SOP Guide for Pharma

Elixir Department: SOP for Bulk Filtration Before Packing – V 2.0

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Elixir Department: SOP for Bulk Filtration Before Packing – V 2.0

Standard Operating Procedure for Bulk Filtration of Elixirs Before Packing

Department Elixir Department
SOP No. SOP/ELX/092/2025
Supersedes SOP/ELX/092/2022
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 a validated procedure for the bulk filtration of elixir formulations prior to packing, ensuring removal of visible particles, microbial load (where applicable), and product clarity as per specifications.

2. Scope

This SOP applies to all elixir products manufactured in the Elixir Department that require filtration before transfer to the final filling or bottling area.

3. Responsibilities

  • Production Operator:
    • Set up filtration system and perform filtration as per BMR instructions.
    • Record filtration parameters and time points.
  • Production Supervisor:
    • Verify filter integrity and cleanliness before use.
    • Ensure filtration is carried out under validated conditions.
  • QA Officer:
    • Review filtration records and authorize release to the packaging stage.

See also  Elixir Department: SOP for Cleaning Flammable Solvent Equipment - V 2.0

4. Accountability

The Head of Production is accountable for ensuring that all filtration activities are performed using qualified equipment, clean filters, and within specified process parameters.

5. Procedure

5.1 Preparation Before Filtration

  1. Ensure the bulk solution is completely mixed and passed visual inspection.
  2. Verify cleanliness of the filtration assembly and holding tank.
  3. Ensure all fittings, gaskets, and transfer lines are properly sanitized and dry.
  4. Use pre-validated filters (e.g., 0.2 μm or as specified in the BMR).

5.2 Filter Installation and Integrity Check

  1. Install filter cartridge into stainless steel housing using aseptic technique.
  2. Perform pre-use integrity test (bubble point or diffusive flow method) if applicable.
  3. Record filter type, manufacturer, lot number, and expiry in the Filtration Log (Annexure-1).

5.3 Filtration Procedure

  1. Start filtration process by slowly transferring the product from mixing/storage tank to the filling vessel or intermediate tank under nitrogen pressure or gravity, depending on equipment design.
  2. Avoid vigorous agitation or splashing to prevent foaming and contamination.
  3. Monitor flow rate and pressure drop across the filter continuously.
  4. Stop filtration immediately if back pressure exceeds acceptable limit or flow slows significantly, and notify the supervisor.
See also  Elixir Department: SOP for Use of Water for Injection (WFI) in Elixir Production - V 2.0

5.4 Post-Filtration Handling

  1. Collect a sample from the filtered product and submit to QC for clarity, microbial, and assay testing.
  2. Label the filtered product container with batch number, volume, and “Filtered—Ready for Packing.”
  3. Complete the post-filtration integrity test if required, and record results.

5.5 Cleaning and Documentation

  1. Clean and dry the filtration assembly immediately after use.
  2. Record all filtration details in the BMR and Filtration Log.
  3. Attach filter usage report and integrity results with batch documentation.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • BMR: Batch Manufacturing Record
  • QC: Quality Control
  • μm: Micron (micrometer)

7. Documents

  1. Filtration Log (Annexure-1)
  2. Filter Integrity Test Record (Annexure-2)
  3. Batch Manufacturing Record (BMR)
See also  Elixir Department: SOP for Calibration of Weighing Balances Used in Elixir Dispensing - V 2.0

8. References

  • 21 CFR Part 211.67 – Equipment Cleaning and Maintenance
  • WHO TRS 1019 – 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: Filtration Log

Date Batch No. Filter Type Filter Lot No. Start Time End Time Operator Remarks
11/04/2025 ELX-1031 0.2 μm Nylon NY-2234 10:00 AM 11:15 AM Rajesh Kumar Flow steady, no interruption

Annexure-2: Filter Integrity Test Record

Filter Type Lot No. Method Used Result Performed By Date
0.2 μm Nylon NY-2234 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 Included post-filtration integrity and QC sampling steps GMP Compliance Update QA Head
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