Soft gelatin capsules are significant to the pharmaceutical industry for their versatility. The capsules are clear or translucent, with excellent elasticity, thermo-reversibility, and the ability to melt at body temperature. They are suitable for non-allergenic health products with their non-toxic and safe profile, and their proteins make the capsules easy to swallow and digest.

Despite those benefits, pharmaceutical gelatin is highly sensitive to temperature and moisture, which can spoil the capsules and complicate manufacturing. When exposed to high humidity levels, the capsules are prone to becoming brittle and melting while showing resistance in solidifying to a band. Worse, high relative humidity results in microbial contamination that deteriorates the quality of medicines and supplements.

Those problems trigger the need to closely monitor the air entering the dryer throughout the drying and manufacturing processes. The air must be thoroughly conditioned to ensure acceptable humidity levels and temperature.

What can you do to prevent moisture damage in gelatin capsules?

Manufacturers can understand the threat of humidity by looking at their manufacturing process. Warm liquid gelatin spreads over a slowly revolving stainless steel drum and chilled dry air is delivered to congeal the gelatin into a tacky, elastic band. The thin band automatically molds into the soft gelatin capsules with the medicine inside.

When humidity and temperature exceed unacceptable levels throughout the process, the soft gelatin cannot solidify and remains soft. In turn, the moist capsules are transferred from encapsulating machines to drying chambers or drums to speed up drying.

Keep humidity and temperature in check

Pharmaceutical gelatin is vulnerable to moisture, making desiccant humidifiers crucial to remove humidity from the air. The soft texture of gelatin makes drying tricky. Humidity and temperature conditions must meet specifications that shouldn’t exceed 20. Humidity levels must be within the range of 30+/-5% at 23 degrees Celsius for encapsulation and packing. For the drying process, humidity must be within 15+/-5% at 20 degrees Celsius.

 

Maintain consistent measures for humidity control

Manufacturers should also be careful when air-veying hygroscopic materials from storage to processing. The process must be controlled in dehumidified conditions to prevent moisture from forming during filling and packaging.