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SOP Guide for Pharma

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SOP for Maintenance of Compressed Gas Systems

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SOP for Maintenance of Compressed Gas Systems

Standard Operating Procedure for Maintenance of Compressed Gas Systems

1) Purpose

The purpose of this SOP is to establish guidelines for the safe maintenance and operation of compressed gas systems in pharmaceutical manufacturing facilities to ensure reliability and safety in handling gases.

2) Scope

This SOP applies to all compressed gas systems used within the facility premises.

3) Responsibilities

The Facilities Management Department is responsible for implementing and adhering to this SOP. The Gas System Technician or designated personnel are responsible for the maintenance and operation of compressed gas systems.

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4) Procedure

  1. Inspection and Testing
    1. Develop a schedule for regular inspections and testing of compressed gas systems, including pressure testing and leak detection.
    2. Inspect gas cylinders, regulators, valves, and piping for signs of wear, corrosion, or leaks.
  2. Handling and Storage
    1. Ensure proper handling and storage procedures for compressed gas cylinders, including securing cylinders in designated areas and using appropriate safety caps.
    2. Monitor gas inventory and rotation to prevent expired or outdated gases from being used.
  3. Emergency Procedures
    1. Develop and maintain emergency response procedures for gas leaks, spills, or other incidents.
    2. Train personnel on emergency shutdown procedures and evacuation protocols.
  4. Documentation and Reporting
    1. Maintain accurate records of gas system inspections, maintenance activities, leak tests, and cylinder inventory.
    2. Document any incidents, repairs, or adjustments made
to the compressed gas system.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Inspection Reports, Pressure Test Records, Emergency Procedures Manual, Gas Cylinder Inventory

7) Reference, if any

OSHA regulations for compressed gas handling, CGA guidelines for gas system maintenance, manufacturer’s recommendations for gas equipment, and local safety codes.

8) SOP Version

Version 1.0

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Standard Operating Procedures V 1.0

  • Aerosols
  • Analytical Method Development
  • Bioequivalence Bioavailability Study
  • Capsule Formulation
  • Clinical Studies
  • Creams
  • Data Integrity
  • Dental Dosage Forms
  • Drug Discovery
  • Environment, Health and Safety
  • Formulation Development
  • Gels
  • Good Distribution Practice
  • Good Warehousing Practices
  • In-Process Control
  • Injectables
  • Liquid Orals
  • Liposome and Emulsion Formulations
  • Lotions
  • Lyophilized Products
  • Maintenance Dept.
  • Medical Devices
  • Metered-Dose Inhaler
  • Microbiology Testing
  • Nanoparticle Formulation
  • Nasal Spray Formulations
  • Nebulizers
  • Ocular (Eye) Dosage Forms
  • Ointments
  • Otic (Ear) Dosage Forms
  • Pharmacovigilance
  • Powder & Granules
  • Purchase Departments
  • Quality Assurance
  • Quality Control
  • Raw Material Stores
  • Regulatory Affairs
  • Tablet Manufacturing
  • Rectal Dosage Forms
  • Transdermal Patches
  • Vaginal Dosage Forms
  • Validations and Qualifications

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NEW! Revised SOPs – V 2.0

  • Aerosols V 2.0
  • Analytical Method Development V 2.0
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Biosimilars V 2.0
  • Capsules V 2.0
  • Creams V 2.0
  • Elixers V 2.0
  • Ointments V 2.0
  • Raw Material Warehouse V 2.0
  • Tablet Manufacturing V2.0

New Publication: A must for All.

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