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Freeze-dryer Beta 1-8 LSCplus

Freeze-dryer Beta 2-8 LSCplus

11 Appendix

Version 04/2013, Rev. 2.9 of 09/03/2020

• sb-dc

115 / 125

Translation of the original operating manual

11.5 EC declaration of conformity in accordance with the Pressure

Equipment Directive

Summary of Contents for 102124

Page 1: ...9 of 09 03 2020 Beta 1 8 LSCplus Freeze dryer Beta 2 8 LSCplus Version 04 2013 Beta 1 8 LSCplus Part no 102124 102126 102128 102130 102132 102134 Beta 2 8 LSCplus Part no 102125 102127 102129 102131 1...

Page 2: ...Freeze dryer Beta 1 8 LSCplus Freeze dryer Beta 2 8 LSCplus 2 125 Version 04 2013 Rev 2 9 of 09 03 2020 sb dc Translation of the original operating manual...

Page 3: ...of the original operating manual In case of inquiries please state the following numbers Order number Serial number Copyright by Martin Christ Gefriertrocknungsanlagen GmbH An der Unteren S se 50 3752...

Page 4: ...Freeze dryer Beta 1 8 LSCplus Freeze dryer Beta 2 8 LSCplus 4 125 Version 04 2013 Rev 2 9 of 09 03 2020 sb dc Translation of the original operating manual...

Page 5: ...ty 22 3 1 Marking of the unit 22 3 2 Explanation of the symbols and notes 23 3 3 Responsibility of the operator 24 3 4 Operating personnel 25 3 5 Informal safety notes 25 3 6 Safety notes concerning t...

Page 6: ...ions 34 4 3 Notes on transport 35 4 4 Packaging 36 4 5 Transport safety devices 36 5 Set up and connection 37 5 1 Location of use 37 5 2 Power supply 38 5 2 1 Type of connection 38 5 2 2 Customer prov...

Page 7: ...in valve 88 7 1 2 3 Pressure control valve 88 7 1 2 4 Rubber valves 88 7 1 2 5 Vacuum sensor 88 7 1 3 Insufficient ice condenser temperature 89 7 2 Process and error messages 89 7 3 Service contact 90...

Page 8: ...endix 104 11 1 Mathematical relations 104 11 2 Brief operating instructions 105 11 3 EC declaration of conformity in accordance with the EC Machinery Directive 111 11 4 Declaration of conformity China...

Page 9: ...substances and aqueous solutions e g bacteria and virus cultures blood plasma serum fractions antibodies sera vaccines and pharmaceutical products such as chloramphenicol streptomycin vitamins ferment...

Page 10: ...o tert Butanol o o DMSO Legend No degradation to be expected o Moderate degradation limited use Severe degradation infrequent use recommended immediate thorough cleaning required The use of other solv...

Page 11: ...nical state use of the freeze dryer within hazardous locations where there is a risk of explosions use of the freeze dryer with unauthorised additions or conversions without the written approval by Ma...

Page 12: ...1 5 Explanation of symbols In this operating manual specialist terms that are explained in the glossary see chapter 12 Glossary are marked by an arrow and printed in italics e g sublimation 1 6 Stand...

Page 13: ...sb dc 13 125 Translation of the original operating manual 2 Layout and mode of operation 2 1 Layout of the freeze dryer 2 1 1 Functional and operating elements 1 Ice condenser chamber 2 LSCplus user i...

Page 14: ...dc Translation of the original operating manual 4 Contact piece 5 Pipe connection of the vacuum sensor 6 Pipe connection of the vacuum pump behind the cover plate 7 Ice condenser Fig 3 Ice condenser c...

Page 15: ...al connection of the vacuum sensor 16 Connection of the vacuum sensor 17 Power supply of the pressure control valve 18 Power supply of the vacuum pump 19 Option USB port 20 Mains fuse 21 Mains cable 2...

Page 16: ...solid phase to the gas phase This happens under vacuum The following section describes the process of sublimation based on the example of water since most products that are processed by freeze drying...

Page 17: ...r will be lowered to the value that corresponds to the freezing temperature in accordance with the vapour pressure curve for ice and water 3 Sublimation Thermal energy is added to the product thus sta...

Page 18: ...013 Rev 2 9 of 09 03 2020 sb dc Translation of the original operating manual Fig 9 Freeze drying phases NOTE Please find further information about basic principles optimum procedures and applications...

Page 19: ...he ice condenser is pre cooled cool down The ice condenser temperature does not have any influence on the product temperature The sole purpose of the ice condenser is to bind the released water vapour...

Page 20: ...uired drying time depends strongly on the drying vacuum At 1 0 mbar one gram of ice takes up a volume of 1 m3 of vapour at 0 1 mbar a volume of 10 m3 of vapour and at 0 001 mbar a volume of 100 m3 The...

Page 21: ...is equipped with a hot gas defrosting system In order to defrost the ice condenser heated refrigerant is fed through the heating coil In addition the bottom of the ice condenser chamber is heated by...

Page 22: ...0 Off Power Caution Risk of bruising Name plate see chapter 2 1 2 Name plate Attention consult the operating manual Filled with natural inflammable refrigerants Protective earth ground CE mark in com...

Page 23: ...th problems up to life endangering injuries DANGER This symbol stands for a direct hazard to the life and health of persons due to electrical voltage Non observance of these symbols causes serious hea...

Page 24: ...d the national laws concerning health and safety and the prevention of accidents must be checked at regular intervals e g every month Working area The operator must perform a risk assessment concernin...

Page 25: ...he fundamental regulations concerning workplace safety and accident prevention have been trained in terms of the operation of this unit and have read and understood this operating manual and in partic...

Page 26: ...th the rules and regulations for the prevention of accidents Wear personal protective equipment safety shoes work gloves and hardhat 3 6 2 Hazards caused by improper transport DANGER Risk of injury ca...

Page 27: ...electrical or mechanical components Work on the power supply system must only be performed by certified electricians Have the electrical equipment of the unit inspected regularly Defects such as loos...

Page 28: ...ron welding equipment are present 3 7 3 Hazards caused by the refrigeration system non flammable refrigerants WARNING Risk of poisoning caused by the refrigerant During its decomposition e g due to na...

Page 29: ...ble protective clothes gloves and respiratory protection 3 7 5 Hazards caused by solvents in the products DANGER Explosion hazard caused by solvents in the products When freeze drying products contain...

Page 30: ...hamber may still be hot There is a risk of burns when touching the surfaces Wear suitable protective clothes and gloves Do not touch the surfaces on purpose 3 7 9 Hazards caused by cold surfaces WARNI...

Page 31: ...ttention immediately Check consciousness and breathing continuously In the case of unconsciousness of lack of normal breathing perform cardiopulmonary resuscitation CPR Burns Cool small area burns e g...

Page 32: ...lagen GmbH see chapter 7 3 Service contact Ensure that all repairs are performed only by authorised and specialised personnel Fire prevention Fuses protect certain electrical circuits within the freez...

Page 33: ...diately If a sample with hazardous materials such as strong acids or bases radioactive substances or volatile organics is spilled inside a chamber they must be cleaned up immediately Caution when hand...

Page 34: ...th 555 mm 80 mm vacuum connection 555 mm 80 mm vacuum connection Weight approx 63 kg approx 78 kg 4 2 Storage conditions In order to ensure the protection against mechanical and climatic influences th...

Page 35: ...e freeze dryer can be transported by a suitable number of persons who reach under it from the sides When lifting the freeze dryer always reach under the freeze dryer from the side Do not grab the unit...

Page 36: ...eeze dryer upwards and out of the crate cardboard box When lifting the unit always reach under the freeze dryer from the side CAUTION The freeze dryer Beta 1 8 LSCplus weighs approx 63 kg The freeze d...

Page 37: ...irculation will be impaired Keep a safety distance of at least 30 cm around the freeze dryer so that the vents in the unit remain fully effective The ambient temperature must be in the range of 5 C to...

Page 38: ...mediately DANGER The operating voltage on the name plate must correspond to the local supply voltage Christ freeze dryers are units of protection class I Freeze dryers of this type have a three wire p...

Page 39: ...o drain off the condensate and the defrosting water Connect the drain hose included in the scope of supply to the hose connector Place a collecting vessel under the unit The hose must be laid with a c...

Page 40: ...ing rings included in the scope of supply Plug the connector to the connection socket and hand tighten the screws on the connector NOTE It is absolutely essential to comply with the manufacturer s ins...

Page 41: ...he electrical outlet for the vacuum pump see the following picture If the current requirement of the vacuum pump is higher than the value that is stated on the label the pump must be supplied separate...

Page 42: ...l valve is integrated in the suction pipe between the vacuum pump and ice condenser chamber During certain specified process phases it interrupts the volume flow to the vacuum pump see chapter 2 2 1 G...

Page 43: ...NOTE The rubber valves come supplied in an ungreased state This is why a thin layer of vacuum grease must be applied to the connector of the freeze dryer as well as to the vessel connector prior to s...

Page 44: ...must be completed in accordance with the drying method that is applied as well as in accordance with the scope of supply 6 3 Preparation The ice condenser chamber must be clean and dry Remove any wate...

Page 45: ...ol of freeze drying processes The clear user interface enables the intuitive operation of the unit Fig 18 Start screen of the LSCplus control unit example 6 5 1 User interface The system is operated v...

Page 46: ...window is used for personalised settings that enable the users to adapt the system as far as possible to their respective area of activity In this window the users can find all of the relevant informa...

Page 47: ...llowing symbols are possible No symbol No USB storage device or LAN network connected USB storage device connected Process recording on a USB storage device active Network available but no network dri...

Page 48: ...lue Select the desired configuration or quit the dialog box by pressing the return button In this way it is possible to configure a personalised overview of the actual values Dialog box Tools 5 This d...

Page 49: ...background Fig 23 Dialog box USB process recording Option Pressure increase test only with the double chamber method The pressure increase test can only be performed when the freeze dryer is equipped...

Page 50: ...button stops the pressure increase test Dialog box Schematic system diagram 6 Pressing the button Schematic system diagram displays a schematic diagram of the system on the left hand side of the scree...

Page 51: ...eliminated yet The colour of the button quit changes from blue to grey once the message has been acknowledged Fig 26 Representation of an error message The advantage of this system is that malfunction...

Page 52: ...all up the individual windows NOTE The error message text is always followed by an error code Always indicate the error code in the event of enquiries or service requests 4 Error message 5 Error code...

Page 53: ...on the equipment of the freeze dryer Standard unit test Apart from the process phases of the freeze drying process Freezing Warm up Main drying and Final drying and the operating mode Defrosting the b...

Page 54: ...that the ice condenser is defrosted Procedure In the main window Manual select the button Operating mode select start Standard unit test Select Performance test and start the test via the Run button T...

Page 55: ...indow Process select the button Standard unit test under Operating mode select start Select Leakage test and start the test via the Run button The parameters for the leakage test have been developed b...

Page 56: ...le If the programmer module is not enabled programs can only be created and edited for demonstration purposes The execution of a program however is not possible 1 Program list 2 Button New program 3 B...

Page 57: ...is used to perform fundamental basic settings of the control system in order to adapt it perfectly to the respective area of application of the freeze dryer General General options 1 Language 2 Scale...

Page 58: ...function depends on the unit type and is not available for all types of freeze dryers Prior to the start of the process the correct process must be selected The following processes are available Singl...

Page 59: ...tration Administration options 1 Date Time 2 Network 3 System properties 4 Access protection 5 Device options 6 Configuration of sensors Abb 37 Dialogfenster Optionen Verwaltung Date Time 1 The LSCplu...

Page 60: ...k System properties 3 This dialog box is used to change various system settings Fig 40 Dialog box System properties Beeper The beeper sounds in the event of a malfunction for example If the setting is...

Page 61: ...protection 4 In this dialog box the access rights can be managed on several levels and they can be protected with a password In the factory setting with an activated access protection data can be vie...

Page 62: ...ous access levels are detailed in the following table Action User Maintenance Administrator Editing of the data of the current process run e g selection of the operating mode changing of set values Ed...

Page 63: ...rations depend on the equipment version of the unit If the configuration is incorrect the correct operation of the unit cannot be guaranteed This dialog box is used to configure the existing vacuum an...

Page 64: ...of the freeze dryer e g the refrigeration unit vacuum pump or pressure control valve In addition to the name the reference designator is also displayed These data are provided for the purpose of infor...

Page 65: ...log box Failure memory Wireless shelf technology 3 NOTE This function depends on the unit type and is not available for all types of freeze dryers The wireless shelf technology enables the wireless co...

Page 66: ...p The interval can be adapted to the vacuum pump model and utilisation When the end of an oil change interval is reached a corresponding message will be displayed Acknowledge the message Change the oi...

Page 67: ...al Fig 51 Dialog box Maintenance Sensor adjustment 6 In this dialogue box the sensors are adjusted based on a predefined reference value CAUTION Sensors that are not properly adjusted will lead to inc...

Page 68: ...manual mode the user switches manually from one freeze drying phase to the next The manual mode is activated by calling up the main window Manual NOTE Prior to any freeze drying process the correct me...

Page 69: ...of the warm up phase this dialog box will be displayed Fig 53 Dialog box after the completion of the warm up phase The unit will remain in the warm up phase until you confirm The transition from main...

Page 70: ...omatic aeration valve this button is used to define the aeration pressure Defrosting 2 This button is used to pre define the defrosting time and temperature1 In addition this button is used to define...

Page 71: ...box is closed by the button return the changes will be discarded 6 5 3 Option freeze drying with the PGMplus programmer module Unlike in the manual mode an entire freeze drying process can be execute...

Page 72: ...s for the temperature and vacuum These ramps start with the set value of the previous section and end with the set value of the current section As a result there is not abrupt change of the set value...

Page 73: ...hase the product temperature may exceed the set value by the defined value In the drying phase the system will provide a signal to the user if the actual value lies below the set value by more than th...

Page 74: ...e warm up phase of the vacuum pump to the freezing phase so that it is before the first drying section Since the pressure control valve remains closed during the warm up of the vacuum pump neither the...

Page 75: ...ned as the loading section In this phase the start conditions of the programs are defined The room temperature 20 C is the standard default NOTE If the product is frozen outside the freeze dryer doubl...

Page 76: ...on the type of freeze dryer see the sections below Proceed in this manner in order to create an entire program according to your specific needs Pressing the button Diagram 3 displays the program in th...

Page 77: ...ressure increase test in the manual mode repeated pressing of the button in the program mode enables the selection of different variants Periodic pressure increase test The test will be performed peri...

Page 78: ...cally during the entire main or final drying phase The maximum pressure increase is limited to 100 referring to the actual value at the beginning of the measurement If this value is exceeded before th...

Page 79: ...he button in the dialog box Progress condition If the difference between the readings of the Pirani and the capacitive vacuum sensor at the end of the last main drying section is below the limit p Com...

Page 80: ...the information the program template will be displayed Similar to a blank program sections can be added or deleted and the set values can be adapted accordingly 6 5 3 2 Editing a program An existing p...

Page 81: ...he program will be automatically assigned to the first free program storage location 6 5 3 4 Loading a program If a freeze drying process is to be executed and controlled by a program the program must...

Page 82: ...his section must be selected manually In this case the button Program continue will be displayed after the start of the program When the precooling loading process is complete this button must be pres...

Page 83: ...sensors fall increasingly in line with one another This difference will be evaluated and used as an indicator for identifying the drying end of the main drying phase Leakage test see also chapter 6 5...

Page 84: ...rying processes Apart from the graphical representation of the measurement data of currently running processes it also enables the data export for additional evaluation LPCplus SCADA system The Christ...

Page 85: ...service department see chapter 7 3 Service contact The password input fails The password is not correct Inform the administrator If you have lost the administrator password contact the service departm...

Page 86: ...condenser temperature The error message Refrigeration unit x x overpressure is displayed during a freeze drying process Leakage on the low pressure side suction side of the refrigeration system leads...

Page 87: ...e to improper small flange connections between the various components and hose connections or to leakages in the valves Loosen the connection and place the centring ring with sealing ring inside in a...

Page 88: ...see chapter 8 1 3 Aeration valve media drain valve Put the freeze dryer into operation again If there is still a leakage the freeze dryer must be checked by qualified specialist personnel see chapter...

Page 89: ...tion system is insufficient when the refrigeration system is overloaded In these cases the refrigeration unit will be switched off automatically If the permissible operating conditions are re establis...

Page 90: ...nctions or spare part enquiries From Germany Contact Martin Christ Gefriertrocknungsanlagen GmbH An der Unteren S se 50 37520 Osterode Germany Tel 49 0 55 22 50 07 44 44 E mail support lab martinchris...

Page 91: ...n Freeze drying of solvent containing products Use soap water or other water soluble mild cleaning agents for cleaning the freeze dryer and the accessories Do not use corrosive and aggressive substanc...

Page 92: ...radioactive or pathogenic substances clean the inside immediately with a suitable decontamination agent depending on the type of contamination see chapter 8 2 Disinfection of the drying chamber and ac...

Page 93: ...ially when cleaning the valves and replacing the seals Contaminants such as product residues may lead to an insufficient vacuum In this case the aeration valve and the media drain valve must be cleane...

Page 94: ...ntricular fibrillation cardiac arrest or respiratory paralysis Only qualified electricians are authorised to perform work on the electrical system of the freeze dryer The electrical equipment of the f...

Page 95: ...k on the refrigeration system of the freeze dryer must only be carried out by qualified specialist personnel who have been trained to handle flammable refrigerants Ensure good ventilation and make sur...

Page 96: ...al conditions of use shorter adjustment intervals may be necessary 8 1 10 Accessories CAUTION For the care of the accessories special safety measures must be considered as these are measures that will...

Page 97: ...and accessories must be disinfected Use commercially available disinfectants such as for example Incidur Meliseptol Sagrotan Buraton or Terralin available at specialised trade The freeze dryers and t...

Page 98: ...rom Germany Contact Martin Christ Gefriertrocknungsanlagen GmbH An der Unteren S se 50 37520 Osterode Germany Tel 49 0 55 22 50 07 44 44 E mail support lab martinchrist de Outside Germany Contact our...

Page 99: ...ct related data They facilitate the assignment and they enable the quick processing of the return If several parts are returned together in one packaging please enclose a separate problem description...

Page 100: ...l 9 1 Disposal of the freeze dryer Martin Christ Gefriertrocknungsanlagen GmbH is a registered manufacturer of electric and electronic devices that are solely intended for commercial use Comply with a...

Page 101: ...ide the ice condenser chamber Room temperature to 60 C Room temperature to 60 C Max shelf surface area single chamber method drying inside the ice condenser chamber 1 shelf 200 mm Atotal 0 031 m2 1 sh...

Page 102: ...m 80 mm vacuum connection 415 mm 780 mm 555 mm 80 mm vacuum connection Weight approx 63 kg approx 78 kg Noise level according to DIN 45635 54 dB A 54 dB A EMC according to EN 55011 Class B Class B Hea...

Page 103: ...paces Altitudes up to 2 000 m Ambient temperature between 5 C and 25 C Maximum relative humidity of 80 Mains voltage fluctuations of up to 10 of the rated voltage 10 2 Technical documentation The tech...

Page 104: ...sec gradient time section elapsed tion previous of value set value set control Example Section Set values Section time h min Temperature C Preceding 30 Current 1 00 60 C min 0 5 min 60 30 min 60 30 60...

Page 105: ...Rev 2 9 of 09 03 2020 sb dc 105 125 Translation of the original operating manual 11 2 Brief operating instructions Functional and operating elements 1 Ice condenser chamber 2 LSCplus user interface F...

Page 106: ...9 of 09 03 2020 sb dc Translation of the original operating manual 4 Contact piece 5 Vacuum sensor 6 Pipe connection of the vacuum pump behind the cover plate 7 Ice condenser Fig 75 Ice condenser cha...

Page 107: ...able 22 Equipotential bonding screw Fig 78 Rear view of the freeze dryer 1 Status line 2 Set process values 3 Button Set values view edit 4 Actual values of the current process 5 Button Tools 6 Button...

Page 108: ...l shut off valve or by waiting for the electromagnetic valve to open Vacuum is applied to the chamber and the freeze drying process commences NOTE The vacuum pump always runs with maximum power With t...

Page 109: ...ted to another valve until the pressure is again lower than 1 030 bar NOTE After the pressure has fallen below 1 030 mbar a frozen sample can be connected to a valve The next frozen sample cannot be c...

Page 110: ...connection of the vacuum pump or vacuum sensor 12 Drain the defrosting water via the defrosting water valve on the left hand side of the unit To do so connect a hose to the hose connector and collect...

Page 111: ...Cplus Freeze dryer Beta 2 8 LSCplus 11 Appendix Version 04 2013 Rev 2 9 of 09 03 2020 sb dc 111 125 Translation of the original operating manual 11 3 EC declaration of conformity in accordance with th...

Page 112: ...Freeze dryer Beta 1 8 LSCplus Freeze dryer Beta 2 8 LSCplus 11 Appendix 112 125 Version 04 2013 Rev 2 9 of 09 03 2020 sb dc Translation of the original operating manual...

Page 113: ...dryer Beta 1 8 LSCplus Freeze dryer Beta 2 8 LSCplus 11 Appendix Version 04 2013 Rev 2 9 of 09 03 2020 sb dc 113 125 Translation of the original operating manual 11 4 Declaration of conformity China...

Page 114: ...Freeze dryer Beta 1 8 LSCplus Freeze dryer Beta 2 8 LSCplus 11 Appendix 114 125 Version 04 2013 Rev 2 9 of 09 03 2020 sb dc Translation of the original operating manual...

Page 115: ...us Freeze dryer Beta 2 8 LSCplus 11 Appendix Version 04 2013 Rev 2 9 of 09 03 2020 sb dc 115 125 Translation of the original operating manual 11 5 EC declaration of conformity in accordance with the P...

Page 116: ...Freeze dryer Beta 1 8 LSCplus Freeze dryer Beta 2 8 LSCplus 11 Appendix 116 125 Version 04 2013 Rev 2 9 of 09 03 2020 sb dc Translation of the original operating manual...

Page 117: ...012 21 24 86 6 3 69 33 0 28 60 0 011 20 23 37 7 3 39 34 0 25 61 0 009 19 21 96 8 3 01 35 0 22 62 0 008 18 20 63 9 2 84 36 0 20 63 0 007 17 19 37 10 2 56 37 0 18 64 0 006 16 18 17 11 2 38 38 0 16 65 0...

Page 118: ...Freeze dryer Beta 1 8 LSCplus Freeze dryer Beta 2 8 LSCplus 11 Appendix 118 125 Version 04 2013 Rev 2 9 of 09 03 2020 sb dc Translation of the original operating manual...

Page 119: ...at which a homogenous mixture e g a eutectic alloy passes directly from the liquid to the solid phase without the formation of a crystal mixture that consists of different phases Pressure increase te...

Page 120: ...diagrams Safety pressure Since the vacuum has a dominating influence on the product temperature Martin Christ Gefriertrocknungsanlagen GmbH has integrated a so called safety pressure feature into the...

Page 121: ...ns 96 China RoHS 2 Declaration of conformity113 Circuit diagram 103 Cleaning 31 Cleaning agents 91 97 Cleaning of the freeze dryer 92 Cleaning the accessories 91 Cleaning the freeze dryer 91 Click on...

Page 122: ...ectrical connection 101 Electrical connection of the vacuum sensor 15 107 Electrical system maintenance 94 Electricity hazards 27 38 94 EMC according to EN 55011 102 End of drying and aeration 20 Ente...

Page 123: ...e dryer 13 Leakage in a rubber valve 85 Leakage in the media drain valve 85 Leakage test 55 69 83 Loading a program 81 Location of use 37 LPCplus SCADA system 84 LSCplus control system 45 Lyes 31 Lyo...

Page 124: ...the vacuum pump 15 107 Preparation 19 44 Pressure control valve 42 Pressure control valve malfunction 88 Pressure increase test 49 77 83 119 Pressure marks 96 Pressure measurement comparative 83 Preve...

Page 125: ...rds 30 Switching the freeze dryer OFF 84 Switching the freeze dryer on 44 System check 30 System properties 60 T Table of the sublimation pressure curve 117 Technical data 101 Technical documentation...

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