Publication : Health Care Radius
Dinesh Gupta, Director, Bry-Air | Health Care Radius | August 13, 2021
Gelatin capsules are one the most popular dosage forms for the drugs and food supplements industry.
Gelatin capsules are being used commonly for the past several years with proven safety and toxicity profile. Gelatin exhibits non-allergic properties, contains proteins that are easy to digest and easy to swallow. These capsules are widely accepted in the pharmaceutical industry.
There are several reasons why it is used widely in the market. Factors like, easy to administer, manufacture, liquid can be encapsulated (non-water soluble) in small to large sizes, producing specialised dosage forms etc. makes it one of the prominent dosage forms in the pharmaceutical industry.
Gelatin or Gelatine is moisture and temperature-sensitive, which makes the manufacturing process quite challenging for the manufacturers. While manufacturing and during the drying stage, if the air entering the dryer is not conditioned in terms of temperature and humidity, the Gelatin becomes brittle or the gel melts and does not solidify into a band. The Presence of High Rh also leads to microbial contamination, which is highly undesirable considering the application of Gelatin in the food and pharmaceutical Industry.
In one of the processes during manufacturing, warm liquid gelatine is spread over a slowly revolving stainless steel drum. A supply of chilled dry air congeals the gelatine as the drum rotates so that a tacky, elastic band rolls off the other end. This thin band is automatically formed into capsules, filled with medicine. If the temperature and humidity are too high, gelatine will remain soft and prevent solidification. From the encapsulating machines, the soft moist capsules are transferred to drying drums or chambers for rapid drying.
The extent of moisture to be removed during drying depends on the size of the vessel from which the moisture is to be removed. The moisture has to be removed gradually, to prevent superficial surface hardening. Drying at elevated temperatures will impair dried product quality.
In the case of encapsulation and packing, the required level of humidity is 30±5% at 23 degrees centigrade. However, the drying is done at 15±5% at 20 degrees centigrade. The drying of soft gel capsule is very tricky, as it has to be dried in very controlled temperature and humidity conditions, both of which should not exceed 20 along with specific air changes and laminar airflow for uniform drying including time for drying. The moment any of the conditions deteriorate, the capsule may get brittle, extra soft, etc.
Moisture is the biggest menace for the pharmaceutical industry because the majority of pharmaceutical products are highly hygroscopic and tend to suffer physical, microbiological and biochemical deterioration after coming in contact with moisture. Thus, each pharmaceutical manufacturing process requires highly controlled environmental conditions before the finished product is packaged and finally reaches the customer.
That is why dehumidified air-veying of hygroscopic chemicals from storage to processing areas becomes critical in the pharmaceutical industry. Also, it is critical to prevent moisture regain when air-veying moisture-sensitive products to filling and packaging operations. The finished capsules need to be stored in a dry environment prior to packaging to prevent moisture regain and spoilage of the product.
Bry-Air engineered dehumidifiers are designed in such a way that they meet the most complex and stringent humidity/moisture control needs of the Pharma Industry. The desiccant dehumidification protects pharmaceutical raw material and products during production, storage and transportation from moisture menace. Bry-Air desiccant dehumidifiers ensure optimum moisture control in storage, packaging etc. and help in maintaining hygienic conditions all year round, regardless of the ambient conditions, at a very low dew point.
With power packaged technology, Bry-Air has designed the package systems with pre-filter, after-filter, precooling (fresh air cooling), post-cooling and bypass arrangement for complete air handling and environmental control solutions for each stage of pharmaceutical production. The Bry-Air BrySmart (BBS) Dehumidifier series is the latest offering catering to the new age requirement of energy-efficient moisture control solutions, providing faster ROI and the lowest cost of ownership.
