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The irradiation dose range is 25.0–45.0 kGy, with test results marked Pass. Inspection confirms 100% visual inspection and compliance for biological reactivity, cytotoxicity, physicochemical properties, EP plastics container testing, endotoxin limits (\u003C0.25 EU/ml by LAL), and particulate matter requirements per USP methods.","# CERTIFICATE OF ANALYSIS\n\nBioProcess ContainerSystems  \nProduct:Tank Liner,Irradiated  \n300 Liter for 24”Diameter DrumStandard  \nExpiration Date:JUL/2028  \nCatalog\\#:SH30647.06  \nLot\\#:ELG118721  \nDrawing Rev:“B”  \nManufacture Date:JUL/2025  \nDrawing\\#:07593  \n\n| ===========三年二兰========  \u003Cbr>===========================   |  | ============  \u003Cbr>=====:   | ===============三===   |\n| --- | --- | --- | --- |\n| Test  \u003Cbr>==========   | Specification   | Units   | Results   |\n| Irradiation Dose   | 25.0-45.0   | kGy   | Pass   |\n\n● Inspection:This lot of BioProcess Container Systems has been 100%visually inspected per specification.  \n·  Biological Reactivity:All product contact materials have passed USP Class VI testing(USP\u003C88>)and/orISO10993.  \n·  Cytotoxicity:All Thermo Scientific product contact films have passed Cytotoxicity testing(USP\u003C87>MEMElution).  \n·Physicochemical:All Thermo Scientific product contact films have passed USP Physicochemical Tests for Plastics(USP\u003C661>).  \n·  EP Testing:AIl Thermo Scientific product contact films have passed EP\u003C3.2.2.1>\"Plastic Containers for AqueousSolutions for Parenteral Infusion”.  \n·  Endotoxin:Samples of representative BioProcess Container Systems are routinely tested in periodic validationsfor the presence of endotoxin per the USP Bacterial Endotoxin Test (USP\u003C85>).Aqueous extracts contained  \n\u003C0.25 EU/ml as determined by the Limulus Amebocyte Lysate Test (LAL).  \n·  Particulate:Samples of representative BioProcess Container Systems have been routinely tested in periodicvalidations and have passed requirements per Particulate Matter in Injections Light Obscuration ParticulateCount Test (USP\u003C788>).  \n# Certificate of Processing\n\nSTERIGENICS 344 Bonnie Circle Corona CA 92878TEL 951340-0700 FAX 951340-1990 www.sterigenics.com  \n07/23/202522:09:24 GMT  \nR55480102  \nPage 1 of 2  \nWork Order\\#  \n3801767  \nCorona  \nThermo Fisher (Life Tech,)-1726 HyClone  \nProcesslng Facitiy:  \nCustomer Name:  \nSales Order  \n3855879  \n279697  \nP.0.\\#  \n07/22/202509:36:00 GMT  \n1rradlatlon Date/Tme:  \nFIS_25-45,GAMMA TREATMENT  \n25-45 kGy  \nCELLA  \nIrradlation Cell:  \n\n| so  \u003Cbr>LIne\\#   | Qty    | UOM    | Customer tem Number   | Customer item Description   | Customer  \u003Cbr>Lot Number   | Customer  \u003Cbr>Load Number   |\n| --- | --- | --- | --- | --- | --- | --- |\n| 101.000   | 4    | CA   | L-47×23×12   | BAGS &TUBING   | ELG121631   | FIS_SH3B5883.01   |\n|  | Dose Map   |  | 104_17460-62J_18976-77   | HI:TA3 LO:0.5C9   |  |  |\n| 102.000   | 15    | CA   | L-47×23×12   | BAGS &TUBING   | ELG133460   | FIS_SH3B16010.02   |\n|  | Dose Map   |  | 104_17460-62J_18976-77   | H:TA3 LO:0.5C9   |  |  |\n| 103.000   | 16    | CA   | L-47×23×12   | BAGS&TUBING   | ELG131315   | FIS_SH3B18535.03   |\n|  | Dose Map   |  | 104_17460-62J_18976-77   | HI:TA3 LO:0.5C9   |  |  |\n| 104.000   | 1    | CA   | M-36×23×12   | BAGS &TUBING   | ELG137682   | FIS_SUT110906   |\n|  | Dose Map   |  | 104_17465-6-85J_18974-75   | HI:7A3 TA3 LO:0.5C9   |  |  |\n| 105.000   | 2    | CA   | M-36×23X12   | BAGS&TUBING   | ELG138295   | FIS_SH3B5510.01   |\n|  | Dose Map   |  | 104_17465-6-85_/_18974-75   | HI:7A3 TA3 LO:0.5C9   |  |  |\n| 106.000   | 2    | CA   | M-36×23×12   | BAGS&TUBING   | ELG138028   | FIS_SUT111940   |\n|  | Dose Map   |  | 104_17465-6-85J_18974-75   | H:7A3 TA3 LO:0.5C9   |  |  |\n| 107.000   | 23    | CA   | M-36×23×12   | BAGS &TUBING   | ELG137684   | FIS_SH3B4916.03   |\n|  | Dose Map   |  | 104_17465-6-85_1_18974-75   | HI:7A3 TA3 LO:0.5C9   |  |  |\n| 108.000   | 1   | CA   | M-36×23×12   | BAGS &TUBING   | ELG998363   | FIS_SUT110953   |\n|  | Dose Map   |  | 104_17465-6-85J_18974-75   | HI:7A3 TA3 LO:0.5C9   |  |  |\n| 109.000   | 1    | CA   | M-36×23×12   | BAGS&TUBING   | ELG137108   | FIS_SH3815132.02   |\n|  | Dose Map   |  | 104_17465-6-85_I_18974-75   | HI:7A3 TA3 LO:0.5C9   |  |  |\n| 110.000   | 1    | CA   | M-36×23×12   | BAGS &TUBING   | ELG139206   | FIS_SH31452.01   |\n|  | Dose Map   |  | 104_17465-6-85_18974-","cbCaib9m5NiDMUgl","https://ap.wps.com/l/cbCaib9m5NiDMUgl","pdf",75853,1,3,"English","en",105,"# CERTIFICATE OF ANALYSIS\n## Product identification\n## Irradiation dose and results\n## Inspection and compliance tests\n## Biological reactivity and USP/EP compliance","[{\"question\":\"What product and lot are covered by this certificate?\",\"answer\":\"The certificate covers an irradiated BioProcess Container Systems Tank Liner (300 Liter, 24” diameter drum), with catalog SH30647.06 and lot ELG118721.\"},{\"question\":\"What irradiation dose range and outcome are reported?\",\"answer\":\"The reported irradiation dose range is 25.0–45.0 kGy, and the test result is marked Pass.\"},{\"question\":\"Which biocompatibility and safety tests are listed?\",\"answer\":\"The document lists biological reactivity with USP Class VI (USP\\u003c88\\u003e), cytotoxicity (USP\\u003c87\\u003e MEM elution), physicochemical tests (USP\\u003c661\\u003e), EP\\u003c3.2.2.1\\u003e plastics container testing, endotoxin testing (USP\\u003c85\\u003e by LAL, \\u003c0.25 EU/ml), and particulate testing (USP\\u003c788\\u003e).\"}]","CERTIFICATE OF ANALYSIS - Irradiated Tank Liner - Lot ELG118721 - 25.0-45.0 kGy | 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