推薦產品
材料
PVDF
品質等級
法律遵循
meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
無菌
non-sterile
滅菌相容性
autoclavable compatible
產品線
Opticap® XL 4
特點
hydrophobic
製造商/商標名
Durapore®
參數
25 °C max. inlet temp.
80 psig max. inlet pressure
技術
sterile filtration: suitable
入口接頭直徑
1.5 in.
出口接頭直徑
9/16 in.
尺寸
4 in.
雜質
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
基質
Durapore®
孔徑
0.22 μm pore size
接頭
(38 mm (1 1/2 in.) Sanitary Flange Inlet and 14 mm (9/16 in.) Hose Barb Outlet)
相關類別
一般說明
Device Configuration: 取样皿滤膜
其他說明
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 installation section of OPTICAP® XL Capsules and OPTICAP® XLT Capsules user guide
- Storage Statement: Store in dry location
- Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.
準備報告
This product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
分析報告
Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
法律資訊
ASTM is a registered trademark of American Society for Testing and Materials
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany
免責聲明
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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