Why Cellulose Capsule Shells are Stored in Temperature & Humidity Controlled Area

Cellulose capsules are capsules made of natural cellulose and are widely used to encapsulate various medications and supplements. Their sensitivity to environmental factors such as temperature and humidity requires them to be stored in a temperature and humidity controlled area. In this blog post, Wecaps will share with you why hard cellulose capsule shells for sale should be stored in a temperature and humidity controlled area.

Understanding Cellulose Capsule Shells

Cellulose is a complex carbohydrate and a primary component of plant cell walls. It is a renewable resource and is used in the pharmaceutical industry to create capsules that can encapsulate both liquid and solid medications. The primary advantages of cellulose capsules include their biocompatibility, biodegradability, and non-toxic nature. They are also free from animal-derived ingredients, making them suitable for vegetarians and vegans.

Sensitivity to Temperature

1. Thermal Expansion: Cellulose is a polymer that can expand when exposed to high temperatures. This expansion can cause the capsule shells to become brittle or even crack, which can compromise the integrity of the encapsulated medication. 

2. Medicinal Stability: High temperatures can also affect the stability of the medication inside the capsules. Certain drugs are sensitive to heat and can degrade or lose their potency if exposed to high temperatures for extended periods.

3. Storage Guidelines: Generally, cellulose capsules should be stored at temperatures between 15°C and 25°C (59°F and 77°F). This range helps maintain their structural integrity and the stability of the encapsulated medication.

Sensitivity to Humidity

1. Moisture Absorption: Cellulose is hygroscopic, meaning it can absorb moisture from the environment. High humidity can lead to the capsules absorbing excess moisture, which can cause them to soften, stick together, or even dissolve prematurely.

2. Medicinal Integrity: The moisture can also affect the medication inside the capsules. Some drugs are sensitive to moisture and can degrade or change their chemical structure when exposed to high humidity, leading to a loss of efficacy.

3. Mold and Microbial Growth: High humidity can also promote the growth of mold and other microorganisms on the surface of the capsules, which can contaminate the medication and pose health risks.

4. Storage Guidelines: The ideal relative humidity for storing cellulose capsules is between 35% and 65%. This range helps prevent moisture-related issues and maintains the quality of the capsules.

The Importance of Controlled Environments

1. Temperature and Humidity Control: By maintaining a controlled environment, the pharmaceutical industry can ensure that cellulose capsules remain stable and effective. This involves using temperature and humidity control systems that can regulate these factors within the recommended ranges.

2. Quality Assurance: A controlled environment is essential for quality assurance. It helps in maintaining the quality of the capsules and the medications they contain, ensuring that they meet the required standards and are safe for consumption.

3. Regulatory Compliance: Many regulatory bodies, such as the FDA and the European Medicines Agency, have specific guidelines for the storage of pharmaceutical products. Compliance with these guidelines is crucial for the approval and distribution of medications.

Recommended storage conditions for hard gelatin capsules:

1. Store capsules away from direct sunlight (e.g. windows and skylights).

2. Store capsules away from hot water/air radiators, hot water pipes and steam pipes.

3. Store capsules on pallets off the ground.

4. Store capsules away from potential sources of water condensation e.g. under water pipes.

5. Do not store empty capsules in freezers.

If capsules stored at high temperature following defects can occur:

1. Stucking of capsules together in lumps and do not come apart.

2. Brittle or shatter capsules.

3. Capsules with distorted shape.

4. Stucking of capsule cap to body and resists separation. 

Storing the cellulose capsule shell in a temperature- and humidity-controlled area helps maintain its integrity and the efficacy of the encapsulated drug. Sensitivity to environmental factors such as temperature and humidity requires careful handling and storage.