such as unloading, washing, sterilization, handling, and transfer within the sterile manufacturing facility.

3. Responsibilities

• Manufacturing Personnel: Handle ampoules aseptically and perform tasks as per defined protocols.
• Engineering Department: Maintain equipment such as ampoule washing machines, sterilizers, and conveyors.
• Quality Assurance: Monitor compliance with SOP and perform line clearances.
• Quality Control: Conduct in-process checks on ampoule quality and cleanliness.

4. Accountability

The Head of Manufacturing is accountable for ensuring sterile handling practices are followed for ampoules. The QA Head is accountable for ensuring regulatory and procedural compliance.

5. Procedure

5.1 Receipt and Unloading of Ampoules

1. Receive ampoules in sealed corrugated boxes or shrink-wrapped trays from approved suppliers.
2. Check for integrity of packaging, supplier label, and quantity as per invoice.
3. Record details in the Ampoule Receipt Logbook (Annexure-1).

5.2 Visual Inspection of Ampoules

1. Visually inspect ampoules for any defects like cracks, chips, or foreign particles.
2. Segregate and document any defective ampoules.

5.3 Washing of Ampoules

1. Load ampoules into the washing machine trays with necks facing upward.
2. Use a validated multijet ampoule washing machine.
3. Run the ampoule washing cycle with WFI (Water for Injection) and compressed filtered air.
4. Final rinse must be with WFI and drained appropriately.
5. Record the washing activity in the Ampoule Washing Log (Annexure-2).

5.4 Sterilization and Depyrogenation

1. Transfer washed ampoules to tunnel sterilizer under unidirectional airflow.
2. Sterilize ampoules at validated parameters (e.g., 300°C for 30 minutes).
3. Cool and transfer sterile ampoules directly into aseptic area via sterile conveyor.
4. Do not manually touch ampoules post-sterilization.

5.5 Handling during Filling

1. Ensure ampoules remain under laminar airflow during loading into filling equipment.
2. Do not use any ampoule found damaged, discolored, or deformed.
3. Only use ampoules within the validated hold time post-sterilization.

5.6 Post-Filling Transfer

1. Transfer ampoules for sealing and visual inspection via sterile conveyor.
2. Avoid accumulation of ampoules during transfer to prevent breakage.

5.7 Documentation

1. Record all details in the respective logbooks such as:
   • Ampoule Receipt Log
   • Ampoule Washing Log
   • Sterilization Record
   • Filling Batch Record

6. Abbreviations

• SOP: Standard Operating Procedure
• WFI: Water for Injection
• QA: Quality Assurance
• QC: Quality Control
• cGMP: current Good Manufacturing Practices

7. Documents

1. Ampoule Receipt Log – Annexure-1
2. Ampoule Washing Log – Annexure-2
3. Sterilization Record – Annexure-3
4. Filling Batch Record – Annexure-4

8. References

• WHO TRS 961 – Annex 6: GMP for Sterile Products
• EU GMP Guidelines – Annex 1
• ISO 14644 – Cleanroom Standards

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 Receipt Log

Date	Supplier	Lot No.	Qty Received	Inspected By	Remarks
20/06/2025	Vimal Glass	VL-AMP-205	50,000	Sunita Reddy	OK

Annexure-2: Ampoule Washing Log

Date	Batch No.	Washer ID	Cycle Start	End Time	Operator	Remarks
21/06/2025	AMP/IV/240	WASH-03	09:00 AM	09:45 AM	Rakesh Yadav	Normal

Annexure-3: Sterilization Record

Date	Batch No.	Tunnel ID	Temperature	Hold Time	Operator	QA Verified
21/06/2025	AMP/IV/240	TUN-02	300°C	30 min	Rakesh Yadav	Yes

Annexure-4: Filling Batch Record

Batch No.	Filling Start	Filling End	Filler ID	Qty Filled	Operator	Remarks
AMP/IV/240	10:30 AM	12:45 PM	FILL-04	48,000	Mahesh Patel	OK

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
10/07/2022	1.0	Initial Release	New SOP	QA Head
24/06/2025	2.0	Enhanced steps for washing and conveyor transfer	Annual Review	QA Head