1. Batching process.
Such as the water temperature of the ingredients, the order of feeding, the adsorption time and temperature of the activated carbon, the time of the liquid storage, and the like.
2, material stability
Some raw materials have polymorphism, and the stability of different crystal forms is different; some raw materials are sensitive to temperature; some raw materials are sensitive to pH; some raw materials are sensitive to oxidation, and so on. Decomposition of unstable substances is likely to be the source of foreign matter.
3, liquid properties
The concentration of the liquid is a very important factor, and I don't need to emphasize this.
In addition, sufficient attention should be paid to the pH stability of the feed liquid. For example, when using buffer pairs, the three principles of analyzing textbooks should be kept in mind: pka is as close as possible to pH, try to make the buffer ratio close to 1, and the concentration is appropriately large.
4, the nature of the auxiliary materials
The obvious examples of zui are hydrochloric acid, sodium bicarbonate, etc. These substances are highly volatile and decomposable, and are easy to rebound and difficult to control.
5, pre-freezing
Regarding the topic of quick-frozen, slow-frozen, and so on, it doesn't matter whether it is repeated or not. Repeated pre-freezing can reduce the ice crystal size difference and the drying rate non-uniformity due to the nucleation temperature difference, improve the drying efficiency and product uniformity; strengthen the crystallization, and increase the crystallization rate of the crystal component and the unfrozen water. You can try to figure out the beauty of it in practice.
6, sublimation
Sublimation speed and temperature have an impact on the clarity. I understand the following two main situations.
*, mainly a sublimation period. If the temperature of the first dried material rises too fast and reaches the collapse temperature, the porosity of the porous skeleton is lowered, and the particles in the dried layer are detached. These sheddings block the microporous channels in the dried part, prevent the sublimation from proceeding, slow down the sublimation rate, and even make the lower part slightly weissuo, affecting the residual moisture content of the product, resulting in poor rehydration, stability and clarity. .
Second, it is mainly the second sublimation period. Small crystals are thermodynamically unstable due to their high surface energy, especially small ice crystals formed during rapid cooling. Recrystallization may occur during heating, and small ice crystals combine to form large ice crystals. The ratio of surface area to volume is small, and large ice crystals make the lyophilized product look bad and the rehydration is poor. Therefore, sublimation or heat preservation at too high a temperature or for a long time may sometimes be detrimental to certain varieties, and an obvious example of Zui is that the clarity is unacceptable.
7, product formability, residual water
Some varieties, not afraid of the air, are afraid of temperature or moisture. Once water and temperature are obtained, the change is very rapid.
8, vacuum, nitrogen filling
Whether there is vacuum, whether there is nitrogen filling, whether the product can be completely isolated from oxygen, avoiding slow oxidation, sometimes it is particularly important.
9, the inner packaging material.
For example, the bottle, the glass material is not good, and it is conceivable that the chip is produced by acid or alkali or high temperature treatment. In addition to the bottle, the rubber stopper also has the possibility of introducing particles.
10, the choice of freeze dryer, the performance of the freeze dryer is particularly important, the shelf temperature, uniformity, flatness, stability and so on.
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