SOP Guide for Pharma

Elixir Department: SOP for Air Drying Process of Cleaned Components – V 2.0

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Elixir Department: SOP for Air Drying Process of Cleaned Components – V 2.0

Standard Operating Procedure for Air Drying Process of Cleaned Components in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/185/2025
Supersedes SOP/ELX/185/2022
Page No. Page 1 of 9
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To establish a validated and consistent procedure for the air drying of cleaned equipment parts and components in the Elixir Manufacturing Department to ensure moisture removal before storage or reuse.

2. Scope

This SOP is applicable to all cleaned product-contact parts including transfer lines, gaskets, nozzles, filters, tanks, stirrers, and valves in the Elixir Department that require air drying after manual or automated cleaning.

3. Responsibilities

  • Production Operator:
    • Perform air drying of cleaned parts using approved procedures and equipment.
    • Record air drying activity and tag the components after drying.
  • Production Supervisor:
    • Verify completion of drying activity and approve components for storage or reuse.
  • QA Officer:
    • Review air drying logs and ensure components are dry and free of water spots or microbial risk.
See also  Elixir Department: SOP for Reconciliation of Raw Materials Post Dispensing - V 2.0

4. Accountability

The Production Head is accountable for implementation and adherence to this SOP. QA Head is

responsible for verification and release of dried equipment for use.

5. Procedure

5.1 General Requirements

  1. All parts must be cleaned and rinsed before being subjected to air drying.
  2. Use only HEPA-filtered air or dedicated drying cabinets for drying product-contact components.
  3. Do not stack or overlap parts during drying.

5.2 Air Drying Methods

  1. Static Air Drying:
    • Place parts on a clean stainless steel tray in a designated drying zone.
    • Allow to dry under ambient conditions with airflow for a minimum validated time (e.g., 1–2 hours).
  2. Forced Air Drying:
    • Use compressed HEPA-filtered air to blow-dry internal and external surfaces.
    • Maintain a safe distance and avoid contamination by using sanitized air guns.
  3. Drying Cabinet Method:
    • Place items in a validated drying cabinet set at 40–50°C with airflow.
    • Monitor drying time and temperature using cabinet display or log sheet.
See also  Elixir Department: SOP for In-process Sampling During Elixir Manufacturing - V 2.0

5.3 Handling and Storage After Drying

  1. Inspect items visually for complete dryness, water spots, and residues.
  2. Use clean gloves to handle dried parts and avoid touching internal surfaces.
  3. Affix “DRIED – READY FOR USE” tag with:
    • Component name
    • Drying method used
    • Date and time
    • Operator initials
  4. Transfer dried parts to covered and labeled clean storage area.

5.4 Hold Time and Re-Drying

  1. If not used within 72 hours, repeat air drying or sanitize as per SOP/ELX/184/2025.
  2. Document re-drying as a separate activity with reference to the previous drying entry.

5.5 Documentation

  1. Record drying activity in the Air Drying Logbook (Annexure-1).
  2. QA to review logbook weekly and check drying labels during routine rounds.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • HEPA: High-Efficiency Particulate Air

7. Documents

  1. Air Drying Logbook (Annexure-1)
  2. Drying Label Template (Annexure-2)
See also  Elixir Department: SOP for Agitation Speed Adjustment Based on Batch Size - V 2.0

8. References

  • ICH Q7 – Good Manufacturing Practices
  • WHO TRS 986 – GMP Annex 4: Cleaning and Equipment Practices
  • 21 CFR Part 211.67 – Cleaning and Maintenance

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Air Drying Logbook

Date Component Drying Method Start Time End Time Operator QA Verified
11/04/2025 Transfer Hose Drying Cabinet 10:00 11:30 Rajesh Kumar Sunita Reddy

Annexure-2: Drying Label Template

Label Fields to Fill
DRIED – READY FOR USE Component Name, Date, Time, Operator Initials

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 Added hold time policy and air gun safety step Process Optimization QA Head
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