SOP for Microscopic Examination

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.
  • 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

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