Standard Operating Procedure (SOP) for Sterility Testing
1.0 Purpose: The purpose of this SOP is to provide guidelines for performing sterility testing in a laboratory setting.
2.0 Scope: This SOP applies to all personnel involved in performing sterility testing in the laboratory.
3.0 Responsibilities: The laboratory personnel responsible for performing sterility testing shall:
- Ensure that the testing area is clean and free from any contaminants.
- Follow the procedures outlined in this SOP.
- Document all procedures and results accurately.
4.0 Materials and Equipment:
- Sterile workbench or laminar flow hood
- Sterilization equipment (e.g. autoclave)
- Sterile culture media
- Sterile syringes and needles
- Incubator
- Sterilized forceps
5.0 Procedure:
5.1 Preparation of Culture Media:
- Follow the manufacturer’s instructions to prepare the culture media.
- Autoclave the media to sterilize it before use.
- Incubate the media to ensure that it is free from any microbial contamination.
5.2 Preparation of Samples:
- Samples to be tested should be collected aseptically using sterile techniques.
- Ensure that the samples are properly labeled with the date, time, and sample identification number.
- Transport the samples to the laboratory using a suitable container to avoid contamination.
5.3 Sterility Testing:
- Sterilize the workbench or laminar flow hood before use.
- Open the sample container aseptically and transfer a small amount of the sample onto the culture media using sterile forceps.
- Repeat the process with a second container of culture media to serve as a control.
- Incubate the culture media at the appropriate temperature and for the appropriate time period.
- Observe the media for the presence of any microbial growth.
- If no microbial growth is observed, the sample is considered sterile.
- If microbial growth is observed, the sample is considered non-sterile.
6.0 Documentation:
- Record all procedures and results in a logbook or other suitable documentation system.
- Include the date, time, sample identification number, and the results of the sterility testing.
7.0 Safety Precautions:
- Wear appropriate personal protective equipment (PPE) when handling samples or culture media.
- Use caution when handling sharps such as syringes and needles.
8.0 References:
- USP <71> Sterility Tests
9.0 Revision History:
- Version 1.0: Initial version.
- Version 2.0: Updated with revised procedures and references
