Christ Epsilon 2-6D LSCplus User manual

Translation of the original operating manual
sb
Rev. 3.0 of 20/07/2022
Epsilon 2-6D LSCplus; ; ; ;
Version 07/2022
Epsilon 2-6D LSCplus
Part no. 111166
Freeze-dryer
Operating Manual
Read the manual thoroughly before use and retain it for later use!

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Translation of the original operating manual

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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 2-6D LSCplus
Table of contents
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Translation of the original operating manual
1General information.............................................................................................................9
1.1 Importance of the operating manual..................................................................................9
1.2 Further applicable documents...........................................................................................9
1.3 Intended use.....................................................................................................................9
1.3.1 Freeze-drying of solvent-containing products (non-aqueous media)..........................11
1.3.2 Freeze-drying of acid-containing products .................................................................12
1.3.3 Freeze-drying of azide-containing products ...............................................................12
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................................................................................................................19
2.2 Mode of operation...........................................................................................................20
2.2.1 General information on freeze-drying.........................................................................20
2.2.2 Freeze-drying process...............................................................................................22
2.2.2.1 Preparation........................................................................................................22
2.2.2.2 Freezing.............................................................................................................23
2.2.2.3 Main drying........................................................................................................23
2.2.2.4 Final drying........................................................................................................24
2.2.2.5 End of drying and aeration.................................................................................24
2.2.2.6 Defrosting ..........................................................................................................24
3Safety..................................................................................................................................25
3.1 Marking of the unit..........................................................................................................25
3.2 Explanation of the symbols and notes.............................................................................26
3.3 Responsibility of the operator..........................................................................................27
3.3.1 Freeze-drying of solvent-containing products.............................................................28
3.4 Requirements concerning the personnel.........................................................................29
3.5 Informal safety notes.......................................................................................................30
3.6 Safety notes concerning the transport, set-up and connection and initial start-up of the
freeze-dryer....................................................................................................................30
3.6.1 General hazards........................................................................................................30
3.6.2 Hazards caused by improper transport......................................................................31
3.6.3 Hazards caused by improper set-up..........................................................................31
3.6.4 Hazards caused by improper connection...................................................................31
3.6.5 Hazards during the initial start-up ..............................................................................31

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3.7 Safety notes concerning the operation............................................................................32
3.7.1 Hazards caused by electricity ....................................................................................32
3.7.2 Hazards caused by natural, flammable refrigerants...................................................32
3.7.3 Hazards caused by nitrogen......................................................................................33
3.7.4 Hazards caused by harmful products.........................................................................33
3.7.5 Hazards caused by solvents in the products..............................................................33
3.7.6 Hazards caused by acids in the products...................................................................34
3.7.7 Hazards caused by azides in the products.................................................................34
3.7.8 Hazards caused by contaminated condensate (defrosting water)..............................35
3.7.9 Oil-sealed vacuum pump: hazards caused by contaminated vacuum pump exhaust
gases.........................................................................................................................35
3.7.10 Oil-sealed vacuum pump: hazards caused by hot and contaminated vacuum pump oil
..................................................................................................................................36
3.7.11 Dry-running vacuum pump: hazards caused by contaminated exhaust air.................36
3.7.12 Hazards caused by noise...........................................................................................36
3.7.13 Hazards caused by the loading door..........................................................................37
3.7.14 Hazards caused by shelves.......................................................................................37
3.7.15 Hazards caused by hot surfaces................................................................................37
3.7.16 Hazards caused by cold surfaces..............................................................................37
3.7.17 Hazards caused by overpressure in the chamber......................................................38
3.8 Safety devices ................................................................................................................38
3.9 Procedures in the event of hazards and accidents..........................................................39
3.10 Maintenance and cleaning of the freeze-dryer ................................................................40
3.11 Additions or conversions of the freeze-dryer...................................................................40
3.12 Measures to be taken to ensure safe operation of the freeze-dryer.................................41
3.13 Remaining hazards.........................................................................................................42
4Storage and transport ....................................................................................................... 43
4.1 Dimensions and weight...................................................................................................43
4.2 Storage conditions..........................................................................................................43
4.3 Unpacking the freeze-dryer.............................................................................................44
4.4 Transport........................................................................................................................45
4.4.1 Transport safety devices............................................................................................46
5Set-up and connection ...................................................................................................... 47
5.1 Installation site................................................................................................................47
5.2 Supply and disposal connections....................................................................................48
5.2.1 Power supply.............................................................................................................48
5.2.1.1 Connection.........................................................................................................48
5.2.1.2 Customer-provided fuses...................................................................................48
5.2.2 Aeration.....................................................................................................................49
5.2.3 Drain..........................................................................................................................49
5.2.4 Vacuum pump ...........................................................................................................50
5.2.4.1 Oil-sealed vacuum pump and exhaust filter (oil mist separator) .........................50
5.2.4.2 Dry-running vacuum pump and silencer.............................................................51

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5.2.5 Pressure control valve...............................................................................................52
5.2.6 Vacuum sensor..........................................................................................................53
5.2.7 Drying cartridge (adsorption filter)..............................................................................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
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 "?".................................................................................................88
6.6.2 Manual freeze-drying.................................................................................................88
6.6.2.1 Entering set values in the manual mode.............................................................89
6.6.3 Freeze-drying with the PGMplus programmer module...............................................91
6.6.3.1 Creating a program............................................................................................95
6.6.3.2 Editing a program.............................................................................................103
6.6.3.3 Copying a program ..........................................................................................104
6.6.3.4 Loading a program...........................................................................................104
6.6.3.5 Deleting a program ..........................................................................................105
6.7 Optional extensions and special equipment..................................................................106
6.8 Switching the freeze-dryer OFF....................................................................................109
7Malfunctions and error correction.................................................................................. 110
7.1 General malfunctions....................................................................................................110
7.1.1 Power failure............................................................................................................111
7.1.2 Insufficient vacuum..................................................................................................112
7.1.2.1 Small flange connections.................................................................................112
7.1.2.2 Aeration valve, media drain valve ....................................................................113
7.1.2.3 Pressure control valve......................................................................................113
7.1.2.4 Vacuum sensor................................................................................................113
7.1.3 Insufficient ice condenser temperature ....................................................................114
7.2 Process and error messages........................................................................................114
7.3 Service contact.............................................................................................................115

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8Maintenance and service................................................................................................. 116
8.1 Maintenance.................................................................................................................116
8.1.1 General....................................................................................................................116
8.1.2 Ice condenser chamber ...........................................................................................118
8.1.3 Drying chamber.......................................................................................................118
8.1.3.1 Lamination of the loading door with a special film ............................................118
8.1.3.2 Door latch ........................................................................................................119
8.1.4 Aeration valve, media drain valve............................................................................120
8.1.5 Heat exchanger (only air-cooled freeze-dryers).......................................................121
8.1.6 Electrical system......................................................................................................121
8.1.7 Vacuum system with an oil-sealed vacuum pump....................................................122
8.1.8 Vacuum system with a dry-running vacuum pump...................................................123
8.1.9 Refrigeration system................................................................................................124
8.1.10 Heat transfer medium system..................................................................................124
8.1.11 Vacuum sensor........................................................................................................125
8.1.12 Accessories.............................................................................................................125
8.2 Disinfection of the drying chamber and accessories .....................................................126
8.3 Maintenance schedule (oil-sealed vacuum pump) ........................................................127
8.4 Maintenance schedule (dry-running vacuum pump)......................................................132
8.5 Service .........................................................................................................................137
8.6 Return of defective parts...............................................................................................137
9Disposal............................................................................................................................ 139
9.1 Disposal of the freeze-dryer..........................................................................................139
9.2 Disposal of the packaging.............................................................................................139
10 Technical data.................................................................................................................. 140
10.1 Ambient conditions .......................................................................................................141
10.2 Technical documentation..............................................................................................141
11 Appendix.......................................................................................................................... 142
11.1 Mathematical relations..................................................................................................142
11.2 EC declaration of conformity in accordance with the EC Machinery Directive...............143
11.3 EC declaration of conformity in accordance with the Pressure Equipment Directive .....145
11.4 Table of the sublimation pressure curve........................................................................147
12 Glossary........................................................................................................................... 149
13 Index................................................................................................................................. 151

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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
Freeze-dryer
Do not use the freeze-dryer unless the following requirements are fulfilled:
•The freeze-dryer has been properly installed.
•The freeze-dryer is in a perfect technical state.
•The freeze-dryer is not located in an area with an explosion hazard.
•No unauthorised design modifications, additions or conversions without
the written approval by Martin Christ Gefriertrocknungsanlagen GmbH
have been performed.
•The vacuum pump used is approved by Martin Christ
Gefriertrocknungsanlagen GmbH. The vacuum pumps approved for this
system are listed in chapter 5.2.4 - "Vacuum pump".
•The accessories used have been approved by Martin Christ
Gefriertrocknungsanlagen GmbH. This does not apply to commercially
available freeze-drying vessels made of glass or plastic.
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.

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All of the process steps that are necessary for freeze-drying as well as any
necessary auxiliary processes (venting, defrosting, draining of media, leak
tests) 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).
The intended use also includes:
•Observation of all of the notes and instructions that are included in the
operating manual (see chapter 1.2 - "Further applicable documents")
•Compliance with the inspection and maintenance instructions (see
chapter 8 - "Maintenance and service").
Exclusion of liability
Any use of the freeze-dryer other than the one described here or any use
going beyond this description is regarded as improper use. Martin Christ
Gefriertrocknungsanlagen GmbH cannot be held liable for any damage
resulting from such improper use.
Requirements concerning the products used in the freeze-dryer
•The product must not damage the material of the components of the
freeze-dryer or affect its mechanical strength.
•A reaction of the product following the supply of high amounts of energy
during the freeze-drying process must be excluded.
•The product must not be explosive or highly flammable since certain
components of the freeze-dryer are a potential source of ignition.
NOTE
The additional information concerning special products in the following
chapters must be absolutely observed (see chapter 1.3.1 - "Freeze-drying
of solvent-containing products (non-aqueous media)", chapter 1.3.2 -
"Freeze-drying of acid-containing products", chapter 1.3.3 - "Freeze-
drying of azide-containing products")!
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1.3.1 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.
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!
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1.3.2 Freeze-drying of acid-containing products
Freeze-drying of products containing acids (with the exception of the sub-
stances already listed under chapter 1.3.1 - "Freeze-drying of solvent-
containing products (non-aqueous media)" in the concentrations stated
there) 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!
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1.3.3 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)!
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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
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 Sealing device
2 Control system
3 Drying chamber
with loading door
4 Vacuum pump
(example, see
chapter 5.2.4 -
"Vacuum pump")
Fig. 1: Front of the freeze-dryer (example illustration)

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5 Connection bar for
the product sensors
6 Connection for the
intermediate valve
7 Intermediate valve
8 Door latch (see
chapter 8.1.3.2 -
"Door latch")
9 Shelf
Fig. 2: Detailed view A –drying chamber

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10 Switch cabinet
(behind the side
panel)
11 Mains switch
12 Drying cartridge
(adsorption filter,
chapter 5.2.7 -
"Drying cartridge
(adsorption filter)"
13 Steerable castors
Fig. 3:Right side of the freeze-dryer

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14 Aeration valve
15 Vacuum sensor
(behind the side
panel)
16 Sight glass of the
ice condenser
17 Vacuum connection
18 Standard option:
Precision control
needle valve for gas
injection
19 Access flanges
DN40 (e.g. for
standard option
WTMplus, behind
the side panel)
20 Connection for
standard option
LyoCam
21 Media drain valve
22 Fixed castors
Fig. 4: Left side of the freeze-dryer

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23 Filler neck for the
heat transfer
medium (with
installed drying
cartridge)
24 Main switch
25 Name plate (see
chapter 2.1.2 -
"Name plate")
26 Heat exchanger for
the heat transfer
medium
(behind the panel)
27 Mains cable
28 Heat exchanger of
the refrigeration unit
(behind the panel)
29 Sight glass for the
heat transfer
medium
30 Standard option:
access flange to the
ice condenser
chamber
Fig. 5: Rear view of the freeze-dryer
31 Ethernet connection
32 USB connection (only
in function if the
standard option "USB
process recording" is
installed)
33 Connection for the
standard option
LyoCoN
Fig. 6: Detailed view B –Connections on the rear side of the freeze dryer
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2.1.2 Name plate
1 Serial number
2 Type
3 Refrigerant data of
RM 1, 1st stage
4 Refrigerant data of
RM 1, 2nd stage
5 Nominal voltage
6 Year of manufacture
(month/year)
7 Part number
8 Refrigerant data of
RM 2
9 Rated current /
apparent power
Fig. 7: 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.