Standard Operating Procedure for Use of Inline Filters During Elixir Manufacturing

Department	Elixir Department
SOP No.	SOP/ELX/093/2025
Supersedes	SOP/ELX/093/2022
Page No.	Page 1 of 8
Issue Date	11/04/2025
Effective Date	15/04/2025
Review Date	11/04/2026

1. Purpose

To define the procedure for the installation, usage, monitoring, and documentation of inline filters used during elixir manufacturing processes to ensure removal of particulates and ensure product clarity and safety.

2. Scope

This SOP applies to the use of inline filters during the transfer of elixir solutions between tanks, during recirculation, or prior to bulk holding and filling in the Elixir Department.

3. Responsibilities

• Production Operator:
  • Install and operate inline filters as per SOP and batch requirements.
  • Record filter details and monitor pressure differentials.
• Production Supervisor:
  • Ensure correct filter specification and installation.
  • Review filter changeover documentation.
• QA Officer:
  • Verify filter integrity, usage logs, and approve transfer or next step.

4. Accountability

The Head of Production is accountable for ensuring the effective use of inline filtration systems, maintaining filter traceability, and preventing product contamination.

5. Procedure

5.1 Filter Selection and Preparation

1. Verify filter specifications in the BMR (e.g., 0.45 μm or 0.2 μm pore size, material compatibility).
2. Check filter packaging integrity, expiry date, and certificate of quality (CoQ).
3. Record filter type, manufacturer, lot number, and pore size in the Inline Filter Log (Annexure-1).

5.2 Installation and System Setup

1. Install the inline filter in the designated position (e.g., transfer line, outlet valve) using sanitary clamps and gaskets.
2. Ensure correct flow direction as per filter markings.
3. Perform pre-use integrity test if required by protocol.

5.3 Filtration Process

1. Start product transfer ensuring smooth flow and avoid pulsation that may damage the filter membrane.
2. Monitor differential pressure during filtration; do not exceed the maximum pressure specified by the manufacturer.
3. If flow rate reduces significantly or back pressure increases, pause operation and check for filter clogging.
4. Replace filter if required and document the change with reason and time in the logbook.

5.4 Post-Use Handling

1. Perform post-use integrity test where applicable.
2. Label used filter and store in designated area for QA inspection.
3. Clean the filter housing and sanitize before next use.

5.5 Documentation

1. Record filtration start and end time, operator initials, pressure observations, and remarks in the Inline Filter Log.
2. Attach the log and filter CoQ to the BMR.

6. Abbreviations

• SOP: Standard Operating Procedure
• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• CoQ: Certificate of Quality
• μm: Micrometer

7. Documents

1. Inline Filter Log (Annexure-1)
2. Filter Integrity Report (Annexure-2)
3. Batch Manufacturing Record (BMR)

8. References

• 21 CFR Part 211.67 – Equipment Cleaning and Maintenance
• WHO TRS 986 – GMP for Pharmaceutical Products
• ICH Q8 – Pharmaceutical Development

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Inline Filter Log

Date	Batch No.	Filter Type	Filter Lot No.	Start Time	End Time	Pressure (bar)	Operator
11/04/2025	ELX-1032	0.2 μm PES	PES-1122	10:30 AM	11:20 AM	1.5	Rajesh Kumar

Annexure-2: Filter Integrity Report

Filter Type	Lot No.	Test Performed	Result	Performed By	Date
0.2 μm PES	PES-1122	Bubble Point	Pass	Sunita Reddy	11/04/2025

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 integrity testing and inline filter changeover guidance	GMP Update	QA Head