Elixir Department: SOP for Dispensing Under Laminar Airflow Cabinet – V 2.0

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Elixir Department: SOP for Dispensing Under Laminar Airflow Cabinet – V 2.0

Standard Operating Procedure for Dispensing of Materials Under Laminar Airflow Cabinet

Department Elixir Department
SOP No. SOP/ELX/031/2025
Supersedes SOP/ELX/031/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

The purpose of this SOP is to define the standardized procedure for dispensing raw materials and excipients under a laminar airflow (LAF) cabinet to maintain cleanliness, prevent contamination, and ensure compliance with GMP in the Elixir Department.

2. Scope

This SOP applies to all activities related to the dispensing of materials under a laminar airflow cabinet, including setup, operation, cleaning, verification, and documentation, for materials used in elixir manufacturing.

3. Responsibilities

  • Dispensing Operator:
    • Perform material dispensing under the LAF as per instructions.
    • Ensure aseptic handling and cleaning before and after dispensing.
  • Production Supervisor:
    • Verify cleanliness and suitability of LAF cabinet prior to use.
    • Monitor dispensing activities and ensure adherence to SOP.
  • QA Officer:
    • Conduct periodic checks and approve the use of the LAF area.
See also  Elixir Department: SOP for Handling Material Return Post Dispensing - V 2.0

4. Accountability

The Production Head of the Elixir Department is accountable for implementing this SOP and ensuring that all

materials are dispensed under controlled conditions using LAF to maintain product integrity.

5. Procedure

5.1 Pre-Dispensing Setup

  1. Ensure the LAF cabinet is validated and has a current certification.
  2. Switch on the cabinet blower and UV light 30 minutes prior to dispensing.
  3. Clean all internal surfaces using 70% IPA (Isopropyl Alcohol) in “L” pattern wiping.
  4. Ensure proper gowning and use of PPE before entering the LAF area.
  5. Calibrate and verify weighing balance inside the LAF before use.

5.2 Material Handling and Dispensing

  1. Bring only required materials and tools inside the LAF cabinet.
  2. Confirm labels, batch numbers, and container integrity before opening.
  3. Dispense materials using pre-cleaned scoops and containers.
  4. Weigh each material accurately and note the readings in the dispensing log.
  5. Close and seal all primary containers immediately after use.
See also  Elixir Department: SOP for Use of Approved Dispensing Aids and Equipment - V 2.0

5.3 Post-Dispensing Activities

  1. Remove all tools, containers, and materials from the LAF cabinet.
  2. Clean all surfaces with 70% IPA and allow to dry naturally.
  3. Switch off the blower after 15 minutes of post-cleaning operation.
  4. Record LAF usage, cleaning, and operator details in the LAF Usage Logbook.

5.4 Labeling and Documentation

  1. Label the dispensed containers with:
    • Material Name
    • Batch Number
    • Quantity Dispensed
    • Date
    • Dispensed By
  2. Document all activities in the Material Dispensing Log (Annexure-1).
  3. Attach Certificate of Analysis (Annexure-2) and Approval and Release Form (Annexure-3).

6. Abbreviations

  • LAF: Laminar Airflow
  • IPA: Isopropyl Alcohol
  • QA: Quality Assurance
  • SOP: Standard Operating Procedure
  • CoA: Certificate of Analysis

7. Documents

  1. Material Dispensing Log (Annexure-1)
  2. Certificate of Analysis (Annexure-2)
  3. Approval and Release Form (Annexure-3)

8. References

  • WHO TRS 961 – Annex 6: GMP for Sterile Pharmaceutical Products
  • EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
  • 21 CFR Part 211 – Current Good Manufacturing Practice
See also  Elixir Department: SOP for Controlled Substance Dispensing for Elixirs - V 2.0

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Material Dispensing Log

Date Material Batch No. Qty Dispensed Dispensed By Verified By
11/04/2025 Citric Acid CA8932 2.0 kg Rajesh Kumar Sunita Reddy
11/04/2025 Propylene Glycol PG7734 5.0 L Ajay Mehta Kiran Joshi

Annexure-2: Certificate of Analysis (CoA)

Material Batch No. Test Result Status
Citric Acid CA8932 Assay 99.7% Complies
Propylene Glycol PG7734 pH 7.2 Complies

Annexure-3: Approval and Release Form

Date Material Batch No. Released By Approved By Remarks
11/04/2025 Citric Acid CA8932 Rajesh Kumar Manoj Verma Approved
11/04/2025 Propylene Glycol PG7734 Ajay Mehta Manoj Verma Approved

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial SOP Issue New Document QA Head
11/04/2025 2.0 Updated to include UV disinfection & gowning instructions Improved Process Control QA Head
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