物料
polyester support
polyethersulfone membrane
polypropylene (end cap)
polypropylene housing
polysulfone (core)
质量水平
无菌性
non-sterile
灭菌适用性
autoclavable compatible
gamma compatible
产品线
Opticap® XL 10
特点
hydrophobic
参数
15 psi max. pressure at 80 °C (forward)
30 psi max. pressure at 4—50 °C (reverse)
60 psi max. pressure at 4—50 °C (forward)
技术
gas filtration: suitable
主体直径
10.7 cm (4.2 in.)
capsule L
33.3 cm (13.1 in.)
直径
14.5 cm (5.7 in.) , vent to vent
过滤面积
0.87 m2
入口接头直径
9/16 in.
出口接头直径
9/16 in.
杂质
<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
重量萃取物
≤54 mg
基质
Millipore Express® SPG
孔径
0.2 μm pore size
配件
(14.3 mm (9/16 in.) Sanitary Flange Inlet and Outlet)
运输
ambient
相关类别
一般描述
Device Configuration: Capsule
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
- Organism Retention: Microorganism
- Mode of Action: Filtration (size exclusion)
- Application: BioProcessing
- Intended Use: Reduction or removal of microorganism/bioburden
- Instructions for Use: Please refer Wetting Instructions for Filter Units with Durapore® Membrane user guide
- Storage Statement: Store in dry location
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations
制备说明
Sterilization Method
Gamma compatible to 40 kGy; 1 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
This product was tested and meets requirements of USP <788> for large volume parenterals.
Gamma compatible to 40 kGy; 1 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
This product was tested and meets requirements of USP <788> for large volume parenterals.
分析说明
Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 107 CFU/cm² using ASTM® F838 methodology.
Gravimetric Extractables:The extractable level was equal to or less than 27 mg/device after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 107 CFU/cm² using ASTM® F838 methodology.
Gravimetric Extractables:The extractable level was equal to or less than 27 mg/device after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
法律信息
ASTM is a registered trademark of American Society for Testing and Materials
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
MILLIPORE EXPRESS is a registered trademark of Merck KGaA, Darmstadt, Germany
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany
免责声明
EMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.
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