlayer Electrical data Rated voltage 230 V AC Rated frequency 50 Hz Rated current a) and rated power 9,4 A or 2162 VA 12,5 A or 2875 VA Protection class I Type of protection IP 20 Connection Fused plug a) : The total rated currrent is decreases by up to 5 A when not using the sockets in the work area. The total load on the sockets must not exceed 5 A! Mechanical data: Width/height/depth in [mm]; see also Fig. 6.3 Overall dimensions base b) 1340/ / / /875 Workspace 1253/ / / /600 Total workspace 1253/-/ /-/600 Usable workspace c) 1253/-/ /-/445 Segmented work surface 4x 313/-/600 6x 313/-/600 Work aperture 1253/180/- 1856/180/- Work opening, with window fully open d) 1253/550/- 1856/550/- Installation dimensions e) 1340/1532/875 bzw. 800 (without rear panel) 1945/1532/875 bzw. 800 (without rear panel) Smallest installation dimension e) f) 1335/885/ /885/763 Workspace height Height of leg room at the front edge Weight ca. 296 kg ca. 400 kg b) : The upper part of the device, base frame, and filters are set up and installed on site! c) : Without the front and rear intake ports d) : Attention: This is not the correct position of the window for safe working! It is only for easy loading and unloading of works area (e.g. bulky equipment), cleaning, etc. e) : Allow an extra 10 mm both horizontally and vertically! The smallest installation dimensions, e.g. door, must be co-ordinated prior to delivery! Device height: take pallet into account! f) : Device will be delivered in separate parts completely and assembled on site (Special installation!) Ventilation data 2-filter system Volumetric flow rate of downflow air ca. 947 m³/h ca m³/h Volumetric flow rate of exhaust / inflow air ca. 357 m³/h ca. 541 m³/h Mean air inflow rate 0,44 m/s 0,45 m/s Displacement flow rate 0,35 m/s 20% AER Normal in the work area 1668 /h AER Night in the work area 715 /h Temperature increase in the work area 2,0 K 2,8 K Thermal load 7005 kj/h (1,9 kw) 9315 kj/h (2,6 kw) Filter class of the 2-filter system with recirculation and exhaust air At least H 14 (filtration rate g) : E 99,995%) in accordance with DIN EN Cleanroom class in the work area EC-GMP-Guide: A; DIN EN ISO : 5 US Federal Standard 209E: M 3,5 / 100; VDI 2083 Blatt 1: 3 g) : Integral filtration rate determines the minimum filtration rate or the maximum penetration. i.e. particles with the so-called Most Penetrating Particle Size (MPPS). info@berner-international.de Page 14 of 75

15 Chapter 6: Description Table 6-2: Safety cabinet data: 3-filter system General data Manufacturer BERNER INTERNATIONAL GMBH Product group BERNER FlowSafe Device Laboratory device Type of device Safety cabinet for cytostatics and class II microbiological safety cabinet Type of construction DIN 12980; DIN EN 12469; NSF 49 Year of construction Please see the model label (outside right) Certificate TÜV GS-certificate Marking CE Production DIN EN ISO 9001 Model C-[MaxPro]³-130 B-[MaxPro]³-130 C-[MaxPro]³-190 B-[MaxPro]³-190 Item number General technical data Sound pressure level pusuant to ISO ,6 db(a) 57,6 db(a) Nominal illuminance 1200 lx 1400 lx Vibration (RMS) on the work tops 5 µm Drip tray volume 9,0 l 12,7 l Material-specific data: Casing Work area material 1,5 mm stainless steel V2A, material number: Work area surface quality 320 grit fine finish, mean roughness value R a 1,6 µm Casing material 1,5 mm thick, powder-coated Zincor sheet steel, material number: Colour of paint coating White RAL 9002 matt; blue RAL 5024 matt Front, side and back panel Multi-layer safety glass with UV-absorbing PVB interlayer Electrical data Rated voltage 230 V AC Rated frequency 50 Hz Rated current a) and rated power 8,0 A or 1840 VA 9,4 A or 2162 VA Protection class I Type of protection IP 20 Connection Fused plug a) : The total rated currrent is decreases by up to 5 A when not using the sockets in the work area. The total load on the sockets must not exceed 5 A! Mechanical data: Width/height/depth in [mm]; see also Fig. 6.3 Overall dimensions base b) 1340/ / / /875 Workspace 1253/ / / /600 Total workspace 1253/-/ /-/600 Usable workspace c) 1253/-/ /-/445 Segmented work surface 4x 313/-/600 6x 313/-/600 Work aperture 1253/180/- 1856/180/- Work opening, with window fully open d) 1253/550/- 1856/550/- Installation dimensions e) 1340/1532/875 or 800 (without rear panel) 1945/1532/875 or 800 (without rear panel) Smallest installation dimension e) f) 1335/885/ /885/763 Workspace height Height of leg room at the front edge Weight ca. 327 kg ca. 444 kg b) : The upper part of the device, base frame, and filters are set up and installed on site! c) : Without the front and rear intake ports d) : Attention: This is not the correct position of the window for safe working! It is only for easy loading and unloading of works area (e.g. bulky equipment), cleaning, etc. e) : Allow an extra 10 mm both horizontally and vertically! The smallest installation dimensions, e.g. door, must be co-ordinated prior to delivery! Device height: take pallet into account! f) : Device will be delivered in separate parts completely and assembled on site (Special installation!) Ventilation data 3-filter system Volumetric flow rate of downflow air ca. 947 m³/h ca m³/h Volumetric flow rate of exhaust / inflow air ca. 357 m³/h ca. 541 m³/h Mean air inflow rate 0,44 m/s 0,45 m/s Displacement flow rate 0,35 m/s 20% AER Normal in the work area 1668 /h AER Night in the work area 715 /h Temperature increase in the work area 2,0 K 2,8 K Thermal load 5962 kj/h (1,7 kw) 7005 kj/h (1,9 kw) Filter class of the 2-filter system with recirculation and exhaust air At least H 14 (filtration rate g) : E 99,995%) in accordance with DIN EN Cleanroom class in the work area EG-GMP-Guide: A; DIN EN ISO : 5 US Federal Standard 209E: M 3,5 / 100; VDI 2083 Blatt 1: 3 g) : Integral filtration rate determines the minimum filtration rate or the maximum penetration. i.e. particles with the so-called Most Penetrating Particle Size (MPPS). info@berner-international.de Page 15 of 75

16 Chapter 6: Description Tabelle 6-4: Data of height-adjustable base frame General data Manufacturer BERNER INTERNATIONAL GMBH Device Laboratory device Type of device Height adjustable base frame Product group BEM - BERNER ErgoMove Year of construction Please see the model label (inside left) Marking CE Production DIN EN ISO 9001 Model BEM - BERNER ErgoMove 130 BEM - BERNER ErgoMove 190 For the SC, Model B-[MaxPro]²-130 [MaxPro]³-130 B-[MaxPro]²-190 [MaxPro]³-190 Item number Material-specific date: Casing Material Powder coated Zinc sheet steel, Material no.: Colour powder coating Blue RAL 5024 matt Electrical data Rated voltage 230 V AC Rated frequency 50 Hz Rated current and rated power 230 V Motor voltage 38 V DC Idle speed 210 min -1 Protection class II Type of protection IP 20 Connection Fused plug Mechanical data Outer dimensions (W/H/D) 1340/ (+10)/930 mm 1950/ (+10)/930 mm Maximum load 550 kg Nominal torque 5 Nm Break away torque 55 Nm Maximum lift 1) ca. 380 mm Actual work surface height (± 5) mm Resulting total height of the SC 1) (+10) mm Weight ca. 100 kg ca. 110 kg 1) : Please pay attention to a minimum room height of up to 2600 mm! If this is not possible, the lift needs to be restricted! info@berner-international.de Page 16 of 75

17 Chapter 6: Description Figure 6-3: Construction, function and measurements of the safety cabinet in front and side views Not for 2-filter system Page 17 of 75

18 Chapter 6: Description 6.3 Accessories The following standardised and optional accessories (s. fig. 6.4) are available for the SC: Table 6-4: -Standard and optional accessories Standards and options Model C-[MaxPro]³-130 B-[MaxPro]²-130 B-[MaxPro]³-130 C-[MaxPro]³-190 B-[MaxPro]²-190 B-[MaxPro]³-190 Nr. General Item number 1+2 Two function sockets 230 VAC, I Max = 5 A Standard 3 Filter-test access Filter in Standard 4 Filter-test access Filter out Standard 5 Additional power socket Dimmable inner lighting 1) Protective covering for cable connection side window panel openings, d= 22 mm S S S S 9 Waste disposal unit 2) (right hand side) / (left hand side) EDP-work station 10 Monitor window ErgoView S S Flat screen holder 3) ScreenBase plus ) ) 12 Integrated monitor 19 / / RS 232-interface 6) DataLink S S Interface adapter RS 232 / LocalCan PC-holder Tower-Base Printer shelf Swivel-mounted keyboard shelf Weighing work top Low-Vibration-System ) / ) Base unit 19 Sitting work space, height: 765 mm (± 20) S S S S 20 Standing work space, height: 1063 mm (± 20) Electrically height adjustable 9) BERNER ErgoMove Exhaust or ventilation system 22 GMP-Cover 10) Potential-free contact, normal mode S S Potential-free contact, night mode Potential-free contact, combined alarm Cleanroom 26 Connection to an external monitoring system 11) Outlet for external flow monitoring Air flow visualisation Fitting for the connection of a fixed or mobile isokinetic sampling probe Integration of an isokinetic sampling probe in the rear wall ) / ) 31 Calibration certificate for the flow sensor Calibration certificate for the pressure sensor Software BERNER FlowSafe Monitoring ) / ) 34 GMP documentation as per EU GMP Guidelines 16) Appendix Biotechnological applications 35 Laboratory equipment gases, water, vacuum / / Segmented recirculation filter Stainless steel finish Item no. available on request 38 UV-C sterilisation system QuickDecon ) Available with a remote control or a radion button. 2) Item numbers for side windows for disposal unit available on request. 3) Suitable for virtually all available standard flat screen monitors with VESA FMPPM 75/100 Standard. 4-5) In the laboratory there must be a minimum of 4) 340 mm and 5) 492 mm space, available to the right and left hand side of the safety cabinet! 6) Further interfaces available on request. 7) Original equipment. and 8) Extra equipment retrofitting. 9) Use currently only possible in recirculated air operation. 10) For a closed cover this is possible up to a maximum height of 3 metres. 11) GRM-System (Integral cleanroom monitoring system (GRM) from the company Briem. 12) Mobile probe, and 13) Fixed probe. 14) Basic licence and 15) additional licence. 16) Specific consultation and quotation, based on individual requirements. info@berner-international.de Page 18 of 75

19 Chapter 6: Description Behind the SC the screen holder model "ScreenBase" can be fitted up to a size of 20". The flat screen is attached in accordance with the "VESA FMPPMI 75/100" standard. The screen holder is made up of aluminium and V2A stainless steel. The waste collection unit [9] is used for the safe disposal of waste, gloves and other items, which have been used in the workspace of the safety cabinet. The power sockets are situated on the rear panel of the work space (s. fig. 6.4), behind splash-proof hinged lids (IP 44): Standard: Power sockets [1+2], Filter test access Filter in [3] and Filter out [4]]. Figure 6-4: Layout of standard and optional accessories from the front [21] [38] [4] [3] [5] [1] [30] [10] [11] [2] [5] [13-14] [16] [15] [17] [20] info@berner-international.de Page 19 of 75

20 Chapter 6: Description Waste collection unit The waste collection unit for the safe removal of waste products. The packaging of materials, which are to be disposed of, substantially reduces the risk of contamination. The tubular foil, wich is sealed on one side only, is filled with the waste materials directly inside the workspace and then subsequently passed to the outside. The materials are isolated by sealing the tubular foil and then removed by cutting off the tube Safety requirements Never pass through sharp or pointed objects! Strong solvents could dissolve the foil! Prior to use check if the disposal unit is suitable for the task! During non-use of the waste transfer unit, the connection inside the safety cabinet (SC) should be covered up using the cap provided Operation All objects which are to be passed through, e.g. gloves, wipes and other materials which have been used in the SC, are to be placed in the sealed tube. If a greater volume is required for the disposal of the objects, the tube can be lengthened by pulling carefully. After sealing the tube on the other side (using a knot, cable tie or glue seal) the tube can be cut off using a pair of scissors. Figure 6-5: Waste collection unit Subsequently the tube is closed on one side again and the waste collection unit can be used again straight away. After use the opening of the unit inside the SC should be closed again using the sealing cap Cleaning instructions It is recommended to clean the equipment with a moist cloth, window cleaner or soapy water. Javell, or hyposchlorite solutions are not to be used on stainless steel (see also Chapter 13) Changing the tube foil roll To avoid contamination, the waste collection unit should cleaned prior to replacement of the tube foil. To change the tube foil the loose semishell should be turned clockwise ca. 10 mm and pulled off. The new tubular foil roll is prepared by removing the safety and pulling the tube foil partly out and subsequently pushing it over the semishell. Figure 6-6 Changing the roll info@berner-international.de Page 20 of 75

21 Chapter 6: Description Before fitting the tube has to be pulled through the tube. Both of the semishells should be pushed into each other so that the nut locks into place. Attention: Please note the direction of the lock! Fix both semishells by a short, clockwise rotating movement (ca. 10 mm). Check that both parts are properly connected by pulling the ring slighty. info@berner-international.de Page 21 of 75

22 Chapter 6: Description 6.4 Area of application In principle, the cytostatic safety cabinet (CSC) model C-[MaxPro]³ or the class II microbiological safety cabinet (MSC) model B-[MaxPro]³ can be used in laboratories that handle particulate chemical and/or biological agents. The SC mentioned above are not laboratory fume cupboards. Chemicals that attack the materials used, such as V2A stainless steel and multi-layer safety glass, must not be used. This includes, for example, hydrofluoric acid and perchloric acid. BERNER INTERNATIONAL GMBH should be consulted in individual cases. The HEPA filters as standard do not filter out gaseous agents! The SC must not be used in potentially explosive areas (gases, vapours, mist or dust)! In applications that require maximum personal, product and cross contamination protection, the above safety cabinets represent an ideal safety device Pharmaceutics The SC, model C-[MaxPro]³ cytostatic safety cabinet was developed for GMP-compliant production of potentially toxic, aseptic parenteral preparations. These include, among other things, CMR drugs, which typically include drugs such as cytostatic and virustatic agents. CMR drugs should be regarded as hazardous substances because they are potentially toxic. As a result, it is imperative to ensure personal protection, or rather containment capability, at the working aperture of a CSC. On the other hand, cytostatic and virustatic agents should be seen as drugs as a result of their specific biological effect. Aseptic production conditions should therefore be ensured for these drugs, which are usually administered parenterally. The conditions in the work area of a CSC model C-[MaxPro]³ are equivalent to a class A clean room as described in the EC GMP Guide. Characteristic safety functions include, among other things, product and cross contamination protection. In our experience, CSCs are used in CMR drug production in, for example, Retail and hospital pharmacy laboratories Institutes for human and veterinary medicine and research facilities Hospitals, e.g. inpatient and outpatient applications The pharmaceutical industry Medical practices, e.g. oncology practices. info@berner-international.de Page 22 of 75

23 Chapter 6: Description Biotechnology The MSC Class II B-[MaxPro]³ were developed for handling biological agents that require a high level of safety functions. Biological agents and biological substances are divided into 4 risk groups based on their infectious, allergenic and toxic potential for humans, the environment and population and animals. In terms of potential danger, biological agents in Risk group 1 are not usually hazardous Risk group 2 are usually slightly hazardous Risk group 3 are usually very hazardous Risk group 4 are usually extremely hazardous. MSC can be used for handling biological agents up to risk group 4. Particularly in safety level 3 and 4 laboratories, which contain biological agents that are potentially very hazardous (e.g. certain prions such as TSE, HIV and tuberculosis pathogens, etc.) the B-[MaxPro]³ ensures maximum personal protection. The product and cross contamination protection feature provides the experiment with reliable protection from undue contamination. In our experience, MSC are used for handling biological agents in, for example, Institutions and research facilities for human and veterinary medicine, Dialysis wards, Medical laboratories, Pathology laboratories, Microbiology laboratories, Chemical laboratories, Genetic engineering laboratories. info@berner-international.de Page 23 of 75

24 Chapter 7: Storage and transport 7 Storage and Transport 7.1 Packaging Recyclable original packaging consisting of wood, corrugated cardboard, polyethylene film and polypropylene straps should be collected separately and recycled in accordance with the waste management plan. The transport company usually disposes of packaging material. Should this not be the case, please ask your city council or local authority for the address of the regional waste disposal company. If the SC is to be transported and, if necessary, stored again after removal of the packaging, please read the sections entitled "Storage" and "Transport". 7.2 Storage The SC should be stored on a palette in a dry, shockproof environment and protected by a plastic sheet. The environmental conditions should be between -10 C and +60 C and the humidity should not exceed 70% RH. The SC should not be exposed to any unnecessary dirt ("dusty" air) or vibrations in order to avoid superfluous adverse effects and perhaps damage. 7.3 Transport The SC may only be transported by trained staff (e.g. forwarding agent). The transport conditions should correspond to the storage conditions. The SC should be transported in an upright position, (maximum incline angle of 10 ). All openings should be sealed or closed for transport. Appropriate lifting devices (e.g. lift trucks, transport trucks and belt systems) should be used to prevent the transport staff from injuring themselves. info@berner-international.de Page 24 of 75

25 Chapter 8: Environmental conditions 8 Environmental conditions We recommend that you contact our experienced sales or service team beforehand in order to select the correct SC, laboratory position, laboratory equipment and ventilation system for the space available. This enables you to ensure that the SC performs all safety functions under the existing environmental conditions. Unnecessary complications in the course of laboratory inspections by the Office of Occupational Safety or industry inspectorate, employers' liability insurance association or accident insurance company and Chamber of Pharmacists through the Pharmacy Council can be effectively avoided. In accordance with basic legal provisions in Germany, such as the Hazardous Substances Ordinance (GefStoffV) in conjunction with TRGS 525 and TRGS 526 the Biological Substances Ordinance (BioStoffV) in conjunction with TRBA 100, TRBA 105 and TRBA 603 the Workplaces Ordinance (ArbStättV) the leaflet Safe Handling of Cytostatics M 620 the leaflet Safe Working at MSC B 011 and/or BGI 863 instructions for health and safety at work provided by professional associations with liability for Industrial safety and insurance officially approved procedures and procedures approved by employers' liability insurance associations (BubaV) the cytostatics agent directive of the German Länder BAK (Federal Chamber of Pharmacists) guidelines ADKA guidelines EC-GMP guide DIN 12980, DIN EN 12469; DIN EN ISO part 1 DIN 1946 part 4 and part 7 The laboratories and their installations must conform to the above requirements, in order to ensure safe operation of the SC. SC used outside Germany must be operated in laboratories that comply with the relevant national regulations. These can be EC directives that have been implemented, such as the EC GMP Guide, interna- tional harmonisation standards (e.g. DIN EN ISO et seq.) or specific national regulations. We recommend that you ask our national distribution partner, if we have one in your country, for support. info@berner-international.de Page 25 of 75

26 Chapter 8: Environmental conditions 8.1 Position Movement of air in the surrounding area is crucial to safe operation of a SC. Movement of air is caused by: Human traffic Open windows and doors ("draughts") Drops in temperature and pressure Ventilation and exhaust systems Ventilation equipment (e.g. SC, LAF units, laboratory fume cupboards and product protection SC). Ideally, the air flow rates that result in the above situations should not exceed 0.2 m/s. Figure 8-1: Suitable sites (1-2), less suitable sites (3+4) and unsuitable sites (5) for safety cabinets The position of the SC should be chosen so that movement of air in the room (see above) does not endanger its safe operation. Fig. 6 helps you choose a location. The above examples of where to put a SC are only intended as an aid to positioning. The positions are not a guarantee that the cabinet will function safely. We recommend that you contact our experienced technicians in order to establish the best possible location in your laboratory. Data relating to minimum distances can be found in the BubaV or the quality standard for pharmaceutical-oncological service (QuapoS). The following minimum distances should be observed: In front of the SC (disturbance-free zone): 1.2 m From side walls, pillars and furnishings: 0.3 m The distance between the back of the SC and the laboratory wall must be approximately 80 mm. The resulting free space behind the SC is needed to ensure easy use of the GMP cover. info@berner-international.de Page 26 of 75

27 Chapter 8: Environmental conditions 8.2 Exhaust air flow operation All of the requirements mentioned must be met. In particular, a SC that is to be used with CMR drugs must be connected to an exhaust air system on the basis of GefStV in conjunction with TRGS 560. Air that is extracted from a SC containing carcinogenic hazardous substances may not be fed back to the workstation. If the SC is to be used for handling volatile (gaseous) substances, especially dangerous substances, in addition to biological agents, connection to an exhaust air system may be required. Connection to an exhaust air system is supported by the requirements of the relevant regulations of the ArbStättV in connection with the workplace guidelines, EC-GMP guide, BAK-guidelines. This means that using a ventilation system fresh air is provided based on the number and activities of the workers the clean room class that must be realised to ensure an appropriate exchange of air. Besides extracting the exhaust air from the SC, an exhaust air system also frequently ensures ventilation of the laboratory. Connection to an exhaust air system must be carried out in such a manner that the SC can maintain its protective function even if the exhaust air system develops a fault (ventilator, air or fire protection valve defect, etc.). In any case, any repercussions on the SC must be avoided. All the pathogenic agents passing through the SC exhaust filters must be directed out of the laboratory via the exhaust air system. Based on current knowledge, the above requirements can only be met with indirect connection of the exhaust air system (draught diverter, chimney, loose coupling, etc.) to the SC. Furthermore, sufficient ventilation of the premises should be ensured. Adequate ventilation of laboratories can often only be carried out using mechanical ventilation. Natural ventilation via open windows and doors often represents an intolerable amount of disturbance (draughts) to the SC. This means that air from the laboratory must be supplied and extracted using a mechanical ventilation system. Using an exhaust air system can both ventilate the laboratory and extract exhaust air from the SC. It should be noted that exhaust air from laboratories handling dangerous materials and safety level 3 and 4 laboratories should always be filtered in any case. Direct or fixed connection does not offer a higher level of safety compared to an indirect connection. In particular if there is a fault, the fixed connection cannot ensure operation of the SC without repercussions at any time. If the SC is directly connected to the exhaust air system, this involves a different type of construction and the device must be regarded as part of the system. This would mean some of the important relevant safety documents, such as the GS certificate and the EC declaration of conformity, would no longer be valid. The exhaust air hood or GMP cover is a coupling solution for the exhaust air system. It operates on the principle of indirect exhaust air extraction, i.e. part of the air flow is also extracted from the environment. This results in a necessary total exhaust air volume of approximately 125% depending on the exhaust air volume flow of the SC. The GMP-conform cladding of the surface above the SC can be carried out using a GMP cover. This minimises the surfaces that need to be cleaned on the SC. info@berner-international.de Page 27 of 75

28 Chapter 8: Environmental conditions Figure 8-2: Connection to an exhaust system Total exhaust volumetric flow GMP-Cover Exhaust volumetric flow Inflow air 8.3 Recirculation process Only in exceptional cases can a connection of a SC to an exhaust air system be avoided by complying with the regulations of the BubaV. If a SC is to be used in a recirculation operation, it is essential to comply with officially approved procedures and procedures approved by employers' liability insurance associations (BubaV) pursuant to Sec. 11, Para. 4 of the German GefStoffV, at least for CSC. The BubaV applies to CSC in recirculation operation and makes many additional demands for CMR drug production: Minimum space requirement: A 10 m²; h 2.5 m Air exchange rate (AER) 8 Ventilation and extraction of air Recurrent tests Test record Service engineer etc. The purpose of these requirements is to raise the safety level as, according to GefStoffV, downflow operation compromises safety technology. As regards space requirements, it is necessary to pay particular attention to the minimum space requirement and AER in conjunction with the volumetric flow rate of exhaust air from the SC. According to BubaV, the AER results from the circulation of laboratory air when it is drawn into the working aperture and blown out via the exhaust air vent of the SC. The AER is defined as the volumetric flow rate of exhaust air from the SC divided by the volume of free air in the laboratory: AER Recirc V V Exhaust sc Lab free Therefore, the AER of 8 and the volumetric flow rate of the exhaust air determine the size of the room. It should be assumed that approx. 5 m³ of the room capacity is taken up by furniture. This increases the total volume of air in the room and total floor surface area required. You can use the table below to work out the total area needed. Table 8-1: Necessary laboratory floor surface area required for downflow operation according to BubaV AER = 8; h Lab = 2,5 m; V Equipment = 5 m³ info@berner-international.de Page 28 of 75

29 Chapter 8: Environmental conditions Model V Exhaustsc A C- or B-[MaxPro] x m³/h 20 m² C- or B-[MaxPro] x m³/h 29 m² The following always applies to recirculation operation: The higher the volumetric flow rate of the exhaust air, the larger the laboratory must be. 8.4 Laboratory The following environmental conditions should be ensured for safe operation of the SC: Interior use only Mains power supply: U 10% of rated value (usually 230 V AC) Temperature: 5-40 C Air pressure: hpa (up to 2000 m above sea level at 15 C standard temperature) Humidity: 50% relative humidity ( 40 C); 80% relative humidity ( 31 C) Vibration: the SC should not be exposed to any long-term heavy vibration. The RMS vibration amplitude of 5 µm at a frequency of 20-20,000 Hz should not be exceeded on the floor. Lighting: 300 lx 8.5 Surfaces The following conditions must be ensured for laboratory surfaces: Floor covering: anti-static and anti-slip The floor must meet static requirements with regard to the expected total weight Surfaces: liquid-tight and free of cracks, joints and pores All surfaces must be resistant to commonly used chemicals, such as disinfectants, cleaning agents, acids, alkalis, solvents, etc. The fire protection classes of the materials used should be selected according to the chemicals used. 8.6 Power requirements and supply connections The following conditions should be ensured for safe operation of the SC: Supply connection: separate three-pin socket with selective fuse protection for a device in protection class I, i.e. 230 V AC, fuse protection with I max = 16 A. The three-pin socket should be positioned out of arm's reach: 1.25 m to the sides and down based on the central standing area in front of the SC. The three-pin socket should be freely accessible and ideally no more than 1 m from the SC on the left. Unplugging the device in an electrical emergency (e.g. fire) ensures that all poles are disconnected. Supplies of compressed air, gas, water, etc. should be connected in accordance with the relevant national regulations (e.g. DVGW, Worksheet GW 3). Supply connections should be integrated in equipotential bonding, where appropriate, in order to avoid static charges. info@berner-international.de Page 29 of 75

30 Chapter 8: Environmental conditions 8.7 Safety instructions Pay careful attention to the layout of the surrounding conditions, especially: Location of the SC Installation of the exhaust air system Size of the laboratory, particular when using recirculated air Laboratory ventilation Mains connection for the SC Page 30 of 75

31 Chapter 9: Assembly 9 Assembly The assembly of the SC may only be carried out by service engineers who have been authorised by BERNER INTERNATIONAL GMBH. It can also be set up, although not installed or assembled, by trained transport companies. If the SC is set up, installed or assembled by persons who are not authorised by BERNER INTERNATIONAL GMBH, we cannot accept any guarantee or liability. Responsibility and liability for any damage to persons or property belongs in this case to the operator filter system: B-[MaxPro]² The following components need to be available for assembly of the 2-filter system: Assembly instructions Base frame: - left and right side sections - rear connecting bar - upper part of SC - screws: 4x M8 x 16; 4 x M6 x 80 (incl. bushings) SC You will also need the following tools for assembly: - offset screwdrivers (socket) 5 and 6 mm - open-ended spanner 13 and 17 mm - lifting device (lift truck or similar): lifting height 710 mm, lifting weight 450 kg - spirit level Base frame The C side parts need to be fixed to the rear connection bar, (the open side pointing towards the back) at the marked positions with four screws M8 x 16. The four feet below the C side parts need to be adjusted to ensure that the base frame is level. Figure 9-1: Assembly of the base frame info@berner-international.de Page 31 of 75

32 Chapter 9: Assembly Positioning of the base unit After loosening the strips of squared timber the upper part of the SC is to be placed carefully onto a suitable lifting device (e.g. a lift truck). Important: the lifting device must not damage the drip tray. Make sure there is extensive padding at the front and back! Carefully place the upper part of the SC in front of the positioned based frame. Lift the upper part of the SC to a height of at least 710 mm, position the base frame under the SC and lower until they are 10 mm apart (see fig. 9-2). Lift the base frame slightly at both sides and align the lower bore holes in the side of the base frame with the threaded bushes in the base of the safety cabinet. Screw two screws (M6 x 80 including brass bushings 70 x 10) into each C-shaped side part from below (see fig. 9-2) and tighten them to ensure a secure connection between the upper part and the base frame. Carefully lower the entire SC (see fig. 9-3). Fig. 9-2: Placing the SC onto the base unit Fig. 9-3: Placing the SC onto the base unit info@berner-international.de Page 32 of 75

33 Chapter 9: Assembly filter system: B- and C-[MaxPro]³ The following parts are needed for the assembly of the 3-filter system: Assembly instructions Base unit: - left and right side sections - rear connecting bar - main filter box - 6 or 9 main cartridge filters, model BFP-Best-Filter-Protection - main filter guard - upper part of the SC - screws: 4x M8 x 16; 13 x M6 x x U washers 6,4 (incl. bushings) - 10 caps SC The following tools are required for the assembly - offset screwdrivers (socket) 5 and 6 mm - open-ended spanner 13 and 17 mm - lifting device (lift truck or similar): lifting height 710 mm, lifting weight 450 kg - sealant materials - spirit level Base frame See section Positioning of the base unit See section Main filter box of the 3-filter system The assembly of the main filter box and the fitting of the main filter must be carried out by a trained service technician! The main filter box should be positioned below the safety cabinet between the base frame (see fig. 9.4) so that you can look into the filter openings from the front. Degrease the top of the main filter box and the bottom of the drip tray and cover with an approx mm thick, continuous silicone strip (transparent). Push the bottom left and right corners of the main filter box onto the angle brackets located on the inside of the C-shaped side part without shaving off any of the silicone. Tip the main filter box upwards so that the top lies flush against the bottom of the drip tray. Use Figure 9-4: Assembly of the main filter box screw clamps for fixation if necessary. Screw 3 x M6 x 16 screws through each side of the base frame (see Fig. 9.4) into the main filter box info@berner-international.de Page 33 of 75

34 Chapter 9: Assembly Seal all outer and inner edges of the sealing surface neatly. Remove the rear panel of the safety cabinet. Use three M6 x 16 screws to attach the frame to the filter box. Now seal the rear edges. The sealant must be left to harden for a few hours before calibration and commissioning. Insert 5 caps into the screw openings on each side part. Insert the main filters and secure each one with 4 screws. Carry out commissioning test! Insert the intake guard above the main filters. Insert worktops from right to left. 9.3 Height adjustable base frame BERNER ErgoMove The height adjustable base frame is delivered readily assembled on a pallet. A fused plug 230V AC / 50Hz on the left inner side of the base frame shall be provided. Place the base frame at the designated SC location and adjust the 4 machine feet. If used for a 3-filter system, please place the main filter box inside the base frame first, before placing the SC onto the base frame. The SC should be placed and attached onto the base frame as in chapter If used for a 3-filter-system the main filter box has to be assembled as in chapter The control unit for the base frame should be placed beneath the drip tray on the left side. Figure 9-5: Height adjustable base Frame 9.4 Safety instructions During assembly please pay special attention to, especially: Watch your fingers to prevent accidents. Check the fixing of the rear bar and ensure that the base frame is level, before positioning the SC onto the base frame. Check the fixing of the SC to the base unit. In case of problems or damage please contact the customer or BERNER INTERNATIONAL GMBH immediately. info@berner-international.de Page 34 of 75

35 Chapter 10: Operation 10 Operation 10.1 Bringing the SC into operation The SC is controlled via the central control element BERNER FlowSafe Control (see fig. 10.1). There are four different operating modes: Normal mode Cleaning mode Night mode Service mode The cleaning, night and service mode should be activated from normal mode using the relevant code. Automatic motor control for adapting to changes in flow conditions (e.g. filter contamination) is only activated in normal mode. It is not active in cleaning, night and service mode! An active green control lamp [2] indicates that it is safe to operate the device! If the red control lamp [6] is active, the operating conditions are not safe. The acoustic warning signal can only be acknowledged in the start-up phase (approx. 1 minute) in normal mode. The acoustic warning signal [5] can always be acknowledged in cleaning, night and service mode and in the event of a power failure alarm. The SC has a power failure alarm with a 24-hour battery backup. If the power supply fails, a visual and acoustic warning signal automatically indicates these unsafe operating conditions. The display [4] will continue to show No voltage since Date and time, until the power supply has been re-established and a key has been pressed. If the SC is connected to a power supply and not in use, the display [4] will show Date and time Safety cabinet off The short operating instructions [1] and the flow and operating principle [16] contain important information. The power sockets in the work area can be operated in all operating modes and when the safety cabinet is switched off. The timer function can be used to control defined time periods, e.g. to monitor the interval at which gloves are changed, decontamination times, or similar. info@berner-international.de Page 35 of 75

36 Chapter 10: Operation Figure 10-1: The control panel element [1] [2] [4] [6] [8] [10] [12] [14] [15] [3] [5] [7] [9] [11] [13] [16] Table 10-1: Numbering and descriptions of the function and information fields of the control element Number Description [1] Short operating instructions [2] Green control lamp: safe operating conditions [3] Timer [4] Display: displays additional information [5] Acoustic alarm acknowledgement button: unsafe operating conditions [6] Red control lamp: unsafe operating conditions [7] Buttons and control lamp for the front window [8] Buttons and control lamp for the lighting in the work area [9] Buttons and control lamp for the power sockets in the work area [10] Buttons and control lamp for a gas connection (optional) [11] Buttons and control lamp for a UV light (optional) [12] Number keypad for switching on and off and changing the operating mode [13] Symbol and control lamp: service mode [14] Symbol and control lamp: cleaning mode [15] Symbol and control lamp: night mode [16] Flow and operating principle info@berner-international.de Page 36 of 75

37 Chapter 10: Operation Normal mode Normal mode is designed and constructed for all normal user activities, such as producing drugs, inoculating cultures, etc. The following functions are possible in normal mode: Switching on: five-digit code "1231 (0...9)" via [12] Until the flow conditions have stabilised (start-up phase: 1 minute), there is a visual [6] and acoustic alarm signal. If necessary, use [7] to move the front window into the target position (an opening height of approx. 180 mm) once the start-up phase is complete. The green control lamp [2] indicates that the operating conditions are safe and the lighting in the work area is switched on automatically. When the operating conditions are safe, the display [4] shows - the date and time - the number of operating hours and the temperature and humidity in the work area When the operating conditions are unsafe, the display [4] shows - the date and time - the number of operating hours and the temperature and humidity in the work area with the error message(s) alternately - E01: WINDOW POSITION - E02: LOW INFLOW - E03: LOW DOWNFLOW - E04: HIGH DOWNFLOW - E05: HIGH INFLOW - E06: LOW BATTERY Timer: press the timer key [3], enter the time in minutes [12] and activate the timer [3]. The time remaining on the timer is shown alternately with the time in the top right-hand corner of the display [4]. When the time on the timer has elapsed, an intermittent acoustic alarm sounds for approx. 10 seconds. Leave time function by pressing CL [12]. Change window position [7] Lighting in the work area on/off [8] Sockets in the work area on/off [9] Gas supply in the work area (optional) on/off [10] Switching off the SC: Enter four-digit code 123 off via [12] Cleaning mode Cleaning mode is designed and constructed only for cleaning activities, loading and unloading the work area, disinfection and operating a UV light (optional). The following functions are possible in cleaning mode: Switching from normal mode: four-digit code "123 2" via [12] The control lamp [14] is activated When the operating conditions are safe, the display [4] shows - the date and time - the number of operating hours, UV light, temperature and humidity in the work area When the operating conditions are unsafe, the display [4] shows - the date and time - the number of operating hours, UV light, temperature and humidity in the work area with the error message(s) alternately -E01: WINDOW POSITION and/or - E02: LOW INFLOW and/or - E03: LOW DOWNFLOW - E04: HIGH DOWNFLOW - E05: HIGH INFLOW - E06: LOW BATTERY Acknowledge acoustic alarm signal with [5] info@berner-international.de Page 37 of 75

38 Chapter 10: Operation Activate timer [3] Change front window position [7] Lighting in the work area on/off [8] Sockets in the work area on/off [9] UV light (optional) on/off [11] when the front window is closed and the inside light is turned off. The motor(s) switch(es) off automatically. The UV light can be turned off automatically using a timer after a period of seconds. Back to normal mode: OFF [12] Night mode Night mode is designed and constructed purely for maintaining safety functions when motor output is reduced. The front window must be moved to the position important for night mode (opening height of 90 mm). Night mode is not suitable for the activities mentioned in the normal, cleaning and service mode sections. The following functions are possible in night mode: Switching from normal mode: four-digit code "123 3" via [12] The control lamp [15] is activated If the target operating conditions exist, the display [4] shows - the date and time - the number of operating hours and the temperature and humidity in the work area with the error message(s) alternately - E02: LOW INFLOW and/or - E03: LOW DOWNFLOW When the operating conditions are unsafe, the display [4] shows - the date and time - the number of operating hours and the temperature and humidity in the work area with the error message(s) alternately - E01: WINDOW POSITION - E02: LOW INFLOW - E03: LOW DOWNFLOW - E04: HIGH DOWNFLOW - E05: HIGH INFLOW - E06: LOW BATTERY Acknowledge acoustic alarm signal with [5] Activate timer [3] Change front window position [7] Lighting in the work area on/off [8] Sockets in the work area on/off [9] Back to normal mode: OFF [12] info@berner-international.de Page 38 of 75

39 Chapter 10: Operation Time For time setting the safety cabinet must be switched off! Clock change because of summer and winter time The clock change in the European Union is standardised. Some other countries like all Eastern Europe ones and Russia has associated to this regulation. Summer time: The clock change will take place every last Sunday in March. At two o clock a.m. the clock set up put forward one hour. This means: the night is one hour shorter. Winter time: The clock change will take place every last Sunday in October. At three o clock a.m. the clock set up put back one hour. This means: the night is one hour longer. Clock set up: Seconds: - Press timer key [3] permanently - reduce seconds: press additionally 0 [12] - arise seconds: press additionally 1 [12] Minutes: - Press timer key [3] permanently - reduce minutes: press additionally 2 [12] - arise minutes: press additionally 3 [12] Hours: - Press timer key [3] permanently - reduce hours: press additionally 4 [12] - arise hours: press additionally 5 [12] info@berner-international.de Page 39 of 75

40 Chapter 10: Operation Height adjustable base frame BEM - BERNER ErgoMove The height adjustable base frame should not be used by unauthorized persons. Before operation please ensure the Cylinders are connected to the pump. The motor unit is not designed for continuous operation. If the motor unit has been working for 1 minute, it needs to be stopped for a minimum of 20 minutes. The maximum load is 550Kg. There should be a maximum ceiling height up to 2600 mm. The maximum lift is 380 mm. The cable of this device can not be replaced. If the cable is damaged, it is imperative to replace the transformer, too. The motor unit should never come in contact with water. There is the danger of a short circuit. A. Assembly The complete hydraulic system (motor unit and pump) is mounted to the table via three holes (1). The cable remote control can be mounted anywhere. The transformer (2) can be mounted to the back side of the pump. The main plug has to be easily accessible after mounting the system. B. Putting into operation The transformer s cable has to be plugged in the motor unit (3) and the net (4). Please ensure that the voltage on the transformer is the same as the voltage in the net. Please check data print on transformer (5). The cable remote control has to be plugged into the motor unit (6). With the main plug the hydraulic system will be disconnected from mains (4). C. Operation To lift the SC, the switch on the cable remote control has to be pushed in the upward direction. To lower the SC, the switch on the cable remote control has to be pushed in the downward direction. info@berner-international.de Page 40 of 75

41 Chapter 10: Operation 10.2 Checklist for setting up operations Table 10-2: Checklist for setting up operations No. Action Completed? Notes Before commencing work activities 1 Have you read the user information before commencing work activities? Yes No N/A 2 Have you instructed and authorised staff and documented this in writing? Yes No N/A 3 Have you received instruction and been authorised? Yes No N/A 4 Are you just using the SC as an individual work station? Yes No N/A 5 Have you made sure that the SC exhaust air can be expelled without restriction? Yes No N/A 6 In your estimation, are the environmental conditions adequate? Yes No N/A 7 Operation of SC using recirculated air: Have all the requirements of the BubaV in accordance with Sec.11 Para. 4 GefStoffV Yes No N/A been complied with? 8 Exhaust air system: are you operating the SC with indirect Yes No N/A exhaust air extraction (loose coupling)? 9 Did you have the SC set into operation or routinely inspected by an authorised specialist service team in accordance with the state of the art? Yes No N/A During work activities 10 Are you using suitable personal protective equipment? Yes No N/A Do you carry out critical activities only - with the front glass in the working position 11 - with an active green control light and - using a closed work surface? Yes No N/A 12 Do you keep all the intake apertures in the work space clear? Yes No N/A 13 Do you avoid using the work space as a storage area? Yes No N/A 14 Do you avoid any strong sources of heat (e.g. gas burners) in the work space? Yes No N/A 15 Have you cleaned and disinfected all materials before using or removing them? Yes No N/A 16 Have you organised transport of materials properly? Yes No N/A 17 Do you clean and disinfect the work space daily? Yes No N/A 18 Do you keep to the rules of good microbiological and/or aseptic techniques? Yes No N/A 19 Do you avoid rapid arm movements in the work space? Yes No N/A 20 Do you avoid air disturbance in the surrounding area caused by people traffic, open windows and doors, etc.? Yes No N/A info@berner-international.de Page 41 of 75

42 Chapter 10: Operation 10.3 Trouble shooting checklist Please note the safety advice in Repairs section! Table 10-3: Trouble shooting checklist Fault Possible cause Corrective action a) SC cannot be switched on SC cannot be switched off Visual and acoustic warning signal, display says NO VOLTAGE SINCE Visual and acoustic alarm, display says E01: WINDOW POSITION Visual and acoustic alarm, the display reads E02: LOW INFLOW Window cannot be moved Visual and acoustic alarm, display reads E04: HIGH DOWNFLOW or E05: HIGH INFLOW Faulty code entry Enter correct code CL No mains voltage Plug in and ensure power is being supplied to the laboratory Faulty fuse Replace fuse (F1, F2 or F3) Faulty motor or control system Service +49/(0)4121/ Faulty code entry Enter correct code 123 OFF Cleaning, night, service operation Enter OFF in normal mode and enter code 123 OFF Faulty control system Service +49/(0)4121/ No mains voltage Plug in at the mains or secure power supply to the laboratory Front window not in target position Move front window into target position Night mode Move front window into target position Faulty position switch Service +49/(0)4121/ Front vent covered Remove cover Exhaust air vent covered Remove cover Cleaning cloths in front of filter intake guard Lift worktops and remove cleaning cloths Monitoring system set incorrectly Service +49/(0)4121/ Night mode If not desidred, change operating mode If desired, acknowledge acoustic alarm IDR moved out of position Service +49/(0)4121/ Preliminary or HEPA filter contaminated Change preliminary filter, or Change HEPA filter: Service +49/(0)4121/ Sensor faulty Service +49/(0)4121/ Start-up phase (approx. 1 min) Wait ca. 1 minute Faulty fuse Replace fuse (F9) Faulty window motor Service +49/(0)4121/ Faulty sensor Service +49/(0)4121/ Monitoring system set incorrectly Service +49/(0)4121/ info@berner-international.de Page 42 of 75

43 Chapter 10: Operation Fault Possible cause Corrective action Front vent covered Remove cover Cleaning cloths in front of filter intake guard Lift worktops and remove cleaning cloths Visual and acoustic alarm, display reads E03: LOW DOWNFLOW Gas supply (optional) cannot be activated UV light (optional) cannot be switched on Lighting in work area cannot be switched on Sockets in work area do not work Timer cannot be activated Display reads LOW BATTERY Control system does not respond Continuous acoustic alarm signal and fan(s) at 100% Monitoring system set incorrectly Service +49/(0)4121/ IDR moved out of position Service +49/(0)4121/ Contaminated preliminary or HEPA filter a) Other countries: Contact service company or Change preliminary filter Change HEPA filter: Service +49/(0)4121/ Exhaust air system extracts too much air Service +49/(0)4121/ Incorrecting operating mode Use OFF in normal mode Gas tap closed Open gas tap Faulty fuse Replace fuse (F8) Option not availabe - Incorrecting operating mode If necessary, go back to normal mode with OFF Activate cleaning mode Position of front window Close front window completely Faulty fluorescent lamps or starter Replace fluorescent lamps and / or starter Faulty fuse Replace fuse (F8) Electrical fault Service +49/(0)4121/ Option not available - Faulty fluorescent lamps or starters Replace fluorescent lamps or starters Safety cabinet off Switch on safety cabinet Faulty fuse Replace fuse (F8) Electrical fault Service +49 (0) Plug inserted incorrectly into socket provided Insert plug Faulty fuse Replace fuse (F6 and/or F7) Electrical fault Service +49 (0) SC off Switch on SC Faulty control system Service +49 (0) Battery not being recharged correctly Service +49 (0) Hardware or software fault Service +49 (0) Faulty control system Service +49 (0) info@berner-international.de Page 43 of 75

44 Chapter 10: Operation 10.4 Sitting position You should use an ergonomic sitting position with a footrest and an individually adjustable chair: The chair must have the following properties: Adjustable seat and backrest Height adjustment Rotatable On rollers Easy to adjust in accordance with EN This ensures a relaxed and comfortable sitting position at the SC. Forced posture and the illnesses this causes are avoided and safety at work is increased Safety instructions During operation, note the following in particular: Carry out a regular inspection (at least annually) Do not cover the exhaust apertures Do not store anything in the work space area Keep the front window in the target position Stop work if the alarm system has been activated Do not cover or close the ventilation aperture Do not work if the SC is switched off Instruct staff Use PPE (at least gloves, arm cuffs, white coats or overalls) info@berner-international.de Page 44 of 75

45 Chapter 11: Inspection 11 Inspection In accordance with current knowledge, SC must be inspected. The basis for the performance testing is DIN (06.05) DIN EN (09.00) detailed information from the manufacturer (technical documentation etc.). Safety devices used at work should be subjected to a regular performance test, i.e. at least once a year. Tests should be carried out more frequently if a risk assessment concludes that the potential risk is increased or on the basis of specific recommendations by the manufacturer. The tests should be conducted using calibrated measuring equipment. All measuring equipment used should be clearly documented (with at least the manufacturer, model or type, serial number, calibration date, etc.) in the test record so that the tests can be reproduced. The tests should be performed under target conditions in terms of the flow rates to be observed. It must be ensured that SC are tested by people with the necessary specialist knowledge, i.e. authorised service engineers. All tests conducted should be documented in a device manual Types of tests Table 11-1: Test types and definitions Test type Definition Responsibility 1 2 Type testing Design testing Construction testing Item testing Production testing An extensive SC test, which is carried out once by the manufacturer or an independent/neutral third party (e.g. TÜV - the German Technical Inspection Association). The manufacturer tests all SC, which are usually manufactured in series, during or after production and before delivery. Manufacturer of the SC 3 4 Start-up testing Installation testing Routine testing Regular testing Servicing Start-up testing includes those checks which must be carried out after a SC has been installed, or if the installation or the location has been changed. Routine testing is all manner of checks that must be carried out at regular intervals (usually annually). Employer Operator info@berner-international.de Page 45 of 75

46 Chapter 11: Inspection 11.2 Procedures and equipment Table 11-2: Requirements, procedures and measuring equipment used in tests Requirement Procedure Measuring equipment and accessories Lighting Optical Luxmeter Documentation Optical Visual check Electrical safety Electrical Electrical measuring kit Ergonomics Optical Visual check, tape measure Filter seal and leak test Optical Particle counter, aerosol generator, dilution level Exhaust air system Optical, acoustic Visual check, anemometer, manometer Flow mechanical Gas supply Optical Visual check, manual check Low contamination filter change Optical Visual check, manual check Leakage protection Mechanical Manometer, compressor, leak detector spray Air flow rate Flow mechanical Anemometer or air capture hood Product protection Microbiological Agar plates, nebuliser Cleanability Optical, microbiological Visual check, swab-test Liquid sampler, channel sampler, Microbiological Containment capability at the work nebuliser aperture Chemical KI-Discus Sound pressure level Acoustic Sound pressure level meter Visual and operational tests Optical Visual check, manual check Stability Optical, Mechanical Visual check, Spring balance, manual check Temperature Thermal Thermometer Monitoring facilities Optical and acoustic Visual check, sound pressure level meter, frequency analysis UV-lighting Optical Visual check, manual check Cross contamination protection Microbiological Agar plates, nebuliser Vibration Mechanical Accelerometer Visualisation of flow Optical Smoke cartridges Materials Optical Visual check Page 46 of 75

47 Chapter 11: Inspection 11.3 Range Table 11-3: Requirements for commissioning and routine inspection Requirement At commissioning Routine Air inflow rate X X Displacement flow rate X X Flow visualisation X X Monitoring facilities X X Filter seal seat and leak test X X Containment capability at the working aperture b) X - Electrical requirements X X Visual and function tests c) X X Gas supply X - UV-lighting X - Specific manufacturer requirements X X Exhaust air system X - Installation plan d) X X Documentation X X b) For MC: Only carry out in exceptional cases (construction type changes, connection to an exhaust air system, etc.). The methods used should be validated with the state of the art (B.subtilits method) beforehand. c) Various tests should be used due to the type of construction. It is especially important that window fixings, such as method of hanging, cord fixings, condition of cord and shock absorbers should be checked! d) BubaV in accordance with Abs. 4 Gef. StoffV 11.4 Documentation All tests carried out should be documented to a level of detail sufficient to repeat them: SC data Location (laboratory) Procedures used (e.g. filter checking in conforming to VDI 2083 sheet 3) Test equipment used Test results in relation to meeting borderline values and evaluation (requirement fulfilled: yes/no) Service company: company name and address, first and last names of service engineer Time 11.5 Safety instructions Make sure that the tests are safe and efficient, especially: Test conforms to state of the art Only carried out by authorised service engineer Maintain target values (e.g. flow rates) Use calibrated test instruments Detailed documentation Empty the work space and thoroughly decontaminate the SC beforehand Document any decontamination carried out Hand over an approval certificate to the service engineer Use personal protective equipment (e.g. gloves, overalls, breathing protection if necessary) Make sufficient space available (1-2 metres of free table top) Only open front hood, when front window in target position (180 mm) info@berner-international.de Page 47 of 75

48 Chapter 12: Repairs 12 Repairs Maintenance and repair work may only be carried out by authorised and trained service engineers. Only trained electricians may intervene in the electrical installation. The device must always be disconnected from the power supply first (by unplugging it). If the SC is connected to an exhaust air system via a potential free electrical contact, the mains fuse for the exhaust air system must be switched off. Use a wrench to open the front flap when changing fluorescent lamps and a screwdriver to open the installation panel when changing fuses. Only open front hood when front screen in target position Replacement parts Only original replacement parts should be used! Only approved fuse links, known as miniature fuses, should be used in accordance with DIN EN ff.! The fuses are located in the component box, which is accessible from above. Table 12-1: Fuse designations and values Fuse designation Value Protected components F1 T 2,0 A Control- and monitoring system F2 T 6,3 A Ventilator 2 F3 T 6,3 A Ventilator 1 F4 T 5,0 A Control of exhaust air system: Night mode F5 T 5,0 A Control of exhaust air system: Normal mode F6 T 5,0 A Power sockets in the workspace (N) F7 T 5,0 A Power sockets in the workspace (L) F8 T 1,25 A Workspace lighting, UV-light (option), gas valve (option) F9 T 0,8 A Front screen motor info@berner-international.de Page 48 of 75

49 Chapter 12: Repairs Figure 12-1: Top view of the component box and position of the fuses X5 / 19 Blower 1 L F3 6,3 AT Blower 1 X5 / 18 Blower 1 N (blue) F4 5,0 AT Floating distance contact (over night lowering) X5 / 17 Blower 2 L F5 5,0 AT Floating distance contact (Safety cabinet) X5 / 16 Blower 2 N (blue) F6 5 AT Power socket X5 / 15 Window up (black) F7 5 AT Power socket X5 / 14 Window N (blue) F8 1,25 AT Light X5 / 13 Window down (brown) F9 0,8 AT Window motor X5 / 12 Power socket L X5 / 11 Power socket N (blue) X4 / V X5 / 10 Light L X4 / 15 Inflow sensor X5 / 9 Light N (blue) X4 / 14 0 V X5 / 8 Gas L X4 / V X5 / 7 Gas N (blue) X4 / 12 Downflow sensor X5 / 6 UV L X4 / 11 0 V X5 / 5 UV N (blue) X4 / 10 Work position X5 / 4 Floating distance contact (Safety Cabinet) X4 / 9 0 V X5 / 3 Floating distance contact (Safety Cabinet) X4 / 8 Night position X7 / 2 Floating distance contact (over night lowering) X4 / 7 0 V X7 / 1 Floating distance contact (over night lowering) X4 / 6 Closed position X4 / 5 0 V X4 / 4 Sensor SCL X4 / 3 Sensor SDA F1 2 AT Transformer X4 / 2 +5 V F2 6,3 AT Blower 2 X4 / 1 0 V info@berner-international.de Page 49 of 75

50 Chapter 12: Repairs Figure 12-2: Position and properties of sensors Page 50 of 75

51 Chapter 12: Repairs Designation of replacement part Table 12-2: Replacement part designation and item number C- [MaxPro]³- 130 C- [MaxPro]³- 190 Item number Model B- [MaxPro]²- 130 B- [MaxPro]²- 190 B- [MaxPro]³- 130 B- [MaxPro]³- 190 Main filter, BFP-Best-Filter-Protection Recirculation filter Divided recirculation filter Exhaust filter Coarse particulate filter G4 (600x140x20 mm) VSG window, front VSG window, side with bore hole VSG window, side with bore hole VSG window monitor Starter Fluorescent tubes UV-C light Keyboard circuit board Power circuit board Nylon-perlon cord Label - Poisonous substances warning with additional Zytostatics" Label - Biohazard warning Touch-up pen RAL 5024 blue Touch-up pen RAL 9002 white info@berner-international.de Page 51 of 75

52 Chapter 12: Repairs 12.2 Repair service You can get further information from the following address: BERNER INTERNATIONAL GMBH +49/(0)4121/ /(0)4121/ Please phone for repair services outside Germany or visit our homepage Safety instructions During repairs, pay meticulous attention to the following: Maintenance and repair work should only be carried out by authorised service engineers To access the electrical installations of the SC: - first disconnect the SC from the mains - move the exhaust air system via a potential free contact of the SC and disconnect the exhaust air system from the mains before commencing work Use only original replacement parts info@berner-international.de Page 52 of 75

53 Chapter 13: Cleaning and care 13 Cleaning and care Harsh cleaning agents and/or disinfectants that attack the surfaces of V2A stainless steel, glass, or powder-coated metal, must never be used. Make sure you use the cleansers and disinfectants recommended for the materials. The disinfectants used must be selected depending on the biological agents available. Only specific disinfectants may be used because of the aseptic working conditions that may be required. Take into account employers' liability insurance association regulations on disinfection in the health industry! Certain hazardous substances, such as CMR drugs, cannot usually be decontaminated by disinfection measures. Do not remove any filter protection devices such as stainless steel laminators for the recirculation filter or the protection grid for the main filter. It is too easy to damage the filter. The following disinfectants are effective over a relatively wide range (bactericidal, fungicidal, virucidal and sporicidal) and can be used for V2A, glass, powder coated metal: 13.1 Disinfectants The following disinfectants are effective over a relatively wide range (bactericidal, fungicidal, virucidal and sporicidal) and can be used for V2A, glass, powder coated metal: Tabelle 13-1: Recommended disinfectants Name of disinfectant Manufacturer Dismozon pur steril BODE Chemie GmbH & Co. Chloroclens Ecolab GmbH und Co. OHG Big Spray Neu ANTISEPTICA Acrylan ANTISEPTICA Descogen ANTISEPTICA Perform (0,5 %ig) Schülke & Mayr GmbH Buraton 10 F Schülke & Mayr GmbH Terralin Liquid Schülke & Mayr GmbH Mikrozid AF Liquid Schülke & Mayr GmbH Ethanol (80%ig) d) - Isopropanol (70%ig) e) - d) Ex lower = 3,5 Vol.-%, Ex upper = 15 Vol.-% e) Ex lower = 2,0 Vol.-%, Ex upper = 12 Vol.-% It is necessary to observe the explosion limits (Ex) for vapours of particularly alcoholic disinfectants. Preference should be given to disinfection that involves scouring and wiping over spray disinfection. As a rule, the explosion limit is not reached if 50 ml of working solution is used for each m² of the surface to be treated. In view of the possible formation of explosive mixtures, always read the user information of the relevant disinfectant carefully before use Cleaning and disinfectant intervals Cleansing and disinfection intervals can vary, depending on the type of activity and level of use of the SC. Arrange shorter intervals depending on the analysis of the level of danger and the hygiene plan. The following cleaning and disinfection intervals are the minimum which should be maintained: Daily: interior work area, i.e. back and side walls, front window, work top(s) Weekly: complete interior work area, including drip tray below the work top(s) and the external surfaces 13.3 Room fumigation Disinfection involving fumigation of the room (e.g. before changing the filter) should be performed in accordance with EN Appendix J. 2. In Germany, TRGS 522 should be observed. The fumigation info@berner-international.de Page 53 of 75

54 Chapter 13: Cleaning and care procedure is as follows: Minimum airborne formaldehyde concentration of 50 mg/m³ Volume to be fumigated: V 70 = 0,6 m³; V 130 = 1,6 m³; V 190 = 2,2 m³ Use a vaporiser with 60 ml of formalin and 60 ml of water per m³ of the SC volume Neutralisation using ammonia Temperature > 20 C and relative humidity of at least 65% Exposure time of at least 6 hours Place the vaporiser in the work area and plug in Make apertures air tight using an aperture cover (optional), plastic film or tape If necessary pressure compensation should be created Block off the laboratory and indicate that fumigation is taking place Observe occupational safety procedures (see TRGS 522) Take control measurements for approval of the SC and laboratory Clean and ventilate the SC and laboratory adequately after fumigation Document the fumigation process You can get further information on lists of approved disinfectants from the Robert Koch-Institute (RKI) and the German Society for Hygiene and Microbiology (DGHM): You can obtain detailed information from the manufacturer of disinfectants, e.g.: Brushed and polished stainless steel During day to day use stainless steel surfaces are contaminated or damaged. According to the type of contamination, this can result in reduced resistance to corrosion or even actual corrosion. Contamination and damages are not just bad for corrosion resistance of the material; also the surface of the stainless steel can be affected. Finger prints, deposits, scratches and similar lend stainless steel an untended appearance. Stainless steel needs, apart from the daily disinfection, regular care (at least once every 3 months). Regular care of brushed and polished stainless is to be carried out as follows: Light contamination These include finger prints, light crusts, light deposits, residues of disinfectants, or similar: Wipe down with a soft cloth with some liquid abrasive cleaner and water. The wiping motion should be carried out in the direction of the grinding of the material. If necessary, spray with stainless steel cleaner, rub in, with a soft, dry cloth. The last treatment provides the stainless steel with a thin protective layer Heavy contamination These include light damages, heavy deposits, heavy crusts, beginning corrosion, light scratches, etc.: Wipe down with a soft cloth with some liquid abrasive cleaner and cleaner. Carry out the wiping motion in the direction of the grinding of the material. Clean the area with a Scotch Brite sponge with some liquid abrasive cleaner and cleaner. Carry out the wiping motion in the direction of the grinding of the material. Spray surface with stainless steel cleaner, rub in, leave for some time and then wipe down in with a soft, dry cloth. The last treatment provides the stainless steel with a thin protective layer Very heay contamination These include corrosion, deep scratches, pitting, etc.: Treat damaged area with SCHLEIFFIX sanding block. Carry out the rubbing motion in the direction info@berner-international.de Page 54 of 75

55 Chapter 13: Cleaning and care of the grinding of the material. If necessary retreat area with Scotch Brite sponge. Spray surface with a stainless steel cleaner, rub in, leave for some time and then rub down with a soft, dry cloth. The last treatment provides the stainless steel with a thin protective layer. Note: For sections and the appearance of the surface of the stainless steel may be altered Replacing preliminary filter The SC B-[MaxPro]² has a large coarse particulate air filter fitted as standard. The preliminary filter is located below the worktops, in front of the rear intake port. The replacement should only take place while the SC is in operation. Figure 13-1: Position of preliminary filter and filter replacement 1. During the preliminary filter protective clothing should be worn (goggles, gloves, P3 mask, overall). 2. Clean and disinfect the worktops and the collecting tray below the worktops thoroughly. 3. Put aside the worktops, but, if possible, leave them inside the SC. 4. Using light pressure on the two holding brackets the frames holding the filter pads can be folded down. 5. Disinfect the contaminated filter within the SC, place in aerosol-tight packaging and seal. Before disposal autoclave if necessary. 6. Insert new filter. 7. Do not operate the device without a preliminary filter. The preliminary filter substantially increases the lifetime of the HEPA-Filter. 8. Replacement intervals can vary according to room quality and type of disinfectants used from 3 to 12 months. info@berner-international.de Page 55 of 75

56 Chapter 13: Cleaning and care 9. Close the holding frames of the filter pads again; ensure that the holding brackets snap properly into place. 10. Replace worktops 13.6 Safety instructions During cleaning and disinfection, pay particular attention to the following: Adhere to the BG-regulations for disinfecting Use PPE CMR-drugs cannot usually be decontaminated Only use cleansers and disinfectants that are suitable for the material Do not remove filter protectors Note the explosion limits Page 56 of 75

57 Chapter 14: Waste removal 14 Waste removal Waste should be removed in accordance with recycling principles In the first instance avoid waste in the second instance reuse materials and energy dispose of waste that cannot be recycled Potential waste should be decontaminated in the SC as far as possible. Biological agents can be inactivated by appropriate disinfection (e.g. surface disinfection or fumigation of the room). The type of disinfectant used must be selected on the basis of the biological agents in question Certain dangerous substances such as CMR-drugs cannot usually be decontaminated using disinfectants. Low contamination material should be collected and disposed of (usually in a hazardous waste incinerator). Suitable containers should be designated for the collection of waste. Waste that must be monitored in particular (e.g. CMR drugs) must be collected in approved transport containers and disposed of. This is usually carried out by approved waste disposal companies. From experience, contaminated waste such as that produced from SC must be treated with particular caution and includes: changed filters used materials: work underlays, swabs, syringes, etc. personal protective equipment gloves, coats, cuffs, etc. product residues: e.g. drugs, containers for culture mediums, cultures, etc. old instruments. When dismantling and disposing of safety cabinets the same procedure as with contaminated waste needs to be carried out, i.e. based on a risk assessment e.g. TRGS 400 and TRBA 400, suitable measures for the decontamination are to be taken to deal with the resulting risks. Consult the relevant environmental authorities for questions about the law on waste, such as disposal and collection sites. Germany: Outside Germany: national sales partner You can get further information on the topic of safe removal of laboratory waste on request. We recommend the BERNER SealSafe sealing device for improvement of operational safety and hygiene when dealing with contaminated waste. The device is used to pick up and seal (aerosol-tight) harmful (e.g. infectious or toxic) waste. info@berner-international.de Page 57 of 75

58 Chapter 14: Waste removal 14.1 Waste code Table 14-1: Description of waste from medical treatment and research in humans or animals Waste from obstetrics, diagnosis, treatment or prevention of human diseases Waste from research, diagnosis, treatment and prevention of animal disease; packaging, extraction and filter materials, cloths and protective clothing Code Description Code Description Pointed or sharp objects except for Pointed or sharp objects except for Body parts and organs, including blood pouches and stored blood, except for * Waste subject to special requirements for their collection and disposal in order to prevent infection * Other waste subject to special requirements for their collection and disposal in order to prevent infection Waste not subject to special collection and disposal requirements to prevent infection Waste not subject to special collection and disposal requirements to prevent infection * Chemical consisting of or containing dangerous substances * Chemical consisting of or containing dangerous substances Chemicals, except for Chemicals, except for * Cytotoxic and cytostatic medicinal products * Cytotoxic and cytostatic medicinal products Medicinal products except for Medicinal products except for * Packaging containing dangerous materials or contaminated by dangerous materials * Amalgam waste from dentistry * Exhaust and filter materials, cloths and protective clothing contaminated by dangerous substances *: Hazardous waste in the sense of guideline 91/689/EWG and requiring special monitoring in accordance with Sec. 41 of the KrW-/AbfG 14.2 Safety instructions During waste disposal note in particular: Decontaminate waste in the SC as far as possible CMR-drugs cannot usually be decontaminated Collect and dispose of hazardous waste separately Only transport hazardous waste in approved transport containers Waste should be transported and disposed of only by specialist disposal companies Decontaminate SC before assembly or dismantling. info@berner-international.de Page 58 of 75

59 Appendix I: Declaration of conformity I I.I Appendix Declaration of conformity info@berner-international.de Page 59 of 75

60 Appendix I: Declaration of conformity Page 60 of 75

61 Safety cabinet BERNER FlowSafe, C- and B -[MaxPro] x -130 and -190 Appendix II: Type testing certificate I.II Type testing certificate info@berner-international.de Page 61 of 75

62 Safety cabinet BERNER FlowSafe, C- and B -[MaxPro] x -130 and -190 Appendix II: Type testing certificate info@berner-international.de Page 62 of 75

63 Safety cabinet BERNER FlowSafe, C- and B -[MaxPro] x -130 and -190 Appendix II: Type testing certificate info@berner-international.de Page 63 of 75

64 Safety cabinet BERNER FlowSafe, C- and B -[MaxPro] x -130 and -190 Appendix II: Type testing certificate info@berner-international.de Page 64 of 75

65 Safety cabinet BERNER FlowSafe, C- and B -[MaxPro] x -130 and -190 Appendix II: Type testing certificate info@berner-international.de Page 65 of 75

66 Safety cabinet BERNER FlowSafe, C- and B -[MaxPro] x -130 and -190 Appendix II: Type testing certificate info@berner-international.de Page 66 of 75

67 Appendix III: Quality assurance certificate I.III Quality assurance certificate Page 67 of 75