How to choose a vacuum freeze dryer for biopharmaceutical applications

How to choose a vacuum freeze dryer for biopharmaceutical applications

A vacuum freeze dryer (referred to as a freeze dryer) used in the field of biopharmaceuticals, mainly used for the production of drugs such as serum, plasma, vaccines, enzymes, antibiotics, hormones, etc.; biochemical examination drugs, immunology and bacteriology; Long-term preservation of blood, bacteria, arteries, bones, skin, cornea, nerve tissue and various organs. The selection of the refrigeration system equipment shall be selected according to the comprehensive considerations of the refrigerant used, the cooling capacity, the environmental conditions and the use occasions; the main dimensions shall be determined by the thermal calculation and heat transfer calculation.

　2. The production of GMP standard drugs meets the requirements of GMP.
According to this requirement, the surface of the freeze-drying box, the laminar layer, the condenser and the water vapor adsorption are all made of stainless steel, and the door of the freeze-drying box should be opened to the clean area. The structure of the freeze-drying machine should be conducive to closing the clean area and the machine room. Isolation, the production of some important drugs also requires the lyophilization tank and condenser to be sterilized with steam. The above requirements need to be explained in advance when ordering, so that the manufacturer can manufacture according to the requirements of the user. Freeze-dryers with steam sterilization are expensive and therefore expensive, and should be cleaned with clean steam. Users should make decisions based on long-term interests.
3, about the box inside the plug device
At present, freeze-drying machines at home and abroad can be equipped with an in-box plug device, which has three functions.
*It is used to freeze the whole bottle in the box after lyophilization. The plug on the small bottle is a special plug with a notch. It is placed on each bottle mouth immediately after the dispensing. Since the plug has a gap, it does not affect sublimation. Drying, at the end of lyophilization, it can be plugged under vacuum, or it can be filled with nitrogen, which not only reduces the production process, but also reduces the chance of product contamination.
The second is to facilitate the product into and out of the box, especially for large freeze dryers, the board layer is lowered when entering the box, the advanced upper layer, and then the side edge rises; when the box is out, the first layer is out, then the side is lowered Out, avoid using the stool or ladder to enter and exit the box. Of course, the piston rod should be designed on the top of the box to have this function. Some manufacturers do not have this function when designing the piston at the bottom of the box. The third is conducive to the cleaning work in the freeze-drying box. Since the layer can be lifted and lowered, the freeze-drying box is easily accessible everywhere, which is convenient for cleaning. According to GMP requirements, the piston rods should be made of stainless steel. Some steam-sterilized lyophilizers also have a stainless steel bellows jacket on the piston rod to ensure strict sterilization in the freeze-drying box.
4. Automatic control system of freeze dryer
Automatic control system of freeze dryer Automatic control system of freeze dryer Many freeze dryers have automatic control system and have manual control functions at the same time, but there are great differences between the manufacturers in the automatic control mode. Must be clear.
The automatic control of the so-called freeze dryer should include two parts. First, the equipment of the freeze dryer automatically stops at the specified time according to the freeze-drying process requirements. Second, the temperature of the freeze-drying tank layer is automatically tracked according to the freeze-drying curve requirements. The whole freeze-drying process does not require manual operation. Of course, manual intervention can be performed if necessary. However, the automatic control of some freeze dryers is incomplete. Only the freeze-drying curve can be automatically tracked, and the rest must be manually operated.
Some lyophilizers can only be controlled automatically until the end of lyophilization. The tampon in the box after the lyophilization is completed, the defrosting of the condenser and the steam sterilization can not be carried out automatically. It requires manual operation, especially the steam disinfection part, because many valves are involved. Control, manual operation is more troublesome, should choose the lyophilizer of the automatic disinfection program.
Some lyophilizers use automatic microcomputers for convenient operation and programming. The displayed language is a freeze-drying language. It also has a fluorescent screen, a printer and a floppy disk. It can store dozens of frozen programs at the same time. Each program content can be displayed. The entire program content can be printed by the printer. The automatic control of the lyophilizer uses a meter, which is troublesome to operate and program, and has less lyophilization procedures that can be stored.
The recording instrument is also an important instrument for the freezer. It can record the vacuum of the actual freeze-dried process for later investigation. Most of the recording instruments use a multi-point recorder, which can be used for both point and direct operation. Text records, as well as digital display systems. Users should understand and choose according to the specific situation.
?
5. Intermediate sampling device, eutectic point measuring device, automatic inlet and outlet device and cooling water device
Intermediate sampling device, eutectic point measuring device, automatic inlet and outlet device and cooling water device. Some manufacturers' lyophilizers can be equipped with intermediate sampling devices. During the lyophilizer process, samples are taken for observation and testing without breaking the vacuum. Decide on the freeze-drying process.
Some manufacturers' freeze dryers are equipped with a eutectic point measuring device that can detect the eutectic point of the product during the pre-freezing process and monitor whether the product melts during the sublimation process. Some manufacturers' freeze-drying machines can be equipped with automatic feeding and unloading devices to reduce the labor force of the camp and ensure that the products are not polluted. Some small and medium-sized freezers are not suitable for air-cooling, and it is troublesome to be equipped with a cooling tower. It can be equipped with a cooling water circulation device, which is equipped with a water pump, a water tank and a freezer, which can be configured to circulate with the portion of the lyophilizer that requires cooling water, and the required temperature of the water is maintained by the refrigerator.
6. Features of bio-pharmaceutical freeze dryer unit:
★Imported refrigeration compressor, reliable operation and long service life;
★Multiple cooling technology, shortening freeze-drying time, import brand guarantee, reducing noise, large cooling capacity, large water catching capacity, high quality and high performance;
★ Touch screen LCD display, curve and data display dry process, new PID control, convenient for users to learn more information according to data changes;
★The observation window is built in, and the freeze-drying process is intuitive. In-situ pre-freezing, all automation from vacuum to drying is achieved, reducing the tedious operation of the drying process;
★The interior of the freeze-drying chamber is made of 304 stainless steel, which is easy to clean and durable.
★Silicone oil freezing medium, the error is ≤1°C, and the drying effect is even;
★Configure the inflation valve to fill the dry inert gas;
★The square shelf is not easy to be deformed, easy to operate and easy to clean;
★The drying room adopts high light transmissive colorless transparent plexiglass door, which can clearly observe the change process of materials during the operation;
★ Optional temperature recorder. Adjustable temperature recording points, real-time monitoring, increase the guarantee for your experience accumulation;
★ Optional eutectic point test device;
★ Optional automatic pressure plug device (cape type freeze dryer).