The primary goal of MLT is to determine the microbial content within pharmaceutical samples and whether it falls within acceptable limits defined by regulatory agencies such as the European Medicines Agency (EMA).
This testing helps mitigate risks associated with microbial contamination, which could compromise product quality and patient safety.
MLT covers a wide range of sample types, including raw materials (e.g., excipients, active pharmaceutical ingredients), intermediates, finished products, and environmental samples.
Each sample type undergoes specific MLT protocols tailored to its characteristics and potential microbial risks.
Microbial Limit Testing is a vital aspect of GMP pharmaceutical microbiological testing, ensuring the safety, quality, and compliance of pharmaceutical products through rigorous assessment and control of microbial contamination.
At Tentamus Pharma UK, we apply the following testing methods:
Plate Count Methods: These methods involve inoculating samples onto culture media and incubating them under suitable conditions to promote microbial growth.
After incubation, colonies are counted and quantified to determine microbial load.Membrane Filtration: This method involves passing a known volume of the sample through a membrane filter with a defined pore size.
The filter is then placed onto suitable agar media and incubated to allow microbial growth.
After incubation, colonies on the filter are counted to estimate the microbial count in the original sample.MLT results are documented in detailed test reports, including sample information, testing methods used, results interpretation, and compliance with acceptance criteria.
These reports serve as essential documentation for regulatory submissions, quality assurance, and batch release decisions.
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