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SERAIL PHARMACEUTICAL LYOPHILIZER
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 The
SERAIL DIVISION, a division of S.G.D., has established itself as a global
leader in design and manufacture freeze dryer. With more than 40 years of
experience in pharmaceutical freeze-drying, Serail's track rercord consists
of more than simply designing and selling equipment. Serail uses and tests
all new ideas to ensure complete satisfaction.
When we present solutions to you, you can have confidence that they are
solutions that have worked for us. We have global experience with both clients
and installation. This knowledge and experience have been incorprated into
Serail's systems to create a High Tech freeze-fryer. SERAIL freeze dryer's
technique is being innovated with time, it has some advantages which other
competitors can never catch up, such as Double Hinge Door Latching System,
patented Unifluid technique,chamber having a sloped bottom, ALUS (Automatically
loading and unloading system), control system according GAMP4, 21CFR Part
11, and so on. It has 20% freeze dryer market share in the world.
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1. Door
Latching System
double gasket--Inflatable gasket can be inflated by air or nitrogen flushing.
An O-ring gasket is exclusively used for vacuum tightness, which can be
sterile on both side during the SIP process and is in a relaxed condition
during SIP. The doors of these freeze-dryers are fitted a double hinge system.
This allows for a closing operation in two phase, with out pinching the
gaskets. The closing cycle of the doors id controlled by the PLC of the
freeze-dryer. |
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2. CIP(Clean
in place)/SIP (Sterilization in place)
 The
CIP systems of Serail's freeze-dryer consists of an over-pressure spraying
system. Four spraying columns are located in chamber's strategic areas.
Each columns is fitted with a number of spray nozzles calculated according
to the surface to be covered and the position of the shelves. Each column
is motorized in order to rotate 180°,and the spraying pressure can be
up to 6 bar. The chamber has a slopped bottom which allows automatic draining.
The spray bar in condenser looks like trees.
The steam injection is achieved by CIP spray
nozzles. This procedure allows a self-sterilization from the CIP system
, as well as the spreading of system eliminate air pockets. Pressure vessel
is made of 316L stainless steel.
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3.
ALUS(Automatic Loading and Unloading System)
Three types can be considered: Carriage system, Pusher system, Shuttle system,
which can be integrated with LAF (lamina flow)、RAB (restrict access barrier)、Isolator.
ALUS is controlled by CAL21 Control System of Serail's freeze-dryer. |
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4.
Refrigeration Unit
 Serail's
freeze-dryer can also be offered with directly expansion system. But if
you choose the Serail's innovative refrigeration system with patent Unifluid,
Compressors Cascade, Liquid Nitrogen Back Up, you can not just control the
shelves temperature,vacuum condition,freezing time, but can also control
condenser's temperature,which other competitor can't obtain. At the same
time ,you can get a homogeneous freezing result, saving energy, expand the
system redundancy. |
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5.
Stoppering Systems
 Two
types can be considered: Entering ram Stoppering and Exiting ram Stoppering,
both of which can meet the requirements of GMP and FDA. The jack is isolated
from the chamber by means of bellows, with device which can test the vacuum
integrality of bellows. The operation is controlled by CAL21 control system.
Variable pressure can be chosen. |
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6. CAL
21 Control System
 According
to 21CFR Part11. For system reliability, computer-controlled systems
are pre-programmed to monitor the performance of all major components. When
parameters deviate from acceptable levels, the control system notifies the
user of the need for maintenance. Our engineers are ready to assist you
on and look directly inside the process when problems occur. Our software
delivers immediately on-line, step-by-sep troubleshooting and documentation
for repair of manufacturing equipment and process. |
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7．
Freeze-dryer Model
LOADING CAPACITY
Total surface area：10 to 60 m2
ICE CAPACITY
Maximum ice capacity / 24 hour：100 to 1000 kg
PERFORMANCE
Freezing temperature limit：-60°C
Condenser temperature limit ：-73°C
Heating temperature limit：+60°C
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8． User List |
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