Freeze Dryers

KRYONIK
Freeze Dryer
Pharmalab has formed an alliance with SERAIL to acquire state-of-the -art technology and manufacture Freeze
Dryers in India. The combined expertise of Pharmalab and Serail is now available to the pharmaceutical and
biotechnology industry in India and worldwide.
PHARMALAB
Pharmalab, founded in 1962, has grown from a modest engineering company manufacturing stainless steel process and packaging
equipments, to a world class company with a reputation for state-of-the-art technology that is trusted globally.
Responsible for hundreds of prestigious installations worldwide in the pharmaceutical, biotech, food and beverages, cosmetics and
agro chemical industries, Pharmalab is a name synonmous with purity and stringent quality standards.
The company is supported by over 650 highly trained engineering professionals working across 4 manufacturing facilities in India
(a total of 100000 sqft) and has tie ups with global leaders for various state-of-the art technologies. Pharmalab has a complete
understanding of the pharmaceutical and other industries and offers a comprehensive package of products to increase the
efficiency of its customers.
Meeting challenges of speed and cost
Freeze Dryers from Pharmalab - Serail
SERAIL
SERAIL, based in France, and a division of Charlem Holding, has established
itself as a globally renowned company engaged in the design and
manufacturing of high technology Freeze Dryers (lyophilizers) along with
automatic loading and unloading systems. With more than 40 years of
experience in Pharmaceutical Freeze Dryers, SERAIL has knowledge and
track record to support customers globally and continually exceeds
customer expectations.
Serail is the pioneer of several innovations:
• UNIFLUID TM refrigeration system ‘
• *Isolated Automatic Shelf Loading/Unloading system,
• *Validated CIP system with 180° mechanically driven rotating spraying
system and various others .
Pharmalab India Private Ltd., Kasturi, 3rd floor, Sanghvi Estate, Govandi Station Rd, Govandi (E), Mumbai 400 088, INDIA.
Tel.: +91-22-66 22 9900 • Fax: +91-22-66 22 9800 • E-mail: pharmalab@pharmalab.com • Website: www.pharmalab.com
Serail lyophilizers are customized to exact application, designed for precise
quality control, operator convenience, efficient production cycles, easy
maintenance, best validation, shorter cycle times and speedier deliveries
and bottom line- best return on investment.
FREEZE DRYING PROCESS
SCADA system for process control
Stoppering system
Vacuum system
Ice Condenser collects sublimed
ice vapours from product until
it is completely dry
Vacuum chamber;
CIP & SIP’ able
Isolation
valve
Mechanical
refrigeration/liquid N2
cooling system
TABLE
SP Series
0.8
1.3
2
3
5
5
7.5
11
14
19
22
33
Kg
30
30
30
70
70
120
120
120
240
240
500
500
Ice capacity (per day) Kg
15
15
15
35
35
60
60
60
120
120
250
250
Shelf area
m2
0.77
1.28
1.87
3.06
4.90
4.60
7.66
11.49
14.04
18.90
22.50
33
Shelf width
mm
340
340
340
680
680
1030
1030
1030
1350
1350
1500
1500
Shelf length
mm
750
750
1100
750
1200
750
1860
1860
1300
2000
1500
2200
Inter shelf spacing
mm
165
90
90
100
100
100
160
100
90
110
90
90
Number of shelves
Nos.
3+1
5+1
5+1
6+1
6+1
6+1
4+1
6+1
8+1
7+1
10+1
10+1
Ice capacity (max)
Ice
vapor
Dried
Product
Glass Vial
Stoppered
Chamber type
Dry
Frozen
Product
Drying
Freezing
Liquid
TYPICAL PRODUCT PROCESSING
+40
+20
Time
-20
-40
-60
Freezing
100
Primary Drying
Secondary Drying
0
ice
Frozen interstitial
material
Sublimation
Desorption
Adsorbed “bound “water
0
% ice formed
RMI
Cylindrical Cylindrical Cylindrical Cylindrical Cylindrical Cylindrical Cylindrical Cylindrical Cylindrical Cylindrical Cylindrical
Cylindrical
Condenser type
Std.
Internal
Internal
Internal
Internal
Internal
Internal
Internal
Internal
Internal
Internal
Internal
Internal
Condenser type
Option
External
External
External
External
External
External
External
External
External
External
External
External
Overall width
mm
1650
1650
1650
2300
2300
2300
2300
2300
2300
2300
2600
2600
Overall length
mm
3165
3165
3415
5150
5600
5240
6000
6000
5300
5800
5300
5800
Overall height
mm
2400
2400
2400
2900
2900
3000
3000
3000
3200
3200
3200
3200
Vial capacity
(16 mm Ø)
Nos.
2600
4300
6500
10600
17300
16100
27200
51000
49700
67300
80300
117000
Vial capacity
(22 mm Ø)
Nos.
1300
2200
3300
5600
8900
8600
14200
21400
26300
35200
42100
62100
Vial capacity
(24 mm Ø)
Nos.
1100
1900
2800
4600
7500
7000
11900
17900
22000
29800
35700
52000
AFTER SALES SERVICE
ADVANTAGE SERAIL-PHARMALABFREEZE
When you partner with Pharmalab your goals become ours too… and
helping you reach them is our commitment.
Our philosophy is to synergize design, material, function and service to ensure our Freeze Dryers are GMP compliant and exceeding
expectations of quality and performance.. Chambers, shelves, door closing systems, stoppering system, condensers and all
interconnections are manufactured and quality controlled in-house to minimize risk and protect against any possible outer
contamination.
MAINTENANCE:
DRYER
When building systems we strictly follow instructions and all qualification tests are carried out in the presence of the buyer prior to
delivery.
To ensure your system maintains its optimal value, regular maintenance
is a necessity and our team is always there to work with you.
For system reliability, computer-controlled systems are preprogrammed 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 immediate on-line, step by-step troubleshooting and documentation for repair of manufacturing equipment
and process documents with trending and multileveled security.
CYLINDRICAL CHAMBER:
• Following PED/ASME design code
• SS316 L construction
• Highest level of assurance maintaining sanitary conditions
• Uniform temperature distribution during SIP
TRAINING:
• Highest resistance to pressure: Design pressure 2.8 Bar(g)
Pharmalab offers training programmes for operators and maintenance
personnel tailored to the customer’s requirements. Based on the
customer’s freeze dryer configuration these trainings cover design and
function of the main components, for example refrigeration skid,
vacuum pumps and control system as well as fundamentals of the
freeze drying process.
• No corners and natural drain ensures easy drainability
• Light in weight for easy installation
• Full door & sub-door design
OUR AFTER SALES SERVICES INCLUDE:
• Maintenance Contracts
• Preventive Maintenance Services
• Recipe Development/Cycle Development
SHELVES:
• OperatorTraining On & Off Site
• SS316 L construction
• Spare Parts and Retrofits
• Surface finish - 0.6 µm or lower
MODEL SPXXS
• Bench top unit
• Ideal for research in clinical biotech &
pharmaceutical labs
• Flatness: < ± 1 mm per meter
• Specific baffle design for uniform temp.
• Helium leak tested
• ± 1° C temperature accuracy
• Compact design
• Flexible
• Top loading system
• Chamber: AISI 316L
• Ice condenser coil located in the chamber: AISI 316L
• 12 port manifold
• Stoppering device
• In-built heating system
• Air cooled refrigeration system
ICE CONDENSER (INTERNAL):
• R404A Eco friendly refrigerant
• Following PED/ASME design code
• PLC operation…option
• SS316 L construction
• 3 channel recorder…option
• Coil externally electro-polished
• Mobile system……option
• Faster sublimation process
• Defrosting by pure steam or hot water
• Uniform ice thickness
• External condenser (option)
VALIDATION
CLEANING IN PLACE (CIP):
• 180° Rotating spray columns
• Spraying columns and nozzles installed on the strategic areas
• Fully validated cycle
FREEZE DRYER
Freeze drying is often an important stage in the purification of products. A lot of work, whether before or after drying, can be
destroyed by uneven drying, and hence/validation of freeze dryers is important
DOCUMENTATION
• Product specific cycle validation
• Over pressure spraying system (option)
Experience shows, that correct documentation can shorten the validation time and simplify the validation process. For this reason,
Pharmalab has developed tests and the corresponding documentation that can streamline your validation process.
STERILIZATION IN PLACE (SIP):
PROJECT MANAGEMENT
• PLC controlled cycle
Each project is handled by a project team consisting of a project manager that coordinates communication between the customer
and the rest of the project team comprising a mechanical design engineer, a quality control engineer, a validation engineer,
a manufacturing engineer and a logistics engineer. Our team partners with you through site supervisión and installation, providing
you with after sales service and maintenance.
• F0 sterilization value
• Fully validated cycle
• Uniform steam penetration due to corner-less chamber
Site Supervision &
Qualification Team
Customer Project Manager
REFRIGERATION SYSTEM:
• Direct expansion system:
reciprocating compressor
2
Assistant Project Manager
stage
• Unifluid™ cooling system: single stage screw
compressor
Project Manager
Engineering Team
• Unifluid™: Patented energy efficient system
Production Project Manager
• Liquid Nitrogen (N2) expansion system
• Hybrid system
After Sales Team
• CFC free refrigerants
A) PRE SALES ACTIVITY
ENQUIRY
U.R.S.
QUOTATION
FORMAL ORDER
VACUUM SYSTEM:
• Roots blower
• Dry vacuum pump (option)
• Minimum vacuum: 10 µbar
B) PROJECT MANAGEMENT
F.A.T. PROTOCOLS
DESIGN QUALIFICATION
MANUFACTURING
INTERNAL TESTING
F.A.T.
REVISION
• Vane type high performance oil ring vacuum
pump
CHANGE CONTROL
DEVIATION
PRE I.Q.
PRE O.Q.
SITE ACCEPTANCE TEST
I.Q.
C) DOCUMENTATION
• Design Qualification:
Functional Specification, Piping & Instrumentation Diagram (P&ID), Layout Drawings, Nomenclature
• Installation Qualification
• Operational Qualification
• Operation Mannual
• Maintenance Mannual
• Material Quality Test Certificates File
O.Q.
AUTOMATIC LOADING AND UNLOADING SYSTEMS (ALUS)
ISOLATION VALVE:
Unique trayless and operatorless loading
• All contact parts SS316 L
Serail - Pharmalab freeze dryer fully autoloading systems are
engineered to maximize product handling efficiency, eliminate
operator intervention and associated contamination risks and
contribute to higher product quality.
• Fully cleanable
The tray-less shelf loaders with option of isolators for operator
protection and product containment. can load all size of vials,
ampoules or syringes under “built-in” HEPA filters or within
isolated systems. Whether you need small or large chambers,
Serail- Pharmalab has the system of choice for you.
• Leak proof
The CAL21 control system is 21CFR11 compliant, easy to
program and contains accurate record keeping and
Maintenance is an important issue for dependability : to achieve
a high degree of assurance, the number and frequency
ofpeople in the sterile area should be limited. On Serail Freeze
Dryers, most maintenance operations can be performed from
the non sterile side.
THE BENEFIT OF ISOLATORS:
Pharmaceutical customers who need to assure a superior
degree of product protection because of high-value and expensive products or of operator protection because of toxic
products (for example *cytotoxic) can rely on Serail- Pharmalab’s
Isolator production systems. Integrating freeze dryers, ALUS
(Automatic Loading and Unloading Systems) and isolators into
one complete system delivers the best solution for the aseptic
production.
• King Valve
• Butterfly valve
• Ensures chamber condenser separation
• Automatic open & close
STOPPERING:
Stoppering is done at the end of the drying process where
vials loaded on shelves are stoppered under vacuum or
under a controlled atmosphere of inert gas.
• The shelf stoppering is achieved by stacking the shelves in
the bottom of the chamber.
• The ram device inside the chamber allows stoppering
under partial or full vacuum.
• The ram as well as all different attendant components are
not connected to the product chamber.
• A sterile bellow preventing any contamination from the
ram to the chamber.
SOME OF THE POSITIVES BEING:
• High degree of sterility assurance
• Only class “C” surrounding environment required
SUB DOOR:
Sub Door (Pizza Door) is designed for high vacuum and
overpressure operation
• Vertical sliding type meets cGMP requirements
• Fully cleanable
• Intelligently engineered to operate in Class A area
SANITARY PIPING:
uses SS 316L tubes to ensure toughness even down to
cryogenic temperatures and offer high creep, stress to
rupture and tensile strength.
A sanitary piping specifications file will be provided that
includes:
- Certificate of degreasing;
- Material certificate;
- Hydrostatic test certificate;
- Welding operator’s certificate;
- Welding procedure specifications;
ARCHITECTURE DETAILS CAL21
ALL SYSTEMS CAN BE VALIDATED TO THE
LEVEL OFDRYER
COMPLIANCE
FREEZE
THAT THE APPLICATION DEMANDS.
SCADA (Supervisory Control And Data Acquisition)
System
This validatable and FDA–compliant system is developed
especially for precise control and monitoring of processes for
their smooth running and easy reproduction and
documentation.. We utilise a colour touch-screen to select, edit
and run recipes, and provide user friendly interface to monitor
the events.
Kryonik SCADA Systems feature fully computerizedPC
supervisor and PLC controlling available with redundant
backup of standard controls. Using Wonderware® or Intellution,
our user-friendly system is ideal for pharmaceutical production,
QA/QC and validation. Serail's IQ and OQ documentation
makes validation easy and fast. The CAL21 control system is
21CFR11 compliant, easy to program and contains accurate
recordkeeping documents with trending and multileveled
security. All of which enhance your product quality and
reproducibility.
P.L.C. and PC software are in house developed by SERAIL
Automation Engineering department for our Freeze dryers and
all our Automatic Loading Unloading Systems.
One (1) SCADA CAL 21 Control System made of a PC supervisor
associated to a PLC offering automated report generation, all
programmed following latest GAMP guidelines.
This system allows for completely automatic Lyophilization
(including freeze holding) Cleaning in Place, Sterilisation in Place
and Vacuum Leak Test.
Microcomputer supervision is customised package including
recipe management, automatic report generation and data
trending and logging. Trouble shooting is in line will be available
from the SCADA level.
The system includes a PLC with power supply and analogue and
discrete Input and Output boards
PMS
level
Ethernet
PC Supervisor
SCADA
level
Deskjet Printer
OVERVIEW:
The CAL 21 HMI/SCADA (Human Machine Interface /
Supervisory Control and Data Acquisition) is a highly specialised
and customised batch management system designed to meet
the integrated control, information and documentation of
industrial freeze dryers.
CAL 21 offers three possible levels including several options as
listed below.
Dot matrix Printer
Controlnet
Modbus
RS 232
Local I/O
PLC
level
Remote I/O ( Lyophilizer )
From lower level to higher level:
- PLC's level
(Process control)
Drive I/O
( Brushless notor / Stepper notor )
( Loading / Unloading )
- SCADA level (Supervisory Control And Data Acquisition)
- PMS level
(Process Management system)
CAL 21 LIFE CYCLE
Cal 21
master description
CAL 21 MASTER
Client spec/
Cal 21
Customized version
FUNCTIONAL
SPECIFICATION
PID/ I/O list
Segments list
Step list
HARDWARE DESIGN
SPECIFICATION
Flow charts
-I/Omatrix
Segment list Step list
SOFTWARE DESIGN
SPECIFICATION
I/O matrix
networks
SOFTWARE MODULE
SPECIFICATION
Sources codes
Analysis
Team review
Master historic
report
Team
review
& Analysis
Customized
historic
report
CAL 21
DEVELOPMENTS
&MODIFICATIONS
SYSTEM
ACCEPTANCE
TESTING ( OQ )
OQ book
HARDWARE
ACCEPTANCE
TESTING ( IQ )
IQ book
SOFTWARE
INTEGRATION
TESTING
Steps/cycles
testing cycle report
SOFTWARE
MODULES
TESTING
CODE MODULES
Modification
or development
demand
Sources codes
Specific networks
testing (stamped)
ARCHITECTURE DETAILS CAL21
ALL SYSTEMS CAN BE VALIDATED TO THE
LEVEL OFDRYER
COMPLIANCE
FREEZE
THAT THE APPLICATION DEMANDS.
SCADA (Supervisory Control And Data Acquisition)
System
This validatable and FDA–compliant system is developed
especially for precise control and monitoring of processes for
their smooth running and easy reproduction and
documentation.. We utilise a colour touch-screen to select, edit
and run recipes, and provide user friendly interface to monitor
the events.
Kryonik SCADA Systems feature fully computerizedPC
supervisor and PLC controlling available with redundant
backup of standard controls. Using Wonderware® or Intellution,
our user-friendly system is ideal for pharmaceutical production,
QA/QC and validation. Serail's IQ and OQ documentation
makes validation easy and fast. The CAL21 control system is
21CFR11 compliant, easy to program and contains accurate
recordkeeping documents with trending and multileveled
security. All of which enhance your product quality and
reproducibility.
P.L.C. and PC software are in house developed by SERAIL
Automation Engineering department for our Freeze dryers and
all our Automatic Loading Unloading Systems.
One (1) SCADA CAL 21 Control System made of a PC supervisor
associated to a PLC offering automated report generation, all
programmed following latest GAMP guidelines.
This system allows for completely automatic Lyophilization
(including freeze holding) Cleaning in Place, Sterilisation in Place
and Vacuum Leak Test.
Microcomputer supervision is customised package including
recipe management, automatic report generation and data
trending and logging. Trouble shooting is in line will be available
from the SCADA level.
The system includes a PLC with power supply and analogue and
discrete Input and Output boards
PMS
level
Ethernet
PC Supervisor
SCADA
level
Deskjet Printer
OVERVIEW:
The CAL 21 HMI/SCADA (Human Machine Interface /
Supervisory Control and Data Acquisition) is a highly specialised
and customised batch management system designed to meet
the integrated control, information and documentation of
industrial freeze dryers.
CAL 21 offers three possible levels including several options as
listed below.
Dot matrix Printer
Controlnet
Modbus
RS 232
Local I/O
PLC
level
Remote I/O ( Lyophilizer )
From lower level to higher level:
- PLC's level
(Process control)
Drive I/O
( Brushless notor / Stepper notor )
( Loading / Unloading )
- SCADA level (Supervisory Control And Data Acquisition)
- PMS level
(Process Management system)
CAL 21 LIFE CYCLE
Cal 21
master description
CAL 21 MASTER
Client spec/
Cal 21
Customized version
FUNCTIONAL
SPECIFICATION
PID/ I/O list
Segments list
Step list
HARDWARE DESIGN
SPECIFICATION
Flow charts
-I/Omatrix
Segment list Step list
SOFTWARE DESIGN
SPECIFICATION
I/O matrix
networks
SOFTWARE MODULE
SPECIFICATION
Sources codes
Analysis
Team review
Master historic
report
Team
review
& Analysis
Customized
historic
report
CAL 21
DEVELOPMENTS
&MODIFICATIONS
SYSTEM
ACCEPTANCE
TESTING ( OQ )
OQ book
HARDWARE
ACCEPTANCE
TESTING ( IQ )
IQ book
SOFTWARE
INTEGRATION
TESTING
Steps/cycles
testing cycle report
SOFTWARE
MODULES
TESTING
CODE MODULES
Modification
or development
demand
Sources codes
Specific networks
testing (stamped)
AUTOMATIC LOADING AND UNLOADING SYSTEMS (ALUS)
ISOLATION VALVE:
Unique trayless and operatorless loading
• All contact parts SS316 L
Serail - Pharmalab freeze dryer fully autoloading systems are
engineered to maximize product handling efficiency, eliminate
operator intervention and associated contamination risks and
contribute to higher product quality.
• Fully cleanable
The tray-less shelf loaders with option of isolators for operator
protection and product containment. can load all size of vials,
ampoules or syringes under “built-in” HEPA filters or within
isolated systems. Whether you need small or large chambers,
Serail- Pharmalab has the system of choice for you.
• Leak proof
The CAL21 control system is 21CFR11 compliant, easy to
program and contains accurate record keeping and
Maintenance is an important issue for dependability : to achieve
a high degree of assurance, the number and frequency
ofpeople in the sterile area should be limited. On Serail Freeze
Dryers, most maintenance operations can be performed from
the non sterile side.
THE BENEFIT OF ISOLATORS:
Pharmaceutical customers who need to assure a superior
degree of product protection because of high-value and expensive products or of operator protection because of toxic
products (for example *cytotoxic) can rely on Serail- Pharmalab’s
Isolator production systems. Integrating freeze dryers, ALUS
(Automatic Loading and Unloading Systems) and isolators into
one complete system delivers the best solution for the aseptic
production.
• King Valve
• Butterfly valve
• Ensures chamber condenser separation
• Automatic open & close
STOPPERING:
Stoppering is done at the end of the drying process where
vials loaded on shelves are stoppered under vacuum or
under a controlled atmosphere of inert gas.
• The shelf stoppering is achieved by stacking the shelves in
the bottom of the chamber.
• The ram device inside the chamber allows stoppering
under partial or full vacuum.
• The ram as well as all different attendant components are
not connected to the product chamber.
• A sterile bellow preventing any contamination from the
ram to the chamber.
SOME OF THE POSITIVES BEING:
• High degree of sterility assurance
• Only class “C” surrounding environment required
SUB DOOR:
Sub Door (Pizza Door) is designed for high vacuum and
overpressure operation
• Vertical sliding type meets cGMP requirements
• Fully cleanable
• Intelligently engineered to operate in Class A area
SANITARY PIPING:
uses SS 316L tubes to ensure toughness even down to
cryogenic temperatures and offer high creep, stress to
rupture and tensile strength.
A sanitary piping specifications file will be provided that
includes:
- Certificate of degreasing;
- Material certificate;
- Hydrostatic test certificate;
- Welding operator’s certificate;
- Welding procedure specifications;
VALIDATION
CLEANING IN PLACE (CIP):
• 180° Rotating spray columns
• Spraying columns and nozzles installed on the strategic areas
• Fully validated cycle
FREEZE DRYER
Freeze drying is often an important stage in the purification of products. A lot of work, whether before or after drying, can be
destroyed by uneven drying, and hence/validation of freeze dryers is important
DOCUMENTATION
• Product specific cycle validation
• Over pressure spraying system (option)
Experience shows, that correct documentation can shorten the validation time and simplify the validation process. For this reason,
Pharmalab has developed tests and the corresponding documentation that can streamline your validation process.
STERILIZATION IN PLACE (SIP):
PROJECT MANAGEMENT
• PLC controlled cycle
Each project is handled by a project team consisting of a project manager that coordinates communication between the customer
and the rest of the project team comprising a mechanical design engineer, a quality control engineer, a validation engineer,
a manufacturing engineer and a logistics engineer. Our team partners with you through site supervisión and installation, providing
you with after sales service and maintenance.
• F0 sterilization value
• Fully validated cycle
• Uniform steam penetration due to corner-less chamber
Site Supervision &
Qualification Team
Customer Project Manager
REFRIGERATION SYSTEM:
• Direct expansion system:
reciprocating compressor
2
Assistant Project Manager
stage
• Unifluid™ cooling system: single stage screw
compressor
Project Manager
Engineering Team
• Unifluid™: Patented energy efficient system
Production Project Manager
• Liquid Nitrogen (N2) expansion system
• Hybrid system
After Sales Team
• CFC free refrigerants
A) PRE SALES ACTIVITY
ENQUIRY
U.R.S.
QUOTATION
FORMAL ORDER
VACUUM SYSTEM:
• Roots blower
• Dry vacuum pump (option)
• Minimum vacuum: 10 µbar
B) PROJECT MANAGEMENT
F.A.T. PROTOCOLS
DESIGN QUALIFICATION
MANUFACTURING
INTERNAL TESTING
F.A.T.
REVISION
• Vane type high performance oil ring vacuum
pump
CHANGE CONTROL
DEVIATION
PRE I.Q.
PRE O.Q.
SITE ACCEPTANCE TEST
I.Q.
C) DOCUMENTATION
• Design Qualification:
Functional Specification, Piping & Instrumentation Diagram (P&ID), Layout Drawings, Nomenclature
• Installation Qualification
• Operational Qualification
• Operation Mannual
• Maintenance Mannual
• Material Quality Test Certificates File
O.Q.
AFTER SALES SERVICE
ADVANTAGE SERAIL-PHARMALABFREEZE
When you partner with Pharmalab your goals become ours too… and
helping you reach them is our commitment.
Our philosophy is to synergize design, material, function and service to ensure our Freeze Dryers are GMP compliant and exceeding
expectations of quality and performance.. Chambers, shelves, door closing systems, stoppering system, condensers and all
interconnections are manufactured and quality controlled in-house to minimize risk and protect against any possible outer
contamination.
MAINTENANCE:
DRYER
When building systems we strictly follow instructions and all qualification tests are carried out in the presence of the buyer prior to
delivery.
To ensure your system maintains its optimal value, regular maintenance
is a necessity and our team is always there to work with you.
For system reliability, computer-controlled systems are preprogrammed 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 immediate on-line, step by-step troubleshooting and documentation for repair of manufacturing equipment
and process documents with trending and multileveled security.
CYLINDRICAL CHAMBER:
• Following PED/ASME design code
• SS316 L construction
• Highest level of assurance maintaining sanitary conditions
• Uniform temperature distribution during SIP
TRAINING:
• Highest resistance to pressure: Design pressure 2.8 Bar(g)
Pharmalab offers training programmes for operators and maintenance
personnel tailored to the customer’s requirements. Based on the
customer’s freeze dryer configuration these trainings cover design and
function of the main components, for example refrigeration skid,
vacuum pumps and control system as well as fundamentals of the
freeze drying process.
• No corners and natural drain ensures easy drainability
• Light in weight for easy installation
• Full door & sub-door design
OUR AFTER SALES SERVICES INCLUDE:
• Maintenance Contracts
• Preventive Maintenance Services
• Recipe Development/Cycle Development
SHELVES:
• OperatorTraining On & Off Site
• SS316 L construction
• Spare Parts and Retrofits
• Surface finish - 0.6 µm or lower
MODEL SPXXS
• Bench top unit
• Ideal for research in clinical biotech &
pharmaceutical labs
• Flatness: < ± 1 mm per meter
• Specific baffle design for uniform temp.
• Helium leak tested
• ± 1° C temperature accuracy
• Compact design
• Flexible
• Top loading system
• Chamber: AISI 316L
• Ice condenser coil located in the chamber: AISI 316L
• 12 port manifold
• Stoppering device
• In-built heating system
• Air cooled refrigeration system
ICE CONDENSER (INTERNAL):
• R404A Eco friendly refrigerant
• Following PED/ASME design code
• PLC operation…option
• SS316 L construction
• 3 channel recorder…option
• Coil externally electro-polished
• Mobile system……option
• Faster sublimation process
• Defrosting by pure steam or hot water
• Uniform ice thickness
• External condenser (option)
FREEZE DRYING PROCESS
SCADA system for process control
Stoppering system
Vacuum system
Ice Condenser collects sublimed
ice vapours from product until
it is completely dry
Vacuum chamber;
CIP & SIP’ able
Isolation
valve
Mechanical
refrigeration/liquid N2
cooling system
TABLE
SP Series
0.8
1.3
2
3
5
5
7.5
11
14
19
22
33
Kg
30
30
30
70
70
120
120
120
240
240
500
500
Ice capacity (per day) Kg
15
15
15
35
35
60
60
60
120
120
250
250
Shelf area
m2
0.77
1.28
1.87
3.06
4.90
4.60
7.66
11.49
14.04
18.90
22.50
33
Shelf width
mm
340
340
340
680
680
1030
1030
1030
1350
1350
1500
1500
Shelf length
mm
750
750
1100
750
1200
750
1860
1860
1300
2000
1500
2200
Inter shelf spacing
mm
165
90
90
100
100
100
160
100
90
110
90
90
Number of shelves
Nos.
3+1
5+1
5+1
6+1
6+1
6+1
4+1
6+1
8+1
7+1
10+1
10+1
Ice capacity (max)
Ice
vapor
Dried
Product
Glass Vial
Stoppered
Chamber type
Dry
Frozen
Product
Drying
Freezing
Liquid
TYPICAL PRODUCT PROCESSING
+40
+20
Time
-20
-40
-60
Freezing
100
Primary Drying
Secondary Drying
0
ice
Frozen interstitial
material
Sublimation
Desorption
Adsorbed “bound “water
0
% ice formed
RMI
Cylindrical Cylindrical Cylindrical Cylindrical Cylindrical Cylindrical Cylindrical Cylindrical Cylindrical Cylindrical Cylindrical
Cylindrical
Condenser type
Std.
Internal
Internal
Internal
Internal
Internal
Internal
Internal
Internal
Internal
Internal
Internal
Internal
Condenser type
Option
External
External
External
External
External
External
External
External
External
External
External
External
Overall width
mm
1650
1650
1650
2300
2300
2300
2300
2300
2300
2300
2600
2600
Overall length
mm
3165
3165
3415
5150
5600
5240
6000
6000
5300
5800
5300
5800
Overall height
mm
2400
2400
2400
2900
2900
3000
3000
3000
3200
3200
3200
3200
Vial capacity
(16 mm Ø)
Nos.
2600
4300
6500
10600
17300
16100
27200
51000
49700
67300
80300
117000
Vial capacity
(22 mm Ø)
Nos.
1300
2200
3300
5600
8900
8600
14200
21400
26300
35200
42100
62100
Vial capacity
(24 mm Ø)
Nos.
1100
1900
2800
4600
7500
7000
11900
17900
22000
29800
35700
52000
FREEZE DRYING PROCESS
SCADA system for process control
Stoppering system
Vacuum system
Ice Condenser collects sublimed
ice vapours from product until
it is completely dry
Vacuum chamber;
CIP & SIP’ able
Isolation
valve
Mechanical
refrigeration/liquid N2
cooling system
TABLE
SP Series
0.8
1.3
2
3
5
5
7.5
11
14
19
22
33
Kg
30
30
30
70
70
120
120
120
240
240
500
500
Ice capacity (per day) Kg
15
15
15
35
35
60
60
60
120
120
250
250
Shelf area
m2
0.77
1.28
1.87
3.06
4.90
4.60
7.66
11.49
14.04
18.90
22.50
33
Shelf width
mm
340
340
340
680
680
1030
1030
1030
1350
1350
1500
1500
Shelf length
mm
750
750
1100
750
1200
750
1860
1860
1300
2000
1500
2200
Inter shelf spacing
mm
165
90
90
100
100
100
160
100
90
110
90
90
Number of shelves
Nos.
3+1
5+1
5+1
6+1
6+1
6+1
4+1
6+1
8+1
7+1
10+1
10+1
Ice capacity (max)
Ice
vapor
Dried
Product
Glass Vial
Stoppered
Chamber type
Dry
Frozen
Product
Drying
Freezing
Liquid
TYPICAL PRODUCT PROCESSING
+40
+20
Time
-20
-40
-60
Freezing
100
Primary Drying
Secondary Drying
0
ice
Frozen interstitial
material
Sublimation
Desorption
Adsorbed “bound “water
0
% ice formed
RMI
Cylindrical Cylindrical Cylindrical Cylindrical Cylindrical Cylindrical Cylindrical Cylindrical Cylindrical Cylindrical Cylindrical
Cylindrical
Condenser type
Std.
Internal
Internal
Internal
Internal
Internal
Internal
Internal
Internal
Internal
Internal
Internal
Internal
Condenser type
Option
External
External
External
External
External
External
External
External
External
External
External
External
Overall width
mm
1650
1650
1650
2300
2300
2300
2300
2300
2300
2300
2600
2600
Overall length
mm
3165
3165
3415
5150
5600
5240
6000
6000
5300
5800
5300
5800
Overall height
mm
2400
2400
2400
2900
2900
3000
3000
3000
3200
3200
3200
3200
Vial capacity
(16 mm Ø)
Nos.
2600
4300
6500
10600
17300
16100
27200
51000
49700
67300
80300
117000
Vial capacity
(22 mm Ø)
Nos.
1300
2200
3300
5600
8900
8600
14200
21400
26300
35200
42100
62100
Vial capacity
(24 mm Ø)
Nos.
1100
1900
2800
4600
7500
7000
11900
17900
22000
29800
35700
52000