SOP for Handling and Operation of Microbial Testing Equipment

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

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