1. Soft capsule process: film forming - lubricating - shaping - filling and sealing.
2. Usually completed under conditions of 21°C, 40% RH to ensure the correct moisture content of the gel and medication.
3. After filling, low-temperature and low-humidity drying is conducted at 21-24°C, 20-30% RH without temperature increase to prevent capsule and medication integrity loss.
4. After drying, unpackaged capsules should be stored in an environment of 21°C, 45% RH, as they will become sticky, soft, and expand when exposed to 60% RH.
1.Hollow capsules are dried in a controlled environment room where drying speed is regulated. Too fast drying can cause shell hardness, dimensional changes, and structural damage, resulting in decreased product uniformity.
2.Hollow capsules are dried to a moisture content of 12-15%; they become brittle below 10%, and there's loss of control over size and transfer of moisture from the capsule to the medication above 16%.
3.Pre-processing and medication filling of hollow capsules require a relative humidity of 35-40% RH.