regulatory standards.

2. Scope

This SOP applies to all filling equipment with integrated temperature control systems used in cleanroom environments within sterile injectable production. It covers both scheduled calibration and post-maintenance validation.

3. Responsibilities

• Maintenance Technician: Performs calibration using certified reference equipment.
• Engineering Supervisor: Reviews calibration reports and ensures schedule adherence.
• QA Officer: Verifies and approves calibration certificates and log entries.
• Production Operator: Initiates calibration requests and halts operation during calibration.

4. Accountability

The Head of Engineering is accountable for compliance with the calibration schedule, procedure adherence, and closure of deviations related to temperature calibration.

5. Procedure

5.1 Calibration Frequency

1. Perform calibration:
   • Before first use after installation or major maintenance
   • Every 6 months (or as per equipment-specific validation protocol)
   • Following any temperature-related deviation or malfunction

5.2 Preparation for Calibration

1. Switch the machine to maintenance mode and display temperature set points.
2. Ensure all temperature probes and heating zones are accessible.
3. Clean sensor surfaces with sterile alcohol wipes.
4. Verify availability of certified temperature calibrator with current calibration traceability (Annexure-1).

5.3 Calibration Procedure

1. Connect the reference temperature probe to each sensor location (e.g., jacket heaters, product path, reservoir areas).
2. Apply known reference temperatures (typically 60°C, 80°C, 100°C).
3. Record displayed values from machine HMI and reference standard simultaneously (±0.5°C tolerance).
4. If deviation exceeds limits, recalibrate via adjustment or replace the sensor and re-validate.

5.4 Post-Calibration Verification

1. Switch machine to production mode and run dummy cycles for 15 minutes.
2. Check system response and log stability of temperature readings.
3. Attach the calibration certificate to Annexure-2 and update the logbook (Annexure-3).

5.5 Handling Out-of-Tolerance Results

1. Quarantine all batches filled since the last successful calibration.
2. Initiate deviation as per QA procedure and investigate impact assessment.
3. Notify QA for further decision regarding reprocessing, hold, or rejection.

6. Abbreviations

• SOP: Standard Operating Procedure
• HMI: Human Machine Interface
• QA: Quality Assurance
• OOS: Out of Specification

7. Documents

1. Certified Reference Equipment List – Annexure-1
2. Temperature Calibration Certificate – Annexure-2
3. Calibration Logbook Entry – Annexure-3

8. References

• ICH Q9 – Quality Risk Management
• WHO TRS 1010 Annex 7 – Equipment Qualification
• 21 CFR Part 211 – Subpart D: Equipment

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Maintenance Executive	QA Executive	Head QA
Department	Engineering	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Certified Reference Equipment List

Instrument ID	Make	Model	Calibration Due Date	Status
CR-302	Fluke	724	12/12/2025	Valid

Annexure-2: Temperature Calibration Certificate

Date	Machine ID	Sensor Location	Set Temp (°C)	Observed Temp (°C)	Deviation	Calibrated By
18/06/2025	VIAL-FM02	Reservoir Zone	80	79.6	0.4	Rajesh Kumar

Annexure-3: Calibration Logbook Entry

Date	Machine ID	Calibrated By	QA Verified By	Remarks
18/06/2025	VIAL-FM02	Sunita Reddy	Vinay Pawar	Within limits

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Issue	New SOP	QA Head
18/06/2025	2.0	Updated calibration ranges and annexures	Periodic Review	QA Head