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Freeze-dryer Gamma 1-16 LSCplus

Freeze-dryer Gamma 2-16 LSCplus

11 Appendix

Version 04/2013, Rev. 2.10 of 09/03/2020

• sb-dc

115 / 126

Translation of the original operating manual

11.5 EC declaration of conformity in accordance with the Pressure

Equipment Directive

Summary of Contents for 102210

Page 1: ...2020 Gamma 1 16 LSCplus Freeze dryer Gamma 2 16 LSCplus Version 04 2013 Gamma 1 16 LSCplus Part no 102210 102212 102214 102216 102218 102220 102226 Gamma 2 16 LSCplus Part no 102211 102213 102215 1022...

Page 2: ...Freeze dryer Gamma 1 16 LSCplus Freeze dryer Gamma 2 16 LSCplus 2 126 Version 04 2013 Rev 2 10 of 09 03 2020 sb dc Translation of the original operating manual...

Page 3: ...on 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 3...

Page 4: ...Freeze dryer Gamma 1 16 LSCplus Freeze dryer Gamma 2 16 LSCplus 4 126 Version 04 2013 Rev 2 10 of 09 03 2020 sb dc Translation of the original operating manual...

Page 5: ...n 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 safety notes...

Page 6: ...e 38 5 2 Power supply 39 5 2 1 Type of connection 39 5 2 2 Customer provided fuses 39 5 3 Aeration valve 39 5 4 Media drain valve 40 5 5 Vacuum sensor 40 5 6 Vacuum pump 41 5 7 Pressure control valve...

Page 7: ...n valve media drain valve 93 8 1 4 Heat exchanger only for air cooled freeze dryers 94 8 1 5 Electrical system 94 8 1 6 Vacuum pump 94 8 1 7 Exhaust filter oil mist separator 95 8 1 8 Refrigeration sy...

Page 8: ...Freeze dryer Gamma 1 16 LSCplus Freeze dryer Gamma 2 16 LSCplus Table of contents 8 126 Version 04 2013 Rev 2 10 of 09 03 2020 sb dc Translation of the original operating manual...

Page 9: ...id 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 ferm...

Page 10: ...ol 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 s...

Page 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...

Page 12: ...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 sublimation 1 6 St...

Page 13: ...20 sb dc 13 126 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 use...

Page 14: ...rsion 04 2013 Rev 2 10 of 09 03 2020 sb dc Translation of the original operating manual 4 Contact bolt 5 Pipe connection of the vacuum pump behind the cover plate 6 Ice condenser 7 Pipe connection of...

Page 15: ...rain valve Fig 5 left side of the freeze dryer 11 Serial interface 12 Electrical connection of the vacuum sensor 13 Name plate see chapter 2 1 2 Name plate 14 Heat exchanger of the refrigeration unit...

Page 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...

Page 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...

Page 18: ...mber 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...

Page 19: ...v 2 10 of 09 03 2020 sb dc 19 126 Translation of the original operating manual Fig 9 Freeze drying phases NOTE Please find further information about basic principles optimum procedures and application...

Page 20: ...e 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 vap...

Page 21: ...required 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...

Page 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...

Page 23: ...ace 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...

Page 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...

Page 25: ...The operator must perform a risk assessment concerning potential accidents in connection with the freeze dryer and take design related countermeasures if necessary perform a compatibility test of all...

Page 26: ...onfirmed this with their signature 3 5 Informal safety notes This operating manual is part of the product This operating manual must be kept at the location of use of the freeze dryer Ensure that it i...

Page 27: ...ty shoes work gloves and hardhat 3 6 2 Hazards caused by improper transport DANGER Risk of injury caused by the uncontrolled movement of loads Units that are not properly fastened or secured may shift...

Page 28: ...the 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 l...

Page 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...

Page 30: ...ining acids is only permissible if special protective measures and equipment related precautions are taken Consultation of Martin Christ Gefriertrocknungsanlagen GmbH is absolutely mandatory in order...

Page 31: ...d gloves Do not touch the surfaces on purpose 3 8 Safety devices 3 8 1 System check An internal system check system monitors the data transfer and sensor signals with regard to plausibility Errors are...

Page 32: ...l attention 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...

Page 33: ...sanlagen 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 fr...

Page 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...

Page 35: ...Depth 675 mm 80 mm vacuum connection 675 mm 80 mm vacuum connection Weight approx 135 kg approx 160 kg 4 2 Storage conditions In order to ensure the protection against mechanical and climatic influenc...

Page 36: ...vices see chapter 4 5 Transport safety devices Always lift the freeze dryer with a lifting device When lifting the freeze dryer always reach under the freeze dryer from the side Do not grab the unit a...

Page 37: ...ze dryer upwards with a lifting device Always reach under the unit from the side CAUTION The freeze dryer Gamma 1 16 LSCplus weighs approx 135 kg The freeze dryer Gamma 2 16 LSCplus weighs approx 160...

Page 38: ...r 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...

Page 39: ...ate 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 power cord with an IEC C13 connector see chapter 10 Te...

Page 40: ...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 The hose must be laid with a...

Page 41: ...tructions in the separate operating manual of the vacuum sensor Thyracont VCP 63 Pirani Pfeiffer CMR 363 capacitive Fig 13 Vacuum sensors of different manufacturers NOTE The vacuum sensor comes suppli...

Page 42: ...oil mist 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 prop...

Page 43: ...lve 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 t...

Page 44: ...s 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 wa...

Page 45: ...trol of freeze drying processes The clear user interface enables the intuitive operation of the unit Fig 17 Start screen of the LSCplus control unit example 6 5 1 User interface The system is operated...

Page 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...

Page 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...

Page 48: ...this 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 wat...

Page 49: ...he background Fig 22 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 equipp...

Page 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...

Page 51: ...en eliminated yet The colour of the button quit changes from blue to grey once the message has been acknowledged Fig 25 Representation of an error message The advantage of this system is that malfunct...

Page 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...

Page 53: ...8 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...

Page 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...

Page 55: ...n 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 develope...

Page 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...

Page 57: ...ons 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 Sc...

Page 58: ...is 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 Si...

Page 59: ...4 Access protection 5 Device options 6 Configuration of sensors Abb 36 Dialogfenster Optionen Verwaltung Date Time 1 The LSCplus control system is equipped with an integrated battery buffered clock Af...

Page 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 th...

Page 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 ti...

Page 62: ...ing 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 a...

Page 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...

Page 64: ...ance 6 Sensor adjustment Fig 45 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 o...

Page 65: ...sage 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...

Page 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...

Page 67: ...owledge 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...

Page 68: ...he 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...

Page 69: ...on of the warm up phase this dialog box will be displayed Fig 52 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 ma...

Page 70: ...automatic 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 defi...

Page 71: ...og 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 execu...

Page 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...

Page 73: ...g 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...

Page 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...

Page 75: ...efined 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 do...

Page 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...

Page 77: ...e 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 p...

Page 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...

Page 79: ...the 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 C...

Page 80: ...f 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...

Page 81: ...n 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 m...

Page 82: ...m 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 p...

Page 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...

Page 84: ...e drying 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 Chr...

Page 85: ...e 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 depar...

Page 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...

Page 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...

Page 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...

Page 89: ...eration 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 estab...

Page 90: ...lfunctions 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 martinch...

Page 91: ...tion 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 subst...

Page 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...

Page 93: ...en 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...

Page 94: ...ventricular 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...

Page 95: ...1 8 Refrigeration system WARNING Risk of poisoning caused by the refrigerant During its decomposition e g due to naked flames or hot surfaces hazardous toxic gases are released Contact with the decom...

Page 96: ...tual 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 wi...

Page 97: ...er 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...

Page 98: ...s 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 o...

Page 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...

Page 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...

Page 101: ...a 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 5 shelves 200 mm each Atotal...

Page 102: ...connection 495 mm 860 mm 675 mm 80 mm vacuum connection Weight approx 135 kg approx 160 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...

Page 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...

Page 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...

Page 105: ...3 Rev 2 10 of 09 03 2020 sb dc 105 126 Translation of the original operating manual 11 2 Brief operating instructions Functional and operating elements 1 Ice condenser chamber 2 LSCplus user interface...

Page 106: ...Version 04 2013 Rev 2 10 of 09 03 2020 sb dc Translation of the original operating manual 4 Contact bolt 5 Pipe connection of the vacuum pump behind the cover plate 6 Ice condenser 7 Vacuum sensor Fig...

Page 107: ...ia drain valve Fig 76 left side of the freeze dryer 11 Serial interface 12 Electrical connection of the vacuum sensor 13 Name plate 14 Heat exchanger of the refrigeration unit 15 Vacuum sensor 16 Opti...

Page 108: ...s in order to let the vacuum pump warm up 5 Place the plate rack on the base plate 6 Transport the frozen samples as quickly as possible from the deep freeze to the freeze dryer and place them on the...

Page 109: ...g mode select start Defrosting CAUTION Ensure that no water gets into the pipe connection of the vacuum pump or vacuum sensor 17 Drain the defrosting water via the condensate drain valve on the left h...

Page 110: ...denser temperature NOTE The drying time depends on the layer thickness of the sample the solids content of the sample and the amount of heat that is supplied during the drying process In the case of a...

Page 111: ...plus Freeze dryer Gamma 2 16 LSCplus 11 Appendix Version 04 2013 Rev 2 10 of 09 03 2020 sb dc 111 126 Translation of the original operating manual 11 3 EC declaration of conformity in accordance with...

Page 112: ...Freeze dryer Gamma 1 16 LSCplus Freeze dryer Gamma 2 16 LSCplus 11 Appendix 112 126 Version 04 2013 Rev 2 10 of 09 03 2020 sb dc Translation of the original operating manual...

Page 113: ...yer Gamma 1 16 LSCplus Freeze dryer Gamma 2 16 LSCplus 11 Appendix Version 04 2013 Rev 2 10 of 09 03 2020 sb dc 113 126 Translation of the original operating manual 11 4 Declaration of conformity Chin...

Page 114: ...Freeze dryer Gamma 1 16 LSCplus Freeze dryer Gamma 2 16 LSCplus 11 Appendix 114 126 Version 04 2013 Rev 2 10 of 09 03 2020 sb dc Translation of the original operating manual...

Page 115: ...s Freeze dryer Gamma 2 16 LSCplus 11 Appendix Version 04 2013 Rev 2 10 of 09 03 2020 sb dc 115 126 Translation of the original operating manual 11 5 EC declaration of conformity in accordance with the...

Page 116: ...Freeze dryer Gamma 1 16 LSCplus Freeze dryer Gamma 2 16 LSCplus 11 Appendix 116 126 Version 04 2013 Rev 2 10 of 09 03 2020 sb dc Translation of the original operating manual...

Page 117: ...9 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 6...

Page 118: ...Freeze dryer Gamma 1 16 LSCplus Freeze dryer Gamma 2 16 LSCplus 11 Appendix 118 126 Version 04 2013 Rev 2 10 of 09 03 2020 sb dc Translation of the original operating manual...

Page 119: ...int 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...

Page 120: ...uit 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...

Page 121: ...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 Click on touch...

Page 122: ...rmity Machinery Directive 12 111 EC declaration of conformity Pressure Equipment Directive 115 Editing a program 80 Electrical connection 101 Electrical connection of the vacuum sensor 15 107 Electric...

Page 123: ...rature 89 Insufficient vacuum 85 87 Intended use 9 IP protection category according to DIN 60529 101 L Language 57 Layout of the freeze dryer 13 Leakage in a rubber valve 85 Leakage in the media drain...

Page 124: ...mperatures 101 Potential hazard to the life and health 24 Potentially hazardous situation 24 Power failure 86 Power supply 39 Power supply of the vacuum pump 15 107 Preparation 20 44 Pressure control...

Page 125: ...Storage conditions 35 Stress corrosion 96 Sublimation 120 Supply voltage 39 Surfaces cold hazards 31 Surfaces hot hazards 30 Switching the freeze dryer OFF 84 Switching the freeze dryer on 44 System...

Page 126: ...16 LSCplus Freeze dryer Gamma 2 16 LSCplus Index 126 126 Version 04 2013 Rev 2 10 of 09 03 2020 sb dc Translation of the original operating manual Weight 35 102 Wireless shelf technology 65 120 Y Yea...

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