Standard Operating Procedure for Setup and Operation of Packaging Lines
1) Purpose
This SOP outlines the procedures for setting up and operating packaging lines used for nasal spray products. It includes instructions for proper machine setup, operation, and packaging checks to ensure that all products are correctly packaged and labeled.
2) Scope
This SOP applies to all personnel involved in the setup and operation of packaging lines at [Company Name].
3) Responsibilities
- Operators: Responsible for setting up the packaging line, operating the machinery, and performing in-process checks to ensure product quality.
- Quality Assurance (QA): Monitors packaging activities to ensure compliance with packaging and labeling requirements, including accuracy and quality control.
- Maintenance Team: Ensures that the packaging line equipment is functional, calibrated, and maintained.
4) Procedure
4.1 Setup of the Packaging Line
4.1.1 Pre-Setup Inspection
- Inspect the packaging line equipment for any signs of damage, wear, or contamination before starting the setup process. Ensure that the equipment has been cleaned and is ready for use.
- Ensure that all safety mechanisms, guards, and emergency stops are functional and in place. Report any defects
to the maintenance team before proceeding.
Document the pre-setup inspection in the equipment logbook.
4.1.2 Loading Packaging Materials
- Load the appropriate packaging materials, such as bottles, labels, and boxes, into the packaging line. Ensure that materials are aligned correctly for smooth operation.
- Set the correct parameters for packaging, including product alignment, label positioning, and packaging size, based on the Batch Packaging Record (BPR). Record the setup parameters in the BPR.
4.2 Operation of the Packaging Line
4.2.1 Packaging Process
- Start the packaging line by pressing the start button and monitoring the process to ensure that all bottles are being filled, labeled, and packaged correctly.
- Check that all bottles are being capped securely and labels are being applied in the correct position. Adjust the speed or alignment if necessary.
4.2.2 In-Process Packaging Checks
- Randomly inspect 10 packaged units during each batch to verify that they meet the correct specifications, including packaging integrity, labeling accuracy, and product sealing.
- Record all in-process checks and results in the packaging inspection log. Notify QA immediately if any deviations are detected.
4.3 Post-Operation Activities
4.3.1 Cleaning of the Packaging Line
- After completing the packaging process, disassemble any removable parts of the packaging equipment and clean them using the appropriate cleaning solutions.
- Rinse the parts with sterile water and allow them to air dry or use lint-free wipes. Document the cleaning process in the cleaning log.
4.3.2 Final Documentation
- Ensure that all packaging records, in-process checks, and cleaning activities are documented in the Batch Packaging Record (BPR) and submitted to QA for approval.
5) Abbreviations, if any
- BPR: Batch Packaging Record
- QA: Quality Assurance
6) Documents, if any
- Batch Packaging Record (BPR)
- Packaging Inspection Log
- Equipment Log
- Cleaning Log
7) References, if any
- Manufacturer’s equipment manual
- Internal SOP for cleaning and maintenance
8) SOP Version
Version 1.0
Annexure
1. Packaging Inspection Log Template
| Date | Batch No. | Packaging Integrity | Labeling Accuracy | Operator Initials | QA Approval |
|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | Pass/Fail | Pass/Fail | Operator Name | QA Name |
2. Cleaning Log Template
| Date | Equipment ID | Cleaning Agent | Operator Initials | QA Approval |
|---|---|---|---|---|
| DD/MM/YYYY | Equipment Name | Cleaning Solution Used | Operator Name | QA Name |