Standard Operating Procedure for Use of Extrusion Machines for Nasal Formulations
1) Purpose
This SOP outlines the procedures for operating extrusion machines used in the preparation of nasal formulations, including nasal powders and nasal gels. Extrusion ensures uniform material properties for optimized nasal delivery.
2) Scope
This SOP applies to all personnel involved in operating extrusion machines at [Company Name].
3) Responsibilities
- Operators: Responsible for setting up, operating, and cleaning the extrusion machines while ensuring consistent product output.
- Quality Assurance (QA): Ensures that the extruded nasal formulations meet product specifications, including particle size, uniformity, and mechanical properties.
- Maintenance Team: Responsible for maintaining and calibrating the extrusion machines to ensure proper functioning.
4) Procedure
4.1 Pre-Operation Setup
4.1.1 Inspection of the Extrusion Machine
- Inspect the extrusion machine for cleanliness, ensuring that it is free from any residue from previous operations. Check all parts, including the die and screws, for wear or damage.
- Ensure that all safety guards are in place and that the cooling and heating systems are functional. Document the inspection in the equipment log.
4.1.2 Setup for Extrusion
- Select the appropriate
die and screw for the formulation to be extruded. Assemble the machine, making sure all components are properly installed.
Set the machine parameters, including barrel temperature, screw speed, and extrusion pressure, according to the formulation’s requirements. Record the setup parameters in the Batch Manufacturing Record (BMR).
4.2 Operation of the Extrusion Machine
4.2.1 Loading the Material
- Weigh the raw materials as specified in the BMR and load them into the extrusion machine’s feed hopper. Ensure that the feed rate is consistent and free from interruptions.
- Start the extrusion process by setting the screw speed and monitoring the machine to ensure a consistent flow of material through the die.
4.2.2 Monitoring the Extrusion Process
- Monitor the extrudate for uniformity, particle size, and texture. Perform in-process checks at regular intervals to ensure that the extruded material meets the specified quality parameters.
- Record all in-process checks in the BMR. If deviations occur, adjust the extrusion parameters and document the changes in the BMR.
4.3 Post-Operation Activities
4.3.1 Shutdown Procedure
- After completing the extrusion process, stop the screw and allow the machine to cool down. Safely remove the extrudate from the cooling system and transport it to the next stage of production.
- Power off the extrusion machine and ensure that all components are properly cleaned and inspected before the next use.
4.3.2 Cleaning of the Extrusion Machine
- Disassemble any removable parts, such as the die and screws, and clean them thoroughly using an approved cleaning solution. Rinse with sterile water and allow to air dry or use lint-free wipes.
- Document the cleaning process in the cleaning log and submit for QA approval before reuse.
4.4 Maintenance of the Extrusion Machine
4.4.1 Routine Maintenance
- Inspect the extrusion machine weekly for wear and tear on critical parts, including screws, dies, and heating elements. Lubricate moving parts as needed.
- Record routine maintenance activities in the maintenance log.
4.4.2 Annual Calibration
- Calibrate the temperature, pressure, and screw speed controls annually to ensure accurate extrusion parameters. Document calibration results in the calibration log.
5) Abbreviations, if any
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
6) Documents, if any
- Batch Manufacturing Record (BMR)
- In-Process Testing Log
- Cleaning Log
- Maintenance Log
- Calibration Log
7) References, if any
- Manufacturer’s equipment manual
- Internal SOP for cleaning and maintenance
8) SOP Version
Version 1.0
Annexure
1. In-Process Testing Log Template
| Date | Batch No. | Extrudate Quality (e.g., Particle Size) | Temperature (°C) | Operator Initials | QA Approval |
|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | Quality Parameter | Temperature Measured | Operator Name | QA Name |