The Ultimate Resource for Pharmaceutical SOPs and Best Practices
The purpose of this SOP is to establish the procedure for selecting plasticizers for soft gelatin capsule shells, ensuring that the selected plasticizer enhances the flexibility, stability, and overall quality of the capsule shells.
Click to read the full article.
The purpose of this SOP is to define the procedure for particle size reduction of fill materials used in capsule formulations. The objective is to achieve the desired particle size distribution to ensure uniformity in capsule filling, dissolution, and bioavailability.
Click to read the full article.
The purpose of this SOP is to define the procedure for granulation development for hard gelatin capsules. Granulation ensures that the active pharmaceutical ingredient (API) and excipients are uniformly distributed in the fill material, improving the flowability, compressibility, and overall quality of the capsule content.
Click to read the full article.
The purpose of this SOP is to establish the procedure for conducting hygroscopicity testing of capsule fill materials. The objective is to evaluate the moisture absorption properties of the materials to ensure stability, prevent clumping, and maintain consistency in capsule fill weights during manufacturing and storage.
Click to read the full article.
The purpose of this SOP is to outline the procedure for preparing development reports for capsule dosage forms. These reports are critical for documenting the formulation, development process, and testing results, ensuring that the capsules meet all required specifications for efficacy, safety, and stability.
Click to read the full article.
The purpose of this SOP is to define the procedure for conducting stability studies during capsule formulation development. Stability testing ensures that the developed formulation maintains its intended quality, safety, and efficacy over time under various environmental conditions.
Click to read the full article.
The purpose of this SOP is to establish the procedure for selecting the appropriate capsule size for different formulations. The goal is to ensure that the selected capsule size accommodates the required dose, ensuring both the stability and ease of administration of the final product.
Click to read the full article.
The purpose of this SOP is to define the procedure for conducting encapsulation trials using new fill materials. Encapsulation trials are essential for ensuring the compatibility of new fill materials with the capsule manufacturing process, as well as verifying that the material can be encapsulated effectively while maintaining the quality of the final product.
Click to read the full article.
The purpose of this SOP is to define the procedure for optimizing the capsule sealing process to ensure uniform, efficient, and secure sealing of capsules. Proper sealing is crucial for preventing content leakage, ensuring product integrity, and enhancing shelf life.
Click to read the full article.
The purpose of this SOP is to outline the process for developing moisture barrier coatings for capsules to protect the fill material from environmental conditions such as moisture and humidity. The barrier ensures that the capsules maintain their integrity, stability, and performance throughout their shelf life.
Click to read the full article.