Standard Operating Procedure for Setting Parameters for Vial Filling Machines

Department	Sterile Injectable Manufacturing
SOP No.	SOP/SIM/045/2025
Supersedes	SOP/SIM/045/2022
Page No.	Page 1 of 14
Issue Date	18/06/2025
Effective Date	20/06/2025
Review Date	18/06/2026

1. Purpose

To establish a standardized procedure for setting up operational parameters on vial filling machines used in sterile injectable manufacturing to ensure uniform fill volumes, aseptic integrity, and compliance with GMP regulations.

2. Scope

This SOP applies to all vial filling equipment used in aseptic areas of the sterile injectable manufacturing facility and covers both manual and automated parameter settings before batch execution.

3. Responsibilities

• Machine Operator: Responsible for implementing the setup and making machine adjustments.
• Production Supervisor: Reviews and authorizes parameter settings.
• Engineering Technician: Assists in technical setup and calibration of components.
• QA Officer: Verifies the documented settings and ensures compliance before batch initiation.

4. Accountability

The Head of Production is accountable for ensuring accurate setup and verification of vial filling machine parameters for each batch.

5. Procedure

5.1 Preparation for Setup

1. Ensure the filling room is qualified and cleared for batch setup as per area clearance checklist.
2. Confirm that the machine has completed preventive maintenance and cleaning procedures (SOP/SIM/051/2025).
3. Gather product-specific batch manufacturing records (BMRs), machine manuals, and prior validation parameters.

5.2 Critical Parameter Identification

1. Parameters to be set include:
   • Filling volume (mL)
   • Speed of conveyor and filling nozzles
   • Nozzle height and alignment
   • Stopper placement pressure and timing
2. Refer to batch-specific process validation data to determine acceptable ranges.

5.3 Machine Configuration

1. Power on the filling machine and enter password-protected interface.
2. Input required vial fill volume into the digital control panel (e.g., 2.0 mL ± 0.05 mL).
3. Adjust filling speed to ensure laminar flow is not disrupted (e.g., 20–40 vials per minute).
4. Use manual controls to adjust nozzle depth ensuring 3–4 mm below the vial neck opening.
5. Set stopper pressing time to synchronize with vial movement and avoid misalignment.
6. Save settings as batch-specific profile and lock with operator ID and timestamp.

5.4 Verification and Documentation

1. Conduct a dry run using sterile empty vials and observe fill weight/volume and nozzle movement.
2. Verify weight of 10 consecutive vials using calibrated balance. Record data in Annexure-1.
3. QA must review the settings and sign off the “Parameter Setting Record” before proceeding.
4. Attach screen printouts of digital settings (if applicable) in batch file.

5.5 During Batch Execution

1. Monitor parameters through HMI interface continuously during filling.
2. Adjustments should only be made with authorization and documented via deviation form if outside validated range.
3. Log any machine alarm or error code in Annexure-2.

5.6 Post-Batch Handling

1. Reset all machine settings to idle or neutral mode.
2. Clean machine components as per SOP/SIM/051/2025 and complete cleaning log.
3. Store batch parameter record with QA for batch archival and review purposes.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• BMR: Batch Manufacturing Record
• HMI: Human-Machine Interface

7. Documents

1. Vial Filling Parameter Log – Annexure-1
2. Machine Alarm/Error Log – Annexure-2

8. References

• EU GMP Annex 1: Manufacture of Sterile Medicinal Products
• WHO GMP Guidelines – Sterile Products
• 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: Vial Filling Parameter Log

Date	Batch No.	Volume Set	Avg Volume (10 Vials)	Set Speed	Checked By
18/06/2025	BJX2025IV01	2.0 mL	2.01 mL	35 vials/min	Rajesh Kumar

Annexure-2: Machine Alarm/Error Log

Date	Time	Error Code	Description	Action Taken	Operator
18/06/2025	10:45	FILL-ERR-02	Nozzle alignment fault	Adjusted nozzle manually	Sunita Reddy

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/03/2022	1.0	Initial Release	New SOP	QA Head
18/06/2025	2.0	Updated procedure and parameter log formats	Annual Review	QA Head