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Revised SOPs for Aerosols V 2.0

Aerosol: SOP for Leak Testing of Aerosol Cans – V 2.0

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This Standard Operating Procedure (SOP) defines the process for conducting leak testing on aerosol cans to ensure they are properly sealed and free from leaks. The purpose of this SOP is to prevent the release of propellants, contaminants, or formulations, ensuring that the aerosol products meet the required safety, quality, and performance standards. Leak testing is a critical step in the quality control process to guarantee product integrity and compliance with Good Manufacturing Practices (GMP).
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Aerosols V 2.0

Aerosol: SOP for Measuring Spray Rate of Aerosol Products – V 2.0

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This Standard Operating Procedure (SOP) outlines the procedure for measuring the spray rate of aerosol products to ensure consistency in product delivery and performance. The spray rate measurement is essential for verifying that the aerosol product dispenses at the intended rate and that the valve and actuator are functioning correctly. Accurate spray rate measurement helps maintain quality control and ensures that the product meets the required specifications for consumer use.
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Aerosols V 2.0

Aerosol: SOP for Testing Particle Size Distribution – V 2.0

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This Standard Operating Procedure (SOP) defines the process for testing the particle size distribution of aerosol products. The objective is to determine the size of the particles in aerosol formulations to ensure uniformity and consistency in the spray delivery. Proper particle size distribution is essential for achieving the desired performance characteristics of aerosol products, such as spray pattern, consistency, and dispersion, and is a critical parameter in product quality control.
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Aerosols V 2.0

Aerosol: SOP for Conducting Valve Functionality Tests – V 2.0

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This Standard Operating Procedure (SOP) outlines the process for conducting valve functionality tests on aerosol products. The objective is to ensure that the aerosol valves are functioning properly, allowing for consistent spray delivery without leakage or malfunction. The proper functioning of the valve is crucial to achieving the desired performance, safety, and quality of aerosol products. Regular valve testing helps to maintain product integrity and comply with Good Manufacturing Practices (GMP).
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Aerosols V 2.0

Aerosol: SOP for Conducting Microbial Limit Testing of Aerosol Products – V 2.0

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This Standard Operating Procedure (SOP) outlines the process for conducting microbial limit testing of aerosol products. The objective is to ensure that aerosol products meet microbial limits specified by regulatory authorities, ensuring the safety and quality of the product. Microbial contamination can affect product safety and efficacy, so regular testing is necessary to confirm compliance with safety standards and protect consumers.
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Aerosols V 2.0

Aerosol: SOP for Conducting Propellant Purity Tests – V 2.0

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This Standard Operating Procedure (SOP) defines the process for conducting propellant purity tests in aerosol products. The purpose of this SOP is to ensure that the propellants used in aerosol formulations are of the required purity and meet regulatory specifications. Propellant purity is critical for the safety, performance, and compliance of aerosol products. The testing verifies that the propellant does not contain impurities or contaminants that could compromise the quality of the product or its safety for consumers.
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Aerosols V 2.0

Aerosol: SOP for Compatibility Testing of Actuator and Formulation – V 2.0

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This Standard Operating Procedure (SOP) defines the process for conducting compatibility testing between actuators and formulations used in aerosol products. The objective is to ensure that the actuator, which controls the spray mechanism, is compatible with the formulation, maintaining product efficacy, safety, and stability. Compatibility testing ensures that the actuator does not degrade or interact negatively with the formulation, which could lead to product failure or suboptimal performance.
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Aerosols V 2.0

Aerosol: SOP for Stability-Indicating Assay Development – V 2.0

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This Standard Operating Procedure (SOP) defines the process for developing stability-indicating assays for aerosol products. The objective is to create analytical methods that can reliably detect and quantify the active ingredients, degradation products, and impurities in aerosol formulations over time. Stability-indicating assays are essential for determining the shelf life, ensuring the safety, efficacy, and quality of the product throughout its intended use period.
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Aerosols V 2.0

Aerosol: SOP for Container Pressure Testing of Aerosol Cans – V 2.0

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This Standard Operating Procedure (SOP) outlines the process for conducting container pressure tests on aerosol cans. The objective is to ensure that aerosol cans can safely withstand internal pressure without failure. Pressure testing is essential for verifying the integrity of the container and the safety of the product, as well as confirming compliance with regulatory standards for product safety and performance.
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Aerosols V 2.0

Aerosol: SOP for Dissolution Testing of Aerosol-Delivered Products – V 2.0

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This Standard Operating Procedure (SOP) defines the process for conducting dissolution testing of aerosol-delivered products. The objective is to evaluate the release profile of active ingredients from aerosol products into the air or target area, ensuring that the product delivers the intended dose consistently and effectively. Dissolution testing helps assess the product’s performance, stability, and consistency over time.
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Aerosols V 2.0

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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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