{"id":1930,"date":"2025-07-14T09:40:30","date_gmt":"2025-07-14T01:40:30","guid":{"rendered":"https:\/\/mxnsaq.com\/?page_id=1930"},"modified":"2025-08-12T16:30:05","modified_gmt":"2025-08-12T08:30:05","slug":"sterility-testing","status":"publish","type":"page","link":"https:\/\/mxnsaq.com\/au\/sterility-testing\/","title":{"rendered":"Sterility Testing"},"content":{"rendered":"\n
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Sterility testing is a test required by authorities to confirm sterile products do not contain microorganisms that might affect product integrity and ultimately consumers<\/strong>.<\/strong><\/strong><\/strong><\/h2>\n\n\n\n

The presence of microorganisms in a product can pose serious risks to patients and consumers, including infections and other adverse reactions. Sterility testing helps to minimize these risks by verifying the absence of viable microorganisms, including bacteria and fungi.<\/p>\n\n\n\n

M\u00e9rieux NutriSciences AQ offers a comprehensive range of microbiology services compliant with GMP & TGA requirements for pharmaceutical, medical and manufacturing products (sterile and non-sterile).<\/p>\n\n\n\n

What is the purpose of a Sterility Test?<\/strong><\/strong><\/strong><\/h3>\n\n\n\n

To determine whether a pharmaceutical product, medical device, or any other healthcare product is free from viable microorganisms. It is a critical quality control measure used to ensure the safety and efficacy of these products.<\/p>\n\n\n\n

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Sterility testing is a crucial microbiological requirement within Good Manufacturing Practices (GMP) standards and TGA. It serves to verify that products claimed to be sterile, such as medical devices, pharmaceuticals, formulations, and tissue materials, are devoid of viable microorganisms prior to their release and eventual administration to patients. The precision of sterility testing methods is of utmost significance due to the critical nature of ensuring the absence of viable microorganisms in these products<\/em><\/p>\n\n\n\n

(<\/strong>TGA Guidelines for Sterility Testing of Therapeutic Goods \u2013 2006<\/a><\/em>)<\/strong><\/p>\n<\/blockquote>\n\n\n\n

Sterility is defined as the absence of viable microorganisms, but achieving absolute sterility often requires harsh conditions that may be unsuitable for active ingredients. Therefore, when it comes to medicinal products, the definition of sterility must be based on practical considerations.<\/p>\n\n\n\n

In pharmaceutical practice, a container is considered sterile if the probability of contamination with replicating microorganisms is less than one in a million. Since it is impractical to open and test every single container of a biological medicinal product, a representative number of samples from the batch, taken at various times during the filling process, are used to monitor sterility.<\/p>\n\n\n\n

This means that if there are only a few non-sterile containers in a large batch of identical containers, the likelihood of detecting a non-sterile container is relatively low.<\/p>\n\n\n\n

Our Sterility Testing Methods<\/h2>\n\n\n\n