of injectable vials, ampoules, and prefilled syringes within the sterile injection manufacturing facility.

3. Responsibilities

• Packing Operator: Conducts sealing tests as per the procedure and records results.
• Quality Assurance Officer: Verifies adherence to sealing quality criteria and reviews documentation.
• Packing Supervisor: Ensures operators are trained and SOP compliance is maintained.

4. Accountability

The Head of Quality Assurance is accountable for ensuring proper implementation of this SOP and for verifying compliance with applicable sealing integrity requirements.

5. Procedure

5.1 Sampling and Frequency

1. Perform sealing quality tests at the start of batch, after every changeover, and at predefined intervals (e.g., every 30 minutes).
2. Sample quantity:
   • Vials: 10 per sampling point
   • Ampoules: 10 per sampling point
   • Prefilled syringes: 5 per sampling point

5.2 Visual Inspection

1. Inspect the seal under adequate lighting for:
   • Proper alignment
   • Absence of crimping or wrinkling
   • No visible leakage or seal gaps
2. Record results in the Sealing Quality Log (Annexure-1).

5.3 Physical Seal Integrity Testing

1. Vials: Perform dye ingress test:
   • Immerse sealed vials in 0.1% methylene blue solution and apply vacuum for 10 minutes.
   • Observe for dye entry; reject any vial with ingress.
2. Ampoules: Conduct flame test:
   • Hold ampoule near flame; observe for leakage via bubbling or flame distortion.
3. Prefilled syringes: Use vacuum chamber method or apply controlled pressure to detect leaks.

5.4 Acceptance Criteria

1. No seal breakage, wrinkles, or misalignment.
2. No leakage, dye ingress, or deformation under pressure.
3. Samples must pass all inspection points; failure in one requires batch hold and investigation.

5.5 Documentation and Control

1. Record test details in Sealing Quality Log (Annexure-1).
2. Report any deviation or failure to QA for disposition.
3. Use the Sealing Defect Report Form (Annexure-2) for non-conformities.
4. Document corrective action taken and submit for QA review.

5.6 Training

1. Operators shall be trained on sealing equipment, defect identification, and test methods.
2. Training records must be maintained as per the training matrix (Annexure-3).

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• GMP: Good Manufacturing Practices
• CCIT: Container Closure Integrity Testing

7. Documents

1. Sealing Quality Log (Annexure-1)
2. Sealing Defect Report Form (Annexure-2)
3. Training Record (Annexure-3)

8. References

• WHO TRS 961 Annex 6 – GMP for Sterile Products
• USP <1207> – Packaging Integrity Evaluation
• ICH Q8 – Pharmaceutical Development

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: Sealing Quality Log

Date	Batch No.	Time	Sample Type	Result	Checked By
24/06/2025	VIAL/240625/01	10:00 AM	Vial	Pass	Sunita Reddy

Annexure-2: Sealing Defect Report Form

Date	Batch No.	Observed Defect	Corrective Action	QA Review
24/06/2025	PFS/240625/03	Seal misalignment	Line adjusted	Reviewed – Rajesh Kumar

Annexure-3: Training Record

Employee Name	Designation	Training Date	Trainer	Remarks
Asha Mehta	Packing Operator	20/06/2025	QA Officer	Completed

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
15/03/2022	1.0	Initial issue	New SOP	QA Head
24/06/2025	2.0	Updated procedure and annexures	Periodic Review	QA Head