The Steridilutor device is equipped with two needles:
- an LVP-type needle that is inserted in the diluting fluid container with an external diameter of 1.20 +/- 0.03 mm,
- a product needle that is inserted in the sample vials which consists of two cannulas, one for the flow with an external diameter of 1.50 +/- 0.03 mm and a length of 16.5 0/- 0.80 mm, one for the venting with an external diameter of 1.30 +/- 0.03 mm and a length of 21.7 +0,80 / 0 mm.
TZV000010
Steridilutor® NEO 装置
For liquids and soluble powders in vials., Devices without an expansion chamber for sample preparation and dilution., pkg of 10 blisters per box, Single packed
同義詞:
Steridilutor® NEO装置，用于无菌检测
跳轉至
材料
Nylon 66 adapter (for needle)
PVC tubing
stainless steel (for needle)
品質等級
agency
EP (2.6.1)
JP (4.06)
USP 71
無菌
sterile; γ-irradiated
特點
Devices without an expansion chamber for sample preparation and dilution.
製造商／商標名
Steridilutor®
包裝
pkg of 10 blisters per box, Single packed
輸入
sample type pharmaceutical(s)
應用
pharmaceutical
sterility testing
相容性
For liquids and soluble powders in vials.
for use with Steritest® Symbio FLEX Pump Kit, 2 media (SYMBFLE01)
for use with Steritest® Symbio ISL Pump Kit, 2 media (SYMBISL01)
for use with Steritest® Symbio LFH Pump Kit (SYMBLFH01)
運輸包裝
ambient
1 of 4
本產品 | TZVC00010 | TZA000010 | TZHALA210 |
|---|---|---|---|
| compatibility For liquids and soluble powders in vials., for use with Steritest® Symbio ISL Pump Kit, 2 media (SYMBISL01), for use with Steritest® Symbio FLEX Pump Kit, 2 media (SYMBFLE01), for use with Steritest® Symbio LFH Pump Kit (SYMBLFH01) | compatibility For liquids and soluble powders in vials., for use with Steritest® Symbio FLEX Pump Kit, 2 media (SYMBFLE01), for use with Steritest® Symbio ISL Pump Kit, 2 media (SYMBISL01), for use with Steritest® Symbio LFH Pump Kit (SYMBLFH01) | compatibility For liquid transfer from ampoules or vials to a diluent vial with septum pooling., for use with Steritest® Symbio FLEX Pump Kit, 2 media (SYMBFLE01), for use with Steritest® Symbio ISL Pump Kit, 2 media (SYMBISL01), for use with Steritest® Symbio LFH Pump Kit (SYMBLFH01) | compatibility For liquids in ampoules or collapsible bags., for use with Steritest® Symbio FLEX Pump Kit, 2 media (SYMBFLE01), for use with Steritest® Symbio ISL Pump Kit, 2 media (SYMBISL01), for use with Steritest® Symbio LFH Pump Kit (SYMBLFH01) |
| application(s) pharmaceutical | application(s) pharmaceutical | application(s) pharmaceutical | application(s) pharmaceutical |
| packaging pkg of 10 blisters per box, Single packed | packaging pkg of 10 blisters per box, Single packed | packaging pkg of 10 blisters per box, Single packed | packaging pkg of 10 blisters per box, Single packed |
| material Nylon 66 adapter (for needle), stainless steel (for needle), PVC tubing | material Nylon 66 adapter (for needle), PVC tubing, stainless steel (for needle) | material Nylon 66 adapter (for needle), PVC tubing, stainless steel (for needle) | material Nylon 66 adapter (for needle), PVC tubing (double lumen), mixed cellulose esters (MCE) membrane, plain filter, stainless steel (for needle), styrene-acrylonitrile (SAN) (for canister) |
| shipped in ambient | shipped in ambient | shipped in ambient | shipped in ambient |
| agency EP (2.6.1) | agency EP (2.6.1), JP (4.06), USP 71 | agency EP (2.6.1), JP (4.06), USP 71 | agency EP (2.6.1), JP (4.06), USP 71 |
一般說明
无扩展室的 Steridilutor® NEO 设备是管和针头组件，用于难溶粉末、稀释超强抗生素和小瓶中库产品。纯产品（固体或液体）难以冲洗，产品中的残留物可能是无菌测试中的主要抑制因素。对于粉末，需要进行充分溶解，避免任何可能的聚集。强烈建议对超强抗生素进行稀释，降低抗菌剂的浓度。这样处理能降低试剂与过滤器结合的可能性。小直径双针头负责将测试产品与稀释剂连接起来。随后将稀释的产品用合适的 Steritest® NEO 装置过滤。
應用
无扩展室的Steridilutor® NEO设备用于难溶粉末、稀释粘性产品和小瓶中的混合产品，有助于更快、更轻松、更安全地进行无菌检测。
法律資訊
STERIDILUTOR is a registered trademark of Merck KGaA, Darmstadt, Germany
STERITEST is a registered trademark of Merck KGaA, Darmstadt, Germany
分析證明 (COA)
輸入產品批次/批號來搜索 分析證明 (COA)。在產品’s標籤上找到批次和批號，寫有 ‘Lot’或‘Batch’.。
文章
Sterility testing is one of the most crucial steps in pharmaceutical product release. Regulatory-compliant membrane filtration sterility testing devices ensure the safety of pharmaceutical products.
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What size is the needle for the Steridiluter? I know it is 20mm in length - but what about the gauge? Thanks in advance.
1 answer-
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