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SOP for Use of Propellants in Aerosol Production

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SOP for Use of Propellants in Aerosol Production

Standard Operating Procedure for Use of Propellants in Aerosol Production

1) Purpose

The purpose of this SOP is to outline procedures for handling and using propellants in aerosol production processes. Proper handling ensures safety, quality, and regulatory compliance throughout the manufacturing process.

2) Scope

This SOP applies to the use of propellants in aerosol production activities conducted at [Company Name], including receiving, storage, handling, and dispensing of propellants.

3) Responsibilities

Production Technicians: Responsible for propellant handling and dispensing.
Quality Control (QC) Personnel: Monitor propellant usage and compliance.
Health and Safety Officers: Ensure adherence to safety protocols.
Facility Manager: Oversee propellant storage and maintenance.

See also  SOP for Clinical Trial Material Production for Aerosols

4) Procedure

4.1 Propellant Handling:
4.1.1 Receive propellants from approved suppliers and verify documentation.
4.1.2 Store propellants in designated areas with proper ventilation and fire safety measures.

4.2 Dispensing and Use:
4.2.1 Transfer propellants to production areas using approved dispensing equipment.
4.2.2 Follow specified procedures for measuring and dispensing propellants into aerosol formulations.

4.3 Safety Precautions:
4.3.1 Wear appropriate personal protective equipment (PPE) during propellant handling.
4.3.2 Implement grounding and bonding procedures to prevent static electricity hazards.

4.4 Quality Checks:
4.4.1 Perform visual inspections of propellant containers for integrity and labeling.
4.4.2 Conduct in-process checks to ensure correct propellant quantities and

formulations.

See also  SOP for Stability-Indicating Methods Development for Aerosols

4.5 Emergency Procedures:
4.5.1 Train personnel on emergency response procedures for propellant spills or leaks.
4.5.2 Maintain emergency response kits and contacts for quick mitigation of incidents.

4.6 Waste Management:
4.6.1 Dispose of empty propellant containers and waste materials according to hazardous waste disposal regulations.
4.6.2 Document disposal activities and maintain records for regulatory compliance.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control
PPE: Personal Protective Equipment

6) Documents, if any

Propellant Handling Procedures
Safety Data Sheets (SDS) for Propellants
Incident Reports (if applicable)

7) Reference, if any

GMP Guidelines
OSHA Regulations
Local Fire Safety Codes

8) SOP Version

Version 1.0

See also  SOP for Documentation Control in Aerosol Production
Aerosols Tags:Aerosol batch manufacturing, Aerosol change control procedures, Aerosol cleaning validation, Aerosol contamination prevention, Aerosol documentation requirements, Aerosol equipment calibration, Aerosol equipment cleaning, Aerosol final product inspection, Aerosol formulation development, Aerosol in-process testing, Aerosol manufacturing process, Aerosol method development, Aerosol microbial testing, Aerosol packaging guidelines, Aerosol particle size analysis, Aerosol personnel training, Aerosol process validation, Aerosol production SOP, Aerosol quality control, Aerosol raw material inspection, Aerosol stability testing, Aerosol stability testing methods, Aerosol sterility maintenance, Aerosol storage conditions, Aerosol waste disposal procedures

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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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