Fd-P Series Process Freeze Dryer for Medicine Use/Lyophilizer

• Customization: Available
• Warranty: 1 Year
• Shelf Area (M2 ): 1.08~51
• Model NO.: FD-P Series
• Type: Preparation Machinery
• Precision: High Precision
• Certification: CE, GMP, ISO
• Voltage: 380V
• Computerized: Computerized
• Customized: Non-Customized
• Condition: New
• Finished Dosage Form: Powder
• Transport Package: Plywood Packing
• Trademark: Xiangyi
• Origin: China
• HS Code: 8419399010
• Production Capacity: 100 PCS/Month

Product Description

CMain Functions

• Shelf pre-freezing function.
• Can be filled with nitrogen or inert protect machine after working.
• lyophilized automatic control system: procedural programming, both freeze-dried and defrost control procedures.
• Shelf: adopting international advanced welding technology without leak (three-year warranty).
• Lyophilized end point test system: automatic lyophilized end testing parsed end of the drying stage, to ensure that the moisture content of the material to reach the standards.
• Vacuum regulator systems: sublimation and vacuum drying process analytical adjustment, avoid special material to foaming & blowing, accelerate lyophilization efficiency.
• Pulse backfill system: slow, medium, fast three backfill mode selection, avoiding the issue for the end of the freeze-dried granular material and flocculent inflatable produce effective substances are blown away loss.
• Large industrial touch screen, human-computer interaction is good, easy to understand, no instructions are also available for easy operation.
• Monitoring system: real-time monitoring system temperature, vacuum, acquisition frequency 50ms / times.
• Lyophilization process recipe storage function: can store 2000 group fixed or user-defined lyophilized formulation process.
• PC remote monitoring system: remote monitoring equipment operating conditions, as far as monitoring distance 1.5KM.
• Eutectic point test function (optional).
• Process data recording system (optional).
• Calibration function: temperature and vacuum calibration ensures long-term accuracy of the measured values.
• Lyophilized curve inquiry function (available temperature and vacuum degree curve, convenient process optimization and lyophilized effect verification).

Features
Cabinet:
Cabinet design according to GB150-2011 / PED ASME standards, in line with FDA and GMP standards. Internal cabinet with large rounded design, with mirror polished surface, bottom of the box with tilt design, also i  n line with CIP and SIP drainage requirements. It can withstand: 0.15Mpa to 0.5Pa full range of positive and negative pressure.
Shelf: adopts international advanced welding process. Internal welding, TIG welding and orbital welding technology
Condenser: with polishing technology, surface bright and smooth. Water vapor channel optimized design to ensure small molecule surge resistance, more efficient water capture.
Refrigeration system uses world famous refrigeration compressors, refrigeration system security and stability.
Vacuum system: vacuum pipe with automatic orbital welding, ensure welding firm appearance. Using helium vacuum leak detector testing to ensure vacuum system to achieve high vacuum requirements.
CIP system CIP system valves and pneumatic actua  tors are imported original, to ensure stable operation, safe and reliable. CIP system piping with automatic orbital welding, ensure welding firm appearance. CIP vacuum system piping using helium leak detector testing to ensure vacuum system to achieve high vacuum requirements. water pump imported from Germany to remove residual moisture after cleaning, cleared completely.
SIP system uses a pulsating pre-vacuum steam sterilization, with Fo value display and recording, with complete safety interlock and interlock functions, box comes with a cooling function. Triple overpressure protection, to ensure absolute safety. Case high pressure vessel design, manufacturing process, all components of industrial X-ray machine detected by testing, ensure that the overall firm, resistant to high pressure. Valves are used in place disinfection system temperature up to above 350 °C of the original imports. Pneumatic actuators are imported original, ensure stable operation, safe and reliable. Reign disinfection system with automatic orbital pipe welding, welding to ensure strong and beautiful. SIP system piping using helium vacuum leak detector testing to ensure vacuum system to achieve high vacuum requirements. Remove residual moisture after sterilization imported from Germany, water ring pumps, pumping speed, completely clear. Maximum sterilization temperature up to 150 °C.
Process Control System, meet FDA 21 CFR PART 11 electronic records, electronic signatures cannot be modified requirements. Precisely controlled, repeatable, can be restored.
Plate heat exchanger, using the world-class plate heat exchanger, heat transfer efficiency.
SIP type suitable for the use of the pharmaceutical sector. CIP type suitable for use in the field of biological engineering. Common type suitable for industrial, food and other fields use

                         

Safety:

• Independent Overcurrent protection for various facilities
• Independent overload protection for various facilities
• Conditions allow individual facilities operating
• Heating overtemperature protection
• Product vacuum freeze-drying process protection
• Vacuum pump protection
• System logic interlock
• Meet the GMP standard

 

Model	Shelf area (m2 )	Shelf qty	Shelf size (mm)	Temp. accuracy(°C)	Condenser water capacity (L)	Vials load  (∮22)	Shelf temp. (°C)	Condenser temp. (°C)	Power (KW)
FD-P1	1.08	4+1	450*600	±1.0	20	2100	-60-80	<-85	9
FD-P2	2.19	4+1	600*900		40	4200			12
FD-P3	3.24	6+1	600*900		60	6300			21
FD-P5	4.86	6+1	900*900		100	9450			24
FD-P7	7.56	7+1	900*1200		150	15750			44
FD-P10	9.72	9+1	900*1200		200	19950			58
FD-P13	12.96	9+1	1200*1200		260	26250			67
FD-P15	16.1	9+1	1200*1490		320	33600			75
FD-P20	19.67	11+1	1200*1490		400	42900			104
FD-P25	25.0	14+1	1200*1490		500	52500			125
FD-P30	31.5	14+1	1490*1490		600	60900			134
FD-P40	42	14+1	1490*1990		800	84000			174
FD-P50	51.0	17+1	1490*1990		1000	105000			210