SOP Guide for Pharma

Elixir Department: SOP for Use of Material Transfer Hatches – V 2.0

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Elixir Department: SOP for Use of Material Transfer Hatches – V 2.0

Standard Operating Procedure for Use of Material Transfer Hatches in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/042/2025
Supersedes SOP/ELX/042/2022
Page No. Page 1 of 8
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

This SOP defines the procedure for the proper use and maintenance of material transfer hatches between different classified areas in the Elixir Department to ensure controlled material movement and prevent cross-contamination.

2. Scope

This SOP applies to the use of dynamic and static pass boxes (material hatches) for transferring raw materials, packaging materials, and finished goods between warehouse, dispensing, and manufacturing areas in the Elixir Department.

3. Responsibilities

  • Dispensing Operator:
    • Ensure materials are placed and removed as per sequence.
    • Clean and disinfect the hatch before and after use.
  • Area Supervisor:
    • Monitor material movement and verify entries in the transfer logbook.
  • QA Officer:
    • Perform periodic checks and ensure compliance with hatch usage protocols.
See also  Elixir Department: SOP for Control of Cross-Contamination During Dispensing - V 2.0

4. Accountability

The Engineering Head and Production Head are accountable for ensuring the proper functioning, maintenance, and use of transfer hatches in accordance with GMP standards.

5. Procedure

5.1 Hatch Description and Types

  1. Static Pass Box: Non-ventilated enclosure used between non-critical areas (e.g., warehouse to corridor).
  2. Dynamic Pass Box: Equipped with HEPA-filtered air for controlled transfer between clean areas (e.g., dispensing to manufacturing).

5.2 Pre-Use Checks

  1. Ensure both doors are closed and interlock is functional.
  2. Inspect the inner chamber for cleanliness and switch on UV light (if applicable) for 15 minutes before first use.
  3. Record cleaning and UV light activation in the Material Transfer Hatch Logbook (Annexure-1).

5.3 Material Loading

  1. Open the non-classified side door, place the material inside the hatch on a clean surface.
  2. Close the door fully and ensure interlock is engaged before opening the classified area door.
  3. Record material name, batch number, source, and destination in the hatch logbook.
See also  Elixir Department: SOP for Storage of Raw Materials for Elixir Manufacturing - V 2.0

5.4 Material Receiving

  1. Personnel from the classified side shall open the door only after confirming the outer door is locked.
  2. Remove the material, verify the label, and disinfect with 70% IPA before transferring to the next process area.

5.5 Post-Use Sanitization

  1. After each use, clean the inner surface with lint-free wipes soaked in 70% IPA.
  2. Switch on UV light (if provided) for 15 minutes between cycles.
  3. Record sanitization time and initials in the hatch logbook.

5.6 Maintenance and Calibration

  1. Engineering department shall:
    • Perform quarterly preventive maintenance.
    • Verify interlocking mechanism, HEPA filter status, and UV lamp efficacy (Annexure-2).

6. Abbreviations

  • IPA: Isopropyl Alcohol
  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • HEPA: High-Efficiency Particulate Air

7. Documents

  1. Material Transfer Hatch Logbook (Annexure-1)
  2. Quarterly Hatch Maintenance Record (Annexure-2)
  3. Hatch Cleaning Checklist (Annexure-3)

8. References

  • WHO TRS 961 Annex 6 – GMP for HVAC Systems
  • EU GMP – Volume 4, Annex 1: Manufacture of Sterile Products
See also  Elixir Department: SOP for Recording Dispensed Quantities in BMR - 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 Transfer Hatch Logbook

Date Material Batch No. From To Transferred By Received By
11/04/2025 Sorbitol Solution SS2025 Warehouse Dispensing Rajesh Kumar Sunita Reddy

Annexure-2: Quarterly Hatch Maintenance Record

Date Hatch ID Interlock Status UV Lamp Function HEPA Integrity Performed By
01/04/2025 HATCH-DYN-01 OK Working Pass Ajay Mehta

Annexure-3: Hatch Cleaning Checklist

Date Hatch ID Cleaning Agent Used Cleaned By Verified By
11/04/2025 HATCH-DYN-01 70% IPA Rajesh Kumar Sunita Reddy

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Issue New SOP Implementation QA Head
11/04/2025 2.0 Added Preventive Maintenance Records Audit Compliance & System Upgrade QA Head
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