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