Elixir Department: SOP for Automated Transfer System Controls – V 2.0

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Elixir Department: SOP for Automated Transfer System Controls – V 2.0

Standard Operating Procedure for Automated Transfer System Controls in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/153/2025
Supersedes SOP/ELX/153/2022
Page No. Page 1 of 10
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To define the standardized procedure for configuring, operating, monitoring, and troubleshooting automated transfer systems used for transferring elixir solutions between vessels, storage tanks, and filling lines in a controlled and validated manner.

2. Scope

This SOP applies to all PLC/HMI/SCADA-integrated automated transfer systems, including those using peristaltic pumps, diaphragm pumps, and valve-controlled pipelines within the Elixir Department.

3. Responsibilities

  • Production Operator:
    • Execute transfers as per BMR instructions via HMI/SCADA panel.
    • Ensure line clearance and system readiness prior to operation.
  • Engineering Department:
    • Maintain system hardware and software, calibrate flow sensors and actuators.
    • Investigate alarms and transfer failures.
  • QA Officer:
    • Review transfer logs, verify cleaning and line clearance records.

4. Accountability

The Production Head is accountable for operational execution. The Engineering Head is responsible for control system integrity. The QA Head ensures compliance and documentation review.

See also  Elixir Department: SOP for Operation of Flow Meter for Liquid Transfer - V 2.0

5. Procedure

5.1 Pre-Transfer Checks

  1. Verify completion of line clearance and cleaning as per checklist (refer to SOP/ELX/070/2025).
  2. Check that destination tank is labeled and has available capacity for incoming batch volume.
  3. Ensure that all interlocks are enabled and valves are in their default closed positions.
  4. Confirm that transfer line is connected as per batch instructions and no leakages are present.

5.2 System Configuration

  1. Login to the HMI using individual operator credentials.
  2. Select the appropriate batch number and destination tank from the system menu.
  3. Input the transfer parameters (target volume or duration, flow rate, valve opening time).
  4. Check if destination valve and source valve are correctly assigned in the control matrix.

5.3 Executing the Transfer

  1. Press the “START TRANSFER” button on the HMI panel to begin operation.
  2. Monitor flow rate, pressure, and transfer status in real time via SCADA or HMI dashboard.
  3. Ensure no deviation from expected flow rate (±5%). If deviation occurs, stop the transfer and investigate.
  4. Once target volume is reached, system will auto-close valves and log the operation.
See also  Elixir Department: SOP for Identification of Critical vs Non-Critical Materials - V 2.0

5.4 Post-Transfer Activities

  1. Confirm batch transfer completion on HMI panel and generate the electronic log.
  2. Disconnect transfer lines and clean immediately as per CIP/SIP procedure (if applicable).
  3. Update BMR with transfer start and end times, total volume transferred, and any issues encountered.

5.5 Alarms and Troubleshooting

  1. In case of high-pressure, low flow, or sensor fault alarms:
    • Stop the transfer using the emergency stop or control panel.
    • Notify Engineering and QA immediately.
    • Record alarm code and nature in the Alarm Logbook.
  2. Engineering shall perform system checks and validate before resuming operation.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • HMI: Human Machine Interface
  • PLC: Programmable Logic Controller
  • QA: Quality Assurance
  • SCADA: Supervisory Control and Data Acquisition

7. Documents

  1. Automated Transfer Logbook (Annexure-1)
  2. Alarm Logbook (Annexure-2)
  3. Batch Manufacturing Record (BMR)
See also  Elixir Department: SOP for Identification of Holding Time and Conditions - V 2.0

8. References

  • 21 CFR Part 211 – Equipment Operation and Monitoring
  • WHO TRS 1010 – Pharmaceutical Engineering Systems
  • ICH Q9 – Quality Risk Management

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Automated Transfer Logbook

Date Batch No. Source Tank Destination Tank Volume Transferred (L) Start Time End Time Operator Remarks
11/04/2025 ELX-2025-022 MXR-01 TK-05 950 10:05 10:28 Rajesh Kumar Normal

Annexure-2: Alarm Logbook

Date Alarm Code Description Equipment ID Operator Corrective Action Engineer
11/04/2025 LOWFLOW-AL01 Low Flow Detected TRANS-SYS-03 Sunita Reddy Pump Reprimed Rakesh Nair

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial SOP Release New SOP QA Head
11/04/2025 2.0 Added SCADA linkage and alarm logging Automation Upgrade QA Head
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