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Freeze-dryer Delta 1-24 LSCplus

Freeze-dryer Delta 2-24 LSCplus

11 Appendix

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

• sb-dc

111 / 125

Translation of the original operating manual

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11.3 EC declaration of conformity in accordance with the

EC Machinery Directive

Содержание 102300

Страница 1: ...us Freeze dryer Delta 2 24 LSCplus Version 04 2013 Delta 1 24 LSCplus Part no 102300 102302 102304 102306 102308 102310 102316 102318 102320 102322 Delta 2 24 LSCplus Part no 102301 102303 102305 1023...

Страница 2: ...Freeze dryer Delta 1 24 LSCplus Freeze dryer Delta 2 24 LSCplus 2 125 Version 04 2013 Rev 2 9 of 09 03 2020 sb dc Translation of the original operating manual...

Страница 3: ...n 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 37...

Страница 4: ...Freeze dryer Delta 1 24 LSCplus Freeze dryer Delta 2 24 LSCplus 4 125 Version 04 2013 Rev 2 9 of 09 03 2020 sb dc Translation of the original operating manual...

Страница 5: ...nd aeration 21 2 2 2 6 Defrosting 22 3 Safety 23 3 1 Marking of the unit 23 3 2 Explanation of the symbols and notes 24 3 3 Responsibility of the operator 25 3 4 Operating personnel 26 3 5 Informal sa...

Страница 6: ...ransport 35 4 4 Packaging 36 4 5 Transport safety devices 36 4 6 On site transport 37 5 Set up and connection 38 5 1 Location of use 38 5 2 Power supply 39 5 2 1 Connection 39 5 2 2 Customer provided...

Страница 7: ...rain 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...

Страница 8: ...ppendix 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 Chi...

Страница 9: ...d 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 ferme...

Страница 10: ...l 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 so...

Страница 11: ...chnical 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...

Страница 12: ...der criminal law 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 subli...

Страница 13: ...b 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 LSCplus user interface see chapter 6 5...

Страница 14: ...of 09 03 2020 sb dc Translation of the original operating manual 5 Contact bolt 6 Pipe connection of the vacuum pump behind the cover plate 7 Ice condenser 8 Pipe connection of the vacuum sensor Fig...

Страница 15: ...Media drain valve 13 Fixed castors Fig 5 Left side of the freeze dryer 14 Vacuum sensor 15 Mains voltage Main switch 16 Electrical connection of the vacuum sensor 17 Serial interface 18 Mains cable 1...

Страница 16: ...of 09 03 2020 sb dc Translation of the original operating manual 2 1 2 Name plate 1 Serial number 2 Type 3 Refrigerant data of the 1st stage 4 Nominal voltage 5 Year of manufacture month year 6 Part n...

Страница 17: ...he 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 dryi...

Страница 18: ...ber 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 s...

Страница 19: ...ev 2 9 of 09 03 2020 sb dc 19 125 Translation of the original operating manual Fig 9 Freeze drying phases NOTE Please find further information about basic principles optimum procedures and application...

Страница 20: ...the 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 vapo...

Страница 21: ...equired 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 T...

Страница 22: ...e condenser chamber by way of a cloth Special equipment defrosting with hot water NOTE For hot water defrosting the freeze dryer must be connected to a hot water supply The ice condenser is defrosted...

Страница 23: ...ce 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 c...

Страница 24: ...alth 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 h...

Страница 25: ...and 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 concern...

Страница 26: ...the 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 part...

Страница 27: ...with 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...

Страница 28: ...he 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 lo...

Страница 29: ...pressure In the case of skin contact with liquid refrigerant cold burns or frostbite may result Only qualified persons are authorised to perform work on the refrigeration system of the freeze dryer 3...

Страница 30: ...l of the components of the freeze dryer and affect the mechanical strength This may lead to severe injuries Freeze drying of products containing acids is only permissible if special protective measure...

Страница 31: ...caused by cold surfaces WARNING Risk of freezing to cold surfaces The ice condenser coils can already be cold during the loading phase There is a risk of freezing to the ice condenser coils when touc...

Страница 32: ...d persons warm and calm Get medical attention immediately Check consciousness and breathing continuously In the case of unconsciousness of lack of normal breathing perform cardiopulmonary resuscitatio...

Страница 33: ...anlagen 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 fre...

Страница 34: ...mediately 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 ha...

Страница 35: ...imatic influences the guidelines of the German Federal Association for Wooden Packages Pallets and Export Packaging Bundesverband Holzpackmittel Paletten Exportverpackung e V the so called HPE packagi...

Страница 36: ...freeze dryer upwards with a lifting device see chapter 4 6 On site transport CAUTION The freeze dryer Delta 1 24 LSCplus weighs approx 215 kg The freeze dryer Delta 2 24 LSCplus weighs approx 250 kg C...

Страница 37: ...nger distances it should be transported by way of suitable lifting equipment e g forklift truck Lift the freeze dryer upwards with a lifting device Always reach under the freeze dryer from the front s...

Страница 38: ...circulation 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...

Страница 39: ...hnical data CAUTION Prior to connecting the unit to the power supply system check the rotary field at the electrical outlet with a suitable measuring instrument The rotary field must be clockwise 5 2...

Страница 40: ...perating elements It is used to 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...

Страница 41: ...entring ring 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...

Страница 42: ...ist separator The filter prevents air pollution by the oil mist that is emitted more or less strongly by the pump depending on the working pressure The exhaust gases must be discharged in a proper man...

Страница 43: ...ve 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...

Страница 44: ...ndenser chamber must be clean and dry Remove any water residues from the preceding run Close the aeration valve and the media drain valve Ensure that all of the valves of the accessories are closed Sw...

Страница 45: ...trol of freeze drying processes The clear user interface enables the intuitive operation of the unit Fig 16 Start screen of the LSCplus control unit example 6 5 1 User interface The system is operated...

Страница 46: ...s 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 infor...

Страница 47: ...age device connected Process recording on a USB storage device active Network available but no network drive connected Network drive connected e g LPCplus LyoLogplus Network drive connected and proces...

Страница 48: ...his way it is possible to configure a personalised overview of the actual values Dialog box Tools 5 This dialog box is used to call up various aids and resources Vapour pressure curve for ice and wate...

Страница 49: ...e background Fig 21 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 equippe...

Страница 50: ...p 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 scr...

Страница 51: ...n eliminated yet The colour of the button quit changes from blue to grey once the message has been acknowledged Fig 24 Representation of an error message The advantage of this system is that malfuncti...

Страница 52: ...ften this error has occurred and the time stamp of the last error message Use the arrow keys to call up the individual windows NOTE The error message text is always followed by an error code Always in...

Страница 53: ...7 Dialog box Operating mode select start The version of the dialog box that is displayed depends on the equipment of the freeze dryer Standard unit test Apart from the process phases of the freeze dry...

Страница 54: ...d 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...

Страница 55: ...window 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...

Страница 56: ...dule 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...

Страница 57: ...ns 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 Sca...

Страница 58: ...s 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 Sin...

Страница 59: ...Access protection 5 Device options 6 Configuration of sensors Abb 35 Dialogfenster Optionen Verwaltung Date Time 1 The LSCplus control system is equipped with an integrated battery buffered clock Aft...

Страница 60: ...is Silent the beeper sounds once when the malfunction occurs If the setting is Off the beeper will not sound at all Click on touch If this function is active a clicking sound can be heard whenever the...

Страница 61: ...unless the access protection is active Password timer runtime In order to prevent unauthorised access the system will automatically switch back to the default setting after a pre defined period of tim...

Страница 62: ...ng of the default settings e g editing of the access protection creating and editing of programs editing of system settings Device options 5 This dialog box lists all of the device options that are av...

Страница 63: ...vacuum and pressure sensors For the vacuum as well as pressure there are two different measuring methods and for each of these methods different sensors can be selected In order to change the sensor p...

Страница 64: ...nce 6 Sensor adjustment Fig 44 Dialog box Service varies depending on the type of system Operating hours 1 This dialog box is used to call up the number of operating hours of the various components of...

Страница 65: ...age will be overwritten Use the arrow keys to call up the individual messages The error message text is always followed by an error code NOTE Always indicate the error code in the event of enquiries o...

Страница 66: ...cted they will all receive the same address resulting in a communication conflict Press the button Address assignment process the prompt and confirm the address assignment Vacuum pump oil change 4 The...

Страница 67: ...wledge the message Make an appointment for the maintenance of your freeze dryer see section 8 Maintenance and service After the maintenance our service engineer will reset the operating hour counter i...

Страница 68: ...e 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...

Страница 69: ...n of the warm up phase this dialog box will be displayed Fig 51 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 mai...

Страница 70: ...on 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 whether the operating mode medi...

Страница 71: ...turn 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 executed fully automatically and under...

Страница 72: ...mps 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 valu...

Страница 73: ...phase 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...

Страница 74: ...the 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 t...

Страница 75: ...fined 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 dou...

Страница 76: ...g 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...

Страница 77: ...pressure 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 pe...

Страница 78: ...dically 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...

Страница 79: ...mparative the drying process will be considered complete at the current conditions Thus the progress condition for switching to the next section is fulfilled and the next section will be initiated Oth...

Страница 80: ...program can be modified as long as it has not been loaded Select the program to be edited from the list in the main window Program Press the button with the program name in order to call up a window t...

Страница 81: ...The 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 mu...

Страница 82: ...this 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 pr...

Страница 83: ...o 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...

Страница 84: ...phical representation of the measurement data of currently running processes it also enables the data export for additional evaluation LPCplus SCADA system The Christ LPCplus system consists of the Su...

Страница 85: ...adjusted Contact the 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 contac...

Страница 86: ...ce 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 lea...

Страница 87: ...due 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...

Страница 88: ...e 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 chapte...

Страница 89: ...ration 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 establ...

Страница 90: ...functions 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 martinchr...

Страница 91: ...apter 1 2 Intended use section 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 corr...

Страница 92: ...c 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...

Страница 93: ...n 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 cleaned Switch...

Страница 94: ...d by electric shock There is a risk of electric shock when touching current carrying components This may lead to ventricular fibrillation cardiac arrest or respiratory paralysis Only qualified electri...

Страница 95: ...7 3 Service contact 8 1 7 Exhaust filter oil mist separator NOTE Please refer to the separate operating manual of the vacuum pump and the exhaust filter The oil mist that is emitted by the vacuum pum...

Страница 96: ...ape in the liquid or gas state and under high pressure In the case of skin contact with liquid refrigerant cold burns or frostbite may result Only qualified persons are authorised to perform work on t...

Страница 97: ...changes Replace any damaged components immediately for your own safety Immediately rinse off the accessories if any liquids that may cause corrosion come into contact with them Clean the accessories...

Страница 98: ...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 martinchrist de Outside Germany Contact ou...

Страница 99: ...duct 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 descriptio...

Страница 100: ...sal 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...

Страница 101: ...area single chamber method drying inside the ice condenser chamber drying in injection vials with sealing under vacuum or nitrogen atmosphere inside the ice condenser chamber 10 shelves 200 mm each At...

Страница 102: ...ction Weight approx 215 kg approx 250 kg Noise level according to DIN 45635 54 dB A 54 dB A EMC according to EN 55011 Class B Class B Heat emission 0 9 kW min 1 9 kW max 1 7 kW min 3 0 kW max Equipmen...

Страница 103: ...Use in closed spaces 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 docume...

Страница 104: ...C 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...

Страница 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 LSCplus user interface 2 Vacuum pump 3 Oil mist s...

Страница 106: ...9 of 09 03 2020 sb dc Translation of the original operating manual 5 Contact bolt 6 Pipe connection of the vacuum pump behind the cover plate 7 Ice condenser 8 Vacuum sensor Fig 73 Ice condenser cham...

Страница 107: ...ve 12 Media drain valve 13 Fixed castors Fig 75 Left side of the freeze dryer 14 Vacuum sensor 15 Mains voltage Main switch 16 Electrical connection of the vacuum sensor 17 Serial interface 18 Mains c...

Страница 108: ...install the base plate 4 Switch the unit on 20 to 30 minutes prior to the start of the drying process in order to let the vacuum pump warm up 5 Place the plate rack on the base plate 6 Transport the...

Страница 109: ...e unit off by actuating the mains power switch and take the product out of the freeze dryer 16 Switch the unit on again and start the defrosting process button Operating mode select start Defrosting C...

Страница 110: ...ly 50 C to 54 C The pressure decreases as a function of the ice condenser temperature NOTE The drying time depends on the layer thickness of the sample the solids content of the sample and the amount...

Страница 111: ...Cplus Freeze dryer Delta 2 24 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...

Страница 112: ...Freeze dryer Delta 1 24 LSCplus Freeze dryer Delta 2 24 LSCplus 11 Appendix 112 125 Version 04 2013 Rev 2 9 of 09 03 2020 sb dc Translation of the original operating manual...

Страница 113: ...ryer Delta 1 24 LSCplus Freeze dryer Delta 2 24 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 Chin...

Страница 114: ...Freeze dryer Delta 1 24 LSCplus Freeze dryer Delta 2 24 LSCplus 11 Appendix 114 125 Version 04 2013 Rev 2 9 of 09 03 2020 sb dc Translation of the original operating manual...

Страница 115: ...us Freeze dryer Delta 2 24 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...

Страница 116: ...Freeze dryer Delta 1 24 LSCplus Freeze dryer Delta 2 24 LSCplus 11 Appendix 116 125 Version 04 2013 Rev 2 9 of 09 03 2020 sb dc Translation of the original operating manual...

Страница 117: ...0 012 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...

Страница 118: ...Freeze dryer Delta 1 24 LSCplus Freeze dryer Delta 2 24 LSCplus 11 Appendix 118 125 Version 04 2013 Rev 2 9 of 09 03 2020 sb dc Translation of the original operating manual...

Страница 119: ...nt 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...

Страница 120: ...it 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 t...

Страница 121: ...al reactions 97 China RoHS 2 Declaration of conformity113 Circuit diagram 103 Cleaning 32 Cleaning agents 91 97 Cleaning of the freeze dryer 92 Cleaning the accessories 91 Cleaning the freeze dryer 91...

Страница 122: ...ing a program 80 Electrical connection 101 Electrical connection of the vacuum sensor 15 107 Electrical system maintenance 94 Electricity hazards 28 94 EMC according to EN 55011 102 End of drying and...

Страница 123: ...a rubber valve 85 Leakage in the media drain valve 85 Leakage test 55 69 83 Loading a program 81 Location of use 38 LPCplus SCADA system 84 LSCplus control system 45 Lyes 32 Lyo Control measuring sys...

Страница 124: ...valve 42 Pressure control valve malfunction 88 Pressure increase test 49 77 83 119 Pressure marks 97 Pressure measurement comparative 83 Prevention of accidents 9 Procedures in the event of hazards a...

Страница 125: ...cold hazards 31 Surfaces hot hazards 31 Switching the freeze dryer OFF 84 System check 31 System properties 60 T Table of the sublimation pressure curve 117 Technical data 101 Technical documentation...

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