Media Hold Time Study is a quality assurance test conducted in the pharmaceutical and biopharmaceutical industries to ensure that growth media used in environmental monitoring and sterility testing maintain their ability to support microbial growth over a defined period. This study is crucial for validating the quality and reliability of the growth media.
Media Hold Time Study
1. Why we make it?
To determine the maximum time period that a growth medium can be held (stored) under specific conditions before being used in testing, without losing its ability to support microbial growth.
2. How and what the Process?
- Preparation: Media is prepared, sterilized, and then stored under specified conditions.
- Sampling: At predetermined intervals, samples of the stored media are taken.
- Testing and physical specifications check: Each sample is inoculated with known quantities of different microbial strains to assess the media’s ability to support growth.
- Evaluation: The media is evaluated for its growth-promoting properties by comparing the growth of microorganisms in the test samples to freshly prepared control samples.
3. What the important of Outcome?
The study helps establish the hold time limit for the media, the period during which the media can be used without compromising its quality. If the media can support growth up to a certain point, it is considered valid for use until that time. If not, it should be used within a shorter period or fresh media should be prepared.
Read also:
