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Dec 24, 2023

Preventing moisture induced damage in soft gelatin capsule production

Gelatin capsules hold an important place in the pharma industry. It is highly preferred for its versatility in the form of elasticity and features clarity, the ability to melt at body temperature,

Gelatin capsules hold an important place in the pharma industry. It is highly preferred for its versatility in the form of elasticity and features clarity, the ability to melt at body temperature, along with thermoreversible flexibility. Soft gelatin is widely sought for non-allergic properties backed up with safety and non-toxic profile. Additionally, the proteins making up the gelatin render the capsule to be easily digestible and swallowed effortlessly.

But even against the endless list of advantages, gelatin, as a material, is highly sensitive to moisture and temperature. Moisture can lead to the spoilage of capsules and make the entire manufacturing process a challenging task. In the presence of high levels of humidity, the capsules are vulnerable to become brittle, melt and show resistance in solidifying into a band. In severe cases, the high relative humidity (RH) accounts for undesirable microbial contamination that invariably deteriorates the capsule quality.

This mandates the close monitoring of air entering the dryer throughout the manufacturing and drying processes. The air should be thoroughly conditioned to achieve acceptable temperature and humidity levels. The humidity threat can be understood through the manufacturing process. In this, warm liquid gelatin is spread over a slowly revolving stainless-steel drum, following this, chilled dry air is supplied for congealing the gelatin into a tacky, elastic band. In the process, the thin band is automatically molded into a capsule filled with medicine inside. During the entire process, if the temperature and humidity are beyond unacceptable levels, then the soft gelatin fails to solidify and remains soft. In turn, the soft moist capsules are shifted from encapsulating machines to drying drums or chambers for carrying out rapid drying.

Looking at the vulnerability of soft gelatin capsules to moisture, it is imperative that manufacturers install desiccant dehumidifiers to get rid of the unwanted humidity from the air. As gelatin has a soft texture, drying the capsule becomes a tricky job. Temperature and humidity conditions must meet the crucial specifications that must not exceed 20 in both cases. The humidity level needs to be maintained in the range of 30±5% at 23°C for the encapsulation and packing processes. Likewise, even during the drying process, the humidity level needs to be kept within the range of 15±5% at 20°C. It is very crucial to abide by the specific air changes and laminar airflow while complying with the time limit for administering uniform drying. Inability to meet the required specifications results in the production of substandard capsules. Here, P95x dehumidifiers are specially crafted to meet the extreme cleanliness and hygiene standards of the pharma industry. It is highly efficient at saving more than 30 per cent energy owing to its regenerating capacity at 95 degrees Celsius. The novel adsorbent, G4 desiccant rotor technology is at the heart of it all.

Not just during manufacturing, but utmost care must be taken when hygroscopic materials are air-veyed from storage to processing areas. The transfer must be mediated in dehumidified conditions to refrain the capsules from regaining moisture during the filling and packaging operations. Considering the varied requirements to be fulfilled, the desiccant dehumidification solution is the ideal technology that is highly efficient in meeting the most complex and stringent humidity/moisture control requirements during capsule manufacturing. The advanced technology achieves optimum moisture level at a very low dew point throughout the production, storage and transportation processes. It fulfills the role of protecting the raw material from moisture menace, and, at the same time, also achieves the highest hygienic conditions all round the year, unaffected by the ambient environment around.

Apart from manufacturing, even storage requires low humidity conditions to avoid any instance of moisture regain that can ruin the entire effort gone into manufacturing the product. As a result, the packaging of gelatin capsules are done in aluminium foil storage which provides a humidity-controlled environment for the moisture-sensitive capsule.

Considering that the quality of gelatin capsules is imperative for the well-being of humans, the drugs must be manufactured with the purpose to elevate the health of humans. Therefore, dehumidification solutions must be installed invariably in the manufacturing infrastructure of the gelatin capsules.

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