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Biopharmaceuticals

Currently, the requirements of production processing environment in the biopharmaceutical field are very strict. With the progress of pharmaceutical technology and the continuous upgrading of product technology over the recent years, industrial standards have been greatly improved, and higher requirements have been proposed for environmental temperature, humidity, and cleanliness in manufacturing technologies and processes.

There are amount of dosage forms in pharmaceutical, and many of them need to control the environment humidity in manufacturing, such as tablet, suppository, powder, liniment, ampoule, capsule, blood products, diagnostic reagent, etc.The control of humidity in pharmaceutical production workshops will affect:

(1) In the production process of effervescent tablets, it requires to control the humidity level of air. If the moisture content in the production area is too high, the moisture will react with tablets, which causes them to adhere to the machines，also affect the surface smoothness of products.

(2） If the humidity in the drying process of soft capsules is too high, it will reduce production efficiency.

(3) Many pharmaceutical raw materials are hydrophilic, so they are prone to clumping or powder clumping. only in a dry environment the raw material powder could be compressed into tablet successfully. If humidity is high, it can cause the tablet pressing process to fail, resulting in drug decomposition and a decrease in medicinal values.

(4) The filling operation requires powder conveyance to pour the powder of the required quantity very accurately into small bottles. The powder must be free to flow and shall be kept dry enough. If humidity is too high, it will clump or become sticky.

(5) Diagnostic kits are an important demand driver for humidity control solutions. Some ingredients in the rapid detection reagent kit have strong hygroscopicity and are prone to react with water, which may lead to inaccurate detection results. Therefore, for the ensured accuracy of the test results, it is essential to maintain the recommended temperature and humidity levels when rapid detection reagent kits are assembled and produced.

(6) Excessive humidity during low-temperature storage of drugs may affect product quality. Furthermore, high humidity environments can easily breed bacteria, which may have a serious threat to the drug quality.

Effervescent tablet and soft capsule are the most typical applications. Effervescent tablet can be made by dry granulating, wet granulating and direct tableting. And there are amount of auxiliary materials inside, many of them are hydrophilic such as disintegrate, binder, diluent, lubricant, sugar substitute and colorant, etc. Normally we need to control RH at 20％～25％ and temperature at 15-25℃。 So desiccant rotors were widely used in this kind of products manufacturing and packing.

Soft capsule make sure the effective medicine components be released and absorbed in digestive organs because of its gelatin wrap, and avoid unpleasant smell and taste, so more and more capsules will be used in oral drugs and health care products. To dry capsules we can use turn cage drying, tracked drying and pallet drying. But we can't use high temperature to dry, normally the best drying condition for capsule is RH with 20-30%, that is a big problem for air conditioner, but for desiccant silica gel rotors that is an excellent solution.

The professional service provider providing core parts in the field of ambient humidity control.Dedicated to the manufacturing of silicone runner equipment and related technical services.Our desiccant rotors perform higher efficiency and stable dehumidification performance, which can also provide more reliable and long-lasting dehumidification effects for the pharmaceutical industry.