Sterility Test<\/h2>\n<\/div>We verify the absence of microbial contaminants in obligatorily sterile products<\/h3>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div>ITELPHARMA\u2019s microbiological quality control laboratory<\/h1><\/div><\/div><\/div><\/div><\/div><\/div><\/div>Sterility tests verify the absence of microbial contamination potentially harmful for humans in raw materials and finished products.<\/p>\n
The sterility test is performed by the Microbiological Laboratory of ITELPHARMA \u2013 Radiopharmaceuticals Division of Itel Telecomunicazioni, in accordance with a method accredited under the UNI CEI EN ISO\/IEC 17025:2018 standard. The test is included in the list of tests accredited by Accredia, as reported in the accreditation certificate available for consultation at www.itelte.it\/certificazioni<\/a>.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div>![](\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%271785%27%20height%3D%271500%27%20viewBox%3D%270%200%201785%201500%27%3E%3Crect%20width%3D%271785%27%20height%3D%271500%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\")
<\/div><\/div><\/div>Analysis are performed following proper validation method, and they verify absence of bacteriostatic and fungistatic effects in the product.<\/p>\n
The test is performed by way of product filtration onto two membranes with a porosity of 0.45\u00b5m contained inside devices called \u201ccanisters\u201d. The membranes are then washed with a specific fluid and then the \u201ccanisters\u201d are filled with TSB or FTM culture media.<\/p>\n<\/div>
<\/div><\/div><\/div><\/div><\/div>![](\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%271026%27%20height%3D%27684%27%20viewBox%3D%270%200%201026%20684%27%3E%3Crect%20width%3D%271026%27%20height%3D%27684%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\")
<\/div><\/div><\/div>The TSB \u201ccanister\u201d is placed inside the incubator at a temperature of 22.5\u00b0C for at least 14 days while at 32.5\u00b0C for the FTM canisters incubation applying the same incubation time.<\/p>\n<\/div>
<\/div><\/div><\/div><\/div><\/div>![](\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%271244%27%20height%3D%27829%27%20viewBox%3D%270%200%201244%20829%27%3E%3Crect%20width%3D%271244%27%20height%3D%27829%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\")
<\/div><\/div><\/div>During tests execution, particulate and microbiological monitoring are performed to demonstrate compliance to the environmental conditions required (Pharmaceutical Class A) of the isolator system during operation.<\/p>\n
At the end of the 14 days of incubation, the results of the analysis are delivered to the customer by way of a suitable analysis certificate.<\/p>\n<\/div>
<\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"footnotes":""},"_links":{"self":[{"href":"https:\/\/itelpharma.com\/en\/wp-json\/wp\/v2\/pages\/2448"}],"collection":[{"href":"https:\/\/itelpharma.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/itelpharma.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/itelpharma.com\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/itelpharma.com\/en\/wp-json\/wp\/v2\/comments?post=2448"}],"version-history":[{"count":1,"href":"https:\/\/itelpharma.com\/en\/wp-json\/wp\/v2\/pages\/2448\/revisions"}],"predecessor-version":[{"id":4835,"href":"https:\/\/itelpharma.com\/en\/wp-json\/wp\/v2\/pages\/2448\/revisions\/4835"}],"wp:attachment":[{"href":"https:\/\/itelpharma.com\/en\/wp-json\/wp\/v2\/media?parent=2448"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
We verify the absence of microbial contaminants in obligatorily sterile products<\/h3>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div>ITELPHARMA\u2019s microbiological quality control laboratory<\/h1><\/div><\/div><\/div><\/div><\/div><\/div><\/div>Sterility tests verify the absence of microbial contamination potentially harmful for humans in raw materials and finished products.<\/p>\n
The sterility test is performed by the Microbiological Laboratory of ITELPHARMA \u2013 Radiopharmaceuticals Division of Itel Telecomunicazioni, in accordance with a method accredited under the UNI CEI EN ISO\/IEC 17025:2018 standard. The test is included in the list of tests accredited by Accredia, as reported in the accreditation certificate available for consultation at www.itelte.it\/certificazioni<\/a>.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>Analysis are performed following proper validation method, and they verify absence of bacteriostatic and fungistatic effects in the product.<\/p>\n
The test is performed by way of product filtration onto two membranes with a porosity of 0.45\u00b5m contained inside devices called \u201ccanisters\u201d. The membranes are then washed with a specific fluid and then the \u201ccanisters\u201d are filled with TSB or FTM culture media.<\/p>\n<\/div>
<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>The TSB \u201ccanister\u201d is placed inside the incubator at a temperature of 22.5\u00b0C for at least 14 days while at 32.5\u00b0C for the FTM canisters incubation applying the same incubation time.<\/p>\n<\/div>
<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>During tests execution, particulate and microbiological monitoring are performed to demonstrate compliance to the environmental conditions required (Pharmaceutical Class A) of the isolator system during operation.<\/p>\n
At the end of the 14 days of incubation, the results of the analysis are delivered to the customer by way of a suitable analysis certificate.<\/p>\n<\/div>
<\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"footnotes":""},"_links":{"self":[{"href":"https:\/\/itelpharma.com\/en\/wp-json\/wp\/v2\/pages\/2448"}],"collection":[{"href":"https:\/\/itelpharma.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/itelpharma.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/itelpharma.com\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/itelpharma.com\/en\/wp-json\/wp\/v2\/comments?post=2448"}],"version-history":[{"count":1,"href":"https:\/\/itelpharma.com\/en\/wp-json\/wp\/v2\/pages\/2448\/revisions"}],"predecessor-version":[{"id":4835,"href":"https:\/\/itelpharma.com\/en\/wp-json\/wp\/v2\/pages\/2448\/revisions\/4835"}],"wp:attachment":[{"href":"https:\/\/itelpharma.com\/en\/wp-json\/wp\/v2\/media?parent=2448"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
ITELPHARMA\u2019s microbiological quality control laboratory<\/h1><\/div><\/div><\/div><\/div><\/div><\/div><\/div>Sterility tests verify the absence of microbial contamination potentially harmful for humans in raw materials and finished products.<\/p>\n
The sterility test is performed by the Microbiological Laboratory of ITELPHARMA \u2013 Radiopharmaceuticals Division of Itel Telecomunicazioni, in accordance with a method accredited under the UNI CEI EN ISO\/IEC 17025:2018 standard. The test is included in the list of tests accredited by Accredia, as reported in the accreditation certificate available for consultation at www.itelte.it\/certificazioni<\/a>.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>Analysis are performed following proper validation method, and they verify absence of bacteriostatic and fungistatic effects in the product.<\/p>\n
The test is performed by way of product filtration onto two membranes with a porosity of 0.45\u00b5m contained inside devices called \u201ccanisters\u201d. The membranes are then washed with a specific fluid and then the \u201ccanisters\u201d are filled with TSB or FTM culture media.<\/p>\n<\/div>
<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>The TSB \u201ccanister\u201d is placed inside the incubator at a temperature of 22.5\u00b0C for at least 14 days while at 32.5\u00b0C for the FTM canisters incubation applying the same incubation time.<\/p>\n<\/div>
<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div>During tests execution, particulate and microbiological monitoring are performed to demonstrate compliance to the environmental conditions required (Pharmaceutical Class A) of the isolator system during operation.<\/p>\n
At the end of the 14 days of incubation, the results of the analysis are delivered to the customer by way of a suitable analysis certificate.<\/p>\n<\/div>
<\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"footnotes":""},"_links":{"self":[{"href":"https:\/\/itelpharma.com\/en\/wp-json\/wp\/v2\/pages\/2448"}],"collection":[{"href":"https:\/\/itelpharma.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/itelpharma.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/itelpharma.com\/en\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/itelpharma.com\/en\/wp-json\/wp\/v2\/comments?post=2448"}],"version-history":[{"count":1,"href":"https:\/\/itelpharma.com\/en\/wp-json\/wp\/v2\/pages\/2448\/revisions"}],"predecessor-version":[{"id":4835,"href":"https:\/\/itelpharma.com\/en\/wp-json\/wp\/v2\/pages\/2448\/revisions\/4835"}],"wp:attachment":[{"href":"https:\/\/itelpharma.com\/en\/wp-json\/wp\/v2\/media?parent=2448"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
Sterility tests verify the absence of microbial contamination potentially harmful for humans in raw materials and finished products.<\/p>\n
The sterility test is performed by the Microbiological Laboratory of ITELPHARMA \u2013 Radiopharmaceuticals Division of Itel Telecomunicazioni, in accordance with a method accredited under the UNI CEI EN ISO\/IEC 17025:2018 standard. The test is included in the list of tests accredited by Accredia, as reported in the accreditation certificate available for consultation at www.itelte.it\/certificazioni<\/a>.<\/p>\n<\/div> Analysis are performed following proper validation method, and they verify absence of bacteriostatic and fungistatic effects in the product.<\/p>\n The test is performed by way of product filtration onto two membranes with a porosity of 0.45\u00b5m contained inside devices called \u201ccanisters\u201d. The membranes are then washed with a specific fluid and then the \u201ccanisters\u201d are filled with TSB or FTM culture media.<\/p>\n<\/div> The TSB \u201ccanister\u201d is placed inside the incubator at a temperature of 22.5\u00b0C for at least 14 days while at 32.5\u00b0C for the FTM canisters incubation applying the same incubation time.<\/p>\n<\/div> During tests execution, particulate and microbiological monitoring are performed to demonstrate compliance to the environmental conditions required (Pharmaceutical Class A) of the isolator system during operation.<\/p>\n At the end of the 14 days of incubation, the results of the analysis are delivered to the customer by way of a suitable analysis certificate.<\/p>\n<\/div>