all prefilled syringe filling machines equipped with automation systems located in the sterile injectable manufacturing facility. It includes machine preparation, software checks, calibration, and line clearance procedures.

3. Responsibilities

• Filling Machine Operator: Responsible for mechanical setup and basic parameter entry.
• Automation Engineer: Oversees control system initialization, calibration, and troubleshooting.
• QA Executive: Verifies setup and ensures readiness for GMP operations.

4. Accountability

The Production Manager and Head QA are accountable for proper execution of this SOP, adherence to GMP, and documentation accuracy.

5. Procedure

5.1 Pre-Setup Requirements

1. Verify machine is clean and free of previous product residues (refer SOP/SIM/056/2025).
2. Ensure all tools, parts, and fixtures required for setup are available.
3. Check for availability of batch manufacturing records and prefilled syringe components.

5.2 Machine Setup

1. Switch on the main power and initialize the PLC and HMI system.
2. Load appropriate filling nozzles and syringe holders as per the syringe size (1 mL, 2.5 mL, etc.).
3. Secure the transfer and conveyor belts using locking pins.
4. Verify that clean-in-place (CIP) and sterilize-in-place (SIP) procedures have been completed.
5. Confirm line clearance using Line Clearance Checklist (Annexure-1).

5.3 Parameter Configuration

1. Input product-specific parameters including fill volume, speed, plunger stroke length, and backpressure.
2. Verify input values with Master Formula Record (MFR).
3. Activate servo control and validate motor synchronization between filling station and stoppering units.

5.4 Sensor and Camera Check

1. Ensure syringe detection sensors are functional by placing test syringes.
2. Test fill-no-syringe and overfill reject logic.
3. Calibrate vision systems for plunger depth and fill level verification.

5.5 Dry Run Validation

1. Conduct a 10-cycle dry run using dummy syringes with water-for-injection (WFI).
2. Inspect movement precision, fill accuracy, and reject path activation.
3. Record results in Dry Run Report (Annexure-2).

5.6 Verification and QA Approval

1. Submit setup logs, dry run results, and MFR reference to QA.
2. QA to verify batch number tagging, label setup, and safety interlocks.
3. QA signs off the Setup Verification Form (Annexure-3).

5.7 Troubleshooting and Alarms

1. In case of deviation in servo speed, verify gear ratios and encoder feedback.
2. For camera errors, clean lens with IPA and reset software interface.
3. Document errors and resolutions in Annexure-4: Machine Troubleshooting Log.

6. Abbreviations

• SOP: Standard Operating Procedure
• PLC: Programmable Logic Controller
• HMI: Human Machine Interface
• QA: Quality Assurance
• MFR: Master Formula Record

7. Documents

• Annexure-1: Line Clearance Checklist
• Annexure-2: Dry Run Report
• Annexure-3: Setup Verification Form
• Annexure-4: Machine Troubleshooting Log

8. References

• EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
• ISO 13408 – Aseptic Processing of Health Care Products

9. SOP Version

Version: 2.0

10. Approval Section

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

11. Annexures

Annexure-1: Line Clearance Checklist

Area	Cleared (Yes/No)	Remarks	Checked By
Infeed Conveyor	Yes	Clean	Sunil Rathi

Annexure-2: Dry Run Report

Cycle No.	Fill Accuracy (%)	Plunger Position	Operator
1	98.7	Correct	Ravi Yadav

Annexure-3: Setup Verification Form

Batch No.	Machine ID	QA Review Status	Reviewed By
BN-2456	SYR-FILL-01	Approved	Neha Kapoor

Annexure-4: Machine Troubleshooting Log

Date	Issue	Root Cause	Action Taken	Engineer
23/06/2025	Servo Jitter	Encoder Cable Loose	Reconnected and Tested	Mohit Verma

Revision History

Revision Date	Version	Description	Reason	Approved By
01/01/2022	1.0	Initial SOP Release	New Equipment	QA Head
24/06/2025	2.0	Added Vision System and Annexures	Annual Review	QA Head