Sterile Injection Manufacturing: SOP for Use of Automated Labeling Machines in Packing Lines – V 2.0

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Sterile Injection Manufacturing: SOP for Use of Automated Labeling Machines in Packing Lines – V 2.0

Standard Operating Procedure for Use of Automated Labeling Machines in Packing Lines


Department Sterile Injection Manufacturing
SOP No. SOP/SIM/194/2025
Supersedes SOP/SIM/194/2022
Page No. Page 1 of 14
Issue Date 24/06/2025
Effective Date 26/06/2025
Review Date 24/06/2026

1. Purpose

To define the procedure for the use, maintenance, and verification of automated labeling machines used during the packaging of sterile injectable products. This SOP ensures correct label application, traceability, GMP compliance, and minimizes

labeling errors.

2. Scope

This SOP applies to all automated labeling machines used in primary and secondary packaging lines of sterile injectable vials and prefilled syringes at the Sterile Injection Manufacturing facility.

3. Responsibilities

  • Machine Operator: Responsible for machine setup, operation, minor adjustments, and in-process checks.
  • Packaging Supervisor: Ensures compliance with labeling specifications, machine performance, and coordinates with QA for verification.
  • QA Personnel: Verifies label placement, batch details, and documents in-process checks.
  • Engineering Department: Handles preventive maintenance and breakdown troubleshooting.

4. Accountability

The Head of Production is accountable for ensuring the proper use and maintenance of automated labeling machines as per GMP and company standards.

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5. Procedure

5.1 Pre-Operation Checks

  1. Verify machine cleanliness and status using the previous batch cleaning log.
  2. Ensure labels are approved by QA and match the batch record.
  3. Check label roll for batch number, expiry date, product name, and ensure alignment with artwork.
  4. Confirm that the reject mechanism is functional and alarm systems are working.
  5. Verify camera system settings for code and label verification.

5.2 Label Roll Loading

  1. Load the label roll onto the designated spindle as per the machine’s operational manual.
  2. Thread the labels through rollers and apply tension as per the manufacturer’s instructions.
  3. Ensure label sensors are active and properly calibrated.
  4. Record label roll details in the Label Usage Log (Annexure-1).

5.3 Machine Start-Up and Operation

  1. Switch ON the labeling machine and allow it to initialize.
  2. Feed a few empty containers (vials/syringes) and verify correct label placement and alignment.
  3. Perform an initial in-process check on 5 labeled units with QA verification.
  4. Start full operation only after receiving QA clearance.
  5. Monitor label presence sensors and reject mechanism regularly during the operation.
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5.4 In-Process Verification

  1. Every 30 minutes or every 1000 units (whichever is earlier), perform a label inspection:
    • Label content accuracy (product name, strength, batch no., expiry).
    • Placement straightness and adhesion quality.
    • Check label camera system logs for rejections or anomalies.
  2. Record findings in the In-Process Label Check Record (Annexure-2).

5.5 Handling Deviations

  1. Immediately stop the machine if any mislabeling or system fault is observed.
  2. Segregate affected units and inform QA.
  3. Record the deviation in the Labeling Deviation Log (Annexure-3).

5.6 Machine Shutdown

  1. Stop label application and allow the conveyor belt to run until the last unit is labeled.
  2. Remove the label roll and store it securely.
  3. Clean machine rollers and sensors using lint-free cloth and IPA 70%.
  4. Document cleaning in Annexure-4: Machine Cleaning Log.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • IPA: Isopropyl Alcohol
  • GMP: Good Manufacturing Practice

7. Documents

  1. Label Usage Log – Annexure-1
  2. In-Process Label Check Record – Annexure-2
  3. Labeling Deviation Log – Annexure-3
  4. Machine Cleaning Log – Annexure-4

8. References

  • WHO TRS 986 Annex 2 – GMP for Sterile Products
  • EU GMP Guide Annex 1 – Manufacture of Sterile Medicinal Products
  • 21 CFR Part 211 – Labeling Requirements
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9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation Manufacturing Executive QA Executive Head QA
Department Production Quality Assurance Quality Assurance

11. Annexures

Annexure-1: Label Usage Log

Date Batch No. Product Name Label Code Roll Start No. Roll End No. Operator
24/06/2025 B12345 Injection A LBL-2025A 0001 1000 Rajesh Kumar

Annexure-2: In-Process Label Check Record

Time Sample Size Parameters Checked Remarks Checked By
10:30 5 Content, Alignment OK Sunita Reddy

Annexure-3: Labeling Deviation Log

Date Batch No. Description of Deviation Action Taken QA Reviewed
24/06/2025 B12345 Skewed label placement on 10 vials Units rejected and re-labeled Amit Verma

Annexure-4: Machine Cleaning Log

Date Machine ID Cleaning Agent Cleaned By Checked By
24/06/2025 LBL-03 IPA 70% Sandeep Patel QA Executive

Revision History:

Revision Date Revision No. Details Reason Approved By
10/05/2022 1.0 Initial Issue New SOP Head QA
24/06/2025 2.0 Updated for digital verification and automated roll tracking GMP Compliance Update Head QA
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