Continued from : MANUFACTURING PROCESS OF SOFT GELATIN CAPSULE (Part I)
 
Drying

Drying process purpose is to decrease the moister content to create a hard and durable finished softgel capsules ready for packaging. After the softgels are formed through the die rolls, they contain around 20 percent water. This amount of water content is needed to keep the gel flexible enough to form the capsules.

Drying process requires an environment with low relative humidity in the air but not hot air. This process divided into two stages :

Fluid Bed Tumble Drier for Softgel


1. First stage : performed by a tumble dryer consists of sections. This equipment tumbles the softgels around 30 to 40 minutes and removes approximately 25 percent of the water content in the softgel capsules.


2. Second stage : softgel capsules are spread on stackable trays and transferred to the drying room or tunnel where high air flow exists and they stay around 24 to 48 hours or until the softgels become hard enough. This process is called natural manual drying. By using a fully automatic Softgel drying machine, this long drying process time can be reduced to a few hours which enables you to save time and money.



 Soft Gelatin Capsule Drying Machine

Typically the environment to be maintained for effective and rapid drying corresponds to a dew point of 25° F or an absolute humidity level of 20 grains per pound of air. The following are typical design conditions: Temperature Humidity 78°F 15% RH 68°F 20% RH In order to achieve the controlled air requirement listed above, refrigeration equipment alone becomes uneconomical, impractical and cumbersome to design, operate and maintain. On the other hand desiccant type dehumidifiers combined with refrigeration can offer a simple and economical solution to controlling both temperature and humidity levels as low as necessary Bry-Air desiccant dehumidifiers have been utilized in many capsulating and soft gel manufacturing applications all over the world resulting in millions of dollars saved annually.


Inspection, In Process Control and Finished Product Testing

Due to air pockets in the gelatin and fill material and district production tolerances, the Softgel capsules may vary in size and need to be inspected visually. Any misshaped, damaged and/or not fully filled capsules are removed manually by using an inspection table. Manual inspection process can be preferred if you have small batch size production but if you intend to manufacture softgel capsules in mass quantities. Manual inspection will be time consuming process which leads to accuracy problems. In order to reduce process time and increase the accuracy, fully automatic softgel sorting machine equipped with electronic sensors can be used to sort and remove the damaged, misshaped, broken etc. gelatin capsules. Two to three percent is an acceptable reject rate.

In-process testing

During the encapsulation process the four most important test are :

  • the gel ribbon thickness
  • soft gel seal thickness at the time of encapsulation
  • fill matrix weight & capsule shell weight
  • soft gel shell moisture level and soft gel hardness at the end of the drying stage.

Finished product testing:
  • Capsule appearance
  • Active ingredient assay & related substances assay
  • Fill weight
  • Content uniformity
  • Microbiological testing/

Polishing

The final step before packaging is to clean and polish the Softgel capsules to remove any mineral oil or glycerine that the capsules may have on their exterior skin. Tumbling is the most used production method to clean the Softgel capsules among others such as washing with solvent.

Packaging

There is no difference between packaging softgels and traditional tablets or hard capsules. Any finished Softgel product should be stored in an environment with temperature around 20-24 oC and relative humidity 35%.

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