Operation and Maintenance of Gel Mixing System
1) Purpose
The purpose of this SOP is to outline the procedures for operating and maintaining the gel mixing system in the pharmaceutical manufacturing process.
2) Scope
This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the gel mixing system in the manufacturing facility.
3) Responsibilities
It is the responsibility of production operators, maintenance staff, and quality control personnel to follow this SOP to ensure proper operation and maintenance of the gel mixing system.
4) Procedure
4.1 Preparation
- Verify the availability of raw materials, batch records, and formulation details.
- Inspect the gel mixing equipment for cleanliness and ensure proper functioning of mixers, heating elements, and cooling systems.
- Ensure all safety protocols are followed, including checking temperature settings and material compatibility.
4.2 Mixing Process
- Prepare the formulation according to batch records and set up the mixing system.
- Initiate the mixing process and adjust parameters as per formulation requirements.
- Monitor the mixing time and ensure uniform dispersion of ingredients.
4.3 Cooling and Packaging
- After mixing, cool the gel mixture to the specified temperature.
- Transfer the cooled gel to the packaging area and fill into designated containers.
- Label containers and conduct final checks before packaging.
5) Abbreviations, if any
N/A
6) Documents, if any
Batch production record, Cleaning log, Gel mixing system specifications
7) Reference, if any
GMP guidelines, Manufacturer’s operating manual for gel mixing system
8) SOP Version
Version 1.0
