Christ Epsilon 1-4 LSCplus User manual

Translation of the original operating manual
sb
Freeze-dryer
Rev. 2.13 of 01/12/2021
Epsilon 1-4 LSCplus;Freeze-dryer;Epsilon 2-4 LSCplus; ;
Version 04/2014
Epsilon 1-4 LSCplus
Part no. 112991, 112993, 112999
Epsilon 2-4 LSCplus
Part no. 112992, 112994, 113000
Freeze-dryer
Operating Manual
Please retain for later use!

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Translation 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 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 Epsilon 1-4 LSCplus
Freeze-dryer Epsilon 2-4 LSCplus
Table of contents
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1General information.............................................................................................................9
1.1 Importance of the operating manual..................................................................................9
1.2 Further applicable documents...........................................................................................9
1.3Intended use.....................................................................................................................9
1.4 Warranty and liability.......................................................................................................12
1.5 Copyright........................................................................................................................13
1.6 Explanation of symbols...................................................................................................13
1.7 Standards and regulations..............................................................................................13
1.8 Scope of supply..............................................................................................................13
2Layout and mode of operation..........................................................................................14
2.1 Layout of the freeze-dryer...............................................................................................14
2.1.1 Functional and operating elements............................................................................14
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
3.6.5 Hazards during the initial start-up ..............................................................................30
3.7 Safety notes concerning the operation............................................................................31
3.7.1 Hazards caused by electricity ....................................................................................31
3.7.2 Hazards caused by natural, flammable refrigerants...................................................31
3.7.3 Hazards caused by nitrogen......................................................................................32
3.7.4 Hazards caused by harmful products.........................................................................32
3.7.5 Hazards caused by solvents in the products..............................................................32
3.7.6 Hazards caused by acids in the products...................................................................33
3.7.7 Hazards caused by azides in the products.................................................................33

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3.7.8 Hazards caused by contaminated condensate (defrosting water)..............................34
3.7.9 Oil-sealed vacuum pump: hazards caused by contaminated vacuum pump exhaust
gases.........................................................................................................................34
3.7.10 Oil-sealed vacuum pump: hazards caused by hot and contaminated vacuum pump oil
..................................................................................................................................35
3.7.11 Dry-running vacuum pump: hazards caused by contaminated exhaust air.................35
3.7.12 Hazards caused by the loading door..........................................................................36
3.7.13 Hazards caused by hot surfaces................................................................................36
3.7.14 Hazards caused by cold surfaces..............................................................................36
3.7.15 Hazards caused by overpressure in the chamber......................................................37
3.8 Safety devices ................................................................................................................37
3.9 Procedures in the event of hazards and accidents..........................................................38
3.10 Maintenance and cleaning of the freeze-dryer................................................................39
3.11 Additions or conversions of the freeze-dryer...................................................................39
3.12 Measures to be taken to ensure safe operation of the freeze-dryer.................................40
3.13 Remaining hazards.........................................................................................................41
4Storage and transport ....................................................................................................... 42
4.1 Dimensions and weight...................................................................................................42
4.2 Storage conditions..........................................................................................................42
4.3 Unpacking the freeze-dryer.............................................................................................43
4.4 Transport........................................................................................................................44
4.4.1 Transport safety devices............................................................................................45
5Set-up and connection ......................................................................................................46
5.1 Installation site................................................................................................................46
5.2 Supply and disposal connections....................................................................................47
5.2.1 Power supply.............................................................................................................47
5.2.1.1 Connection.........................................................................................................47
5.2.1.2 Customer-provided fuses...................................................................................47
5.2.2 Aeration.....................................................................................................................48
5.2.3 Special equipment - water cooling system: cooling water inlet and outlet ..................48
5.2.4 Oil-seales vacuum pump ...........................................................................................49
5.2.5 Dry-running vacuum pump.........................................................................................51
5.2.6 Pressure control valve...............................................................................................52
5.2.7 Vacuum sensor..........................................................................................................53
5.2.8 Rubber valves............................................................................................................54
6Operation............................................................................................................................ 55
6.1 Initial start-up..................................................................................................................55
6.2 Installation of accessories...............................................................................................55
6.3 Preparation.....................................................................................................................55
6.4 Switching the freeze-dryer on .........................................................................................55
6.5 Loading door...................................................................................................................56

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6.6 LSCplus control system..................................................................................................58
6.6.1 User interface............................................................................................................58
6.6.1.1 Main window "Manual".......................................................................................59
6.6.1.2 Main window "Program".....................................................................................72
6.6.1.3 Main window "Options" ......................................................................................73
6.6.1.4 Main window "?".................................................................................................87
6.6.2 Manual freeze-drying.................................................................................................87
6.6.2.1 Entering set values in the manual mode.............................................................88
6.6.3 Freeze-drying with the PGMplus programmer module...............................................90
6.6.3.1 Creating a program............................................................................................94
6.6.3.2 Editing a program.............................................................................................102
6.6.3.3 Copying a program ..........................................................................................103
6.6.3.4 Loading a program...........................................................................................103
6.6.3.5 Deleting a program ..........................................................................................104
6.7 Optional extensions and special equipment..................................................................105
6.8 Switching the freeze-dryer OFF....................................................................................107
7Malfunctions and error correction.................................................................................. 108
7.1 General malfunctions....................................................................................................108
7.1.1 Power failure............................................................................................................109
7.1.2 Insufficient vacuum..................................................................................................110
7.1.2.1 Small flange connections.................................................................................110
7.1.2.2 Aeration valve..................................................................................................111
7.1.2.3 Pressure control valve......................................................................................111
7.1.2.4 Rubber valves..................................................................................................111
7.1.2.5 Vacuum sensor................................................................................................111
7.1.3 Insufficient ice condenser temperature ....................................................................112
7.2 Process and error messages........................................................................................112
7.3 Service contact.............................................................................................................113
8Maintenance and service................................................................................................. 114
8.1 Maintenance.................................................................................................................114
8.1.1 General....................................................................................................................114
8.1.2 Chamber..................................................................................................................115
8.1.2.1 Lamination of the loading door with a special film ............................................116
8.1.2.2 Special equipment: Stainless steel door latch at the loading door....................117
8.1.3 Aeration valve..........................................................................................................117
8.1.4 Heat exchanger (only air-cooled freeze-dryers).......................................................118
8.1.5 Electrical system......................................................................................................118
8.1.6 Vacuum system with an oil-sealed vacuum pump....................................................119
8.1.7 Vacuum system with a dry-running vacuum pump...................................................120
8.1.8 Refrigeration system................................................................................................121
8.1.9 Vacuum sensor........................................................................................................122
8.1.10 Accessories.............................................................................................................122

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8.2 Disinfection of the drying chamber and accessories .....................................................123
8.3 Maintenance schedule..................................................................................................124
8.4Maintenance schedule..................................................................................................125
8.5 Service .........................................................................................................................128
8.6 Return of defective parts...............................................................................................128
9Disposal............................................................................................................................ 130
9.1 Disposal of the freeze-dryer..........................................................................................130
9.2 Disposal of the packaging.............................................................................................130
10 Technical data.................................................................................................................. 131
10.1 Ambient conditions .......................................................................................................133
10.2 Technical documentation..............................................................................................133
11 Appendix.......................................................................................................................... 134
11.1 Mathematical relations..................................................................................................134
11.2 EC declaration of conformity in accordance with the EC Machinery Directive...............135
11.3 EC declaration of conformity in accordance with the Pressure Equipment Directive .....137
11.4 Table of the sublimation pressure curve........................................................................139
12 Glossary........................................................................................................................... 141
13 Index................................................................................................................................. 143

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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 Further applicable documents
The following documents apply in addition to these operating instructions if
the freeze-dryer is equipped with the corresponding features:
•Operating instructions of the CHRIST SCADA software LPCplus
(instructions for the operation of the freeze-dryer by way of a SCADA
system)
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1.3 Intended use
The freeze-dryer has been exclusively designed for the freeze-drying of
solid or liquid products in ampoules, vials or dishes. It is, therefore, solely
intended for this application.
All of the process steps that are necessary for freeze-drying can be
performed in the system:
•freezing of the products with time and temperature setpoints that can be
preset as desired
•main drying of the products with time, temperature and pressure
setpoints (sublimation) that can be preset as desired
•secondary drying of the products with time and temperature setpoints
that can be preset as desired, and with a high final vacuum for
eliminating any water that is bound by capillary or molecular effects
(desorption)
The freeze-dryer is suitable for freeze-drying solid 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, ferments and plant extracts for
biochemical tests).

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Freeze-drying of solvent-containing products (non-aqueous media)
With regards of corrosion resistance, the use of some organic solvents in
aqueous solutions with low concentrations is acceptable.
A freeze-dryer is designed to be chemically resistant to most compounds
that are commonly used in freeze-drying processes. However, by
necessity, the freeze-dryer is comprised of several different materials,
some of which may be attacked and degraded by certain chemicals.
The methods of fabrication and/or conditions of exposure of an acrylic door,
as well as the way the chemicals are applied, can influence the results.
Some of these factors are listed below:
•Fabrication: Stress generated while sawing, sanding, machining,
drilling, polishing, and/or forming.
•Exposure: Length of exposure, stresses induced during the life of the
product due to various loads, changes in temperature etc.
•Application of chemicals: by contact, rubbing, wiping, spraying etc.
The following table can be used as a general guide for the expected
degradation during normal freeze-drying processes of organic solvents with
a total max. concentration of 10 vol-% in aqueous solutions.
Solvent
Acrylic
glass
Stainless
steel
Silicon
rubber
EPDM
Acetic acid 20%
+
+
+
o
Formic acid up to 10%
+
O
o
-
Trifluoracetic acid (TFA)
-
+
O
+
Calcium chloride
+
+
+
+
Sodium phosphate
+
+
-
+
Acetone
-
+
+
+
Acetonitrile
-
+
-
O
Carbon tetrachloride
-
+
-
-
Cyclohexane
+
+
-
-
Dioxane
-
+
-
o
Methyl-t-butyl ether
+
+
o
-
Pyridine
-
+
-
o
Methanol
-
+
+
+
Ethanol
o
+
o
+
tert-Butanol
-
+
-
o
DMSO
-
+
-
+
Legend:
+ No degradation to be expected
o Moderate degradation; limited use
- Severe degradation; infrequent use recommended;
immediate thorough cleaning required

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The chemical attack on devices and accessory components can be
significantly reduced by immediate cleaning after the end of operation. All
parts of the freeze-dryer that have come in contact with the product must
be checked regularly for damages and replaced if necessary.
The following features are not permissible or must be deactivated:
•omission or removal of product temperature sensors of the PT100 or
LyoRx type or of specially connected PT100 sensors (with a cable
connection),
•omission or removal of WTMplus,
•omission of the LyoCoN process or removal of the LyoCoN reservoir
and sealing of the access opening.
NOTE
Solvents that are not listed in the table above, or the listed solvents in a
concentration higher than 10% by volume, must not be used!
Freeze-drying of acid-containing products
Freeze-drying of products containing acids is only permissible if special
protective measures and equipment-related precautions are taken.
Otherwise, there is a risk of damage to property and personal injury.
Consultation of Martin Christ Gefriertrocknungsanlagen GmbH is absolutely
mandatory in order to define the measures that need to be taken!
Freeze-drying of azide-containing products
Freeze-drying of products containing azides is only permissible following a
case-by-case examination and the written approval by Martin Christ
Gefriertrocknungsanlagen GmbH, since azides may form explosive dust-
air-mixtures and also explosive metal azides when combined with non-
ferrous metals (e.g. copper, brass, bronze)!
Decontamination with hydrogen peroxide (H2O2)
Decontamination of the freeze-dryer with hydrogen peroxide (H2O2) in
combination with an H2O2steam generator is only permissible if the freeze-
dryer is equipped with the following:
•key switch for H2O2operation,
•removable handles,
•flange connections with specially secured locks on the chamber,
•adapted control system.

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The following features are not permissible or must be deactivated:
•omission of the LyoCoN process or removal of the LyoCoN reservoir
and secured sealing of the access opening.
Otherwise, there is a risk of personal injury. Consultation of Martin Christ
Gefriertrocknungsanlagen GmbH is absolutely mandatory in order to define
the measures that need to be taken!
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 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.
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 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, with the exception of
commercially available freeze-drying vessels made of glass or plastic;
•use of the freeze-dryer with concentrated solvents;
•freeze-drying of products that may react during the freeze-drying
process following the supply of high amounts of energy;
•freeze-drying of products that may damage the material of the chamber
walls, shelves, pipes, or seals, or that may affect the mechanical
strength.
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1.4 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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1.5 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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1.6 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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1.7 Standards and regulations
EC declaration of conformity in accordance with the EC Machinery
Directive and EC declaration in accordance with the Pressure Equipment
Directive (see chapter 11.2 - "EC declaration of conformity in accordance
with the EC Machinery Directive" and chapter 11.3 - "EC declaration of
conformity in accordance with the Pressure Equipment Directive").
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1.8 Scope of supply
The scope of supply comprises:
•1 tube of high-vacuum grease
•1 operating manual
In addition, if a vacuum pump is included:
•1 litre of vacuum pump oil
•1 drain hose 0.5 m
•1 hexagon socket key or combination spanner
(depending on the brand of the vacuum pump)
In addition, if the special equipment of a stainless-steel door latch at the
loading door is included:
•1 slide pad for the door latch (part no. 177270, chapter 8.1.2.2 -
"Special equipment: Stainless steel door latch at the loading door")
Accessories and commissioning
According to your order, our order confirmation, and our delivery note.
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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 Option: sealing
device with manifold
2 Control system
3 Drying chamber with
loading door and door
latch
Fig. 1: Overview of the freeze-dryer

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4 Connections for the
product sensors and a
LyoRX sensor
5 Shelf
6 Ice condenser
7 Defrosting water
collecting tray
Fig. 2: Detailed view A –drying chamber
8 Mains switch
Fig. 3: Right side of the freeze-dryer

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9 Aeration valve
10 Access flange DN40
(e.g. for weighing
device, behind the
side panel)
Fig. 4: Left side of the freeze-dryer
11 Name plate
12 Electrical connection
of the vacuum sensor
13 Ethernet interface
14 Heat exchanger for
the heat transfer
medium
(behind the panel)
15 Vacuum flange
Standard:
Air-cooled freeze-dryer
Fig. 5: Rear view of an air-cooled freeze-dryer

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16 Connector for the
cooling water outlet
17 Connector for the
cooling water inlet
Special equipment:
water-cooled freeze-dryer
Fig. 6: Rear view of a water-cooled freeze-dryer
18 Vacuum sensor
connection
19 Internal fuse
20 Power supply of the
pressure control valve
21 Power supply of the
vacuum pump
22 Automatic circuit
breaker 1F1
23 Equipotential bonding
screw
Fig. 7: Detailed view B –Connections on the rear side of the freeze-dryer
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2 Layout and mode of operation
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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. 8: Example of a name plate (here: Epsilon 2-4 LSCplus)
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Freeze-dryer Epsilon 1-4 LSCplus
Freeze-dryer Epsilon 2-4 LSCplus
2 Layout and mode of operation
Version 04/2014, Rev. 2.13 of 01/12/2021 • sb
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Translation of the original operating manual
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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.

Freeze-dryer Epsilon 1-4 LSCplus
Freeze-dryer Epsilon 2-4 LSCplus
2 Layout and mode of operation
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Version 04/2014, Rev. 2.13 of 01/12/2021 • sb
Translation of the original operating manual
Fig. 9: 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.