Freeze Drying Machine <small>(Dryer for Active Pharmaceutical Ingredients)</small> Manufacturer

Freeze Drying Machine (Dryer for Active Pharmaceutical Ingredients)

Freeze Drying Machine <small>(Dryer for Active Pharmaceutical Ingredients)</small>

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Application
Our freeze drying machine usually has a nominal freeze-drying area of over 25m2 and is mainly applicable for the mass production of heat-sensitive products such as chemical intermediates and vitamins.

Features
1. This lyophilization equipment allows the raw material liquid to be fed in needing no tray or shelf, thereby guaranteeing the uniform quality of the freeze-dried products.
2. The dryer for active pharmaceutical ingredients has shelves which are parallel-inclined. The internal cleaning and sterilization of this freeze drying equipment are completed through pressure steam jetting. These make sure the soluble residues like dust can be completely removed.
3. Fitted with external feeding and discharging unit, our freeze drying machine is able to achieve automatic aseptic API feeding and discharging.
4. The freeze drying machine for APIs developed based on our years of experience as a freeze dryer manufacturer is produced in accordance with the Good Manufacturing Practice of Drugs. A machine group composed of 4 sets of lyophilizers with nominal freeze-drying area of 50m2 can achieve the optimal APIs freeze drying effects.

Composition of Freeze Drying Machine
Our company is a pharmaceutical freeze dryer supplier in China and the pharmaceutical freeze drying machine we produce is composed of the following components.

Drying Cabinet of Freeze Drying Machine
The drying cabinet of our pharmaceutical freeze drying machine is designed in accordance with the GB150-2011/PED/ASME standard and it conforms to the requirements of CGMP and FDA. The drying cabinet has a polished mirror-like inside and an inclined bottom, facilitating water discharging in the CIP and SIP processes.

Cold Trap of Freeze Drying Machine
The cold trap used in our pharmaceutical freeze dryer employs the direct expansion refrigeration principle. Our cold trap can be vertical or horizontal. Reasonable design of the water vapor channel allows the molecules to move more smoothly with smaller resistance. The valve between the drying cabinet and the cold trap can achieve recognition of the finishing of the freezing-drying process.
The cold trap can be designed to support CIP and SIP. It can also be used for cooling the tank of large pharmaceutical freeze dryer after SIP.

Shelf of Freeze Drying Machine
The shelf of our pharmaceutical freeze drying equipment adopts indirect refrigeration method and can also be heated to supply power for the products to sublimate. The shelf spacing of our large pharmaceutical freeze dryer is adjustable to make it applicable for placing vials of various heights.

Vacuum System ofFreeze Drying Machine
The vacuum system which is made up of vacuum pumps or roots pumps is mainly used for building up vacuum and expelling gases. The air intake port of every vacuum pump is assembled with an automatic stop valve preventing gas backflow. The vacuum gauge assembled to our pharmaceutical freeze dryer is MKS capacitive gauge or Edwards Pirani vacuum gauge.

SIP System of Freeze Drying Machine
The SIP system of our freeze drying machine adopts the impulse forvacuum steam sterilizing method and is equipped with an FO displaying & recording device. This SIP system has complete interlocking function. In the steam inlet manifold there is a pneumatic controlled steam master valve. Inside the SIP system there is a safety valve which can relief automatically when the working pressure exceeds the designed pressure. The tank not only has its own cooling system, but also has pressure and temperature protection devices. When the pressure or temperature is higher than the preset value, the protection devices will work automatically to turn off the steam inlet valve and turn on the air release valve. The dual protection devices guarantee the SIP system of our lyophilizer works safely.

Circulation System ofFreeze Drying Machine
The circulation system which uses circulating pumps to achieve forced circulation of the secondary refrigerant is mainly used to achieve hot and cold energy exchange between refrigerating medium and secondary refrigerant; secondary refrigerant and shelf; shelf and the product to be freeze-dried.

CIP System of Freeze Drying Machine
The CIP system of our freeze drying machine accords with the FDA/CGMP standard. This system consists of a CIP workstation and is designed with no dead corners. Our CIP system can achieve steam sterilization and the pipelines are welded with trajectory welding technology.

Hydraulic System of Freeze Drying Machine
The hydraulic pump station and oil cylinder are mounted on the top of the drying cabinet. Powdered by the hydraulic pumps, the oil cylinder drives the shelf to move up and down stably. Sealing units of the oil cylinder include Y-fluororubber, O-luororubber and dust prevention assembling units. The components of the hydraulic pump are from internationally famous manufacturers. Stainless steel corrugated pipes can be fitted to the outside of the hydraulic rod.

Refrigeration System of Freeze Drying Machine
The refrigeration system of our pharmaceutical freeze dryer is mainly composed of the refrigeration compressor, water condenser, expansion valve, plate evaporator, oil separator, etc. The main machine of the refrigeration system adopts imported two-stage semi-hermetic compressor or screw compressor. Each compressor works as an independent refrigeration circulation system and freeze the shelf and the cold trap through plate heat exchanger and condenser pipe respectively. The pipeline of the refrigeration system is well engineered and accurately installed to ensure the whole refrigeration system is able to run efficiently and stably for a long period of time.

Our refrigeration system is designed to have adequate energy to cope with the vapor produced in sublimation. This refrigeration system also come with many protection functions such as motor over-temperature protection, overload protection, high pressure protection, low pressure protection, medium pressure protection, oil pressure difference protection, and cooling water low level protection.

Control System ofFreeze Drying Machine
We adopt PID control mode to control the temperature of the shelf and the vacuum degree of our freeze drying machine to achieve quick freeze, slow freeze, repeated freeze and constant temperature keeping.

a. Programmable Logic Controller b. Computer (Remote Control) c. Touch Screen (Control Terminal)
d. Output Module e. Input Module f. Temperature Control Module g. Communication Module
h. AD Module i. CPU Module j. Power Supply Module

Software of Freeze Drying Machine
The intelligent control software used for our pharmaceutical freeze dryer is internationally advanced configuration software which is developed based on the terminal and remote control technology. The intelligent control software has the functions of PID control, automatic monitoring and freeze-drying formula management. As a set of industrial software dedicated for vacuum freezing drying equipment, it also supports multi-language operation and remote control.

Parameter setting
Processing curve programming
Defrosting
Full-automatic running
Data recording

Parameters of Pharmaceutical Freeze Dryer

Parameters			Unit	GLZY-B (CIP) Pharmaceutical Freeze Dryer					GLZY-BS (CIP SIP) Pharmaceutical Freeze Dryer
Nominal area			Unit	1	2	3	5	7.5	1	2	3	5	7.5
Capacity	Effective shelf area		m²	1.08	2.16	3.24	4.86	7.56	1.08	2.16	3.24	4.86	7.56
	Condenser capacity		kg/B	20	40	60	100	150	20	40	60	100	150
	Vial quantity	Φ16mm	piece	4100	8200	12300	18450	30750	4100	8200	12300	18450	30750
	Vial quantity	Φ22mm	piece	2100	4200	6300	9450	15750	2100	4200	6300	9450	15750
	Liquid capacity of tray		L	20	40	60	100	150	20	40	60	100	150
Basic parameters	Shelf size	Width	mm	450	600	600	900	900	450	600	600	900	900
	Shelf size	Length	mm	600	900	900	900	1200	600	900	900	900	1200
	Shelf spacing		mm	100
	Shelf quantity		layer	4 1	4 1	6 1	6 1	7 1	4 1	4 1	6 1	6 1	7 1
	Shelf temperature range		℃	-55~ 80
	Shelf temperature difference		℃	±1.0 (Balanced)
	Lowest temperature of cold trap		℃	≤-75
	Final vacuum degree		Pa	≤1
Basic kit supply	Cooling water consumption: ≤30℃, 0.15~0.2MPa		m³/hr	3.2	4.2	4.5	11	16	3.2	4.2	4.5	11	16
	Cleaning water consumption: CIP-WIP: ≥65℃, 0.15~0.2MPa		L/min	100	100	100	100	100	100	100	100	100	100
	Pure steam consumption for SIP: 0.2-0.3MPa		kg/hr						20	40	60	100	150
	Steam consumption for defrosting: 0.2-0.3MPa		kg/hr						5	10	15	25	40
	Compressed air consumption: 0.6-1.0MPa		m³/min	0.1
	Water consumption for defrosting: ≈50℃, 0.1-0.2MPa		kg/B	270	270	300	400	1200
	Installation power: 400V, 3P5W, 50Hz (±5%)		kW	9	12	21	24	44	9	12	21	24	44
	Total weight		t	1.9	2.3	2.8	4.2	6	2	2.6	3.8	4.5	8.2
Overall dimension	Length		mm	3100	3510	4470	4790	5320	3230	3640	4600	4930	5460
	Width		mm	1180	1340	1340	1740	1740	1500	1620	1620	2020	2020
	Height		mm	2550	2550	2800	3100	3200	2550	2550	2800	3100	3200
Nominal area			Unit	1	2	3	5	7.5	1	2	3	5	7.5
200mm-300mm If the pharmaceutical freeze dryer is fitted with a corrugated pipe protective sleeve, the total height of the freeze drying equipment will increase by 200~300mm.

Parameters			Unit	GLZY-B (CIP) Pharmaceutical Freeze Dryer								GLZY-BS (CIP SIP) Pharmaceutical Freeze Dryer
Nominal area			Unit	10	13	15	20	25	30	40	50	10	13	15	20	25	30	40	50
Capacity	Effective area of shelf		m²	9.72	12.96	16.1	19.67	25.0	31.5	42	51.0	9.72	12.96	16.1	19.67	25.0	31.5	42	51.0
	Condenser capacity		kg/B	200	260	320	400	500	600	800	1000	200	260	320	400	500	600	800	1000
	Vial quantity	Φ16mm	piece	38950	51250	65600	83160	102500	118900	164000	205000	38950	51250	65600	83160	102500	118900	164000	205000
	Vial quantity	Φ22mm	piece	19950	26250	33600	42900	52500	60900	84000	105000	19950	26250	33600	42900	52500	60900	84000	105000
	Liquid capacity of tray			200	260	300	400	500	600	800	1000	200	260	300	400	500	600	800	1000
Basic parameters	Shelf size	Width	mm	900	1200	1200	1200	1200	1490	1490	1490	900	1200	1200	1200	1200	1490	1490	1490
	Shelf size	Length	mm	1200	1200	1490	1490	1490	1490	1990	1990	1200	1200	1490	1490	1490	1490	1990	1990
	Shelf spacing		mm	100				90				100				90
	Shelf quantity		layer	9 1	9 1	9 1	11 1	14 1	14 1	14 1	17 1	9 1	9 1	9 1	11 1	14 1	14 1	14 1	17 1
	Shelf temperature range		℃	-55~ 80
	Shelf temperature difference		℃	±1.0 (Balanced)
	Lowesttemperature of cold trap		℃	≤-75
	Final vacuum degree		Pa	≤1
Basic kit supply	Cooling water consumption: ≤30℃, 0.15~0.2MPa		m³/hr	18	20	20	20	38	38	50	50	18	20	20	20	38	38	50	50
	Cleaning water consumption: CIP-WIP: ≥65℃, 0.15~0.2MPa		L/min	100	100	100	150	200	200	200	200	100	100	100	150	200	200	200	200
	Pure steam consumption for SIP: 0.2-0.3MPa		kg/hr									200	260	300	400	500	550	600	650
	Steamconsumption for defrosting: 0.2-0.3MPa		kg/hr									50	65	75	100	125	150	200	250
	Compressed air consumption: 0.6-1.0MPa		m³/min	0.1
	Water consumption for defrosting: ≈50℃, 0.1-0.2MPa		kg/B	1300	1400	1700	1900	2500	6000	8000	10000
	Installation power: 400V, 3P5W, 50Hz (±5%)		kW	58	67	75	104	125	134	174	210	58	67	75	104	125	134	174	210
	Total weight		t	7	8	9	12.5	13	18	20	25	8.6	9	12	18	20	25	28	35
Overall dimension	Length		mm	5300	5530	5850	6810	7020	7560	8080	8350	5440	5680	6000	6950	7160	7700	8220	8490
	Width		mm	1740	2050	2050	2050	2050	2450	2450	2450	2016	2316	2316	2316	2316	2716	2716	2716
	Height		mm	3420	3450	3450	4100	4250	4310	4350	4960	3420	3450	3450	4100	4250	4310	4350	4960
Nominal area			Unit	10	13	15	20	25	30	40	50	10	13	15	20	25	30	40	50
The total height of the lyophilization equipment will increase by 200mm~300mm if a corrugated pipe protective sleeve is fitted.