Standard Operating Procedure for Preparation of Nasal Gels and Suspensions
1) Purpose
The purpose of this SOP is to describe the procedures for preparing nasal gels and suspensions, ensuring homogeneity, stability, and patient safety.
2) Scope
This SOP applies to all personnel involved in the formulation and preparation of nasal gels and suspensions at [Company Name].
3) Responsibilities
- Operators: Responsible for preparing the gels and suspensions according to formulation guidelines.
- QA: Verifies the preparation steps, ensuring compliance with quality standards.
4) Procedure
4.1 Gel Preparation
4.1.1 Raw Material Weighing
- Weigh the required quantities of gel-forming agents (e.g., carbomer, xanthan gum).
4.1.2 Mixing and Hydration
- Gradually add the gel-forming agent to purified water while continuously stirring to prevent clumping.
- Allow the mixture to hydrate fully, stirring until a uniform gel is formed.
4.2 Suspension Preparation
4.2.1 Weighing Suspended Solids
- Weigh the solid components to be suspended (e.g., APIs) as per formulation requirements.
4.2.2 Dispersion
- Disperse the solids in the gel base or a suitable suspending agent while ensuring even distribution.
4.3 pH and Viscosity Testing
4.3.1 pH Testing
- Measure the pH of the formulation and adjust using dilute acid or base to achieve the target pH.
4.3.2
Viscosity Testing
- Test the viscosity of the nasal gel or suspension using a viscometer, ensuring it meets the formulation specifications.
4.4 Sterilization and Packaging
4.4.1 Filtration and Sterilization
- If the formulation is preservative-free, filter the suspension through a 0.22-micron filter.
4.4.2 Packaging
- Transfer the sterile formulation into sterilized nasal spray containers or tubes for gels.
4.5 Documentation
- Document all preparation steps, including pH and viscosity values, in the batch manufacturing record (BMR).
5) Abbreviations, if any
- QA: Quality Assurance
- BMR: Batch Manufacturing Record
6) Documents, if any
- Batch Manufacturing Record (BMR)
- pH and Viscosity Log
7) References, if any
- USP 39 – Viscosity Standards for Gels
8) SOP Version
Version 1.0
Annexure
pH and Viscosity Log Template
| Date | Formulation | pH | Viscosity (cP) | Operator Initials | QA Approval |
|---|---|---|---|---|---|
| DD/MM/YYYY | Formulation Name | pH Value | Viscosity | Operator Name | QA Name |