Christ Alpha 3-4 LSCbasic User manual

Translation of the original operating manuel
sb
Rev. 1.9 of 01/12/2021
Alpha 3-4 LSCbasic; ;
Version 11/2018
Alpha 3-4 LSCbasic
Part no. 102444, 102456, 102445, 102474, 102486, 102475,
102458, 102462, 102460, 102488, 102492, 102490
Freeze-dryer
Operating Manual
Please retain for later use!

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In case of inquiries, please state the following numbers:
Order number:
Serial number:
© Copyright by
Martin Christ Gefriertrocknungsanlagen GmbH
An der Unteren Söse 50
37520 Osterode am Harz
Germany
Tel.: [phone] / 5007-0
Fax: [phone] / 5007-12
Web: www.martinchrist.de
E-mail: [e-mail]

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Freeze-dryer Alpha 3-4 LSCbasic
Table of contents
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1General information.............................................................................................................9
1.1 Importance of the operating manual..................................................................................9
1.2 Intended use.....................................................................................................................9
1.3 Warranty and liability.......................................................................................................10
1.4 Copyright........................................................................................................................11
1.5 Explanation of symbols...................................................................................................11
1.6 Standards and regulations..............................................................................................11
1.7 Scope of supply..............................................................................................................11
2Layout and mode of operation..........................................................................................16
2.1 Layout of the freeze-dryer...............................................................................................16
2.1.1 Functional and operating elements............................................................................16
2.1.2 Name plate................................................................................................................18
2.2 Mode of operation...........................................................................................................19
2.2.1 General information on freeze-drying.........................................................................19
2.2.2 Freeze-drying process...............................................................................................21
2.2.2.1 Preparation........................................................................................................21
2.2.2.2 Freezing.............................................................................................................22
2.2.2.3 Main drying........................................................................................................22
2.2.2.4 Final drying........................................................................................................23
2.2.2.5 End of drying and aeration.................................................................................23
2.2.2.6 Defrosting ..........................................................................................................23
3Safety..................................................................................................................................24
3.1 Marking of the unit..........................................................................................................24
3.2 Explanation of the symbols and notes.............................................................................25
3.3 Responsibility of the operator..........................................................................................26
3.4 Requirements concerning the personnel.........................................................................28
3.5 Informal safety notes.......................................................................................................29
3.6 Safety notes concerning the transport, set-up and connection and initial start-up of the
freeze-dryer....................................................................................................................29
3.6.1 General hazards........................................................................................................29
3.6.2 Hazards caused by improper transport......................................................................29
3.6.3 Hazards caused by improper set-up..........................................................................30
3.6.4 Hazards caused by improper connection...................................................................30
3.7 Safety notes concerning the operation............................................................................31
3.7.1 Hazards caused by electricity ....................................................................................31
3.7.2 Hazards caused by the refrigeration system (natural, flammable refrigerants)...........31
3.7.3 Hazards caused by harmful products.........................................................................32
3.7.4 Hazards caused by acids in the products...................................................................32
3.7.5 Hazards caused by contaminated condensate (defrosting water)..............................32
3.7.6 Oil-sealed vacuum pump: hazards caused by contaminated vacuum pump exhaust
gases.........................................................................................................................33
3.7.7 Oil-sealed vacuum pump: hazards caused by hot and contaminated vacuum pump oil
..................................................................................................................................33
3.7.8 Dry-running vacuum pump: hazards caused by contaminated exhaust air.................34

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3.7.9 Hazards caused by hot surfaces................................................................................34
3.7.10 Hazards caused by cold surfaces..............................................................................34
3.7.11 Hazards caused by breaking glass............................................................................35
3.8 Safety devices ................................................................................................................35
3.8.1 System check............................................................................................................35
3.8.2 Earth conductor check...............................................................................................35
3.9 Procedures in the event of hazards and accidents..........................................................36
3.10 Maintenance and cleaning of the freeze-dryer................................................................36
3.11 Measures to be taken to ensure safe operation of the freeze-dryer.................................37
3.12 Remaining hazards.........................................................................................................38
4Storage and transport ....................................................................................................... 39
4.1 Dimensions and weight...................................................................................................39
4.2 Storage conditions..........................................................................................................39
4.3 Notes on transport..........................................................................................................40
4.4 Packaging.......................................................................................................................41
4.5 Transport locking devices...............................................................................................41
5Set-up and connection ...................................................................................................... 42
5.1 Location of use ...............................................................................................................42
5.2 Power supply..................................................................................................................43
5.2.1 Type of connection ....................................................................................................43
5.2.2 Customer-provided fuses...........................................................................................43
5.3 Aeration valve.................................................................................................................44
5.4 Media drain valve............................................................................................................44
5.5 Vacuum sensor...............................................................................................................45
5.6 Vacuubrand RC6 vacuum pump (oil-sealed)...................................................................46
5.7 Edwards nXDS 10iC vacuum pump (dry-running)...........................................................48
5.8 Pressure control valve ....................................................................................................49
5.9 Installation of the accessories.........................................................................................50
5.9.1 Rubber valves............................................................................................................56
6Operation............................................................................................................................ 57
6.1 Initial start-up..................................................................................................................57
6.2 Preparation.....................................................................................................................57
6.3 Switching the freeze-dryer on .........................................................................................57
6.4 LSCbasic control system ................................................................................................58
6.4.1 User interface............................................................................................................58
6.4.1.1 Main window "Process"......................................................................................59
6.4.1.2 Main window "Options" ......................................................................................67
6.4.1.3 Main window "?".................................................................................................77
6.4.2 Starting a freeze-drying process................................................................................77
6.4.2.1 Entering set values ............................................................................................78
6.5 Optional extensions........................................................................................................82
6.6 Switching the freeze-dryer OFF......................................................................................82

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7Malfunctions and error correction....................................................................................83
7.1 General malfunctions......................................................................................................83
7.1.1 Power failure..............................................................................................................84
7.1.2 Insufficient vacuum....................................................................................................85
7.1.2.1 Small flange connections...................................................................................85
7.1.2.2 Aeration valve, media drain valve ......................................................................86
7.1.2.3 Pressure control valve........................................................................................86
7.1.2.4 Rubber valves....................................................................................................86
7.1.2.5 Vacuum sensor..................................................................................................86
7.1.3 Insufficient ice condenser temperature ......................................................................87
7.2 Process and error messages..........................................................................................87
7.3 Service contact...............................................................................................................88
8Maintenance and service................................................................................................... 89
8.1 Maintenance...................................................................................................................89
8.1.1 General......................................................................................................................89
8.1.2 Ice condenser chamber .............................................................................................91
8.1.3 Aeration valve, media drain valve..............................................................................91
8.1.4 Heat exchanger (only for air-cooled freeze-dryers)....................................................92
8.1.5 Electrical system........................................................................................................93
8.1.6 Vacuum system with oil-sealed vacuum pump, type Vakuubrand RC6......................93
8.1.7 Vacuum system with a dry-running vacuum pump, type Edwards nXDS 10iC...........94
8.1.8 Refrigeration system..................................................................................................95
8.1.9 Vacuum sensor..........................................................................................................95
8.1.10 Accessories...............................................................................................................96
8.2 Disinfection of the drying chamber and accessories .......................................................97
8.3 Service ...........................................................................................................................97
8.4 Return of defective parts.................................................................................................99
9Disposal............................................................................................................................ 100
9.1 Disposal of the freeze-dryer..........................................................................................100
9.2 Disposal of the packaging.............................................................................................100
10 Technical data.................................................................................................................. 101
10.1 Ambient conditions .......................................................................................................102
10.2 Technical documentation..............................................................................................102
11 Appendix.......................................................................................................................... 103
11.1 EC declaration of conformity in accordance with the EC Machinery Directive...............103
11.2 Declaration of conformity –China RoHS 2....................................................................105
11.3 EC declaration of conformity in accordance with the Pressure Equipment Directive .....107
11.4 Table of the sublimation pressure curve........................................................................109
12 Glossary........................................................................................................................... 111
13 Index................................................................................................................................. 113

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1 General information
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1 General information
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1.1 Importance of the operating manual
A fundamental requirement for the safe and trouble-free operation of the
unit is to be familiar with the fundamental safety instructions and all
possible hazards.
The operating manual includes important information concerning the safe
operation of the freeze-dryer.
This operating manual, and in particular the notes on safety and hazards,
must be observed by all persons operating the unit.
In addition, the local rules and regulations for the prevention of accidents
must be complied with.
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1.2 Intended use
The freeze-dryer has been exclusively designed for the freeze-drying of
solid or liquid products. It is, therefore, solely intended for this application.
The freeze-dryer must correspond to one of the following solvent packages:
1 Solvent package flask, part no. 102444
(with vacuum pump, type Vakuubrand RC6)
2 Solvent package flask, part no. 102456
(with vacuum pump, type Vakuubrand RC6)
3 Solvent package universal, part no. 102445
(with vacuum pump, type Vakuubrand RC6)
4 Solvent package flask, part no. 102474
(with vacuum pump, type Edwards nXDS 10iC)
5 Solvent package flask, part no. 10248
(with vacuum pump, type Edwards nXDS 10iC)
6 Solvent package universal, part no. 102475
(with vacuum pump, type Edwards nXDS 10iC)
7 Solvent package flask, part no. 102458
(without vacuum pump, type Vakuubrand RC6)
8 Solvent package flask, part no. 102462
(without vacuum pump, type Vakuubrand RC6)
9 Solvent package universal, part no. 102445
(without vacuum pump, type Vakuubrand RC6)
10 Solvent package flask, part no. 102458
(without vacuum pump, type Edwards nXDS 10iC)
11 Solvent package flask, part no. 102462
(without vacuum pump, type Edwards nXDS 10iC)
12 Solvent package universal, part no. 102445
(without vacuum pump, type Edwards nXDS 10iC)
The packages 7-9 may only be used in combination with an RC6 vacuum
pump by Vakuubrand.
The packages 10-12 may only be used in combination with an nXDS 10iC
vacuum pump by Edwards.
The freeze-dryer may only be used with the specified accessories made by
Martin Christ Gefriertrocknungsanlagen GmbH.

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The freeze-dryer is suitable for freeze-drying solid substances and liquid
solutions (e.g. bacteria and virus cultures, blood plasma, serum fractions,
antibodies, sera, vaccines and pharmaceutical products such as
chloramphenicol, streptomycin, vitamins, ferments and plant extracts for
biochemical tests).
The solvents that are used must be of the temperature classes T1 to T4 as
per DIN EN-60079-0:2014-06. We recommend performing a workplace
evaluation in terms of the handling of flammable solutions in accordance
with the local labour legislation.
Any other use beyond this area of application is regarded as improper use.
Martin Christ Gefriertrocknungsanlagen GmbH cannot be held liable for any
damage resulting from such improper use.
The following operations are regarded as NOT PERMISSIBLE:
•operation of the freeze-dryer if it is not properly installed
•use of the freeze-dryer if it is not in a perfect technical state
•use of the freeze-dryer within hazardous locations where there is a risk
of explosions
•use of the freeze-dryer within locations with insufficient ventilation
•use of the freeze-dryer with unauthorised additions or conversions
without the written approval by Martin Christ Gefriertrocknungsanlagen
GmbH
•use of the freeze-dryer with accessories that have not been approved
by Martin Christ Gefriertrocknungsanlagen GmbH
•freeze-drying of products that may react during the freeze-drying
process following the supply of high amounts of energy
•freeze-drying of azide-containing products
•use of substances that damage the material (stainless steel 1.4404 and
1.4435, borosilicate glass, EPDM, PVDF, ceramic AI2O3and PTFE) or
decrease the mechanical strength
The intended use also includes:
•observation of all of the notes and instructions that are included in the
operating manual
•compliance with the inspection and maintenance instructions
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1.3 Warranty and liability
The warranty and liability are subject to our "General Terms and
Conditions" that were distributed to the operator upon the conclusion of the
contract.
Warranty and liability claims are excluded if they are due to one or several
of the following reasons:
•improper use
•non-compliance with the safety instructions and hazard warnings in the
operating manual
•improper installation, start-up, operation, and maintenance of the
freeze-dryer.
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1.4 Copyright The copyright concerning the operating manual remains with Martin Christ
Gefriertrocknungsanlagen GmbH.
The operating manual is solely intended for the operator and their
personnel. It includes instructions and information that may not be
•duplicated,
•distributed, or
•communicated in any other way neither in full nor in parts.
Non-compliance may be prosecuted under criminal law.
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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).
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1.6 Standards and regulations
EC declaration of conformity in accordance with the EC Machinery
Directive (see chapter 11.1 - "EC declaration of conformity in accordance
with the EC Machinery Directive")
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1.7 Scope of supply
The following solvent packages are available:
Solvent package flask, part no. 102444:
Name
Part number
Freeze-dryer Alpha 3-4 LSCbasic
102372
Capacitive vacuum sensor CMR 364
125498
Vacuum pump Vakuubrand RC6
125295
Corrugated hose, stainless steel
510085
Reducing adapter DN 25/DN 16
141717
Pressure control valve
125908
Horizontal manifold with 12 rubber valves, including a glass cover
121212

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Solvent package flask, part no. 102456:
Name
Part number
Freeze-dryer Alpha 3-4 LSCbasic
102372
Capacitive vacuum sensor CMR 364
125498
Vacuum pump Vakuubrand RC6
125295
Corrugated hose, stainless steel
510085
Reducing adapter DN 25/DN 16
141717
Pressure control valve
125908
Vertical manifold with 12 rubber valves
110538
Glass cover
121448
Solvent package universal, part no. 102445:
Name
Part number
Freeze-dryer Alpha 3-4 LSCbasic
102372
Capacitive vacuum sensor
125498
Vacuum pump Vakuubrand RC6
125295
Corrugated hose, stainless steel
510085
Reducing adapter DN 25/DN 16
141717
Pressure control valve
125908
Base plate, stainless steel
120921
Guide tube
122036
3 shelves
120903
Adapter ring
113412
Drying chamber made of real glass
122300
Connecting ring with 12 rubber valves
113398
Glass cover
121448
Solvent package flask, part no. 102474:
Name
Part number
Freeze-dryer Alpha 3-4 LSCbasic
102372
Capacitive vacuum sensor CMR 364
125498
Vacuum pump Edwards nXDS 10iC
125251
Corrugated hose, stainless steel
510085
Reducing adapter DN 25/DN 16
141717
Pressure control valve
125908
Horizontal manifold with 12 rubber valves, including a glass cover
121212

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Solvent package flask, part no. 102486:
Name
Part number
Freeze-dryer Alpha 3-4 LSCbasic
102372
Capacitive vacuum sensor CMR 364
125498
Vacuum pump Edwards nXDS 10iC
125251
Corrugated hose, stainless steel
510085
Reducing adapter DN 25/DN 16
141717
Pressure control valve
125908
Vertical manifold with 12 rubber valves
110538
Glass cover
121448
Solvent package universal, part no. 102475:
Name
Part number
Freeze-dryer Alpha 3-4 LSCbasic
102372
Capacitive vacuum sensor
125498
Vacuum pump Edwards nXDS 10iC
125251
Corrugated hose, stainless steel
510085
Reducing adapter DN 25/DN 16
141717
Pressure control valve
125908
Base plate, stainless steel
120921
Guide tube
122036
3 shelves
120903
Adapter ring
113412
Drying chamber made of real glass
122300
Connecting ring with 12 rubber valves
113398
Glass cover
121448
Solvent package flask, part no. 102458
(without vacuum pump, type Vakuubrand RC6):
Name
Part number
Freeze-dryer Alpha 3-4 LSCbasic
102372
Capacitive vacuum sensor CMR 364
125498
Corrugated hose, stainless steel
510085
Reducing adapter DN 25/DN 16
141717
Pressure control valve
125908
Horizontal manifold with 12 rubber valves, including a glass cover
121212

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Solvent package flask, part no. 102462
(without vacuum pump, type Vakuubrand RC6):
Name
Part number
Freeze-dryer Alpha 3-4 LSCbasic
102372
Capacitive vacuum sensor CMR 364
125498
Corrugated hose, stainless steel
510085
Reducing adapter DN 25/DN 16
141717
Pressure control valve
125908
Vertical manifold with 12 rubber valves
110538
Glass cover
121448
Solvent package universal, part no. 102460
(without vacuum pump, type Vakuubrand RC6):
Name
Part number
Freeze-dryer Alpha 3-4 LSCbasic
102372
Capacitive vacuum sensor CMR 364
125498
Corrugated hose, stainless steel
510085
Reducing adapter DN 25/DN 16
141717
Pressure control valve
125908
Base plate, stainless steel
120921
Guide tube
122036
3 shelves
120903
Adapter ring
113412
Drying chamber made of real glass
122300
Connecting ring with 12 rubber valves
113398
Glass cover
121448
Solvent package flask, part no. 102488
(without vacuum pump, type Edwards nXDS 10iC):
Name
Part number
Freeze-dryer Alpha 3-4 LSCbasic
102372
Capacitive vacuum sensor CMR 364
125498
Corrugated hose, stainless steel
510085
Reducing adapter DN 25/DN 16
141717
Pressure control valve
125908
Horizontal manifold with 12 rubber valves, including a glass cover
121212

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Solvent package flask, part no. 102492
(without vacuum pump, type Edwards nXDS 10iC):
Name
Part number
Freeze-dryer Alpha 3-4 LSCbasic
102372
Capacitive vacuum sensor CMR 364
125498
Corrugated hose, stainless steel
510085
Reducing adapter DN 25/DN 16
141717
Pressure control valve
125908
Vertical manifold with 12 rubber valves
110538
Glass cover
121448
Solvent package universal, part no. 102490
(without vacuum pump, type Edwards nXDS 10iC):
Name
Part number
Freeze-dryer Alpha 3-4 LSCbasic
102372
Capacitive vacuum sensor CMR 364
125498
Corrugated hose, stainless steel
510085
Reducing adapter DN 25/DN 16
141717
Pressure control valve
125908
Base plate, stainless steel
120921
Guide tube
122036
3 shelves
120903
Adapter ring
113412
Drying chamber made of real glass
122300
Connecting ring with 12 rubber valves
113398
Glass cover
121448
NOTE
The freeze-dryer Alpha 3-4 LSCbasic may only be used with a chemical-
resistant, oil-sealed vacuum pump of the type RC6 by Vakuubrand or a
dry-running vacuum pump of the type nXDS 10iC by Edwards and only
with the specified configurations. Otherwise, the CE mark will be rendered
void.
In addition, every package includes:
•1 tube of high vacuum grease
•1 litre of vacuum pump oil
•1 set of small parts
•1 drain hose 0.4 m (EPDM DN 10, electrically conductive)
•1 operating manual
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2 Layout and mode of operation
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2.1 Layout of the freeze-dryer
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2.1.1 Functional and operating elements
1 Ice condenser
chamber
2 LSCbasic control
system (see chapter
6.4.1 - "User
interface")
3 Mains power switch
Fig. 1: Total view of the freeze-dryer
4 Pipe connection of the
vacuum sensor
5 Pipe connection of the
vacuum pump (behind
the cover plate)
6 Ice condenser
Fig. 2: Ice condenser chamber

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7 Aeration valve
8 Media drain valve
Fig. 3: Left side of the freeze-dryer
9 Touchpanel
Fig. 4: User interface with touchpanel

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10 Heat exchanger of the
refrigeration unit
11 Name plate (see
chapter 2.1.2 - "Name
plate")
12 Vacuum connection
13 Serial interface
14 Electrical connection of
the vacuum sensor
15 Connection of the
vacuum sensor
16 Power supply of the
pressure control valve
17 Power supply of the
vacuum pump (4.0 A
max.)
18 Mains fuse
19 Mains cable
20 Equipotential bonding
screw
Fig. 5: Rear view of the freeze-dryer
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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 number
7 Refrigerant data of
the 2nd stage
8 Rated current /
apparent power
Fig. 6: Example of a name plate
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2.2 Mode of operation
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2.2.1 General information on freeze-drying
What is freeze-drying?
Freeze-drying or lyophilisation is a procedure for the gentle drying of high-
quality products. The product is dried by →sublimation without passing
through the liquid phase.
What are typical applications for freeze-drying?
An important area of application is the drying of biotechnological and
pharmaceutical products, e.g. tissues and tissue extracts, bacteria,
vaccines, and sera. Products that would not keep well when they are
dissolved in water can be preserved by freeze-drying. During this process,
the biological properties of these sensitive substances are preserved. The
compounds remain unchanged from a qualitative and quantitative point of
view. After the addition of water, the products will have the same
characteristics as the original products.
How does freeze-drying work?
Freeze-drying is a very gentle procedure for the extraction of water from a
product in the frozen state. The drying process takes place through →
sublimation, i.e. the direct transition of a product from the 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
are aqueous solutions. Their behaviour is based on identical fundamental
principles.
The vapour pressure curve for ice and water (sublimation pressure curve)
describes the phase transition as a function of the pressure and
temperature. The higher the temperature is, the higher the vapour
pressure.
•If the vapour pressure is higher than 6.11 mbar (A), water passes
through all three phases: solid, liquid, and gas (see the illustration).
•At 6.11 mbar and 0.0098°C, the melting pressure curve, vapor pressure
curve, and sublimation pressure curve meet in one point, the so-called
triple point. In this point, all three phases coexist (simultaneously).
•If the vapour pressure is below 6.11 mbar (B) and energy is added, the
ice will be directly converted into water vapour once the sublimation
curve is reached. This transition is called “sublimation”. If thermal
energy is added to pure ice with a temperature of less than –30°C at a
pressure of 0.37 mbar, it will be converted into water vapour once it
reaches –30°C (see figure).
The vacuum prevents the melting of ice when energy is added. If thermal
energy is added to a frozen product under vacuum, thawing of the product
will be prevented and the water that is contained within the product will be
released in the form of water vapour.

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Fig. 7: Vapour pressure curve for ice and water
From a physical point of view, the freeze-drying process covers three
phases (see figure below):
(1) Freezing: The product to be dried is frozen under atmospheric pressure.
This can be done either directly in the freeze-dryer or in a separate deep-
freeze. The freezing temperature should be approximately 10°C below the
solidification point of the product.
(2) Evacuation: When the product is sufficiently frozen, the vacuum pump is
activated. The pressure inside the drying chamber 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 starting the
sublimation process. Due to the added energy, the water in the product is
converted into water vapour. Since the ice condenser is much colder than
the product that is to be dried, the vapour pressure in the ice condenser is
considerably lower than above the product. As a result, the water vapour
that is released by the product streams to the ice condenser, where it
condenses on the condenser coils.
Once the free water has been extracted from the product during the main
drying phase, the last traces of bound water will also be removed at a final
pressure that is as low as possible and at higher temperatures. This takes
place by way of →desorption. This drying phase is also called final drying.