SOP Guide for Pharma

Elixir Department: SOP for Compressed Air System in Mixing Units – V 2.0

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Elixir Department: SOP for Compressed Air System in Mixing Units – V 2.0

Standard Operating Procedure for Compressed Air System in Mixing Units in Elixir Manufacturing

Department Elixir Department
SOP No. SOP/ELX/156/2025
Supersedes SOP/ELX/156/2022
Page No. Page 1 of 10
Issue Date 11/04/2025
Effective Date 15/04/2025
Review Date 11/04/2026

1. Purpose

To establish a standard procedure for the safe and compliant operation, maintenance, and monitoring of the compressed air system used in elixir mixing units to ensure uninterrupted support to pneumatic controls, actuators, and valves.

2. Scope

This SOP applies to the compressed air distribution systems connected to mixers, transfer lines, valve controls, and automated processing units used in the Elixir Department.

3. Responsibilities

  • Production Operator:
    • Check air pressure and moisture trap status before and during use.
    • Report low-pressure or air quality deviations immediately.
  • Engineering Department:
    • Ensure the air compressor, receiver, filters, and regulators are maintained and calibrated.
    • Conduct regular system integrity checks and preventive maintenance.
  • QA Officer:
    • Verify air quality test reports and compliance with manufacturing requirements.
See also  Elixir Department: SOP for Vendor Qualification for Raw Materials - V 2.0

4. Accountability

The Engineering Head is accountable for the system’s availability and reliability. The Production Head is responsible for ensuring operational compliance. QA

Head ensures air quality validation.

5. Procedure

5.1 System Overview

  1. The compressed air system comprises an oil-free air compressor, dryer, receiver tank, regulator panel, distribution manifold, and inline filters.
  2. The system supplies pneumatic power to:
    • Automated valves
    • Pneumatic actuators
    • Air-powered mixers (where applicable)

5.2 Pre-Operation Checklist

  1. Ensure air compressor is labeled “READY FOR USE.”
  2. Check that pressure in the receiver tank is ≥ 6.0 bar.
  3. Drain moisture from the receiver and inline filters before starting shift.
  4. Inspect differential pressure gauges on filters—should be within green zone.

5.3 Operation of Compressed Air Supply

  1. Turn on the main compressor switch and observe startup diagnostics.
  2. Monitor outlet pressure on regulator—typically 5.0 to 6.5 bar depending on process needs.
  3. Ensure the air dryer is functioning (dew point display, alarm-free status).
  4. Use flow control valves to isolate or direct air to designated equipment.
See also  Elixir Department: SOP for Compatibility Testing with Containers - V 2.0

5.4 Air Quality Monitoring

  1. Engineering shall sample air quarterly for:
    • Oil mist content
    • Moisture/dew point
    • Microbial contamination (if air contacts product)
  2. Acceptable limits as per ISO 8573-1 Class 1.4.1 or internal specifications.
  3. Reports shall be retained and reviewed by QA (refer to Annexure-2).

5.5 Preventive Maintenance Schedule

  1. Daily: Drain condensate from receiver and inline filters.
  2. Weekly: Check belts, lubrication, and noise level.
  3. Monthly: Inspect dryer performance and filter pressure differentials.
  4. Quarterly: Perform air quality testing and clean air dryer desiccant (if applicable).

5.6 Troubleshooting

  1. Low Pressure: Check for leaks in lines or faulty pressure regulators.
  2. Moisture Presence: Verify drain trap functionality and dryer operation.
  3. Oil Odor: Replace filters and ensure oil separator integrity in compressor.

6. Abbreviations

  • SOP: Standard Operating Procedure
  • QA: Quality Assurance
  • ISO: International Organization for Standardization
  • bar: Unit of Pressure

7. Documents

  1. Compressed Air Operation Logbook (Annexure-1)
  2. Air Quality Test Report (Annexure-2)
  3. Preventive Maintenance Checklist
See also  Elixir Department: SOP for Dispensing Humidity Sensitive Materials - V 2.0

8. References

  • ISO 8573-1: Compressed Air Quality Standards
  • WHO TRS 961 – Environmental and Utility Systems
  • 21 CFR Part 211 – Equipment Maintenance and Controls

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Compressed Air Operation Logbook

Date Time Receiver Pressure (bar) Dew Point Status Operator Remarks
11/04/2025 08:00 6.2 OK Rajesh Kumar Normal Operation

Annexure-2: Air Quality Test Report

Parameter Test Method Specification Result Status
Oil Content Gravimetric < 0.01 mg/m³ 0.006 Pass
Dew Point Digital Sensor < -20°C -28°C Pass
Microbial Air Sampling No growth No growth Pass

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial Release New Utility SOP QA Head
11/04/2025 2.0 Added dew point and ISO standard reference Compliance Enhancement QA Head
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