KTGRA02NN3

Aervent^® 0.2 µm，Opticap^® XL囊式

Opticap^® XL 2, inlet connection diam. 1/4 in., pore size 0.2 μm, cartridge nominal length 2 in. (5 cm)

• 同義詞: Opticap XL 2 with Aervent - 2" 0.2um NPT/NPT 3pk
• 分類程式碼代碼: 23151806
• eCl@ss: 32031690

屬性

• 材料: PTFE ; polypropylene ; polypropylene housing; polypropylene vent cap; silicone seal
• 品質等級: 400
• 無菌: non-sterile
• 滅菌相容性: autoclavable compatible
• 產品線: Opticap^® XL 2
• 特點: hydrophobic
• 製造商／商標名: Opticap^®
• 參數: 1.0 bar max. differential pressure (15 psid) at 80 °C (Forward); 1.0 bar max. inlet pressure (15 psi) at 80 °C; 2.75 bar max. inlet pressure (40 psi) at 60 °C; 25 °C max. inlet temp.; 4.1 bar max. differential pressure (60 psid) at 25 °C (Reverse; intermittent); 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward); 5.5 bar max. inlet pressure (80 psi) at 25 °C; 80 psig max. inlet pressure
• 技術: gas filtration: suitable
• 長度: 5.6 in.
• 寬度: 3.3 in.
• 柱標稱長度: 2 in. (5 cm)
• 直徑: 8.4 cm (3.3 in.)
• 過濾面積: 0.1 m²
• 入口接頭直徑: 1/4 in.
• 出口接頭直徑: 1/4 in.
• 雜質: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• 重量法萃取物: ≤15 mg
• 基質: Aervent^®
• 孔徑: 0.2 μm pore size
• 接頭: 1/4 in. drain/vent hose barb (with double O-ring Seal); (6 mm (1/4 in.) NPT 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 Steam Sterilization & Integrity Testing Procedures guide and first page of Visual Inspection 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
30 autoclave cycles of 30 min @ 135 °C; not in-line steam sterilizable

This product was manufactured with a PTFE 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.

Gravimetric Extractables: after 24 hours in a 70/30% IPA/water mixture at controlled room temperature

法律資訊

AERVENT is a registered trademark of Merck KGaA, Darmstadt, Germany

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

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.