Nowadays, most drug ingredients are highly hygroscopic and easily absorbs moisture in the air. With these absorptions, the moisture will seriously affect the change in the weight of the finished product, hardness, quality and preservation status. The desire to avoid the wasteful loss of large amounts of finished products, created the necessity focus on how to prevent these sensitive materials from adsorbing moisture during the manufacturing process.
Mixing and weighing
In order to maintain its chemical consistency, it is important to maintain the high-absorbency material in a humidity controlled environment during the mixing of pharmaceutical raw materials and weighing process. With the variety of different materials during the drug mixture, if the relative humidity of the environment is in an unstable state, any absorbed moisture by the materials from the ambient air will affect the finished weighing average. And the daily weighing result will be different due to the environmental humidity changes from day to day.
Additionally, moisture will also affect the state of the powder i.e., poor powder flow, granulation over-wetting/under-wetting, capping, lamination, chipping, and overall hardness of the tablets.
Clean room production and laboratory moisture management
During the experiment stages is the most important time and a pre-requisite for strict humidity control. To ensure that no additional yeast, mold, bacteria and the results of microbial growth impacting the experiment, the relative humidity shall be maintained below 50% RH. Most tablet pressing process requires precise control environment of relative humidity at 20-35% RH, and 21-24 ℃. Having a cool, dry environment can also speed up production while producing higher quality products and extend product shelf life.
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