and regulatory requirements.

2. Scope

This procedure applies to all ampoules used in sterile manufacturing areas during filling operations at [Company Name], covering activities such as unloading, washing, sterilization, transfer, and handling until the point of filling.

3. Responsibilities

• Production Personnel: Responsible for handling ampoules as per the SOP and maintaining proper documentation.
• Engineering Department: Maintain and calibrate ampoule processing equipment.
• QA Department: Monitor compliance, perform area clearance, and ensure GMP adherence.
• QC Department: Perform sampling, inspection, and quality testing of ampoules as needed.

4. Accountability

The Head of Production shall be accountable for execution of sterile handling operations. The QA Head is accountable for ensuring compliance with cGMP and regulatory standards.

5. Procedure

5.1 Receiving and Preliminary Inspection

1. Receive ampoules from the approved supplier along with Certificate of Analysis (CoA).
2. Visually inspect ampoules for physical damage, dirt, particulate matter, and packaging defects.
3. Segregate rejected ampoules and document findings in the Incoming Material Inspection Log.

5.2 Storage Prior to Use

1. Store ampoules in the quarantine area at ambient conditions away from direct sunlight.
2. Ensure FIFO (First In First Out) principle is followed for dispensing to production.

5.3 Washing of Ampoules

1. Transfer ampoules to the washing area using stainless steel (SS) trays.
2. Place ampoules into the ampoule washing machine with necks facing downward.
3. Use pre-validated washing cycles including:
   • External wash with WFI
   • Internal wash with compressed air and WFI
   • Final rinse with WFI and clean compressed air
4. Visually inspect 10 randomly selected ampoules for cleanliness after washing.
5. Record the washing cycle details in the Ampoule Washing Log (Annexure-1).

5.4 Depyrogenation (Sterilization)

1. Transfer washed ampoules to a depyrogenation tunnel or hot air sterilizer.
2. Set validated parameters (e.g., 300°C for 45 minutes for dry heat tunnel).
3. Use temperature data logger to confirm cycle compliance.
4. After sterilization, transfer ampoules to aseptic area using validated pass box.
5. Record sterilization batch details in the Sterilization Logbook (Annexure-2).

5.5 Handling within the Aseptic Area

1. Operators must don full sterile garments before entering the Grade A area.
2. Handle ampoules only under LAF or RABS systems to ensure aseptic conditions.
3. Minimize manual contact; use sterile tongs or tools wherever possible.
4. Ensure ampoules are loaded onto the filling machine without delay post-sterilization.
5. Do not re-sterilize ampoules once transferred into aseptic area.

5.6 Labeling and Segregation

1. Do not label empty ampoules. Label only after final sealing and inspection.
2. Use batch-specific identification tags during internal movement to prevent mix-ups.

5.7 Documentation and Record Keeping

1. Maintain the following records:
   • Ampoule Washing Log
   • Sterilization Record
   • Batch Identification Tag Log
2. QA to review and archive documents as per document control procedure.

6. Abbreviations

• SOP: Standard Operating Procedure
• WFI: Water for Injection
• QA: Quality Assurance
• QC: Quality Control
• SS: Stainless Steel
• CoA: Certificate of Analysis
• LAF: Laminar Air Flow

7. Documents

1. Ampoule Washing Log – Annexure-1
2. Sterilization Record – Annexure-2
3. Batch Identification Tag Log – Annexure-3

8. References

• EU-GMP Guidelines Annex 1 – Manufacture of Sterile Medicinal Products
• WHO TRS 961 Annex 6 – GMP for Sterile Pharmaceutical Products
• ICH Q9 – Quality Risk Management

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: Ampoule Washing Log

Date	Batch No.	No. of Ampoules	Cycle No.	Operator	Remarks
23/06/2025	BN124A	10,000	W-2025-01	Rajesh Kumar	Clean

Annexure-2: Sterilization Record

Date	Batch No.	Temp (°C)	Time (min)	Result	Operator
23/06/2025	BN124A	300	45	Pass	Sunita Reddy

Annexure-3: Batch Identification Tag Log

Date	Batch No.	Label Code	Status	Operator
23/06/2025	BN124A	TAG-2025-A1	Applied	Amit Sharma

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
10/01/2022	1.0	Initial SOP release	New SOP	QA Head
24/06/2025	2.0	Updated with Annexures and aseptic controls	Periodic Review	QA Head