SOPs for Capsules V 2.0

The purpose of this SOP is to provide guidance for validating the continuous manufacturing process for capsule production. Continuous manufacturing improves efficiency and reduces batch-to-batch variability. This SOP ensures that the continuous manufacturing process meets all the required quality standards for capsule production, including uniformity, dosage accuracy, and capsule integrity.

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The purpose of this SOP is to establish a standardized process for validating the sealing process for soft gelatin capsules. Proper sealing is essential to ensure that the capsules remain intact during storage, transport, and use, preventing leakage or contamination. This SOP ensures that the sealing process is consistent, reproducible, and compliant with regulatory and quality standards.

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The purpose of this SOP is to provide detailed instructions for the validation of the multi-layer capsule filling process. Multi-layer capsules are used to deliver active pharmaceutical ingredients (APIs) in layers, which can be critical for specific release profiles. This SOP ensures that the multi-layer filling process is consistently reproducible and meets the required quality attributes, including uniformity, stability, and dosage accuracy.

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The purpose of this SOP is to define the procedure for validating the capsule drying process in capsule manufacturing. The drying process is essential for ensuring the correct moisture content in capsule shells. This SOP ensures that the drying process consistently meets predetermined quality standards and regulatory requirements, and that the capsules are properly dried to maintain stability and integrity.

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The purpose of this SOP is to define the process for validating gelatin solution preparation processes used in capsule manufacturing. The gelatin solution serves as the base for capsule shells, and its consistency and quality are critical to the final product’s integrity. This SOP ensures that the gelatin preparation process is consistently reproducible and meets all necessary specifications.

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The purpose of this SOP is to outline the procedure for process validation of capsule filling operations. Process validation ensures that the capsule filling process consistently produces a product meeting predetermined quality standards and regulatory requirements. The objective is to establish the effectiveness and reproducibility of the filling process.

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The purpose of this SOP is to establish a procedure for cleaning calibration tools used in capsule manufacturing equipment. Calibration tools must be kept free of contamination and residues to maintain the accuracy of measurements and ensure the proper functioning of the equipment. This procedure helps ensure that calibration tools are properly cleaned between uses, maintaining GMP compliance and product quality.

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The purpose of this SOP is to provide detailed guidelines for inspecting cleaned capsule manufacturing equipment. Ensuring that all manufacturing equipment is properly cleaned and ready for use is critical to maintaining product quality and GMP compliance. This SOP outlines the procedure for inspecting the equipment to confirm that it is free of residues and contaminants before production.

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The purpose of this SOP is to describe the procedure for cleaning sieves and screens used in capsule production. Sieves and screens are critical to ensuring the quality and consistency of the materials used in capsule manufacturing. Proper cleaning of these components is essential to avoid contamination, maintain their efficiency, and meet GMP requirements.

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The purpose of this SOP is to outline the procedure for cleaning the heating systems used in gelatin preparation tanks. Proper cleaning of these heating systems is crucial to avoid any contamination, ensure the safety and quality of the gelatin used for capsule shells, and comply with GMP standards.

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