Telstar LyoQuest Troubleshooting guide

USER & SERVICE MANUAL
MANUAL DE USUARIO Y MANTENIMIENTO
Laboratory Freeze Dryers
Liofilizadores de laboratorio
LyoQuest
LyoQuest Arctic
DOMINIQUE DUTSCHER SAS

DOMINIQUE DUTSCHER SAS

USER & SERVICE MANUAL
Laboratory Freeze Dryers
LyoQuest
LyoQuest Arctic
DOMINIQUE DUTSCHER SAS

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DOMINIQUE DUTSCHER SAS

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TABLE OF CONTENTS
1. SYMBOLS, ABBREVIATIONS AND STICKERS .................................................... 5
2. GENERAL DATA ................................................................................................
2.1. Aim of this manual ........................................................................................ 6
2.2. Application ................................................................................................... 6
3. DESCRIPTION OF THE FREEZE DRYER .............................................................. 7
3.1. Technical features ......................................................................................... 7
4. INSTALLATION INSTRUCTIONS ....................................................................... 8
4.1. Transport and unpacking................................................................................ 8
4.2. Placing on site .............................................................................................. 8
4.3. Electrical connection ...................................................................................... 9
5. BEFORE START-UP ......................................................................................... 10
5.1. Vacuum pump ............................................................................................ 10
5.2. efrigerating unit ........................................................................................ 11
. DETAILS OF THE FREEZE-DRYER .................................................................... 11
6.1. Description ................................................................................................. 11
7. RECOMMENDATIONS ..................................................................................... 12
7.1. Ice condenser ............................................................................................. 12
7.2. Greasing .................................................................................................... 12
7.3. Long storage .............................................................................................. 12
8. WORKING PRINCIPLE .................................................................................... 13
8.1. Freeze ....................................................................................................... 13
8.2. Lyophilization ............................................................................................. 13
8.2.1. In manifold ........................................................................................... 13
8.2.2. In chamber ........................................................................................... 14
8.2.3. End of the process ................................................................................. 15
8.3. Lyophilization modes ................................................................................... 15
8.4. Selectable processes ................................................................................... 15
9. OPTIONAL ACCESSORIES ............................................................................... 1
9.1. Chambers .................................................................................................. 16
9.2. Manifolds ................................................................................................... 18
9.3. Flasks condensations collector (Drip tray) ...................................................... 18
9.4. Lyologger software ...................................................................................... 19
10. OPERATION AND CONTROL INSTRUCTIONS ................................................ 20
10.1. Start up ..................................................................................................... 20
10.1.1. Main indo ......................................................................................... 20
10.2. Freeze-drying ............................................................................................. 22
10.2.1. Probes ................................................................................................. 23
10.2.2. Recipe .................................................................................................. 23
10.2.3. Semiautomatic cycle .............................................................................. 25
10.3. Auxiliary cycles ........................................................................................... 26
10.3.1. Defrosting ............................................................................................ 26
10.3.2. Alarms ................................................................................................. 27
10.3.3. Alarms list ............................................................................................ 28
10.4. Synoptic .................................................................................................... 29
10.5. Settings ..................................................................................................... 31
10.5.1. Language ............................................................................................. 32
10.5.2. Date/hour ............................................................................................. 32
10.5.3. IP Settings ............................................................................................ 33
10.5.4. Technical Service ................................................................................... 33
10.6. ecipe edition ............................................................................................. 34
10.6.1. Load recipe ........................................................................................... 35
10.7. Users ......................................................................................................... 36
10.7.1. User’s levels ......................................................................................... 36
10.7.2. User login ............................................................................................. 36
10.7.3. Pass ord change ................................................................................... 37
10.7.4. Users management ................................................................................ 38
10.7.5. User’s log out ........................................................................................ 40
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11. MAINTENANCE ............................................................................................ 41
11.1. Cleaning and disinfection of the unit .............................................................. 41
11.1.1. Cleaning ............................................................................................... 42
11.1.2. Disinfection ........................................................................................... 42
11.2. Vacuum unit maintenance ............................................................................ 43
11.3. efrigerating system maintenance ................................................................ 45
11.4. Maintenance table ....................................................................................... 45
12. TROUBLESHOOTING .................................................................................... 4
12.1. Vacuum unit ............................................................................................... 46
12.2. efrigerating unit ........................................................................................ 47
12.3. Freeze-dryer .............................................................................................. 47
13. ANNEXES .................................................................................................... 48
13.1. Equipment spare part codes ......................................................................... 48
13.2. Examples of recipes .................................................................................... 49
13.3. Maintenance records ................................................................................... 50
13.4. Decontamination declaration ........................................................................ 52
13.5. efrigerating system P&ID (LyoQuest -55) ..................................................... 53
13.6. efrigerating system P&ID (LyoQuest -85) ..................................................... 54
13.7. efrigerating system P&ID (LyoQuest Arctic -85) ............................................ 55
13.8. Vacuum system P&ID .................................................................................. 56
13.9. Declaration of conformity ............................................................................. 57
13.10. Accessories configuration .......................................................................... 58
Translation of the original manual
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1. SYMBOLS, ABBREVIATIONS AND STICKERS
Abbreviations used in this manual:
V Volts s, h Seconds, hours
A Amperes Hz Hertz
W, kW Watts, kilowatts dB Decibel
mm, cm, m Millimetres, centimetres, metres ºC Celsius
kg Kilogram GLP Good Laboratory Practice
The European Union issued the Directive 2012/19/EU on Waste of Electrical and Electronic
Equipment (WEEE).
This product is required to comply with the European Union’s Waste
Electrical & Electronic Equipment (WEEE) Directive. Mark symbol is shown
at the right.
Azbil Telstar sells products through distributors throughout Europe.
Contact your local distributor for recycling/disposal.
The name plate & CE mark sticker is located at one side of the freeze-dryer.
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2. GENERAL DATA
2.1. Aim of this manual
The aim of this manual is to give the user guidelines for the handling and operation of the
LyoQuest / LyoQuest Arctic laboratory freeze dryers. This equipment is designed to be
a multipurpose unit in the research and development field. of biological, pharmaceutical and
food products. This instruction manual is valid for the following models:
LyoQuest -55 / LyoQuest -55 Plus
LyoQuest -85 / LyoQuest -85 Plus
LyoQuest Arctic -85 Plus
WARNING
 This manual must be read and fully understood before its installation, maintenance and
operation of the equipment.
 All safety instructions contained herein must be respected.
 Any use or application failing to comply with the recommendations expressed in this manual
may cause danger and loss of rights to manufacturing guarantee as well as freeing the
manufacturer from all responsibility arising.
 Before carrying out any maintenance work on the equipment, it must be disconnected
from the energy source.
2.2. Application
This model of freeze-dryer can be used for the freeze-drying in flasks, vials, ampoules or
in bulk, by means of the different configurations of the basic unit and the possibility of
coupling several accessories.
WARNING
 This freeze dryer is NOT a sterilizable unit.
 This freeze dryer consists of methacrylate parts. Not following the instructions about the
disinfection of the unit (chapter 11.1) or in the event of freeze-drying methacrylate corrosive
products can damage the parts, being excluded of the guarantee of the unit.
 Under no circumstances may the unit be used with corrosive, flammable or explosive gases.
 In the event of freeze-drying products containing corrosive or explosive solvents, please
contact the Customer Service, to take the specific preventive actions for the specific product.
 Certain freeze-drying cycles increase the required preventive maintenance actions on the
vacuum pump. See chapter 11.2
MANUFACTURER: AZBIL TELSTAR TECHNOLOGIES, S.L.U.
Av. Font i Sagué, 55
Parc Científic i Tecnològic Orbital 40
08227 TE ASSA (SPAIN)
Telf ([phone]
Fax [phone]
e-mail: [email protected]
http://www.telstar.com
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3. DESCRIPTION OF THE FREEZE DRYER
3.1. Technical features
VACUUM PUMP (optional) ULVAC version ILMVAC version
Dimensions
(length x width x height)
mm 487.5x170x249.5 500 x 300 x 340
Weight kg 27 25.4
Vacuum
at the pump inlet
mbar See user manual of the pump
Motor power kW 0.4 0.4
ICE CONDENSER LQ -55 LQ -85 LQ Arctic -85
Condensation surface m2 0.25 0.25
Minimum temperature
(T≤+21ºC)
ºC -55 -85 -85
Ice capacity kg 8 (4 kg/24 h) 8 (6 kg/24 h) 8 (6 kg/24 h)
Material AISI – 316L AISI – 316L
REFRIGERATING UNIT LQ -55 LQ -85 LQ Arctic -85
Number of compressors 1 2 2
hermetic type One stage One stage
efrigeration power
(at 35ºC)
W 495 800 800
efrigerant (free of CFCs) -507 -507/ -23 -290/ -170
efrigeration of the unit By air circulation
EQUIPMENT LQ -55 LQ -85 LQ Arctic -85
Process vacuum.
Unloaded, T≤ 21ºC,
conden
ser temperature:
-55ºC
(LyoQuest -55),
condens
er temperature:
-85ºC
(LyoQuest -85),
condenser temperature:
-85ºC
(LyoQuest Arctic -85)
mbar < 5 x 10-2 < 3 x 10 –2 < 3 x 10 –2
Dimensions
(height x width x depth) mm 480 x 425 x 575 480 x 506 x 575
Weight kg 65 70 71
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4. INSTALLATION INSTRUCTIONS
4.1. Transport and unpacking
When our products leave our warehouse, they have been tested thoroughly and packed with
precision. At delivery, examine the packing and the handling indicators meanwhile the
forwarder is present.
The freeze-dryer is delivered together with the optional accessories and documentation in a
single pack; it is packed in a suitable way to prevent it from being damaged during
transportation.
The unit has to be shipped in vertical position according to the crate indications (adhesive
labels).
The pack includes a tube of silicone grease, to carry-out the maintenance of the equipment
seals. This manual is included in the scope of supply.
When unpacking the freeze-dryer, check if the supply includes accessories, separately
packed to ensure suitable protection.
ed ShockWatch or Tiltwatch indicators means impact or unacceptable tilting. In this case
mark this on the shipping documentation while the forwarder is present and state an official
complaint to the forwarding company.
If there is no visible damage to the unit, unpack inspect (and test) the equipment within 8
days of delivery. Do not return goods without notifying and authorization.
4.2. Placing on site
The unit must be placed on a table that has a smooth and horizontal surface. The basic unit
must be firmly settled to prevent vibrations.
WARNING
 When assembling the chamber to the LyoQuest / LyoQuest Arctic, do not forget to
assembly the methacrylate base. It is required for proper working when chamber is
installed.
 The optimal working conditions are:
- Temperature: < 25ºC (recommended 23ºC±2ºC)
- elative humidity: 50%±20%
If any of these conditions is not fulfilled, optimum equipment performance cannot be
guaranteed.
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4.3. Electrical connection
a) Ensure that the power supply is the correct one for the unit.
b) Ensure that the connection to the power supply suits the freeze-dryer's power.
c) Connect the electrical cable of the unit to the power supply.
WARNING
 Before switching the Freeze-Dryer on, check that the supply voltage is the same as the
one mentioned on the specification plate. It should be connected to a suitable socket base
with a grounded plug.
 Whenever there is a power cut or the supply fails for a long period of time, stop the
freeze-dryer.
 Installation in the place where the Freeze-Dryer is connected to must meet the safety
regulations in force and be according to the local regulations of the country or customer
facilities.
Connect the cable of the vacuum pump to the unit.
Connect the electrical cable of the basic unit to the power supply (example for plug wire
supplied with a European plug).
Electrical supply: 230V monophase + PE, 50 Hz
230V monophase + PE, 60 Hz
Installed power (*): LyoQuest –55: 2.5 kW
LyoQuest –85: 3.5 kW
LyoQuest Arctic –85: 3.5 kW
Consumption (*): LyoQuest –55: 8.6A (11A max)
LyoQuest –85: 10.6A (15A max)
LyoQuest Arctic –85: 10.6A (15A max)
* 230V 50 Hz
EA TH
WI
E
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5. BEFORE START-UP
Before proceeding with the start-up of the freeze-dryer the following instructions must be
followed step by step.
WARNING
 Prior to begin start up, electrical connection must meet all requirements
according to chapter 4.3.
NOTE
Before beginning a new operation:
 Open the drain valve in order to check that all water from the last operation has been
totally eliminated. Close the valve again.
 Check that the condenser is covered by its transparent cover (manifold or chamber).
 Check that all valves of the chamber are closed correctly.
5.1. Vacuum pump
The pump is supplied with the oil loaded. Verify the oil level (see section Vacuum unit
maintenance).
In order to prevent the non-condensable vapors of the product from contaminating the oil of
the pump, the system has Gas-Ballast function (see section Vacuum unit maintenance).
When the pump is switched off, a closing valve isolates the pump from the freeze-dryer,
preserving the vacuum.
The vacuum pump is equipped with an exhaust filter, whose function is to retain oil vapors.
The electrical connection of the vacuum pump has to be connected to the base placed at the
side of the unit. Furthermore, the vacuum pump admission has to be connected to the basic
unit through the supplied pipe.
Drain valve
(
op
en
)
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Connection of the vacuum pump expulsion:
To direct the vapors outside of the pump, connect the pipe to vacuum pump exhaust,
removing the installed filter.
ULVAC pump ILMVAC pump
5.2. Refrigerating unit
In order to assure a suitable cooling of the refrigerating unit (via forced air circulation by
means of a fan), all vents must be separated by at least 20cm from other equipment or the
walls.
. DETAILS OF THE FREEZE-DRYER
.1. Description
The LyoQuest / LyoQuest Arctic freeze-dryers are constructed as a compact desktop
version. The basic unit consists of a metallic box with lateral access doors to perform
maintenance tasks. The vacuum pump is supplied separately and is optional. The control
panel is located at the front.
A refrigerating system cools the condenser coil to the working temperature. The
condensation surface has been dimensioned ensuring the condensation of the water vapor
released by the products that are being freeze dried. This prevents vapors from entering
the vacuum pump. The refrigerating system is formed by:
- Compressor:
LyoQuest -55: one-stage hermetic compressor, condensed by air.
LyoQuest -85 / LyoQuest Arctic -85: two one-stage hermetic compressors,
condensed by air.
- Condenser:
Material: AISI 316L stainless steel.
Models:
 LyoQuest: Prepared to work with all accessories, but not with heated plates.
 LyoQuest Plus / LyoQuest Arctic Plus: Prepared to work with all accessories and
heated plates.
Filt
er
F
ilte
r
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7. RECOMMENDATIONS
7.1. Ice condenser
Before each operation it is necessary to open the water drain valve of the condenser in order
to assure that the ice condensed during the previous operation has been totally eliminated. If
water residues remain in the condenser or in the drainpipe, they will be frozen as a result of
the vacuum, thus possibly compromising work conditions.
7.2. Greasing
Slightly grease the airtight seals with silicone grease. The contact surfaces should always be
kept clean and greased. Avoid dirt accumulation.
7.3. Long storage
WARNING
 In case of extended shutdown of the freeze-dryer, the vacuum pump oil must be changed
to avoid any corrosive waste that could damage it. Disconnect the unit from the electricity
supply Clean all the components of the equipment (manifold, chamber, …). Clean the
inside of the chamber, check that the condenser has been completely emptied and
lubricate the airtight gaskets of the chamber, valves and condenser.
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8. WORKING PRINCIPLE
8.1. Freeze
The product inserted into the equipment can either be previously frozen or can be frozen in
the ice condenser. To freeze it in the condenser, the product is placed into the plate stack
(optional accessory), and the condenser is cooled selecting the option "freezing" on the touch
screen, both in semiautomatic mode and in automatic mode.
The freeze temperature is proportional to the solidification point of product. Freezing speed
influences the size of the crystals and, consequently, sublimation speed. Therefore, the most
suitable freeze parameters for each product must be determined. It is advisable to freeze
products at a temperature below -20°C for a period of 3-4 hours.
8.2. Lyophilization
8.2.1. In manifold
It is used to lyophilize bulk products in glass flasks with a grinding mouth (29/32mm Ø). The
products contained in the flasks (filling a quarter up to maximum half the flask) have to be
previously congealed in a rotating bath of alcohol, freezing the product to the walls of the
flask.
When the condenser has reached the programmed temperature, the following steps must be
performed:
1. Connect the vacuum unit.
2. Connect the flasks or bottles (with previously frozen product) to the valves connected
to the condenser.
3. Open the valves.
Then the vacuum is done inside flasks, and the sublimation of the product starts. A pressure
of less than 10mbar is reached within 10 minutes. If this does not happen, the pump will
stop, and the alarm of the vacuum system will appear. In this case the valve-flask
connections must be reviewed in order to assure that there is no leak.
CONNECTION VALVE
Air inlet Start vacuum process
If it is necessary to connect additional flasks when the freeze-drying process has already
begun, the following steps must be performed:
1. Close all valves.
2. Connect the new flask and open its corresponding valve.
3. Wait 10-15 seconds in order for the pressure to be restored in the unit.
4. Open the valves of the other flasks.
It is possible to provide external heat by means of an electric heat source, in order to speed
up the drying process. The heat source should be at the suitable distance to apply the
radiation heat that the product requires. A hot air heater directed directly to the flasks may
also be used.
At the beginning of the process a layer of ice will form on the outside wall of the flask; this
will gradually disappear as drying out continues. When the exterior of the flask is at ambient
temperature, no ice remains in the product (the process has finished). Once the process has
finished, the corresponding valves of the manifold are closed, and air enters in the flasks. So,
they can be removed.
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8.2.2. In chamber
The product may be freeze-dried inside the condenser or in the chamber:
 Inside the condenser (see Fig. A): It is advisable to load the product only on the
lower and middle plates. The higher plates do not receive cold as do the other plates
because the vacuum supply is placed at top of the condenser. The equipment allows
you to program recipes (see chapter 10.6) to run a complete cycle without making
any manual actions.
 Outside the condenser: This is recommended when the quantity of product allows
you to load the three plates. It is advisable to freeze the product inside the
condenser because the heated plates will be cold and heating rates from negative
temperatures may be reached. Once the product is frozen, remove the plates of the
condenser and place them in the chamber (see Fig. B). Also, it is possible to load a
product that has been frozen in other equipment. The equipment allows you to
program recipes (see chapter 10.6) to run a complete cycle without making any
manual actions once the product is frozen and the chamber has been placed.
NOTE
Fig. A Fig. B

The pr
oduct laye
r shoul
d
be as thin
as pos
si
ble
(
r
ecommended
hei
ght <20m
m
).
The tim
e
of the freeze-drying process depends for an important part from this height. It is very
advisable to load the freeze-dryer uniformly and that the height of product is the same in
all zones.
 The time of the process also depends on:
-The heat provided to product (external if the manifold is used or by means of an
electrical resistor placed inside the plates).
-The maximum temperature accepted by the product.
-The final degree of humidity desired.
-The percentage of solid material in the product.
-The vacuum degree obtained.
-The total amount of product to be dried each time.
-The temperature of the condenser.
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8.2.3. End of the process
Stop the pump and the refrigerating circuit. Open the air inlet of the valve on the side of the
chamber. The air inlet has to be opened very slowly to avoid the formation of turbulences
that will spread about dust in the flasks or plates. Then, the defrosting function is activated.
At the end of the process, the pump and the refrigerating unit will stop (the compressor stop
is delayed in order to extract all gases from the circuit). Next, a connection valve of the
manifold or the venting valve placed at the top cover has to be opened in order to ventilate
the inside of the equipment.
It is necessary to connect a container to the outlet of the outflow pipe. Once this is done the
manual outflow valve placed at the left side can be opened. Start defrosting mode (see
chapter 10.3.1) in order to heat the surface of the condenser which allows you to extract the
ice block in a few minutes. Also, it is possible to heat the condenser until the entire ice block
has been defrosted and all the water has been drained through the outflow valve. In both
cases it is advisable to remove the chamber or the manifold to accelerate the defrosting.
Before the start of a new operation, check that the condenser has been totally defrosted,
that there are no water traces in the overflow pipe, and that the overflow valve is closed
again.
8.3. Lyophilization modes
There are two possible lyophilization modes: the AUTOMATIC mode (see chapter 10.2) and
the SEMIAUTOMATIC mode (see chapter 10.2.3). The automatic mode allows you to
establish the processes, the parameters and the time by means of a ECIPE (see chapter
10.6).
8.4. Selectable processes
Freezing: It starts up the refrigerating system and cools the condenser. The cooling system
requires a preparation time (5 minutes approx.) in which the temperature may increase
slightly. After this the temperature will quickly decrease. This step must be longer than 30
min to make sure that the system can reach the minimum temperature.
Cool+Vacuum: It starts up the refrigerating system, cools the condenser and starts up the
vacuum unit. The vacuum begins when the temperature of the condenser is lower than the
established parameter (normally -40ºC). The control of the vacuum level will depend on the
programmed Set Point. The system will need a time longer than 20 min to reach the
minimum vacuum level.
Heat plates: It starts up the electrical resistors of the plates. They warm up until the
programmed temperature has been reached. Also, it starts up the vacuum unit. The vacuum
begins when the temperature of the condenser is lower than the established parameter
(normally -40ºC). The control of the vacuum level will depend on the programmed Set Point.
Each one of the processes may have parameters to set. In the automatic cycle it is also
necessary to set the time for each step. The parameters are the following ones:
Semiautomatic Automatic
Freezing - Time (HH:mm)
Cool + vacuum Vacuum (mBar)
Vacuum (mBar)
Time (HH:mm)
Heat plates
Vacuum (mBar)
Plates temperature (ºC)
Vacuum (mBar)
Plates temperature (ºC)
Time (HH:mm)
Depending on the temperature of the condenser probe, the electrically operated valve of the
refrigerating circuit may take a certain time to start working. As a result, the temperature
may increase some degrees initially.
The pump starts to work when the Set Point has been reached. The vacuum valve will open
few seconds later.
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9. OPTIONAL ACCESSORIES
(Compilation at the end of the manual)
9.1. Chambers
Model Description Diameter Distance
between plates
C220 SP3 Cylindrical chamber equipped with 3 standard
plates 220mm 70 mm
standard
C220 HP3 Cylindrical chamber equipped with 3 heated
plates 220mm
70 mm
standard
/
140 mm
large spacer (LS)
C220 HP3 S Cylindrical chamber equipped with 3 heated
plates and vial stoppering device 220mm
C220 HP3 M8 Cylindrical chamber equipped with 3 heated
plates and 8 inlets manifold 220mm
C220 HP3 S M8
Cylindrical chamber equipped with 3 heated
plates, vial stoppering device and 8 inlets
manifold
220mm
C350 HP3 Big size cylindrical chamber equipped with 3
heated plates 350mm 71 mm
standard
/
142 mm
large spacer (LS)
C350 HP3 S Big size cylindrical chamber equipped with 3
heated plates and vial stoppering device 350mm
C350 HP4 Big size cylindrical chamber equipped with 4
heated plates 350mm 71 mm
standard
C350 HP4 S Big size cylindrical chamber equipped with 4
heated plates and vial stoppering device 350mm
Material: Methacrylate (PMMA).
220mm versions optionally available in Pyrex®.
The (under vacuum) vial stoppering devices are operated manually, and they require vials
provided with closure.
C220 SP3 C220 HP3 C220 HP3 S
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C220 HP3 M8 C220 HP3 S M8
C350 HP3 C350 HP3 S C350 HP4 C350 HP4 S
Model Description
Standard
plates
Distance
between
plates
CC SP Cubic
chamber
2 145 mm
4 70 mm
6 56 mm
Material: Stainless steel AISI 316
Material: Methacrylate (PMMA).
Internal dimensions: 484x340x376 mm
External dimensions: 542X460X617 mm
(height x width x depth)
CC SP
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9.2. Manifolds
Manifolds with 8-12-1 inlets
Horizontal manifold. Each one of the manifold inlets is provided with a 3-way valve which
allows isolating and restoring the pressure in each one of the flasks independently. The
valves allow the junction to grinding flasks by means of the conical adapter that they
incorporate (external diameter: 29-32 mm; internal diameter 18 mm). By removing this
adapter, tubes or flasks can be inserted directly in the valve.
Circular manifold with 8 inlets (fig C) and straight one with 12 inlets (fig D).
By joining together two 8 inlets manifolds it is possible to get 16 inlets (fig E).
Fig. C Fig. D Fig. E
Manifolds with 40-80 inlets
Manifold with 40 inlets for 13mm diameter pipes (fig F). By means of a distributor it is
possible to get 80 inlets (fig G).
Fig. F Fig. G
9.3. Flasks condensations collector (Drip tray)
Cover to collect the condensations generated on the outer part of the flasks of the manifold
(Fig. H).
Fig. H
DOMINIQUE DUTSCHER SAS