The influence of moisture on production
Pharmaceutical products are generally more sensitive, when they come into contact with moisture in the air, are very easy to lose efficacy, adhesive into pieces, mold, or fragile, and made into machine block, thus greatly reduce the production efficiency.
1. Has the need for humidity control in the production process of drugs have a tablet, capsule, powder, suppositories, ampoule, small medicine bottles, medicine, etc.
The components of a) tablet most material is easy to moisture absorption, under different environmental conditions, they will remain at different water content. When they after moisture absorption, volume and density is also follow changes, it will make in the mixed and pressure for a little while the content of active ingredient change, leading to overdose or inadequate.
B) for the capsule, hard capsule and soft capsule, hard capsule is a solid, hollow capsules to dry in the controlled environment room, its drying speed also needs to be controlled, because too fast drying can lead to shell harden, dimension change and structure damage. Hollow capsules with 12-15% of the moisture content is dry, less than 10% become brittle, above 16% will cause water from the capsule to drugs. Soft capsule is liquid, usually need to 21 ℃, 40% under the condition of complete, to ensure that the correct water content of gel and drugs, after filling in 21-24 ℃, 20-30% RH drying conditions, such as when 60% RH will become sticky and soft swell.
C) in the powder production is similar to the benefits of tablet production control humidity, humidity control to ensure accurate measurement, promote the flow, so as to improve the quality of our products and speed up the production speed.
D) suppository is mainly composed of active ingredient and a large number of wax base material, usually are designed to dissolve under body temperature, therefore this kind of product in the production of dry, was done under the condition of low temperature and humidity. Its base material production and must be completed in the low temperature and dry environment, in order to prevent the absorption of moisture.
E) test: test bar made by paper, injected chemical drugs, it must be in low humidity conditions (in some cases 12% RH) and strict production environment
F) sutures: artificial sutures can be dissolved, in the production and packaging should be done in the dry conditions in order to prevent the premature deterioration, generally below 10% RH production, at the same time, sterile conditions are necessary.
G) small bottle filling and ampoule production, relative humidity control is required, in order to prevent drug was moisture absorption.
2. In the packaging and storage of medicines, environment humidity control is necessary, because it can no longer absorb moisture to ensure completion of medicines, not only guarantee the quality of the products, also reduce the congestion when the packaging machinery, so as to improve the working efficiency.
