{"id":39,"date":"2020-02-03T13:36:40","date_gmt":"2020-02-03T13:36:40","guid":{"rendered":"https:\/\/www.almacgroup.com\/analytical-solid-state\/?page_id=39"},"modified":"2025-02-14T11:15:38","modified_gmt":"2025-02-14T11:15:38","slug":"microbial-limit-testing-and-validation","status":"publish","type":"page","link":"https:\/\/www.almacgroup.com\/analytical-solid-state\/pharmaceutical-drug-product-release-testing\/microbiology-testing-overview\/microbial-limit-testing-and-validation\/","title":{"rendered":"Microbial Limit Testing and Validation"},"content":{"rendered":"\n<h4 class=\"wp-block-heading\" id=\"h-when-a-new-product-is-submitted-for-microbial-limits-testing-mlt-the-method-of-choice-must-first-be-verified-to-ensure-it-is-fit-for-purpose-for-the-new-product\">When a new product is submitted for Microbial Limits Testing (MLT), the method of choice must first be verified to ensure it is fit for purpose for the new product<\/h4>\n\n\n\n<p>Once the test method has been verified and deemed fit for purpose this test method can be used to test the product for routine analysis for Microbial Limits Testing.<\/p>\n\n\n\n<p>Our Microbial Limits Test consists of two main requirements:<\/p>\n\n\n\n<p><strong>Quantitative Testing<\/strong><\/p>\n\n\n\n<p>This examines the\u00a0<a href=\"\/analytical-solid-state\/bioburden-validation-and-analysis\/\">Bioburden<\/a>\u00a0levels of the product\/s by determining the number of Total Aerobic Microbial Count (Bacterial) and the Total Yeast and Mould counts (Fungal) present in the product\/s, also known as TAYC and TYMC testing respectively.<\/p>\n\n\n\n<p>The pour plate method is a technique also used to isolate and count viable microorganisms in a given liquid specimen.<\/p>\n\n\n\n<p><strong>Qualitative Testing<\/strong><\/p>\n\n\n\n<p>This examines the absence and presence of \u201cObjectionable Organisms\u201d in the product\/s. Objectionable organisms include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>E-coli<\/li>\n\n\n\n<li>Salmonella<\/li>\n\n\n\n<li>Pseudomonas aeruginosa<\/li>\n\n\n\n<li>Staphylococcus aureus<\/li>\n\n\n\n<li>Bile Tolerant Gram Negative Bacteria<\/li>\n\n\n\n<li>Candida albicans<\/li>\n\n\n\n<li>Others<\/li>\n<\/ul>\n\n\n\n<p><a href=\"\/analytical-solid-state\/contact-us\/\" class=\"c-btn\">Contact Us<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>When a new product is submitted for Microbial Limits Testing (MLT), the method of choice must first be verified to ensure it is fit for purpose for the new product Once the test method has been verified and deemed fit for purpose this test method can be used to test the product for routine analysis [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":38,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-39","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.3.1 (Yoast SEO v26.3) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Microbial Limit Testing and Validation - Analytical &amp; 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