Standard Operating Procedure for Sterilizing Nebulizer Production Equipment
1) Purpose
The purpose of this SOP is to outline the sterilization procedures for nebulizer production equipment to ensure the elimination of microbial contamination and maintain product quality and safety standards.
2) Scope
This SOP applies to all production equipment used in nebulizer manufacturing, including filling machines, mixing tanks, transfer lines, and packaging units.
3) Responsibilities
Operators: Execute sterilization procedures as outlined in this SOP.
Maintenance Team: Inspect equipment pre- and post-sterilization and handle any technical issues.
Quality Assurance (QA): Verify the sterilization process, validate outcomes, and document activities.
4) Procedure
4.1 Pre-Sterilization Preparation
- Ensure all equipment is cleaned as per the cleaning SOP before starting the sterilization process.
- Inspect the equipment for visible dirt, residues, or damages that might hinder the sterilization process.
- Verify the availability and functionality of sterilization equipment, such as autoclaves, dry heat ovens, or chemical sterilizers.
- Ensure proper personal protective equipment (PPE) is worn to handle sterilization chemicals or equipment safely.
4.2 Sterilization Methods
The sterilization method to be used depends on the type of equipment:
4.2.1 Autoclaving (Moist Heat Sterilization)
- Load the equipment into the autoclave as per the manufacturer’s guidelines.
- Set the autoclave to the required temperature (e.g., 121°C) and
4.2.2 Dry Heat Sterilization
- Place the equipment in the dry heat oven, ensuring even spacing for airflow.
- Set the oven to the required temperature (e.g., 160°C) and duration (e.g., 2 hours).
- Allow the equipment to cool completely before handling.
4.2.3 Chemical Sterilization
- Prepare the sterilizing solution as per the manufacturer’s instructions.
- Immerse the equipment in the solution for the required contact time (e.g., 30 minutes).
- Rinse the equipment with sterile water to remove chemical residues, if applicable.
4.3 Post-Sterilization Activities
- Inspect the equipment visually to ensure no residues or contaminants remain.
- Record sterilization parameters (temperature, duration, and pressure) in the logbook.
- Transfer sterilized equipment to the sterile storage area using sanitized tools.
4.4 Frequency of Sterilization
- Daily: Small equipment used continuously in production.
- Weekly: Large equipment not in daily use.
- After Maintenance: Any equipment that has undergone maintenance.
5) Abbreviations
- PPE: Personal Protective Equipment
- QA: Quality Assurance
6) Documents
The following documents should be maintained:
- Sterilization Log
- Equipment Sterilization Validation Report
7) References
Relevant regulatory guidelines and references include:
- ISO 13485: Medical Devices Quality Management Systems
- Equipment Manufacturer’s Guidelines
8) SOP Version
Version: 1.0
Annexure
Annexure Title: Sterilization Log for Nebulizer Production Equipment
| Date | Equipment Name | Sterilization Method | Parameters (Temp/Pressure/Time) | Operator Initials | Remarks |
|---|---|---|---|---|---|
| DD/MM/YYYY | Equipment Identifier | Autoclave/Dry Heat/Chemical | XXX°C / XX psi / XX mins | Operator Name | Sterilization completed as per SOP |
Annexure Title: Equipment Sterilization Validation Report
| Date | Equipment Name | Sterilization Method | Validation Status | Operator Initials | Supervisor Signature |
|---|---|---|---|---|---|
| DD/MM/YYYY | Equipment Identifier | Autoclave/Dry Heat/Chemical | Pass/Fail | Operator Name | Supervisor Name |