KHVES05HH1

Opticap 无菌 XL 5 Millipore Express SHR 带预滤器 0.5/0.1 µm 9/16 in. HB/HB

Opticap^® XL 5, sterile, inlet connection diam. 9/16 in., pore size 0.5/0.1 μm, cartridge nominal length 5 in. (12.5 cm)

• 同義詞: Millipore Express^® SHRP，Opticap^® XL囊式
• 分類程式碼代碼: 23151806

屬性

• 材料: polyester support; polyethersulfone ; polypropylene (gamma-stable); polypropylene housing; polypropylene vent cap (Gamma stable); polysulfone ; silicone seal
• 品質等級: 400
• 法律遵循: meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
• 無菌: irradiated; sterile
• 產品線: Opticap^® XL 5
• 特點: hydrophilic
• 製造商／商標名: Millipore Express^®
• 參數: ≤13.6 mL/min air diffusion at 3.45 bar (50 psig) and 23 °C (in water); 1.0 bar max. differential pressure (15 psid) at 80 °C (Forward); 1.0 bar max. inlet pressure (15 psi) at 80 °C; 100 psi max. differential pressure (6.9 bar) (intermittent); 2.1 bar max. differential pressure (30 psid) at 25 °C (Reverse; intermittent); 2.75 bar max. inlet pressure (40 psi) at 60 °C; 25 °C max. inlet temp.; 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward); 5.5 bar max. inlet pressure (80 psi) at 25 °C; 6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent); 6.9 bar max. inlet pressure (100 psi) at 25 °C (intermittent); 80 psi max. differential pressure (5.5 bar) (continuous); 80 psig max. inlet pressure
• 技術: sterile filtration: suitable
• 長度: 21.6 cm (8.5 in.)
• 柱標稱長度: 5 in. (12.5 cm)
• 直徑: 14.5 cm (5.7 in.)
• 過濾面積: 0.24 m²
• 入口接頭直徑: 9/16 in.
• 入口到出口寬度: 21.6 cm (8.5 in.)
• 出口接頭直徑: 9/16 in.
• 雜質: ≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• 基質: Millipore Express^® SHR (w/Prefilter)
• pore size: 0.5/0.1 μm pore size
• 起泡點: ≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water at 23 °C
• 接頭: 1/4 in. drain/vent hose barb (with double O-ring Seal); inlet hose barb; outlet hose barb; (14 mm (9/16 in.) Hose Barb Inlet and Outlet)

描述

一般說明

Device Configuration: 取样皿滤膜

包裝

Double Easy-Open bag

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

Sterilization Method
3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable

This product was manufactured with a Millipore Express^® 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.

TOC/Conductivity
After sterilization and a controlled water flush of 9.5 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L

法律資訊

ASTM is a registered trademark of American Society for Testing and Materials

MILLIPORE EXPRESS 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.