Elixir Department: SOP for In-Process Filter Integrity Testing – V 2.0

Posted on By

Elixir Department: SOP for In-Process Filter Integrity Testing – V 2.0

Standard Operating Procedure for In-Process Filter Integrity Testing in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/201/2025
Supersedes SOP/ELX/201/2022
Page No. Page 1 of 9
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To define the procedure for performing integrity testing of in-process filters used in the elixir manufacturing process to ensure their integrity, prevent contamination, and maintain compliance with regulatory standards.

2. Scope

This SOP applies to the integrity testing of 0.2 μm or other rated filters used during the manufacturing, filtration, and transfer of elixirs. It includes pre-use, post-use, and in-process integrity testing.

3. Responsibilities

  • Production Operator:
    • Install the filter assembly and initiate testing with QC assistance.
  • QC Analyst:
    • Perform integrity testing and record results in logbooks.
  • QA Officer:
    • Verify test results and authorize use of filters for batch processing.

See also  Elixir Department: SOP for Color and Odor Testing - V 2.0

4. Accountability

The Production Head is accountable for filter usage and batch integrity. QC is responsible for executing and documenting tests. QA ensures compliance with SOP and regulatory standards.

5. Procedure

5.1 Types of Filter Integrity Tests

  1. Bubble Point Test: Measures pressure at which liquid is displaced by air from the largest pore.
  2. Diffusion Test: Measures the rate of air diffusion through a wetted filter membrane.
  3. Pressure Hold Test: Monitors pressure drop across a sealed filter system over time.

5.2 Pre-Use Integrity Testing

  1. Install the filter cartridge or capsule as per equipment SOP.
  2. Wet the membrane with purified water or suitable wetting fluid (e.g., 60:40 IPA:Water).
  3. Perform bubble point or diffusion test using a validated integrity tester.
  4. Record the observed values and compare with filter manufacturer’s specification.
  5. Proceed with the batch only if the filter passes integrity testing.

5.3 In-Process Verification

  1. During long processing runs, integrity testing may be repeated at defined intervals (e.g., every 8 hours).
  2. If any abnormal filtration behavior is observed (e.g., low flow rate or pressure rise), pause process and perform in-process integrity check.
See also  Elixir Department: SOP for Use of Data Loggers for Process Validation - V 2.0

5.4 Post-Use Integrity Testing

  1. After batch completion, flush filter with WFI or nitrogen to remove product residue.
  2. Repeat the same integrity test performed earlier (bubble point or diffusion).
  3. Failure of post-use testing must result in product quarantine and investigation.

5.5 Acceptance Criteria

  1. Results must fall within the specified range given by the filter manufacturer:
    • Bubble Point: ≥ minimum specified value (e.g., ≥ 3.5 bar for 0.2 μm)
    • Diffusion Rate: ≤ maximum allowable limit (e.g., ≤ 15 mL/min)
  2. Any deviation from these limits must be reported and investigated.

5.6 Documentation

  1. Enter results in the Filter Integrity Test Logbook (Annexure-1).
  2. Attach instrument printouts and calibration certificates.
  3. Ensure signatures from operator, QC, and QA.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QC: Quality Control
  • QA: Quality Assurance
  • WFI: Water for Injection
  • IPA: Isopropyl Alcohol
See also  Elixir Department: SOP for Assay of API by HPLC - V 2.0

7. Documents

  1. Filter Integrity Test Logbook (Annexure-1)
  2. Calibration Certificate
  3. Batch Manufacturing Record (BMR)

8. References

  • USP <1207> – Sterile Product Packaging Integrity Evaluation
  • 21 CFR Part 211.113 – Control of Microbiological Contamination
  • WHO TRS 986 – GMP for Pharmaceutical Products

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Filter Integrity Test Logbook

Date Batch No. Filter ID Test Type Result Pass/Fail Tested By QA Verified
11/04/2025 ELX-0425-020 FLT-2025-101 Bubble Point 3.8 bar Pass Rajesh Kumar Sunita Reddy

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Release New SOP QA Head
11/04/2025 2.0 Inclusion of in-process testing and failure investigation Process Enhancement QA Head
Elixers V 2.0 Tags:, , , , , , , , , , , , , , , , , , , , , , , ,