Vacuum Pharmaceutical Lyophilizer
Vacuum Pharmaceutical Lyophilizer
1. Preparation of drug:
In order to form the stable porous structure, the concentration of drug solution is required to be at certain level. For hot-sensitive drug like hormone and enzymes, in order to maintain the structure of the product, Natural instinct agent is required.
For macromolecular biological protein drugs or slow-release drugs with bio-film structure, it is important to add some lyophilized protective agent. The final temperature of drug should be lower than the eutectic temperature.
2. Main drying process:
The drying of medicine is from up to bottom, from outside to inside, the energy needed in sublimation process is mostly from partition that uses to display drugs. Therefore in the bio-chemical field, the partition in freeze dryer need to have the temperature control function. The setting of temperature of partition needs experience.
If the temperature of partition is too low, the energy partition can provided is much lower than the energy required to sublimate, the rate of sublimation decreases, time needed for drying is longer. If the temperature is too high, the reaction of spray bottle effect may appear.
If the below 3 conditions are satisfied, the temperature of partition can be risen to speed up the reaction:
(1)The temperature of the product is 5 ℃ below the eutectic point and disintegration temperature.
(2)The pressure of the sample chamber is 10%-30% of the saturated vapor pressure corresponding to the product temperature.
(3)The cold trap temperature is 20 ℃ lower than the product temperature.
3. Secondary drying:
Secondary drying is to use relatively high temperature and low pressure to eliminate the remained water in the product. In this process, product temperature can be heated to a highest level that does not cause damages to product. While during the secondary drying process, due to the product less water than sublimation, cold trap capture water vapor decreases, so the cold trap temperature decreases, the temperature of cold trap reduce further improve and make the vacuum freeze-drying box, shall generally be in the state to maintain a minimum of 2 ~ 3 h, make the content of residual moisture in the products meet the requirements of qualified.
4. Sealing process:
Generally, the stopper/capping system is used in the lyophilizer to compress the half-stoppered bottle stopper; It can also be sealed before stoppage, after nitrogen filling.
Parameters:
Model | KFD-20 |
Capacity (Kg/Batch) | 200 |
Shelf Area (㎡) | 20 |
Shelf Size (Mm) | 2200*600 |
Shelf Quantity (Layer) | 8+1 |
Shelf Quantity (Piece) | 18 |
Space Between（Mm） | 95 |
Shelf Temperature (℃) | room to 120 |
Water Catcher Temper (℃) | -65±5 |
Max Catch Water（Kg） | 300 |
Ultimate Vacuum （Pa） | 5 |
Electricity（Kw） | 63 |
Weight（Kg） | 8000 |
Certificates：
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