Elixir Department: SOP for Environmental Conditions for Dispensing of Elixirs – V 2.0

Posted on By

Elixir Department: SOP for Environmental Conditions for Dispensing of Elixirs – V 2.0

Standard Operating Procedure for Environmental Conditions for Dispensing of Elixirs

Department Elixir Department
SOP No. SOP/ELX/007/2025
Supersedes SOP/ELX/007/2022
Page No. Page 1 of 8
Issue Date 13/04/2025
Effective Date 15/04/2025
Review Date 13/04/2026

1. Purpose

To define the environmental controls and conditions required during the dispensing of raw materials for elixir manufacturing to ensure product integrity, avoid contamination, and maintain regulatory compliance.

2. Scope

This SOP applies to all dispensing rooms and controlled areas where raw materials for elixirs are weighed, measured, or prepared prior to production within the Elixir Department.

3. Responsibilities

  • Engineering Department:
    • Maintain HVAC systems and ensure environmental parameters are within specification.
  • Warehouse Staff and Operators:
    • Work only within validated and clean areas.
    • Report any deviation in environmental conditions to QA and Engineering.
  • Quality Assurance (QA):
    • Monitor environmental records and perform periodic audits.

4. Accountability

The Head of Engineering and the Head of QA are jointly accountable for ensuring that all dispensing activities are carried out under qualified and controlled environmental conditions.

See also  Elixir Department: SOP for Dispensing Under Laminar Airflow Cabinet - V 2.0

5. Procedure

5.1 Environmental Specifications

  1. The dispensing area must maintain:
    • Temperature: 18°C to 25°C
    • Relative Humidity (RH): Not more than 60%
    • Air Classification: ISO Class 8 or Grade D (EU GMP)
  2. Air changes per hour (ACH) should be at least 20.
  3. Differential pressure between adjoining areas: 10–15 Pascals.

5.2 Monitoring of Parameters

  1. Temperature and RH shall be monitored and recorded twice daily on the Environmental Monitoring Log (Annexure-1).
  2. In case of critical materials, continuous monitoring using data loggers is recommended.
  3. Differential pressure should be recorded once per shift.

5.3 Cleaning and Sanitization of Dispensing Area

  1. Daily cleaning must be performed before the start of dispensing activity:
    • Dusting of walls and equipment surfaces
    • Wet mopping of floors with approved disinfectant
  2. Record cleaning activity in the Cleaning Logbook (Annexure-2).
  3. Perform sanitization using disinfectants like IPA 70% weekly.
See also  Elixir Department: SOP for Dispensing Solvents and Vehicles - V 2.0

5.4 Access and Gowning Control

  1. Only authorized personnel in cleanroom garments are allowed entry.
  2. Gowning must be performed in gowning rooms adjacent to the dispensing area.
  3. Use of masks, caps, gloves, and coveralls is mandatory.

5.5 Material and Equipment Control

  1. All materials entering the area must be cleaned externally using IPA 70%.
  2. Weighing balances and containers should be cleaned prior to use and stored in a covered manner when idle.

5.6 Alarm and Deviation Handling

  1. If temperature or RH exceeds the permissible limit:
    • Stop dispensing activities.
    • Inform QA and Engineering immediately.
    • Investigate cause and document deviation.
  2. Restart activity only after corrective action and QA approval.

5.7 Periodic Qualification and Maintenance

  1. Dispensing area HVAC should undergo periodic qualification:
    • HEPA filter integrity: Semi-annually
    • Airflow visualization: Annually
  2. Filters, air ducts, and grills should be cleaned as per the Preventive Maintenance Schedule.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • RH: Relative Humidity
  • ACH: Air Changes per Hour
  • QA: Quality Assurance
See also  Elixir Department: SOP for Segregation of Quarantined and Approved Materials - V 2.0

7. Documents

  1. Environmental Monitoring Log (Annexure-1)
  2. Dispensing Area Cleaning Logbook (Annexure-2)
  3. Deviation Report Form

8. References

  • WHO GMP Guidelines for HVAC and Cleanroom Environments
  • EU GMP Annex 1 – Manufacture of Sterile Medicinal Products
  • 21 CFR Part 211 – Subpart D: Equipment and Facilities

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Environmental Monitoring Log

Date Time Temperature (°C) RH (%) Differential Pressure (Pa) Checked By
13/04/2025 09:00 22.5 52 12 Sunita Reddy

Annexure-2: Dispensing Area Cleaning Logbook

Date Area Cleaned Cleaning Agent Used Performed By Checked By
13/04/2025 Dispensing Platform, Floor IPA 70% Rajesh Kumar QA Officer

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
10/01/2022 1.0 Initial Version New SOP Creation QA Head
13/04/2025 2.0 Enhanced HVAC and alarm protocols GMP Compliance Update QA Head
Elixers V 2.0 Tags:, , , , , , , , , , , , , , , , , , , , , , , ,