is to ensure thorough internal and external washing of vials to eliminate particulate matter, pyrogens, and microbial contamination prior to sterilization and filling.

2. Scope

This SOP applies to all vial washing machines used in the sterile area of the injectable manufacturing department. It is relevant for operators, technicians, and maintenance personnel responsible for preparation and operation of washing equipment for different vial sizes and formats.

3. Responsibilities

• Machine Operator: Operates the vial washing machine, performs routine checks, and records operational data.
• Engineering Technician: Performs machine setup, troubleshooting, and preventive maintenance.
• QA Officer: Verifies cleanliness, checks for line clearance, and ensures compliance with SOP requirements.

4. Accountability

The Production Head is accountable for ensuring that the vial washing process complies with current GMP standards, and that equipment is used and maintained correctly.

5. Procedure

5.1 Pre-Operation Checks

1. Verify cleaning status and line clearance of the vial washing area using the Vial Washing Area Clearance Checklist (Annexure-1).
2. Ensure machine components such as vial infeed tray, nozzles, grippers, spray needles, and water/air filters are assembled correctly and cleaned as per the cleaning SOP.
3. Check utility connections: purified water (PW), water for injection (WFI), compressed air (CA), and drain system.
4. Ensure the machine is connected to power and that the emergency stop button is in the release position.
5. Confirm that calibration of temperature gauges and pressure meters has been performed (see Annexure-2: Calibration Log).

5.2 Operation of the Vial Washing Machine

1. Switch ON the main power supply and wait for the HMI (Human Machine Interface) to initialize.
2. Select vial size and set parameters for:
   • Washing sequence (e.g., PW, WFI, CA)
   • Washing cycles per station (e.g., 3-2-2)
   • Infeed and outfeed conveyor speed
3. Load dry, depyrogenated vials onto the infeed tray.
4. Initiate the washing cycle using the START button on HMI panel.
5. Observe the movement of vials through grippers into the rotating carousel where internal and external jets wash with PW, WFI, and compressed air sequentially.
6. Monitor pressure and temperature of WFI and CA—ensure:
   • WFI Temp: 80–85°C
   • Compressed Air: 3–4 bar (filtered)
7. Collect washed vials on the outfeed tray with HEPA-filtered laminar airflow.

5.3 Post-Wash Handling

1. Transfer washed vials to sterilization tunnels or autoclaves promptly to avoid recontamination.
2. Cover trays with sterile polybags if transfer is delayed beyond 30 minutes.

5.4 Machine Shutdown Procedure

1. Stop the cycle after the last batch.
2. Flush the internal pipelines with PW and then drain completely.
3. Switch off the utility valves (PW, WFI, CA) and disconnect main power supply.

5.5 Cleaning and Maintenance

1. Clean all contact parts using validated disinfectants after daily operation.
2. Perform weekly and monthly preventive maintenance as per equipment checklist.
3. Record all cleaning and maintenance activities in the Machine Usage Logbook (Annexure-3).

5.6 Deviations and Troubleshooting

1. If the machine jams, press the emergency stop and inform the engineering team.
2. Do not open the access door during operation to avoid exposure to high-pressure jets.
3. Log all deviations in the Deviation Log (Annexure-4).

6. Abbreviations

• SOP: Standard Operating Procedure
• PW: Purified Water
• WFI: Water for Injection
• CA: Compressed Air
• HMI: Human Machine Interface

7. Documents

1. Vial Washing Area Clearance Checklist – Annexure-1
2. Calibration Log – Annexure-2
3. Machine Usage Logbook – Annexure-3
4. Deviation Log – Annexure-4

8. References

• WHO TRS 961 Annex 6 – GMP for Sterile Pharmaceutical Products
• EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
• 21 CFR Part 211.67 – Equipment cleaning and maintenance

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: Vial Washing Area Clearance Checklist

Area	Status	Checked By	Date
Machine Cleaned	Yes	Ravi Sharma	24/06/2025
Line Clearance	Yes	Anjali Nair	24/06/2025

Annexure-2: Calibration Log

Instrument	Calibrated On	Next Due	Calibrated By
Pressure Gauge	20/06/2025	20/06/2026	Sunil Desai
WFI Thermometer	20/06/2025	20/06/2026	Sunil Desai

Annexure-3: Machine Usage Logbook

Date	Shift	Batch No.	Operator	Remarks
24/06/2025	1st	INJ-B234	Deepak Rao	Normal Operation

Annexure-4: Deviation Log

Date	Description	Immediate Action	Investigated By
22/06/2025	Nozzle Blockage	Stopped machine, flushed nozzle	Ramesh Nair

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Issue	New SOP	QA Head
24/06/2025	2.0	Updated pressure specs, added annexures	Scheduled Review	QA Head