Mainly used in pharmaceutical industry for producing sterile API or constablessuch as blood, vaccine, biological product, antibody product, antibiotics,oncology products and etc. The Ice capacity from 4KG to 1, 000KG. The machinehas compact design to reduce the occupation of plant area. Machine compliancewith GMP, all the system has modular design, more easily for maintenance andoperation, and its best choice before mass production started.
■ Allthe parts contacting the products are made of stainless steel 316L , thesurface 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 runningCIP(Clean-in-Place) and SIP(Sterilization-in-Place) functions to ensure thehigh quality of cleaning and sterilizing the equipment.
Useoverheats pure steam (121℃).
■ Equipped with cooling water jacket, after sterilizing, it can fast reduce thetemperature of the chamber(if less than 20 m2, the equipment isstandard configuration.)
■ Optional pneumatic door lock, it locks automatically.
■ Use imported sterilization filter to ensure absolutely sterilized airentering equipment.
■ The chamber and various kinds of container and tube are all wrapped withimported 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 thechamber.
Highpressure clean water thoroughly wash inner surface of the chamber and icecondenser.
■ 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 fromleaking and product can be protected.
■ The freeze dryer made by our company has a proper layout and enough space tobenefit 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 andmaintain.
■ Working temperature scope of ice condenser: -8℃( when it is dry)~+121℃(whenin 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 recordand 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 reliablerunning.
■ There is no dead corner in the chamber, the connection of tube is simple andreasonable, easy to clean.
The freeze dryer uses thebest refrigeration system to freeze the product and condensate
thesteam produced during freeze-drying procedure. Freeze-drying technologyrequires the refrigeration system to keep a low temperature status for a longperiod of time, therefore, the requirements to the refrigeration system arevery high. But the freeze dryer of our company can easily help you to reachyour goal.
■ Use world famous brand, e.g. Frascold, Danfoss, Copeland, Castel, Edwards,and etc.
■ The system uses double stage half sealed piston compressor to reach firstclass temperature reducing speed rate and the lowest temperature in China.
■ Power in the system is much greater than needed to efficiently ensure therefrigeration performance.
■ Digital and module design has a high protection to ensure the system to runnormally and stably.
■ The powerful refrigeration system, liquid spray cooling system and otherprotection installations keep to the best working temperature and highreliability for system.
■ The sensitive transducing system can provide alarm and protection in timeagainst abnormal running situation.
■ Uses refrigeration conforming to the world environment protectionrequirement, such as HCFCR22 and HFCRA for choice.
■ Special synthetic lubricating oil can eliminate various kinds of problem dueto high temperature of normal mineral oil.
The vacuum system of the freeze dryer providers a necessary pressureenvironment to freeze drying procedure. Cooperating with ice condenser, it canreach the vacuum level required by the freeze-drying procedure. To make thesystem run stably under high vacuum situation,the key point is the performanceof the vacuum pump, and the valve, seal and instrument that cooperate with thepump.
The vacuum system of ourfreeze dryer has the following characteristics:
■ Standard configuration, uses Edwards double stage oil sealed rotary vanevacuum pump.
■ Option: Edwards pump
■ Equipped with two vacuum probes, for measuring the vacuum level of dryingchamber and pump respectively.
■ Option: condenser type vacuum meter.
■ There are two methods for controlling drying chamber vacuum level:
1. Control opening and closing of the air inlet valve, introduce the sterilizedair from sterilized room.
2. Control opening angle of main separated butterfly valve to reach the purposeof controlling the vacuum level.
Separated butterfly valve between drying chamber and ice condenser, circulationpump, spotlight and other components and etc. of the freeze drier, use thefirst class brands from other countries or from domestic factories.
The above systems of ourfreeze dryer have the following characteristics:
■ A main separated butterfly valve or mushroom valve is equipped between thedrying chamber and ice condenser to keep a no leakage seal in both directions.
■ Use labial margin seal design to compensate the change of temperature andpressure during operation.
■ Eccentric valve rod and eccentric butterfly valve eliminate the wear-out ofupper 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 ofbutterfly valve, control the vacuum level of the drying chamber to avoid frombeing polluted.
■ Stainless steel valve body and TEF elastic valve seat conform with GMPspecification.
■ The drying chamber and ice condenser are equipped with sight glass. The sightglass can be equipped with spotlight to obtain clear monitoring.
■ Shelf refrigerating heating system uses Denmark Grundfos UPS circulationpump, Sweden plate type heat exchanger, The size of the exchanger is small,this reduces the heat conduction mediator and energy consumption, raises therefrigeration efficiency.
The control system of the freeze dryer provides a reliable whole procedurecontrol for the freeze drier. It has advanced functions of display, control,recording, printing and alarming.
The control system of ourfreeze dryer has the following characteristics:
■ The mains air switch, transformer and AC contactor fixed in electric cabinetare Siemens products. The electric cabinet is secured on machine frame. Allmachine pump motors are equipped with overheat protection, solenoid valve andheating 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 normallyunder high temperature, ultra-low temperature and high vacuum level with highreliability.
■ The control system can display the running status of all components of thewhole system, and can store and process the operation information and variousdata. It can provide procedure recording report of whole freeze-drying process.It can alarm on failure or abnormal situation, provide checking formaintenance, the operator can set and modify data and steps.
Our company operates it’s own internal Quality Management system that providesthe foundation for ISO 9001 accreditation. This system provides the basis forcomprehensive documentation of the manufacture of all its products, ensuringcustomers 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 customerswith equipment validation. Calibration documentation is also available. Theseservices are not part of the standard scope of supply.
It is made of several systems like chamber/door, shevles/ice condenser,isolation valve(butterfly valve or mushroom valve)/refrigeration system, vacuumsystem/circulation system, hydraulic system, CIP/SIP system and automaticcontrol system.
We use main components from world top brand like BOC Edwards vacuum pump,Bitzer compressor, Japanese KOBELCO or MYCOM screw compressor, Alfa Laval plateheat exchanger, Grundofs circulation pump, NASH water ring pump, German GEMÜ/Bü Rkert valves, Edwards/MKS vacuum gauge, German WIKA pressure gauge, SiemensPLC and etc. So the stable quality can be guaranteed.
Compact design, Reliability running under high performance, vacuum or air filledstoppering, Eutectic device detector are available. Control system designedwith multirecipe, user can choose different recipe for different process. Thecontrol system can automatically validate the machine performance before eachproduction cycle, thus the safety for each production cycle can be ensured.
1. Eutectic point detector
2. Organic solvent collector.
3. Inter-shelf distance adjust mechanism
4. Vacuum or air filled stoppering (with pressure adjustable)
5. Sampling device
7. Chamber isolation valve with mushroom/butterfly type.
8. Constant height loading(pizza door)
9. Filter integrity tester/water intrusion test(WIT)
10. Vials Automatic Loading and Unloading System
(fixed row-by-row or flexible AGV: Automatic guided vehicle)
|Usable shelf area(m2)||0.5|
|Number of shelf||2+1||4+1||4+1||4+1||5+1|