Elixir Department: SOP for Microbial Sampling During Process – V 2.0

Posted on By

Elixir Department: SOP for Microbial Sampling During Process – V 2.0

Standard Operating Procedure for Microbial Sampling During Elixir Manufacturing Process

Department Elixir Department
SOP No. SOP/ELX/198/2025
Supersedes SOP/ELX/198/2022
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 microbial sampling during elixir manufacturing to monitor microbial contamination and ensure compliance with cGMP and regulatory requirements.

2. Scope

This SOP applies to in-process microbial sampling of product, equipment, personnel, and environment at predefined stages of elixir manufacturing prior to final filtration and filling.

3. Responsibilities

  • Production Operator:
    • Assist microbiology personnel in accessing sampling points during processing.
  • Microbiologist:
    • Perform microbial sampling and testing as per schedule and protocol.
  • QA Officer:
    • Review sampling reports and ensure corrective actions for deviations.

4. Accountability

The Microbiology Head is accountable for sample analysis and timely reporting. The Production Head ensures sampling access and coordination. QA is responsible for review and compliance monitoring.

See also  Elixir Department: SOP for Calibration of Dispensing Balances - V 2.0

5. Procedure

5.1 Sampling Plan

  1. Prepare and approve a microbial sampling plan for each batch or campaign including:
    • Product sampling (bulk
stage)
  • Surface swabs (mixing tanks, transfer lines)
  • Air sampling (settle plates)
  • Personnel hand/glove swabs (selected operators)

    • 5.2 Sampling Points and Frequency

    1. Bulk Product: After final mixing and before filtration.
    2. Surface Swab: Inner walls of mixing tank and agitator blades post-mixing.
    3. Air Monitoring: Using settle plates placed at operator head height and near open processing area for 4 hours.
    4. Personnel Monitoring: Palm and glove swabs of operators at end of batch.

    5.3 Sampling Procedure

    1. Follow aseptic technique and wear sterile gowning during sampling.
    2. Use sterile sampling containers, swabs, and pre-incubated media plates.
    3. Label all samples with product name, batch number, date, time, location, and sampler initials.
    4. Transport all samples to the Microbiology Lab within 1 hour under controlled conditions (20–25°C).

    5.4 Microbial Testing

    1. Perform Total Aerobic Microbial Count (TAMC), Total Yeast and Mold Count (TYMC), and specified pathogen testing (e.g., E. coli, Salmonella) as per pharmacopeial methods.
    2. Use validated methods as per current USP, BP, or IP guidelines.
    3. Incubate:
      • Bacteria at 30–35°C for 3–5 days
      • Fungi at 20–25°C for 5–7 days

    5.5 Acceptance Criteria

    1. Bulk Product: Should comply with in-process microbial limits (e.g., TAMC NMT 100 CFU/mL, TYMC NMT 10 CFU/mL).
    2. Surface Swab and Personnel Swab: NMT 10 CFU/swab (or as per SOP/ENV/010).
    3. Air Monitoring: NMT 100 CFU/plate/4hr exposure in Grade D (as per ISO 14644-1).
    4. No presence of objectionable pathogens (e.g., E. coli, Salmonella).

    5.6 Actions in Case of Deviation

    1. Inform QA and initiate investigation for source of contamination.
    2. Review sanitation, water quality, cleaning records, and personnel hygiene.
    3. Hold the batch and initiate CAPA as per deviation SOP.

    5.7 Documentation

    1. Record all sampling details in the Microbial Sampling Logbook (Annexure-1).
    2. Attach microbiological test reports to the batch record.
    3. Ensure QA review and approval before batch clearance.

    6. Abbreviations

    • SOP: Standard Operating Procedure
    • QA: Quality Assurance
    • QC: Quality Control
    • TAMC: Total Aerobic Microbial Count
    • TYMC: Total Yeast and Mold Count
    • CFU: Colony Forming Units

    7. Documents

    1. Microbial Sampling Logbook (Annexure-1)
    2. Batch Manufacturing Record (BMR)
    3. Microbial Test Report

    8. References

    • USP <61>, <62> – Microbiological Examination of Non-Sterile Products
    • WHO TRS 986 – Annex 2
    • 21 CFR Part 211.113 – Control of Microbiological Contamination

    9. SOP Version

    Version: 2.0

    10. Approval Section

    Prepared By Checked By Approved By
    Signature
    Date
    Name
    Designation
    Department

    11. Annexures

    Annexure-1: Microbial Sampling Logbook

    Date Batch No. Sample Type Sampling Point Sampler Time Remarks
    11/04/2025 ELX-0425-017 Surface Swab Mixing Tank Rajesh Kumar 10:30 AM Sample collected after mixing completion

    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 Expanded sampling scope and updated acceptance criteria Regulatory Alignment QA Head
    Elixers V 2.0 Tags:, , , , , , , , , , , , , , , , , , , , , , , ,