Non-condensation drug vacuum drying oven Guangzhou Baiyunshan Chinese Medicine Factory (510515) Feng Jian Wenzhou Jianqi Pharmaceutical Machinery Manufacturing Co., Ltd. (325024) Sun Chengjie Shanghai Sanming Drying Research Institute (00232) Shen Shanming vacuum drying oven.
1 Overview The vacuum drying oven with a canister type medicine has been successfully developed and has been put into batch production. This solves the problem that the deep vacuum drying oven cannot be thoroughly cleaned according to GMP cleaning requirements for a long period of time, and improves the drying efficiency. Since the moisture evaporating from the vacuum drying oven is in the state of saturated water vapor, the wall temperature of the inner wall of the box is lower than the steam dew point temperature under the vacuum condition due to the heat dissipation of the shell, and the steam will condense on the inner wall. Into the dewdrops, the walls of the drying box are wet and even large dewdrops smash down into the pool.
Various vacuum drying ovens have a large surface area of ​​the box. Although insulation measures have been made for the insulation of the various vacuum drying boxes, large or small heat loss is unavoidable, and condensation on the inner wall of the box is normal. Therefore, the condensation phenomenon has been considered as normal since its own vacuum drying oven (excluding jacket type heating), and it is believed that vacuum drying operation is not affected. After research, if the trays are removed immediately after the drying process is completed, condensation may not have a noticeable effect on the drugs. If the drug is not promptly removed after the drying process has ended, and the dryable drug is highly hygroscopic and the drug product has dried to a very low level, the dew on the inner wall of the case will evaporate under the influence of the residual heat in the case. As the air humidity rises, the moisture in the air will be absorbed by the dried medicine and returned to the tide. Therefore, the phenomenon of condensation in the vacuum drying oven should be regarded as an abnormal phenomenon that affects the quality of the product, and the stress can be eliminated as much as possible.
With the continuous improvement of drug quality requirements, the medicine drying oven also needs to be set in the clean operating area. The cost of clean workshops is far greater than that of non-cleanliness. The clean room has constant temperature and air conditioning, and the surface area of ​​the drying box is continuously cooled, which naturally increases the load on the air conditioning system. The drug vacuum drying oven can completely refer to the method of isolation of the lyophilizer, and most of the boxes with heat dissipation characteristics are isolated outside the clean room. Conditions can be used to arrange the boxes in the open air, and the boxes are only exposed in the clean room. The door is open, which not only saves the door flanges of the existing vacuum drying ovens in the clean room, but also depends on many flanges to open and close the screws. It takes time and effort to operate these bolts. In particular, the chain box door still occupies a considerable space after opening. And it hinders the operation.
2 Introduction to the structure of high-performance pharmaceutical vacuum drying oven According to our understanding of the needs of the pharmaceutical vacuum drying oven structure, we must meet the following requirements: to meet the requirements of the GMP standard for thorough cleaning; the box can be isolated, most of the box can be in Non-clean area; ~118C saturated steam as the heat source for drying; provide a large area of ​​heating flat feed trays close to it; tray loading and unloading and opening and closing the door to facilitate effort; in the drying process no condensation inside the box phenomenon.
As shown in the figure, the non-condensing pharmaceutical vacuum drying oven structure was developed and designed in accordance with the above requirements.
3 Structure and working principle Multi-piece heating plate (8) is embedded in the steam condensation water pipe (7) perpendicular to the low-temperature steam generator (6), and the door (5) is attached with a radiation-type opening and closing device (4) (5) Welding is fixed on the steam communicating tube (7) and the low temperature steam generator (6) to form a complete heating system component with a box door. This component is propelled along the inner and outer guide rails (2, 12) by the outer fixed wheel (3) fixed on the box door (5) and the pulley (13) inside the box, and is vacuum-evacuated in the exhaust pipe (9) after adding the tray. After entering the steam heat source, it enters the drying operation.
The movable support wheel (11) is lowered, and the entire heating system component with the box door (5) can be pulled out of the box along the guide rail (12). The tray can be easily loaded or unloaded on both sides of the heating plate (8). When the heating system components are pushed into the box and the radiant pod door is locked, the steam and condensate short pipes on the low temperature steam generator (6) are automatically inserted into the steam inlet pipe (14) with the O-ring seal and Condensate outlet pipe (15). The area of ​​10 can save the big stupid air-conditioning operation fee gamma coffee brew ingI! All the shell shells are equipped with an independent heating system that compensates for heat loss, ensuring that the temperature of the inner wall of the box is slightly higher than the dew point temperature, eliminating the conditions of condensation, and even if the products are not dried for a long time, they will not affect the quality. . Because the temperature of the heating system that compensates for heat loss is adjustable, the system can only compensate for the loss of heat without wasting heat energy.
The use of four steam condensate water pipes to weld and fix the heating plate can support evenly and stably regardless of the size of the heating plate. Compared with the cantilever welding support, heating the dry plate is easier to maintain long-term formation.
The internal heating structure of the heating plate in the oven has adopted the internal welding reinforcement method, and no longer inserts and welds the reinforcing nail structure after punching the two thin plates as in the traditional method, there are several tens of hundreds of welding pots on two planes, and welding. After grinding, prone to micro leaks.
4 Conclusion In summary, the high-performance pharmaceutical vacuum drying oven is based on the development of vacuum drying ovens on the basis of cover-type drugs to further improve the drying equipment, so it has all the advantages of the hood type, but also added a lot of mask type The lack of many advantages, so the non-condensation drug vacuum drying oven is the latest pharmaceutical drying equipment to replace the existing vacuum drying oven, which will contribute to the development of pharmaceutical production and competition after China entered the WTO.
Non-condensing drug vacuum drying oven technology has been declared a national patent.
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