Severn LS40/60 Manual de usuario
LS40/60 FREEZE DRYER
Publication reference 1HZ204-1 1
LS40/60 Freeze Dryer
Instruction Manual
Severn Science Limited
4ShortWay
Thornbury
Bristol
BS353UL
Tel: 01454 414723
Fax: 01454 281680
LS40/60 FREEZE DRYER
Publication reference 1HZ204-1 2
CONTENTS
1.0 INTRODUCTION
1.1 Scope
1.2 General safety
1.3 General description
1.3.1 Freeze Drying – Basic Principles
1.3.2 The Condenser Unit
1.3.3 The Drying Chamber
1.3.4 Control System
2.0 TECHNICAL DATA
3.0 INSTALLATION
3.1 Unpack and inspect
3.2 Equipment Placement
3.3 Preparation of Vacuum Pump
3.3.1 Check Pump Oil Level
3.3.2 Vacuum Pump Settings
3.3.3 Pump Exhaust Connection
3.4 Preparation of Refrigeration System
3.5 Electrical Installation
4.0 OPERATION
4.1 Power Up
4.2 Security Control
4.3 Switch On Condenser
4.4 Switch On Shelf Refrigeration
4.5 Loading the Product
LS40/60 FREEZE DRYER
Publication reference 1HZ204-1 3
4.6 Running a Freeze Drying Cycle
4.6.1 Run a program Now
4.6.2 Run a program from a Point
4.6.3 Scheduling a Program
4.6.4 End of Program Sequence (EPS)
4.7 Program Monitoring
4.7.1 Monitor Facility
4.7.2 Pre-Plot Facility
4.7.3 Trends
4.8 Holding a Program
4.9 Aborting a Program
4.10 Stoppering
4.11 Removing Product
4.12 Condenser Defrost
5.0 CREATING / EDITING A PROGRAM
5.1 Save / Save As
5.2 Inserting a Segment
5.3 Deleting a segment
5.4 Amending the End-of-Program Sequence
6.0 DATA LOGGING
6.1 Changing Logging Configuration
6.2 Logging Monitor
7.0 MANUAL OPERATION
LS40/60 FREEZE DRYER
Publication reference 1HZ204-1 4
8.0 ALARMS
8.1 Alarm Acknowledgment
8.2 Alarm History
8.3 Alarm Note
8.4 Alarm History Archive
9.0 MAINTENANCE
9.1 Maintenance Plan
9.2 Vacuum pump Oil level
9.3 Oil Mist Filter Element
9.4 Oil Drain Kit
9.5 Change Vacuum Pump Oil
9.6 Vacuum Pump Service
9.7 Door Seals
9.8 Drying Chamber Silicone Fluid
9.9 Refrigeration Heat Exchangers
Appendix 1 Manufacturers Literature
Appendix 2 List of Drawings
LS40/60 FREEZE DRYER
Publication reference 1HZ204-1 5
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Manufacturer’s Name: Severn Science Ltd
Manufacturer’s Address: 5 Short Way
Thornbury, Bristol
BS35 3UL England
Model / Serial No:
Date of Issue:
Severn Science Limited hereby declares that the above
product conforms with the essential protection requirements
of:
Low Voltage Directive 73/23/EEC amended by 93/68/EEC.
EMC Directive 89/336/EEC as amended by 92/31/EEC.
Machinery Directive 89/392/EEC
by application of the following standards:
Safety: BS EN61010, 1993
Safety: BS EN 292-1, -2 : 1991
Emissions: BS EN 50081-2: 1994
Immunity: BS EN 50082-2 : 1995
Signed on behalf of Severn Science Limited
Dr A.D Hilton (Technical Director)
Severn Science Limited
5 Short Way,
Thornbury, Bristol, BS35 3UL
Tel: 01454 414723 Fax: 01454 281680
LS40/60 FREEZE DRYER
Publication reference 1HZ204-1 6
1.0 INTRODUCTION
1.1 SCOPE
This manual provides installation and operation instructions for the LYOSCIENCE LS40
and LS60 freeze dryers. The manual and all accompanying documentation must be
read before operating the equipment.
Important safety information is highlighted as WARNING and CAUTION instructions;
you must obey these instructions. The use of WARNINGS and CAUTIONS are defined
in the general safety section.
LS40/60 FREEZE DRYER
Publication reference 1HZ204-1 7
1.2 GENERAL SAFETY
WARNING: Warnings are given where failure to observe the instruction could result
in injury or death to persons.
CAUTION: Cautions are given where failure to observe the instruction could
damage to the equipment, associated equipment or process. Refer to the
accompanying manufacturers’ instruction manuals for the technical data on
individual components.
See Appendix 1 for list of Instruction Manuals.
WARNING: Sodium Azide Explosion Hazard
Sodium Azide, which is sometimes used in the freeze-drying process, is a toxic and
(when dry) highly explosive material. In the process of pumping product containing
this chemical, a reaction can occur in the presence of heavy metals (copper, lead,
zinc and cadmium). The resulting reaction is the formation of heavy metal azides
that are highly unstable, and which present a very severe explosion hazard.
Standard LS40 and LS60 freeze dryers are not suitable for use with Sodium
Azide. Please contact Severn Science if you wish to use Sodium Azide; the
equipment can be modified by the manufacturer for safe operation with Sodium
Azide if required.
1.3 GENERAL DESCRIPTION
1.3.1 FREEZE DRYING - BASIC PRINCIPLES
Freeze drying is a method used to dehydrate heat sensitive materials via a process involving the
sublimation of any water content (in the form of ice) under vacuum conditions. The process can
be subdivided into three (3) stages; freezing, primary drying, where the bulk of the water content
is removed by sublimation, and secondary drying where residual bound water is removed at
higher temperatures. The LS range of freeze dryers is capable of automatically performing all
these functions in a controlled and reproducible manner.
The equipment consists of a large vacuum drying chamber mounted directly above a
refrigerated condenser with integral vacuum pump. The drying chamber contains up to five
refrigerated shelves that can be moved up and down via an electrically operated ram for
stoppering processes. Both condenser and drying chambers are fitted with their own
refrigeration systems, specified for either high temperature (denoted model LS40) or low
temperature (model LS60) use. The temperature of the product shelves used in the LS40
can be controlled between +60oC and –40oC whereas shelf temperatures can be varied
between +60oC and –60oC for the LS60 version. Both systems have a compact footprint
allowing the equipment to be moved through standard sized doorways. Commissioning is
simple and straightforward, requiring no external services other than mains power. All
components are housed inside a free-standing cabinet with detachable inspection panels at
the front, rear and sides for easy maintenance.
LS40/60 FREEZE DRYER
Publication reference 1HZ204-1 8
1.3.2 THE CONDENSER UNIT
The condenser unit consist of a cylindrical chamber (290 X 620 mm) with an inlet port
situated near the front of the chamber and a 25 mm outlet port positioned at the rear
of the chamber. The chamber walls are cooled directly by an integral CFC free
refrigeration system mounted in the base of the unit. During freeze drying, water
vapour that is extracted from the product, is condensed onto the chamber walls,
resulting in the formation of an ice ‘plug’. The chamber has a total ice capacity of
~15Kg between defrost cycles. The minimum temperature of the chamber wall under
vacuum conditions with no load applied is –45oC and –80oC for the LS40 and LS60
models respectively.
The condenser inlet is connected to the drying chamber via an electrically actuated
high vacuum butterfly valve. The chamber outlet is connected to the inlet of an RV12
vacuum pump. A transparent perspex door at the front of the condenser allows the
operator to inspect the ice plug and provides convenient access for cleaning
purposes.
The chamber is automatically defrosted when the condenser refrigeration system is
turned off. Defrosting is assisted using a band heater that is wound round the external
surface of the chamber. The ice can be removed as a solid plug after defrosting the
chamber for ~ 1 hr. Any ice that has melted can be removed via a solenoid operated
drain valve in the bottom of the chamber or removed by the operator during general
maintenance.
A two stage oil-sealed rotary vacuum pump (RV12) mounted on the base of the unit is
used to evacuate both condenser and drying chambers. The pump outlet is fitted with
a mist filter to prevent oil mist escaping to the atmosphere. The exhaust of the filter is
piped to a stub connection at the rear of the freeze dryer, which in turn should be
connected to the user’s exhaust extraction system.
Oil collected in the mist filter is continuously returned into the gas ballast port of the
pump.
The condenser temperature and pressure is monitored with a PT100 and a pirani
gauge respectively; data can be continuously displayed on the touch screen if
required.
1.3.3 THE DRYING CHAMBER
The drying chamber is mounted directly above the condenser unit (refer to figure 1).
The chamber is fitted with up to five temperature controlled product shelves, a
refrigeration / heater plant with heat transfer fluid circuit and a shelf stoppering
mechanism. A transparent perspex door at the front of the chamber allows the
operator to inspect the product during the freeze drying process and provides access
for loading and unloading.
Each shelf contains an internal network of channels through which the heat transfer
fluid can flow freely and continuously. Heat is extracted or introduced into the fluid via
the refrigeration / heater plant and is then distributed to each shelf in parallel through
LS40/60 FREEZE DRYER
Publication reference 1HZ204-1 9
a common manifold and liquid re circulating pump. Sensors in the fluid circuit provide
feedback for closed loop temperature control. Temperature control is achieved by
modulating the flow of heated and cooled fluid with the use of solenoid operated
isolation valves in the fluid circuit.
The shelves are mechanically linked to an electrically actuated ram with variable
torque drive. The ram moves the shelves up and down allowing automatic stoppering
of vials under vacuum and other controlled atmospheres. Operation of the ram is
interlocked with safety switches on the front perspex door ensuring that the actuating
mechanism is disabled when the door is opened.
WARNING: The interlock switches should never be removed or tampered with.
1.3.4 CONTROL SYSTEM
The freeze dryer is controlled by an on-board microprocessor with touch screen
display (see figure 1). Freeze drying cycles (process recipes) can be programmed
directly using the touch screen (refer to section 5). The general layout of the controller
is shown in figure 2. All freeze drying segments (e.g., primary and secondary drying,
end point determination, backfill and stoppering) can be fully automated if required
with an almost limitless number of temperature / pressure profiles with defined ramp
rates, dwell points and times. Programs can be saved and retrieved for use at a later
date, if required. The operator can access all status and control functions from the
display screens and system data can be reviewed in real time or downloaded onto
1.44Mb floppy disks via the integral disk drive.
The control system is password protected for various levels of access.
An emergency stop button is situated on the front control panel, for disabling the
stoppering drive in cases of emergency.
2.0 TECHNICAL DATA
Table 1: Technical Specification
FUNCTION MODEL PERFORMANCE
Minimum condenser temperature (@ 25oC
ambient) LS40
LS60 -45oC
-80oC
Minimum shelf temperature (@ 25oC
ambient) LS40
LS60 -40oC
-60oC
Shelf cool down times (fitted with 3 product
shelves). Temperatures measured on shelves. LS40 (to -35oC)
LS40 (to –40oC)
LS60 (to –55oC)
LS60 (to –60oC)
100 minutes
220 minutes
130 minutes
160 minutes
Maximum shelf temperature LS40/60 60oC
Temperature uniformity (between shelves) LS40/60 +0.6oC
Temperature uniformity (across each shelf) LS40/60 +0.3oC
Temperature control LS40/60 +0.2oC
Condenser capacity LS40/60 15 kg
Defrost time (for ice plug removal) LS40/60 1 hour
LS40/60 FREEZE DRYER
Publication reference 1HZ204-1 10
Vacuum Pump
1. Type
2. Nominal Pumping speed
3. Pump down time (to 0.5 mbar)
LS40/60
Edwards RV12
12 m3/hr
Approx 10 minutes
Vacuum Pump Oil LS40/60 Ultragrade 19
Heat Transfer Fluid LS40/60 Silicone M90.055.03
Electrical
a) Supply
b) Power rating
(ambient temperature 20oC)
LS40/60
LS40
LS60
230V, 50Hz, 1 ph, or
110V, 60 Hz, 1 ph.
5.1 kW
6.9kW
Dimensions (w x h x d) LS40/60 700 x 1906 x 950 mm
Weight LS40/60
600 Kg
Shelf area
a) Maximum (5 shelves)
b) Standard (3 shelves)
LS40/60
0.85 m2
0.51 m2
Refrigerants LS40
LS60 R404A
R404A / R508B
Maximum ambient operating temperature
(measured at inlet to heat exchangers) LS40/60 30oC
3. 0 INSTALLATION
3.1UNPACK AND INSPECT
Remove all packing material and protective covers from vacuum outlet port.
CAUTION: Remove all packing material before operating system.
If the equipment is damaged, notify your supplier and the carrier in writing within three
days.
3.2 EQUIPMENT PLACEMENT
Locate the freeze dryer in the required position, ensuring that the floor is adequate to
support the equipment and that due consideration is given to:
a) Air flow for ventilation
b) Access to framework panels.
c) Adequate space for maintenance.
CAUTION:The ventilation holes in the framework panels must not be blocked or
impeded in any way. If they are, overheating and damage may result.
CAUTION: Heat generated by the refrigeration compressors is significant. If the
equipment is situated in a confined space it may be necessary to provide some
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