Introduction
The pharmaceutical vacuum freeze dryer is made up of four parts if classified by system, i.e. refrigeration system, vacuum system, heating system and control system and five components by structure, i.e. drying cabinet, condenser, refrigerator, vacuum pump and valve, electrical control elements.
The pharmaceutical vacuum freeze drying technology refers to the technique of drying materials by freezing of wet materials or solutions to solid state under low temperature (-10℃~-50℃) followed by direct sublimation of water to reach liquid and air free state under vacuum (1.3~13pa).
Main Functions
1. Pre-freezing function of shelves.
2. Storage with filling of nitrogen or inert gas after drying.
3. Automatic control system of freeze-drying: programmable programming to realize programmable control from freeze-drying to defrosting.
4. Shelves: adopting advanced welding technique without leakage (3 years of warranty).
5. Testing system for freeze-drying end-point: freeze-drying end-point test can be conducted automatically upon completion of resolution and drying to ensure conformity of moisture content of materials to standard.
6. Vacuum adjustment system: vacuum degree adjustment is performed during sublimation, resolution and drying to avoid problems of bubbling, bottle blowing, and freeze-drying efficiency.
7. 3 types of impulse filling system: slow speed, medium speed and fast speed are available to avoid the problem of loss of effective matters resulted by air inflation of granular and flocculent materials after completion of freeze-drying.
8. Large-size industrial touch screen is adopted with friendly HMI, which is simple and understandable and can be operated without user manual.
9. Monitoring system: monitoring temperature and vacuum degree in real time with sampling frequency of 50ms/time.
10. Storage of freeze-drying formula: it can store 2000 groups of fixed or customized freeze-drying formulas.
11. PC remote monitoring system: remote monitoring on equipment operation conditions with the largest monitoring distance of 1.5km.
12. Eutectic point testing function (optional).
13. Process data recording system (optional).
14. Calibration function: calibration of temperature and vacuum degree to ensure accurate measurement results in long service.
15. Freeze-drying curve query function (temperature and vacuum degree curve can be checked to facilitate technological optimization and validation of freeze-drying effect).
Performance Characteristics
Cabinet body
The cabinet of pharmaceutical freeze dryer is designed as per GB150-2011/PED and ASME standards, conforming to GMP requirements. The interior of the cabinet adopts large rounded corner, the surface is bright polished and the bottom of the cabinet is designed with dip angle in line with drainage requirement in CIP and SIP. The cabinet can withstand a positive and negative pressure within the range of 0.15Mpa to 0.5Pa.
Shelves
The shelves are welded with advanced welding techniques.
1. Welding inside.
2. TIG welding
3. Track welding technique
Cold trap
The cold trap adopts mirror finish technology to obtain bright and flat surface. The water-vapor channel is optimized to achieve smaller molecular flowing resistance and higher water catching efficiency.
Refrigeration system
The refrigeration system adopts refrigeration compressor of world-known brands, which is safe and stable.
Vacuum system
The vacuum pipes in pharmaceutical freeze dryer are welded with the automatic track welding technology to ensure sturdy and beautiful welding. The vacuum leak of the system is detected by the helium mass spectrometer leak detector to ensure that the high vacuum requirement is met.
Cleaning in place (CIP) system
The valves and pneumatic executing mechanism of the CIP system adopt imported parts to ensure stable, safe and reliable operation. The pipelines are welded with the automatic track welding technology to ensure sturdy and beautiful welding. The pipeline vacuum leak of the system is detected by the helium mass spectrometer leak detector to ensure that the high vacuum requirement is met. And the discharge of remaining water after cleaning adopts water ring pump imported from Germany with large pumping speed to ensure thorough removal.
Sterilization in place (SIP) system
The sterilization in place (SIP) system employs pulsating pre-vacuum steam sterilization method, equipped with F0 value display and recording functions, complete safety interlocking and mutual interlocking functions and self-contained cooling function. Triple protection against overpressure is taken to ensure safety. The cabinet adopts high-pressure vessel design and all parts are inspected and tested by industrial X-ray machines to ensure overall solidity and high pressure resistance. The valves of SIP system are all imported parts with a temperature resistance of 350°C or higher. The pneumatic executing mechanism adopts imported parts to ensure stable, safe and reliable operation. The pipelines are welded with automatic track welding technology to ensure sturdy and beautiful welding. The pipeline's vacuum leak is detected by the helium mass spectrometer leak detector to ensure high vacuum requirement is met. And the discharge of remaining water after sterilization adopts the water ring pump imported from Germany to ensure thorough removal, with a large pumping speed and a sterilizing temperature up to 150°C.
Process control system
The precise process control system satisfies the requirements of FDA 21 CFR PART 11 that electronic records and signatures cannot be modified, so that the data is repeatable, and recoverable.
Plate heat exchanger
Plate heat exchanger of world-known brands is adopted with high heat exchanging efficiency.
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