Standard Operating Procedure for Use of Stabilizers in Aerosol Production
1) Purpose
The purpose of this SOP is to establish procedures for the proper use and incorporation of stabilizers in aerosol formulations. Stabilizers ensure product stability, quality, and performance throughout manufacturing and storage.
2) Scope
This SOP applies to the handling, testing, and incorporation of stabilizers in aerosol production processes at [Company Name]. It covers new formulation development, routine production, and quality control testing.
3) Responsibilities
Formulation Scientists: Responsible for selecting appropriate stabilizers and determining concentrations.
Production Technicians: Responsible for accurate measurement and addition of stabilizers.
Quality Control (QC) Personnel: Monitor stabilizer effectiveness and compliance.
Quality Assurance (QA) Manager: Oversee adherence to SOPs and regulatory requirements.
4) Procedure
4.1 Stabilizer Selection:
4.1.1 Evaluate stabilizer options based on formulation requirements (e.g., pH stability, chemical compatibility).
4.1.2 Obtain approval for stabilizer selection from formulation team and QA.
4.2 Preparation and Addition:
4.2.1 Weigh or measure stabilizers accurately according to formulation instructions.
4.2.2 Prepare stabilizer solutions or dispersions as necessary for uniform distribution in aerosol formulations.
4.3 Mixing and Homogenization:
4.3.1 Incorporate stabilizers into aerosol formulations using approved mixing equipment.
4.3.2 Ensure thorough homogenization to achieve uniform distribution of stabilizers.
4.4 Compatibility Testing:
4.4.1 Perform compatibility tests
4.4.2 Assess stability of stabilizer-treated formulations under varying conditions (e.g., temperature, light exposure).
4.5 Quality Checks:
4.5.1 Conduct in-process checks to verify stabilizer concentrations and effectiveness.
4.5.2 Record and report any deviations from expected stabilizer performance or formulation standards.
4.6 Documentation:
4.6.1 Document stabilizer addition procedures, test results, and any adjustments made during production.
4.6.2 Maintain accurate records in batch records, formulation documents, and stability testing reports.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
Stabilizer Selection Criteria
Stabilizer Addition Protocols
Compatibility Testing Reports
7) Reference, if any
GMP Guidelines
Pharmacopeial standards (e.g., USP, EP)
Internal Formulation Standards
8) SOP Version
Version 1.0