SOP Guide for Pharma

SOP for Microbiological Stability Testing of Liposomes

SOP for Microbiological Stability Testing of Liposomes

Microbiological Stability Testing of Liposomes

1) Purpose

The purpose of this SOP is to outline the procedure for conducting microbiological stability testing on liposome formulations. This testing ensures that the liposomes remain free from microbial contamination during storage, thereby maintaining product quality and safety over the defined shelf life.

2) Scope

This SOP applies to personnel involved in the microbiological testing of liposomal formulations, including quality control and microbiology teams. It covers the evaluation of microbial contamination over time and ensures compliance with regulatory standards for sterile or non-sterile formulations.

3) Responsibilities

4) Procedure

4.1 Sample Preparation

4.2 Microbiological Testing Parameters

The following microbiological tests should be performed at specified intervals to monitor contamination levels:

4.3 Testing Schedule

4.4 Data Recording and Analysis

4.5 Acceptance Criteria for Microbiological Stability

The liposomal formulation is considered microbiologically stable if the following criteria are met throughout the study:

5) Abbreviations

6) Documents

7) References

8) SOP Version

Version 1.0

Annexure

Annexure 1: Microbiological Stability Test Report Template

Time Point Storage Condition TAMC (cfu/mL) TYMC (cfu/mL) Pathogens Operator Initials
Initial 25°C/60% RH Below Limit Below Limit None Operator Name
1 Month 40°C/75% RH Below Limit Below Limit None Operator Name
3 Months 40°C/75% RH Below Limit Below Limit None Operator Name
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