1. The impact of moisture on production
Medical products are generally sensitive. When they come into contact with moisture in the air, they tend to lose their efficacy, stick to clumps, become moldy or fragile, causing machine blockage, which greatly reduces production efficiency.
1. There are tablets, capsules, powders, suppositories, ampoules, vials, injection medicines, etc. that require humidity control during the production process.
a) The composition of the tablet is that most of the materials are hygroscopic, and under different environmental conditions, they will maintain different water content. When they absorb moisture, their volume and density also change, which will change the content of active ingredients during mixing and tableting, leading to over or under-dispensing.
b) For capsules, there are hard capsules and soft capsules. Hard capsules are solid, and hollow capsules need to be dried in a controlled environment room. The drying speed must also be controlled, because too fast drying will cause the shell to become hard and hard. Dimensional changes and structural damage. Hollow capsules are dried with a moisture content of 12-15%, and become brittle when it is less than 10%, and moisture transfer from the capsule to the medicine when it is higher than 16%. Soft capsules are liquid and usually need to be completed at 21°C and 40% to ensure the correct water content of the gel and medicine. After filling, they need to be dried at 21-24°C and 20-30% RH, such as 60% RH. It will become sticky and soft and swollen.
c) The benefits of controlling humidity in powder production are similar to those of tablet production. Humidity control can ensure accurate measurement and promote flow, thereby improving product quality and speeding up production.
d) Suppositories are mainly composed of active ingredients and a large amount of wax-based materials, and are usually designed to dissolve at body temperature. Therefore, when such products are produced dry, they are completed under low temperature and low humidity conditions. The production of the base material also needs to be completed in a low temperature and dry environment to prevent the absorption of moisture.
e) Test rod: The test rod is made of paper and injected with chemicals. It must be produced under low humidity conditions (12%RH in some cases) and strict environments
f) Sutures: Artificial sutures are soluble, and must be completed under dry conditions during production and packaging to prevent premature deterioration. Generally, they are produced below 10% RH. At the same time, sterilization conditions are also necessary.
g) For the filling of vials and the production of ampoules, relative humidity control is also necessary to prevent the drug from absorbing moisture again.
2. When packaging and storing medicines, environmental humidity control is also necessary, because it can ensure that the finished medicines no longer absorb water, which not only guarantees the quality of the product, but also reduces mechanical blockage during packaging, thereby improving work efficiency .
Second, the runner dehumidification solution
The dehumidification system of the Nesda rotary dehumidifier avoids the growth of bacteria in both design and installation. Some drugs, such as parenteral drugs, can flow directly into the blood, so the presence of bacteria and pyrogens must be strictly prohibited. But the main source of bacteria and pyrogens is the airflow of the air-conditioning system, especially the humid process in the air-conditioning system. When the relative humidity exceeds 70%, the bacteria multiply very quickly. At this time, the best way is to reduce These dangerous substances ensure that the entire air-conditioning system runs under dry conditions and does not reach the dew point of the air during the cooling process, but Nysda's rotary dehumidifier can solve these problems. Whether in the production workshop, warehouse or in the transportation process, the humidity control can achieve a continuous and perfect state to ensure the smooth progress of production.
