Microbial Identification Testing
Microbial identification testing is aimed at ensuring the safety and quality of pharmaceuticals. It involves the systematic analysis of samples collected from various stages of the manufacturing process, including raw materials, in-process materials, finished products, medical devices and environmental monitoring samples.
About
Initially, microorganisms present in the samples are isolated and cultured using appropriate media and incubation conditions to obtain pure cultures. Subsequently, a combination of techniques such as microscopic examination and biochemical tests are applied for accurate identification inside of our dedicated microbiological labs.
MALDI-TOF
Automated systems such as our matrix-assisted laser desorption/ionisation time-of-flight mass spectrometry (MALDI-TOF) are increasingly used for rapid and accurate identification. Visit our Microbial Identification via MALDI-TOF page to learn more about our rapid Microbial Identification testing service for your pharmaceutical products and medical devices.
The results then are analysed and interpreted by our qualified microbiologists. And we provide our clients with detailed documentation of procedures, results, and any deviations from acceptance criteria are maintained for regulatory compliance and quality assurance purposes. Corrective actions are implemented in case of microbial contaminants or deviations to mitigate risks and ensure product safety.
Importance of Microbial Identification Testing
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Product Integrity
Ensures the integrity of pharmaceutical products by identifying and controlling microbial contamination.
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Regulatory Compliance
Maintains compliance with industry standards and regulatory requirements.
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Public Health
Safeguards public health by ensuring the safety and quality of pharmaceutical products.