SOPs for Capsules V 2.0

The purpose of this SOP is to provide a standardized cleaning procedure for the equipment used in the production of soft gelatin and hard gelatin capsules. Cleaning is essential to avoid cross-contamination between different types of gelatin and ensure the quality and safety of the final product. This SOP ensures that all equipment is thoroughly cleaned before switching between soft and hard gelatin batches.

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The purpose of this SOP is to outline the process for cleaning stainless steel surfaces in capsule manufacturing areas. Proper cleaning is necessary to prevent contamination and maintain compliance with Good Manufacturing Practices (GMP). The cleaning procedures are designed to ensure that stainless steel surfaces are free from residues, product build-up, or microbial contamination.

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The purpose of this SOP is to provide a standardized method for cleaning sampling probes used in capsule manufacturing. These probes are critical for ensuring that product samples are free from contamination and meet quality specifications. The SOP ensures that sampling probes are cleaned thoroughly between uses to maintain the integrity of the manufacturing process and prevent cross-contamination.

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The purpose of this SOP is to provide clear guidelines for the daily and weekly cleaning of capsule manufacturing tools. This process ensures that all tools are cleaned adequately after use to prevent contamination, cross-contamination, and maintain product integrity. It also ensures compliance with Good Manufacturing Practices (GMP).

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The purpose of this SOP is to outline the procedures for validating cleaning methods used for capsule manufacturing equipment. Validation ensures that the cleaning methods effectively remove residues, contaminants, and cleaning agents, maintaining product quality and compliance with regulatory standards. This process ensures that cleaning methods consistently deliver reproducible results and prevent contamination in future batches.

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The purpose of this SOP is to establish standardized procedures for monitoring cleaning cycles in capsule manufacturing areas. This process ensures that all equipment, tools, and production areas are cleaned properly and meet regulatory cleanliness standards. It helps verify that no residues or contaminants are left behind, thereby preventing cross-contamination and maintaining product quality.

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The purpose of this SOP is to establish a standard procedure for cleaning high-shear mixers used in capsule granulation processes. Cleaning these mixers thoroughly after each batch is critical to prevent cross-contamination and ensure that no residues from previous formulations remain. This procedure helps in maintaining equipment performance, product quality, and compliance with Good Manufacturing Practices (GMP).

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The purpose of this SOP is to outline the procedures for environmental cleaning of capsule manufacturing areas. This process ensures that the manufacturing environment remains free from contamination and complies with Good Manufacturing Practices (GMP). Environmental cleaning is essential for maintaining product quality and preventing cross-contamination between batches.

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The purpose of this SOP is to define the procedures for cleaning filter elements used in capsule production lines. Filters are critical to maintain the quality of the raw materials and prevent contamination in the production process. Regular cleaning of these filter elements ensures optimal performance and compliance with Good Manufacturing Practices (GMP).

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The purpose of this SOP is to outline the standardized procedure for handling and cleaning vacuum loaders used in capsule filling machines. Vacuum loaders are critical for transferring powder and granular materials to the filling machines. Proper handling and cleaning of these components ensure the prevention of cross-contamination, maintain equipment performance, and comply with GMP standards.

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