Capping, Sealing, & Labeling

Capping, Sealing, & Labeling

Capping, sealing, and labeling are crucial steps in the manufacturing of pharmaceutical liquids, including lipid nanoparticles (LNPs) and nanomedicines. These steps ensure proper sealing, identification, and compliance with regulatory requirements. Here are the general steps involved in the preparation and setup for capping, sealing, and labeling of LNPs and nanomedicines:

1. Equipment Preparation:

  • Clean and sanitize the capping, sealing, and labeling equipment, including the capping machine, sealing machine, labeling machine, and any associated components. Follow validated cleaning procedures to ensure the equipment is free from contaminants.
  • Calibrate and validate the equipment to ensure accurate and consistent capping, sealing, and labeling.


2. Environment Preparation:

  • Prepare the capping, sealing, and labeling area, typically a cleanroom or controlled environment, by following appropriate cleaning and disinfection procedures.
  • Maintain the required environmental conditions, such as temperature, humidity, and particle counts, as per the specific requirements for the product being processed.


3. Material Preparation:

  • Verify the availability and integrity of all necessary materials, including caps, seals, labels, and batch documentation.
  • Inspect the caps, seals, and labels for quality and suitability, ensuring they are compatible with the containers and meet the required specifications.


4. Line Setup:

  • Set up the capping, sealing, and labeling line by adjusting the machine settings and ensuring proper alignment and synchronization with the filling and stoppering processes, if applicable.
  • Install the appropriate capping heads, sealing mechanisms, and label dispensing systems, ensuring they are clean and properly sized for the containers.


5. Pre-Sterilization:

  • If required, perform pre-sterilization steps for the caps, seals, labels, and any other components that will come into direct contact with the product. This may involve methods such as autoclaving, gamma irradiation, or other validated sterilization methods.


6. Capping, Sealing, and Labeling Process:

  • Ensure that the containers are properly aligned and positioned on the capping, sealing, and labeling line for seamless integration with the process.
  • Initiate the capping, sealing, and labeling process by starting the respective machines and ensuring that the caps, seals, and labels are accurately applied to the containers.
  • Monitor the process to ensure proper alignment, consistent application, and integrity of the caps, seals, and labels.


7. Inspection and Quality Checks:

  • Perform visual inspection and quality checks on the capped, sealed, and labeled containers to ensure proper alignment, closure integrity, and accurate labeling.
  • Verify the cap torque or seal integrity, if applicable, to prevent leakage or contamination.
  • Check for accurate placement and legibility of labels, including adherence to regulatory guidelines.


8. Packaging and Secondary Labeling:

  • Prepare the packaged products for secondary packaging, such as placing them in trays or cartons, and ensure appropriate labeling and coding of secondary packaging materials.
  • Apply any required secondary labels or product information on the secondary packaging, including batch number, expiry date, and any additional regulatory-required information.


9. Cleaning and Line Clearance:

  • Conduct thorough cleaning and sanitization of the capping, sealing, and labeling equipment, surrounding areas, and any utensils used during the process to prevent cross-contamination and maintain a clean environment.
  • Perform line clearance activities to ensure that all product remnants and materials from the previous batch are removed, and the area is ready for the next production run.


10. Documentation and Batch Record Keeping:

  • Accurately record all relevant production and process data, including capping, sealing, and labeling activities, inspections, equipment calibrations, and any deviations or quality control checks performed during the process.
  • Ensure all necessary batch records, logbooks, and associated documentation are completed, signed, and stored according to regulatory requirements.


It is important to note that the specific steps and requirements may vary based on the product formulation, container types, regulatory guidelines, and specific manufacturing facility. Compliance with current Good Manufacturing Practices (cGMP) and adherence to standard operating procedures (SOPs) are essential throughout the capping, sealing, and labeling process of LNPs and nanomedicines.