Gzl10 Vacuum Freeze Drying Machine for Pharmaceuticals

• Customization: Available
• Certification: CE, GMP, ISO
• Condition: New
• Model NO.: Gzl10
• Customized: Non-Customized
• Voltage: According to Your Requirement
• Usable Shelf Area(M2): 10
• Shelf Size(mm): 1215* 1215
• Number of Shelf: 7+1
• Shelf Spacing(mm): 100
• Shelf Level(mm/M): +/-0.2
• Type: Preparation Machinery
• Precision: High Precision
• Computerized: Computerized
• Warranty: 1 Year
• Finished Dosage Form: Powder
• Transport Package: Seaworthy
• Specification: GMP
• Trademark: SPM
• Origin: Shanghai
• HS Code: 8419399010
• Production Capacity: 10m2

Product Description

Gzl10 Vacuum Freeze Drying Machine for Pharmaceuticals
Model GZL10
Usable shelf area() 10
Shelf  size(mm) 1215*1215
Number of shelf 7+1
Shelf  spacing(mm) 100
Shelf level(mm/m) ±0.2
shelf surface roughness(Ra) 0.8
Shelf lowest temperature(ºC) -50~-60
Shelf temperature scope (ºC) -60/+121
Shape of chamber  Rectangular
Chamber inner surface polish Mirror
Structure and shape of ice condenser  Horizontal vertical cylinder
Lowest temperature of ice condenser(ºC) 80
Ice capacity(kg) 150
Refrigerator power 2*15hp
Vacuum suction rate(m3/h ) 160
Power of whole machine(kw) 55
Cooling water amount(T/H) 12
Hydraulic plug(option) √
Hydraulic plug(option) Hydraulic plug bellows(option) √
SIP(option) √
CIP(option) √
Freeze-drying trays(option) √
Diagram recording instrument √
Weight of whole machine(kg) 9000
External size(L*W*H (m) ) 4100*2300*3600
 
The freeze dryer made by our company is designed and manufactured strictly according to GMP Specifications, and has the following merits:
All the parts contacting the products are made of stainless steel 316L , the surface roughness reaches Ra≤0.5um.
The inner circle of the chamber has a smooth transition without dead corner, no objects accumulated.
Considering for user, the structure is easy to clean.
Option for steam sterilization or chemical sterilization.
Except for the above, our company can also provide automatic running CIP(Clean-in-Place) and SIP(Sterilization-in-Place) functions to ensure the high quality of cleaning and sterilizing the equipment.

SIP:
¬  Use overheats pure steam (121ºC).
¬  Equipped with cooling water jacket, after sterilizing, it can fast reduce the temperature of the chamber(if less than 20, the equipment is standard configuration.)
¬  Optional pneumatic door lock, it locks automatically.
¬  Use imported sterilization filter to ensure absolutely sterilized air entering equipment.
¬  The chamber and various kinds of container and tube are all wrapped with imported insulation material to efficiently avoid from heat transmission.
¬  Can carry out constant humidity control to the refrigeration humidity.
¬  Equipped with water ring pump capable to eliminate residual water inside the chamber.
 
CIP:
¬  High pressure clean water thoroughly wash inner surface of the chamber and ice condenser.
¬  Equipped with large flux CIP pump.
¬  Fixed with CIP tubing that automatically drains the residual water.
¬  Use rotary fixed nozzles with 360 angle spraying.
¬  The hydraulic rod in hydraulic system adopts bellows to prevent oil from leaking and product can be protected.

The freeze dryer made by our company has a proper layout and enough space to benefit the maintenance and operation of the equipment.
¬  Rectangular or cylinder shape drying chamber(user may choose one of them)
¬  Horizontal of vertical ice condenser
¬  Integral design can fully use space.
¬  Separated design can make each component independent, easy to operate and maintain.
¬  Working temperature scope of ice condenser: -8ºC( when it is dry)~+121ºC(when in steam sterilizing).
¬  Pressure scope of the chamber:1Pa
¬  Use industrial pressure vessel standard: GB150-1998 series.
¬  Conform to national vacuum equipment standard: GB/T3163-3164
¬  GMP and FDA relevant regulations.
¬  Standard of international Electrotechnical Commission(IEC)
¬  China Electric Equipment Standard(GB)
¬  The drying chamber,shelf and ice condenser is made of stainless steel 316L .
¬  TIG welding avoids gap that can not be cleaned and possible leakage.
¬  The welding point the tube is photographed with X-ray, with inspection record and certification of qualification.
¬  The roughness of inner surface reaches Ra≤0.5um, mirror polished.
¬  Leakage rate of the system≤ 5x10-2mbar l/sec to ensure normal and reliable running.
¬  There is no dead corner in the chamber, the connection of tube is simple and reasonable, easy to clean.
 
The freeze dryer uses the best refrigeration system to freeze the product and condensate the steam produced during freeze-drying procedure. Freeze-drying technology requires the refrigeration system to keep a low temperature status for a long period of time, therefore, the requirements to the refrigeration system are very high. But the freeze dryer of our company can easily help you to reach your goal.
¬  Use world famous brand, e.g. Frascold, Copeland, Castel, Edwards, and etc.
¬  The system uses double stage half sealed piston compressor to reach first class temperature reducing speed rate and the lowest temperature in China.
¬  Power in the system is much greater than needed to efficiently ensure the refrigeration performance.
¬  Digital and module design has a high protection to ensure the system to run normally and stably.
¬  The powerful refrigeration system, liquid spray cooling system and other protection installations keep to the best working temperature and high reliability for system.
¬  The sensitive transducing system can provide alarm and protection in time against abnormal running situation.
¬  Uses refrigeration conforming to the world environment protection requirement, such as HCFCR22 and HFCRA for choice.
¬  Special synthetic lubricating oil can eliminate various kinds of problem due to high temperature of normal mineral oil.
 
The vacuum system of the freeze dryer providers a necessary pressure environment to freeze drying procedure. Cooperating with ice condenser, it can reach the vacuum level required by the freeze-drying procedure. To make the system run stably under high vacuum situation,the key point is the performance of the vacuum pump, and the valve, seal and instrument that cooperate with the pump.
 
The vacuum system of our freeze dryer has the following characteristic:
¬  Standard configuration, uses Edwards double stage oil sealed rotary vane vacuum pump.
¬  Option: Edwards pump
¬  Equipped with two vacuum probes, for measuring the vacuum level of drying chamber and pump respectively.
¬  Option: condenser type vacuum meter.
¬  There are two methods for  controlling drying chamber vacuum levell:
1.Control opening and closing of the air inlet valve, introduce the sterilized air from sterilized room.
2.Control opening angle of main separated butterfly valve to reach the purpose of controlling the vacuum level.
Separated butterfly valve between drying chamber and ice condenser, circulation pump, spotlight and other components and etc. of the freeze drier, use the first class brands from other countries or from domestic factories.
The above systems of our freeze dryer have the following characteristics:
¬  A main separated butterfly valve or mushroom valve is equipped between the drying chamber and ice condenser to keep a no leakage seal in both directions.
¬  Use labial margin seal design to compensate the change of temperature and pressure during operation.
¬  Eccentric valve rod and eccentric butterfly valve eliminate the wear-out of upper and lower ends of valve seat during frequent opening.
¬  May choose electric of pneumatic driving device.
¬  Imported original electric driver can steplessly adjust the opening angle of butterfly valve, control the vacuum level of the drying chamber to avoid from being polluted.
¬  Stainless steel valve body and TEF elastic valve seat conform with GMP specification.
¬  The drying chamber and ice condenser are equipped with sight glass. The sight glass can be equipped with spotlight to obtain clear monitoring.
¬ 
Shelf refrigerating heating system uses Denmark UPS circulation pump, Sweden plate type heat exchanger, The size of the exchanger is small, this reduces the heat conduction mediator and energy consumption, raises the refrigeration efficiency.
 
The control system of the freeze dryer provides a reliable whole procedure control for the freeze drier. It has advanced functions of display, control, recording, printing and alarming.
The control system of our freeze dryer has the following characteristics:
¬
The mains air switch, transformer and AC contactor fixed in electric cabinet are Siemens products. The electric cabinet is secured on machine frame. All machine pump motors are equipped with overheat protection, solenoid valve and heating circuit are equipped with separate protection.
¬  The display screen uses Mitsubishi touch screen, PLC, indicating light, sound-light alarming system, and etc.
¬  Temperature measuring, pressure measuring, the components can work normally under high temperature, ultra-low temperature and high vacuum level with high reliability.
¬  The control system can display the running status of all components of the whole system, and can store and process the operation information and various data. It can provide procedure recording report of whole freeze-drying process. It can alarm on failure or abnormal situation, provide checking for maintenance, the operator can set and modify data and steps.
 
Our company operates it's own internal Quality Management system that provides the foundation for ISO 9001 accreditation. This system provides the basis for comprehensive documentation of the manufacture of all its products, ensuring customers are provided with full details of their equipment.
Standard documentation supplied with every freeze dryer includes:
¬  electrical diagram
¬  piping and instrumentation diagram/drawing (P&ID)
¬  Component list
¬  Certificates of conformance for Critical components
¬  Operating instructions
¬  Maintenance instructions
¬  Copies of pressure vessel certificates
Our company also able to provide IQ and OQ documentation to assist customers with equipment validation. Calibration documentation is also available. These services are not part of the standard scope of supply.

Specification

Shelf temperature scope (ºC)

-60/+121

Shape of chamber

Cylinder

Rectangular

Rectangular

Rectangular

Rectangular

Rectangular

Rectangular

Rectangular

Rectangular

Rectangular

Rectangular

Rectangular

Chamber inner surface polish

Mirror

Mirror

Mirror

Mirror

Mirror

Mirror

Mirror

Mirror

Mirror

Mirror

Mirror

Mirror

Structure and shape of ice condenser

Horizontal cylinder

Horizontal vertical cylinder

Horizontal cylinder

Lowest temperature of ice condenser(ºC)

-80

-80

80

-80

80

-80

80

-80

80

-80

80

-80

Ice capacity(kg)

7.5

15

30

45

90

120

150

225

300

450

600

750

Refrigerator power

1*5hp

1*5hp

1*10hp

1*10hp

2*10hp

2*15hp

2*15hp

2*25hp

2*30hp

3*30hp

4*30hp

4*30hp

Vacuum suction rate(m3/h )

18

30

40

60

80

120

160

240

350

525

700

825

Control system

Automatic + manual

Power of whole machine(kw)

5

7.5

12

20

40

50

55

75

100

125

180

220

Cooling water amount(T/H)

Cooling by air

2

4

4

8

12

12

20

24

36

48

48

Hydraulic plug(option)

√

√

√

√

√

√

√

√

√

√

√

√

Hydraulic plug(option) Hydraulic plug bellows(option)

√

√

√

√

√

√

√

√

√

√

√

√

SIP(option)

√

√

√

√

√

√

√

√

√

√

√

√

CIP(option)

√

√

√

√

√

√

√

√

√

√

√

√

Freeze-drying trays(option)

√

√

√

√

√

√

√

√

√

√

√

√

Diagram recording instrument

√

√

√

√

√

√

√

√

√

√

√

√

Weight of whole machine(kg)

2000

3000

3500

5000

6500

7500

9000

12500

13800

17800

22800

26000

External size(L*W*H (m) )

1500* 1000* 2300

2280* 950* 2520

2752* 1302* 2650

3100* 1650* 2930

3630* 1950* 3600

3630* 1950* 3600

4100* 2300* 3600

6165* 2524* 3700

6165* 2524* 4050

6165* 2800* 4050

5500* 5000* 4530

5500* 5000* 5130