Standard Operating Procedure for Microscopic Examination

Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines and procedures for examining microbial cultures under a microscope in the pharmaceutical manufacturing facility.

Scope

This SOP applies to all personnel involved in microscopic examination procedures within the pharmaceutical manufacturing facility.

Responsibilities

• Quality Control (QC) Department: Responsible for overseeing the implementation and compliance of this SOP.
• Microbiologist: Responsible for performing microscopic examination procedures according to the instructions outlined in this SOP.
• Laboratory Technicians: Responsible for preparing microscope slides and assisting with examination procedures.

Procedure

1. Preparation of Microscope Slides:
   • Prepare clean microscope slides using appropriate techniques to minimize contamination.
   • Apply a small amount of the microbial sample onto the slide using a sterile pipette or loop.
   • Cover the sample with a coverslip to prevent drying and distortion of the specimen.
2. Microscopic Examination:
   • Place the prepared slide on the microscope stage and adjust the objective lens to the lowest magnification.
   • Scan the slide to locate areas of interest and adjust the focus as needed.
   • Gradually increase the magnification to observe microbial morphology, motility, and other characteristics.
   • Take note of any observed abnormalities, such as cell shape, size, arrangement, and presence of motility.
3. Microscopic Analysis:
   • Interpret microscopic findings based on established criteria and reference materials.
   • Record observations accurately and thoroughly in laboratory notebooks or electronic systems.
   • Consult with senior microbiologists or colleagues for interpretation and verification of findings, if necessary.
4. Cleaning and Maintenance:
   • After examination, clean the microscope thoroughly using appropriate cleaning agents and techniques.
   • Store the microscope in a designated area, ensuring protection from dust and other contaminants.

Abbreviations

• SOP: Standard Operating Procedure
• QC: Quality Control

Documents

• Microscopic Examination Log
• Laboratory Notebook
• Reference Materials

Reference

United States Pharmacopoeia (USP) General Chapter Microbiological Examination of Non-sterile Products: Microbial Enumeration Tests

SOP Version

Version 1.0