Standard Operating Procedure for Use of Humectants in Nasal Spray Formulations
1) Purpose
The purpose of this SOP is to outline the process for incorporating humectants into nasal spray formulations, ensuring the product retains moisture and enhances patient comfort.
2) Scope
This SOP applies to all personnel involved in the formulation, preparation, and testing of nasal sprays containing humectants at [Company Name].
3) Responsibilities
- Operators: Responsible for incorporating humectants during the formulation process.
- QA: Verifies the formulation to ensure correct humectant concentration.
4) Procedure
4.1 Preparation of Formulation with Humectants
4.1.1 Raw Material Weighing
- Weigh the required amount of humectants (e.g., glycerin, sorbitol) as per the formulation guidelines.
- Ensure all weights are documented in the batch manufacturing record (BMR).
4.1.2 Mixing
- Mix the humectant into the nasal spray base solution, ensuring uniform distribution.
- Stir the mixture continuously at a controlled temperature until a homogenous solution is obtained.
4.2 pH and Osmolality Adjustment
4.2.1 pH Adjustment
- Measure the pH of the formulation and adjust as necessary using a buffer solution to maintain the target pH.
4.2.2 Osmolality Adjustment
- Check the osmolality of the formulation to ensure it meets the isotonicity requirements.
- Adjust the formulation with additional tonicity agents if necessary.
4.3 Sterilization and Filtration
4.3.1 Filtration Process
- Filter the formulation through a 0.22-micron filter to ensure sterility.
4.3.2 Filling
- Fill the filtered solution into sterile nasal spray containers.
4.4 Documentation
- Document all process steps, including the quantity of humectants used, pH, and osmolality adjustments in the BMR.
5) Abbreviations, if any
- QA: Quality Assurance
- BMR: Batch Manufacturing Record
6) Documents, if any
- Batch Manufacturing Record (BMR)
- pH and Osmolality Log
7) References, if any
- USP 39 – Humectants in Drug Products
8) SOP Version
Version 1.0
Annexure
pH and Osmolality Log Template
| Date | Formulation | pH | Osmolality (mOsm/kg) | Operator Initials | QA Approval |
|---|---|---|---|---|---|
| DD/MM/YYYY | Formulation Name | pH Value | Osmolality | Operator Name | QA Name |