Martin Christ Epsilon 2-6D LSCplus User Manual

Name: Martin Christ Epsilon 2-6D LSCplus
Brand: Martin Christ
SKU: 1715370
Rating: 4.7 (3 reviews)

4.7 (3)

Operating Manual

Freeze-dryer

EPSILON 2-6 LSCplus

Part no. 113100, 113120

Freeze-dryer EPSILON 2-6 LSCplus

Version 10/2012, Rev. 1.6 of 16/12/2014 • sb

Translation of the original operating manual

Freeze-dryer EPSILON 2-6 LSCplus

In case of inquiries, please state the following numbers:

Order number

Serial number

Martin Christ Gefriertrocknungsanlagen GmbH An der Unteren Söse 50

37520 Osterode am Harz Germany

Tel.: +49 (0) 5522 / 5007-0

Fax: +49 (0) 5522 / 5007-12

Web: www.martinchrist.de

E-mail: info@martinchrist.de

Version 10/2012, Rev. 1.6 of 16/12/2014 • sb

Translation of the original operating manual

				Freeze-dryer EPSILON 2-6 LSCplus
				Table of contents

1	General information.............................................................................................................			9
1.1	Importance of the operating manual..................................................................................			9
1.2	Intended use.....................................................................................................................			9
1.3	Warranty and liability.......................................................................................................			10
1.4	Copyright ........................................................................................................................			10
1.5	Explanation of symbols ...................................................................................................			10
1.6	Standards and regulations ..............................................................................................			10
1.7	Scope of supply ..............................................................................................................			11
2	Layout and mode of operation..........................................................................................			12
2.1	Layout of the freeze-dryer ...............................................................................................			12
2.1.1		Functional and operating elements ............................................................................		12
2.1.2		Name plate ................................................................................................................		16
2.2	Mode of operation...........................................................................................................			17
2.2.1		General information on freeze-drying.........................................................................		17
2.2.2		Freeze-drying process ...............................................................................................		19
	2.2.2.1		Preparation ........................................................................................................	19
	2.2.2.2		Freezing.............................................................................................................	20
	2.2.2.3		Main drying ........................................................................................................	21
	2.2.2.4		Final drying ........................................................................................................	21
	2.2.2.5		End of drying and aeration .................................................................................	22
	2.2.2.6		Defrosting ..........................................................................................................	22
3	Safety..................................................................................................................................			23
3.1	Marking of the unit ..........................................................................................................			23
3.2	Explanation of the symbols and notes.............................................................................			24
3.3	Responsibility of the operator..........................................................................................			25
3.4	Operating personnel .......................................................................................................			25
3.5	Informal safety instructions .............................................................................................			25
3.6	Safety instructions...........................................................................................................			26
3.6.1		Electrical safety .........................................................................................................		26
3.6.2		Mechanical safety......................................................................................................		27
	3.6.2.1		Pressure relief device.........................................................................................	27
3.6.3		Fire prevention...........................................................................................................		28
3.6.4		Thermal safety...........................................................................................................		28
3.6.5 Chemical and biological safety...................................................................................				28
3.7	Safety devices ................................................................................................................			29
3.7.1		System check ............................................................................................................		29
3.8	Procedures in the event of hazards and accidents..........................................................			29
3.9	Remaining hazards.........................................................................................................			30

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Table of contents

4	Storage and transport .......................................................................................................	31
4.1	Dimensions and weight...................................................................................................	31
4.2	Storage conditions ..........................................................................................................	31
4.3	Notes on transport ..........................................................................................................	31
4.4	Packaging.......................................................................................................................	32
4.5	Transport safety devices.................................................................................................	33
4.6	On-site transport .............................................................................................................	33


5	Set-up and connection ......................................................................................................			34
	5.1	Installation site ................................................................................................................		34
	5.2	Power supply ..................................................................................................................		34
	5.2.1		Connection ................................................................................................................	34
	5.2.2		Customer-provided fuses...........................................................................................	34
	5.3	Drying cartridge (adsorption filter) ...................................................................................		35
	5.4	Vacuum sensor...............................................................................................................		36
	5.5	Operation of the loading door..........................................................................................		37
	5.6	Aeration valve .................................................................................................................		38
	5.7	Media drain valve............................................................................................................		39
	5.8	Special equipment: Precision control needle valve for air injection..................................		39
	5.9	Vacuum pump.................................................................................................................		39
	5.10	Pressure control valve ....................................................................................................		40
	5.11	Rubber valves.................................................................................................................		41


6	Operation		............................................................................................................................	42
6.1	Initial start ..................................................................................................................-up			42
6.2	Installation ...............................................................................................of accessories			42
6.3	Preparation .....................................................................................................................			42
6.4	Switching .........................................................................................the freeze-dryer on			42
6.5	LSCplus ..................................................................................................control system			43
6.5.1		User ............................................................................................................interface		43
	6.5.1.1 .......................................................................................		Main window "Manual"	44
	6.5.1.2 .....................................................................................		Main window "Program"	52
	6.5.1.3 ......................................................................................		Main window "Options"	53
	6.5.1.4 .................................................................................................		Main window "?"	67
6.5.2		Manual .................................................................................................freeze-drying		67
	6.5.2.1 .............................................................		Entering set values in the manual mode	68
6.5.3 Freeze ...............................................-drying with the PGMplus programmer module				70
	6.5.3.1 ............................................................................................		Creating a program	73
	6.5.3.2 ...............................................................................................		Editing a program	82
	6.5.3.3 ............................................................................................		Copying a program	82
	6.5.3.4 .............................................................................................		Loading a program	82
	6.5.3.5 ............................................................................................		Deleting a program	84
6.6	Optional ....................................................................extensions and special equipment			85
6.7	Switching ......................................................................................the freeze-dryer OFF			87

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				Table of contents

7	Malfunctions and error correction....................................................................................				88
7.1		General malfunctions ......................................................................................................			88
7.1.1			Power failure..............................................................................................................		89
7.1.2			Insufficient vacuum ....................................................................................................		90
	7.1.2.1			Small flange connections ...................................................................................	90
	7.1.2.2			Aeration valve, media drain valve.......................................................................	91
	7.1.2.3			Pressure control valve........................................................................................	91
	7.1.2.4			Rubber valves....................................................................................................	91
	7.1.2.5			Vacuum sensor ..................................................................................................	91
7.1.3			Insufficient ice condenser temperature ......................................................................		92
7.2		Process and error messages ..........................................................................................			92
7.3		Service contact ...............................................................................................................			93
8	Maintenance and service...................................................................................................				94
8.1		Maintenance ...................................................................................................................			94
8.1.1			Freeze-dryer..............................................................................................................		94
	8.1.1.1			Ice condenser chamber......................................................................................	95
	8.1.1.2			Special equipment: Stainless steel door latch at the loading door ......................	95
	8.1.1.3			Aeration valve, media drain valve.......................................................................	96
	8.1.1.4			Heat exchanger (only air cooled freeze-dryers)..................................................	96
8.1.2			Vacuum pump ...........................................................................................................		97
8.1.3 Exhaust filter (oil mist separator)................................................................................					97
8.1.4			Vacuum sensor..........................................................................................................		98
8.1.5			Accessories ...............................................................................................................		98
8.2		Disinfection of the drying chamber and accessories........................................................			99
8.3		Maintenance schedule ..................................................................................................			100
8.4		Service..........................................................................................................................			102
8.5		Return of defective parts...............................................................................................			102
9	Disposal............................................................................................................................				104
9.1		Disposal of the freeze-dryer ..........................................................................................			104
9.2		Disposal of the packaging .............................................................................................			104
10	Technical data..................................................................................................................				105
10.1		Ambient conditions........................................................................................................			107
10.2		Technical documentation ..............................................................................................			107
11	Appendix ..........................................................................................................................				108
11.1		Mathematical relations ..................................................................................................			108
11.2		EC-Declaration of conformity ........................................................................................			109
11.3 Resistance to stress cracking and chemical influences "Plexiglas" ...............................					111
12	Glossary ...........................................................................................................................				129
13	Index		.................................................................................................................................		131

Version 10/2012, Rev. 1.6 of 16/12/2014 • sb

Translation of the original operating manual

Freeze-dryer EPSILON 2-6 LSCplus

Table of contents

Version 10/2012, Rev. 1.6 of 16/12/2014 • sb

Translation of the original operating manual

Freeze-dryer EPSILON 2-6 LSCplus

1 General information

1.1Importance 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.

1.2Intended use

CHRIST freeze-dryers have been solely designed for the freeze-drying of solid or liquid products in ampoules, vials or dishes. They are, therefore, solely intended for these applications.

The freeze-dryer is suitable

•for freeze-drying materials such as bacteria and virus cultures, blood plasma, serum fractions, antibodies, sera, vaccines, and pharmaceutical products

•for freeze-drying plant extracts, e.g. for biochemical tests

•for freeze-drying inorganic materials, e.g. nanoparticles

•for freeze-drying numerous other products (for further information please contact our qualified personnel)

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 the notes and instructions included in the operating manual

•compliance with the inspection and maintenance instruction

•prohibition of any type of extensions to, or conversions of the unit.

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1 General information

1.3Warranty 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.

1.4Copyright

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.

1.5Explanation of symbols

In this operating manual, specialist terms that are explained in the glossary are marked by an arrow and printed in italics (e.g. sublimation).

1.6Standards and regulations

EC declaration of conformity (see chapter 11.2 - "EC-Declaration of conformity").

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1 General information

1.7Scope of supply

The scope of supply comprises:

•1 tube of high-vacuum grease

•1 litre of vacuum pump oil (only if a pump is included)

•1 set of flange components and several small parts for service and maintenance purposes

•1 drain hose 0.5 m (silicone 8 x 12 mm)

•1 operating manual

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 8.1.1.2 - "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

2.1Layout of the freeze-dryer

2.1.1Functional and operating elements

1 Option: sealing device

2 Control system

3 Drying chamber with loading door

4 Vacuum pump

Fig. 1:

Front of the freeze-dryer

5 Connections for the product sensors

6 Connection for the intermediate valve

7 Intermediate valve

8 Shelves

Fig. 2:

Detailed view A – drying chamber

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2 Layout and mode of operation

9 Option: Precision control needle valve for air injection

10 Pressure control valve

Fig. 3:

Detailed view B - vacuum pump

11 Mains switch

12 Steerable castors

Fig. 4:

Right side of the freeze-dryer

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Freeze-dryer EPSILON 2-6 LSCplus

2 Layout and mode of operation

13 Sight glass of the ice condenser

14 Aeration valve

15 Vacuum sensor (behind the side panel

16 Access flange DN40 (e.g. for weighing device, behind the side panel)

17 Media drain valve

18 Fixed castors

Fig. 5:

Left side of the freeze-dryer

Air-cooled freeze-dryer:

19 Sight glass for the heat transfer medium

20 Connection valve for the adsorption filter

21 Name plate

22 Mains switch

23 Ethernet interface

24 Heat exchanger for the heat transfer medium

(behind the panel) 25 Mains cable

26 Heat exchanger of the refrigeration unit (behind the panel)

27 Option: Access flange

28 Vacuum flange

Fig. 6:

Rear view of an air-cooled freezedryer

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2 Layout and mode of operation

Water-cooled freeze-dryer:

29Cooling water connection (see detailed view)

Fig. 7:

Rear view of a water-cooled freeze-dryer

30 Connector for the cooling water outlet

31 Connector for the cooling water inlet

Fig. 8:

Detailed view C -

cooling water connections

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2 Layout and mode of operation

2.1.2Name plate

1	Manufacturer
2	Registered office
3	Type
4	Serial number
5	Nominal power
6	Nominal voltage
7	Rated current
8	Degree of
	interference
	suppression
9 Refrigerant data of
	RM 1, 1st stage
10	Refrigerant data of
	RM 1, 2nd stage
11	Refrigerant data of
	RM 2
12	Part number
13	Year of manufacture
	(month/year)
14	Country of origin

Fig. 9: Example of a name plate (enlarged photo)

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2 Layout and mode of operation

2.2Mode of operation

2.2.1General information on freeze-drying

What is freeze-drying?

Freeze-drying or lyophilisation is a procedure for the gentle drying of highquality products. The product is dried by sublimation without passing through the liquid phase.

What are typical applications for freeze-drying?

As far as their sheer quantity is concerned, foodstuffs are the major application for freeze-drying. One widely known example is the production of granulated instant coffee or the drying of fruit, e.g. for breakfast cereals. Other areas of application are the restoration of water-damaged documents or the drying of archaeological artefacts.

Another 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 above ice 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).

•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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2 Layout and mode of operation

Pressure

(mbar)

t r

LIQUID

i u

o c

p e

i s

t s

M p

SOLID

Melting

Evaporation

6.11 mbar

B Sublimation

Triple point

0.37 mbar

GASEOUS

-30°C

Temperature (°C)

Fig. 10: Vapour pressure curve above ice

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 deepfreeze. 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 above ice.

(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.

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2 Layout and mode of operation

Pressure

(mbar)

LIQUID

1 bar

o c

i s

SOLID

t s

e r

M p

Triple point

r p

GASEOUS

20°C

Temperature (°C)

Fig. 11: Freeze-drying phases

Please find further information about basic principles, optimum procedures and applications in the brochure "Smart freeze-drying", which can be downloaded at www.martinchrist.de [Applications].

NOTE

2.2.2Freeze-drying process

The main components of a freeze-dryer are:

•vacuum drying chamber with a temperature control system for adding thermal energy

•vacuum pump for generating a vacuum inside the drying chamber

•ice condenser for binding the water vapour that is released by the product.

2.2.2.1Preparation

The ice condenser chamber must be clean and dry. Any water residues from a preceding drying run must be removed.

The media drain valve and the aeration valve must be closed.

In the case of units that are equipped with a pressure control valve (standard on LSCplus units), the vacuum pump should be warmed up (“warm-up”) for at least 15 minutes prior to the start of the main drying phase. Do not subject the vacuum pump to condensable gases until the operating temperature is reached. In this way, the service life of the vacuum pump can be extended.

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2 Layout and mode of operation

At the same time, the ice condenser is pre-cooled ("cool-down"). The ice condenser temperature does not have any influence on the product temperature. The sole purpose of the ice condenser is to bind the released water vapour.

2.2.2.2Freezing

First, the product that is to be dried is frozen. This can be carried out either directly in the freeze-dryer or in a separate deep-freeze. Especially in the case of small filling quantities, we recommend pre-cooling the shelves as well in order to prevent the product from thawing during the evacuation.

Two very different structures of the frozen material can be distinguished:

•crystalline structures with clearly distinguishable crystals

•amorphous structures with no crystal junctions at all (e.g. glass) The majority of the freeze-drying products have a crystalline form.

When freezing these kinds of products, one must take into consideration that too deep and too quick freezing leads to smaller ice crystals, which has a negative effect on the duration of the drying process.

For every product to be dried, the solidification point must be determined as a first step. This is the point at which the water that is contained in the product has completely crystallised. In order to ensure an optimum freezedrying process, the product temperature should be approximately 10°C below the solidification point.

A layer thickness of the product of 1-2 cm should not be exceeded, since otherwise the drying duration would be negatively affected. If liquids are to be dried in bottles with a layer thickness of more than 1 cm, we recommend freezing them in a cooling bath with the aid of a shell or spin freezing device (see figure). Due to the centrifugal force, the liquid to be frozen will rise on the inner wall of the bottle and freeze. This procedure reduces the layer thickness and, thereby, the total drying time will be shortened to a considerable extent (see figures on the right side).

Fig. 12: Shell freezing

Fig. 13: Cooling bath with spin freezing device

Fig. 14: Spin freezing

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2 Layout and mode of operation

	If the product that is to be dried contains solvents or high salt
	concentrations, it may start to thaw during the drying process, which is
	indicated by clearly visible foaming. In order to prevent this, the product
	must be frozen as deeply as possible, e.g. with the aid of liquid nitrogen,
NOTE	prior to putting it into the unit.

2.2.2.3Main drying

When the product is frozen to a sufficiently deep extent, the main drying phase commences. The vacuum pump is switched on. 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 above ice. At the same time, thermal energy will be added to the product. In the case of products in round-bottom flasks, wide-neck bottles, etc., this is realised through the environment that is considerably warmer (direct contact heat), in the case of unheated shelves by way of thermal radiation from the environment, and in the case of temperature-controlled shelves directly via the shelves. As a result, the sublimation process starts.

At the beginning of the drying process, the maximum drying rate will be reached. The more the sublimation area recedes into the product, the further the produced water vapour must pass through the layers that have already been dried.

Under certain conditions, it is possible that the vacuum inside the ice condenser chamber increases during the main drying phase (e.g. from 0.63 mbar to 0.47 mbar) although the valve towards the vacuum pump is closed. From a physical point of view, this is due to the pumping effect of the ice condenser ("cryo-pumping effect").

The required drying time depends strongly on the drying vacuum. At 1.0 mbar, one gram of ice takes up a volume of 1 m3 of vapour, at 0.1 mbar a volume of 10 m3 of vapour, and at 0.001 mbar a volume of 100 m3. The closer the vacuum is to the solidification point, the smaller is the resulting vapour volume. The drying rate increases and the drying time decreases.

The end of the main drying phase is reached, when the product temperature and the shelf temperature are nearly identical. The temperature difference between the shelf and the product should be approximately 3 K to 5 K.

2.2.2.4Final drying

Final drying is an option whenever one requires a product with minimal residual moisture. In the physical sense, this process is a desorption process, i.e. the removal of adsorptively bound water. Final drying is performed under the lowest possible final pressure that depends on the ice condenser temperature in accordance with the vapour pressure curve above ice as well as on the final vacuum of the vacuum pump that is used. The process is supported by a higher shelf temperature.

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2 Layout and mode of operation

2.2.2.5End of drying and aeration

The end of the drying process is reached when both the product and shelf temperature are clearly in the positive range (+15 to +20°C) and if their difference is not greater than 5 K.

Another indication of the end of the drying process is the behaviour of the vacuum and of the ice condenser temperature. The ice condenser is no longer subject to load and reaches the final temperature of approximately - 55°C or -85°C. The pressure in the drying chamber decreases in accordance with the ice condenser temperature.

The vacuum pump will be switched off and the drying chamber will be aerated via a rubber valve or via the aeration valve. The aeration valve can also be used to flood the unit with nitrogen or another inert gas instead of ambient air.

Then, the product can be removed from the unit.

2.2.2.6Defrosting

Defrosting with hot gas

As standard, the freeze-dryer is equipped with a hot-gas defrosting system. In order to defrost the ice condenser, heated refrigerant is fed through the heating coil. In addition, the bottom of the ice condenser chamber is heated by way of a heating collar.

In order to avoid damage, the condensate must be drained off through the media drain valve directly after the completion of the defrosting process. Then, any residual water must be removed from the ice condenser chamber by way of a cloth.

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3 Safety

3.1Marking of the unit

The following symbols are used for CHRIST freeze-dryers:

Gefährliche elektrische Spannung

Dangerous voltage

Courant haute tension

Achtung, Betriebsanleitung lesen

Attention, consult the instruction manual

Attention, consulter le mode d'emploi

Ein (Netzverbindung)

On (Power)

Marche (mise sous tension)

Aus (Netzverbindung)

Off (Power)

Arrêt (mise hors tension)

Schutzleiteranschluss

Protective earth (ground)

Raccord à la terre

Erde

Earth (ground)

Terre

Netzstecker ziehen

Unplug the mains plug

Débrancher la prise

Vorsicht Quetschgefahr

Caution! Risk of bruising

Attention ! Risque de blessure

Drehrichtungspfeil

Arrow indicating the direction of rotation

Flèche de sens de rotation

Heiße Oberfläche

Hot surface

Surface chaude

CE-Zeichen gemäß Richtlinie 2006/42/EG

CE mark in compliance with the directive 2006/42/EC Symbole CE conforme à la directive 2006/42/CE

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3 Safety

3.2Explanation of the symbols and notes

DANGER

WARNING

CAUTION

This operating manual uses the following names and symbols to indicate hazards:

This symbol stands for a direct hazard to the life and health of persons.

Non-observance of these symbols causes serious health problems up to life-endangering injuries.

This symbol stands for a direct hazard to the life and health of persons due to electrical voltage.

Non-observance of these symbols causes serious health problems up to life-endangering injuries.

This symbol stands for a potential hazard to the life and health of persons.

Non-observance of these symbols can cause serious health problems up to life-endangering injuries.

This symbol indicates a potentially hazardous situation

Non-observance of these notes can cause minor injuries or damage to property.

This symbol indicates important information.

NOTE

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3.3Responsibility of the operator

The operator is responsible to authorise only qualified personnel to work on the freeze-dryer (see chapter 3.4 - "Operating personnel").

The areas of responsibility of the personnel concerning the operation, maintenance, and care of the unit must be clearly defined.

The safety-conscious work of the personnel in compliance with the operating manual and the relevant EC and national health and safety regulations as well as with the accident prevention regulations must be checked at regular intervals (e.g. every month).

The operator is responsible to check the chemical compatibility of all substances to be used inside the freeze-dryer (product to be processed, cleaning media, etc.) with the material of the chamber walls, shelves, pipes, and gaskets. Substances that may damage the material an degrade the mechanical strength must not be used.

The freeze-dryer has to be maintained regularly (see chapter 8 - "Maintenance and service").

Components that are not in a perfect state must be replaced immediately.

3.4Operating personnel

Persons operating the unit must

•be familiar with the fundamental regulations concerning workplace safety and accident prevention

•have read and understood this operating manual (and in particular the safety sections and warning notes) and confirmed this with their signature.

3.5Informal safety instructions

This operating manual is a part of the product.

•The operating manual must be kept at the location of use of the freezedryer. Ensure that it is accessible at all times.

•The operating manual must be handed over to any subsequent owner or operator of the freeze-dryer.

•Any changes made must be added to the operating manual.

•In addition to the operating manual, the general and local rules and regulations concerning the prevention of accidents and the protection of the environment must also be supplied.

•Safety and danger indications on the freeze-dryer must be kept readable at all times. If necessary, they must be replaced.

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3 Safety

3.6Safety instructions

The following instructions must be observed prior to every drying process:

			• Ensure that the freeze-dryer was set up and connected properly (see
			chapter 5 - "Set-up and connection").
			• Connections to customer-provided pipes must be forceand torque-
			free.
	WARNING		free.
	WARNING		• Maintain a safety distance of at least 30 cm (12 inches) around the
			freeze-dryer.

•Do not store any dangerous goods in the safety area of the freezedryer.

•Do not stay in the safety area longer than what is absolutely necessary for the operation of the freeze-dryer.

•Only use accessories that have been approved by the manufacturer (except for commercial vessels made of glass or synthetic materials). We explicitly warn against the use of equipment of poor quality. Breaking glass or bursting vessels can cause dangerous situations.

•Observe the instructions on the installation of accessories (see the separate document).

3.6.1Electrical safety

CHRIST freeze-dryers are units of safety class I. Please comply with the following points in order to preserve the safety features:

			• Ensure that the local mains voltage matches the nominal voltage that is
			stated on the name plate.
			• Do not place any dangerous material, e.g. glass vessels containing
			liquid substances, within the safety area of 30 cm around the freeze-
	DANGER		dryer. Spilled liquids may get into the freeze-dryer and damage the
	DANGER		electrical or mechanical components.
			electrical or mechanical components.
			• Work on the power supply system must only be performed by certified
			electricians.
			• Inspect the electrical equipment of the unit regularly. Defects such as
			loose or burnt cables must be eliminated immediately.

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3.6.2Mechanical safety

In order to ensure the safe operation of the freeze-dryer, please comply with the following points:

		• Do not use the freeze-dryer if it was installed incorrectly.
		• Do not use the freeze-dryer without panels.

		• Do not use the freeze-dryer with accessories that shows signs of
WARNING		damage.
WARNING		• Only use the freeze-dryer with accessories that have been approved by

		the manufacturer. In case of doubt, contact the manufacturer (see
		chapter 7.3 - "Service contact").

•Do not hit or move the freeze-dryer during its operation.

•Do not lean against or rest on the freeze-dryer during its operation.

•Check the freeze-dryer and the accessories before every start-up for any visible signs of damage.

•Do not dry any substances that could damage the material of the ice condenser chamber, drying chamber, lid, or accessories in any way, e.g. highly corrosive substances such as hydrogen chloride (HCl).

•Stop the freeze-dryer immediately in the event of a malfunction. Eliminate the malfunction (see chapter 7 - "Malfunctions and error correction") or contact the after-sales service of Firma Martin Christ Gefriertrocknungsanlagen GmbH (see chapter 7.3 - "Service contact").

•Ensure that all repairs are performed only by authorised and specialised personnel.

3.6.2.1Pressure relief device

			The double chamber is designed for vacuum. It is not a pressure vessel!
			In order to prevent dangerous excess pressure from building up, the
			customer must install a safety device for the aeration with gases under
	DANGER		pressure.
	DANGER		Non-compliance will cause severe up to life-threatening injuries when the
			chamber bursts!

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3.6.3Fire prevention

Fuses protect certain electrical circuits within the freeze-dryer against overcurrent conditions.

• Always use fuses of the same type and rating.

• Do not dry explosive or inflammable substances.

• Do not use the freeze-dryer within hazardous locations where there is a

risk of explosion.

DANGER

3.6.4Thermal safety

During the operation of the freeze-dryer, the ice condenser can reach surface temperatures of –85°C depending on the power.

•Wear suitable protective gloves when installing or removing accessories. Do not reach into the ice condenser chamber without this protection – your limbs may freeze onto the chamber walls!

DANGER

3.6.5Chemical and biological safety

	If infectious, toxic, pathogenic, or radioactive substances are intended to be
	dried, it is in the responsibility of the user to ensure that all necessary
	safety regulations, guidelines, precautions, and practices are adhered to
	accordingly.

	• Infectious, toxic, pathogenic, and radioactive substances must be dried
	in suitable accessories. Take suitable precautions for your own safety!
	• Do not dry products with a high solvent concentration or acidic
	products without special protective measures or device-based
DANGER	precautions (e.g. an additional cooling trap to protect the vacuum
	pump). It is absolutely necessary to consult the manufacturer in these
	cases (see chapter 7.3 - "Service contact").
	• Special caution is necessary when handling azides, as a dangerous
	explosive develops in combination with copper or nonferrous metals! It
	is absolutely necessary to contact the manufacturer (see chapter 7.3 -
	"Service contact").

	• Keep informed about local measures to avoid harmful emissions
	(depending on the substances to be dried).
	• As personal protective equipment, safety gloves are required for the
	use of the freeze-dryer.
WARNING	The materials to be dried may, however, require additional special
	safety measures (e.g. drying of infectious, toxic, radioactive, or
	pathogenic substances)

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3.7Safety devices

3.7.1System check

An internal system check system monitors the data transfer and sensor signals with regard to plausibility. Errors are detected by continuous selfmonitoring of the system. Error messages are displayed in the main window under "Process & equipment messages" (chapter 6.5.1.1 - "Main window "Manual"", chapter 7.2 - "Process and error messages").

3.8Procedures in the event of hazards and accidents

	Fire:
	•	A fire in the electrical control system must be extinguished with a CO2
		fire extinguisher!

	•	Burning oil must be extinguished with a CO2 fire extinguisher or powder
DANGER	•
DANGER		fire extinguisher!

Hazardous electrical incident:

•Set the main switch and the mains power switch of the control system to the "OFF" or "0" position in order to interrupt the power supply completely.

Injuries caused by liquids under higher pressure (e.g. hydraulic oil):

•Liquids that leak out under high pressure, e.g. hydraulic oil, can penetrate the skin and cause severe injuries.

Seek medical treatment immediately! There is a risk of embolism!

Burns:

•Small-area burns (e.g. finger) should be cooled immediately with lukewarm water for approximately 2 minutes.

•Large-area burns should not be cooled because of the resulting risk of hypothermia.

•Cover the burns loosely and in a sterile manner (e.g. with a sterile dressing).

•Cover the injured person with a blanket.

Chemical burns (e.g. caused by H2O2):

•	Eyes:	Rinse for at least 10 minutes with sterilised water.
•	Lungs:	Remove the injured person immediately to fresh air and keep
		them at rest and warm.
•	Skin:	Soak with water, remove clothing.

•Mouth: Rinse thoroughly with water, provide plenty to drink.

IF IN DOUBT, CALL THE EMERGENCY PHYSICIAN (AMBULANCE)!

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Freeze-dryer EPSILON 2-6 LSCplus

3 Safety

3.9Remaining hazards

All CHRIST freeze-dryers were built state-of-the-art and according to the accepted safety rules. Danger to life and limb of the operator, or of third parties, or impairments of the units or other material assets, however, cannot be completely excluded when the units are being used.

Use the freeze-dryer

•only for the purpose that it was originally intended for (see chapter 1.2 - "Intended use") and

•only if it is in a perfect running state.

•Immediately eliminate any problems that can affect safety.

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