Standard Operating Procedure for Handling and Operation of Microbial Testing Equipment
1) Purpose
The purpose of this SOP is to outline the procedures for handling and operating microbial testing equipment used in the analysis of nasal spray formulations. Proper handling ensures the accuracy of microbial contamination testing results.
2) Scope
This SOP applies to all personnel involved in microbial testing at [Company Name].
3) Responsibilities
- Operators: Responsible for preparing samples, operating microbial testing equipment, and recording results.
- Quality Assurance (QA): Reviews microbial test results and ensures that they meet the specified standards for contamination control.
- Maintenance Team: Responsible for regular maintenance and calibration of microbial testing equipment.
4) Procedure
4.1 Operation of Microbial Testing Equipment
4.1.1 Pre-Operation Inspection
- Inspect the microbial testing equipment to ensure it is clean, calibrated, and free from contaminants. Verify that the incubators, air samplers, and culture media systems are functional.
- Document the pre-operation inspection in the equipment log.
4.1.2 Sample Preparation
- Collect the nasal spray samples in sterile containers following the guidelines in the Batch Manufacturing Record (BMR). Ensure the samples are representative of the batch.
- Label all
sample containers clearly and prepare culture media for testing as per the specified method.
4.1.3 Microbial Testing Procedure
- Load the samples onto the microbial testing equipment, ensuring that sample containers and culture media plates are correctly positioned for accurate readings.
- Set the testing parameters, including incubation time and temperature, based on the test method outlined in the BMR. Start the test and monitor the equipment for proper operation.
4.1.4 Recording Results
- After the incubation period, observe and record the microbial growth results. Document the colony-forming units (CFUs) or microbial count in the Batch Manufacturing Record (BMR).
- Submit the test results to QA for review and approval.
4.2 Post-Operation Activities
4.2.1 Cleaning and Sterilization of Equipment
- Disassemble any removable parts, such as incubator trays and sampling nozzles, and clean them thoroughly using an approved cleaning solution. Sterilize all components in an autoclave.
- Document the cleaning and sterilization process in the cleaning log.
4.2.2 Final Documentation
- Ensure that all test results, equipment inspections, and cleaning activities are recorded in the BMR and equipment log. Submit all documents for QA review.
4.3 Maintenance and Calibration of Microbial Testing Equipment
4.3.1 Routine Maintenance
- Inspect microbial testing equipment weekly for signs of wear and tear. Clean and sterilize the equipment regularly to avoid contamination during testing.
- Document all maintenance activities in the maintenance log.
4.3.2 Annual Calibration
- Perform annual calibration of microbial testing equipment, including air samplers and incubators. Record the calibration results in the calibration log.
- Submit the calibration report to QA for approval.
5) Abbreviations, if any
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
- CFUs: Colony-Forming Units
6) Documents, if any
- Batch Manufacturing Record (BMR)
- Equipment 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. Microbial Test Results Log Template
| Date | Batch No. | Sample ID | CFU Count | Incubation Temperature (°C) | Operator Initials | QA Approval |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | Sample Identifier | CFU Count | Temperature | Operator Name | QA Name |