产品说明
一般描述
T-line/Gauge Port: T-line
Device Configuration: 取样皿滤膜
特点和优势
Format: Single Layer
包装
Double Easy-Open bag
其他说明
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Directions for Use
制备说明
Sterilization Method
3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable
分析说明
Gravimetric Extractables: after 24 hours in water at controlled room temperature
法律信息
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany
POLYGARD is a registered trademark of Merck KGaA, Darmstadt, Germany
基本信息
eCl@ss | 32031690 |
产品性质
质量水平 | 400 |
物料 | polypropylene polypropylene housing polypropylene support polypropylene vent cap silicone seal |
reg. compliance | meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials) |
manufacturer/tradename | Opticap® |
参数 | 25 ℃ max. inlet temp. 80 psig max. inlet pressure |
cartridge nominal length | 30 in. (75 cm) |
inlet connection diam. | 1.5 in. |
outlet connection diam. | 1.5 in. |
总尺寸 | 30 in. |
杂质 | ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction) <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction) |
gravimetric extractables | ≤165 mg/capsule |
基质 | Polygard®-CN |
孔径 | 1.2 μm nominal pore size 1.2 μm pore size |
input | sample type liquid |
配件 | inlet sanitary flange 38 mm (1 outlet sanitary flange |
Sigma-Aldrich