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
- 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.
- 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.
- 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