MFGL06GL3

Durapore^® 0.22 µm、Millipak^®Final Fillカプセル

Millipak^® Final Fill 60

• UNSPSCコード: 23151806

特性

• 物質: polysulfone device; polysulfone support
• 品質水準: 400
• 認証: meets EP 2.6.14; meets JP 4.01; meets USP 85
• 無菌性: irradiated; non-sterile
• 滅菌適合性: gamma compatible
• 製品種目: Millipak^® Final Fill 60
• 特徴: hydrophilic
• メーカー／製品名: Millipak^®
• パラメーター: 1.51 L/min flow rate at 0.86 bar (ΔP); 10 psi max. differential pressure (0.7 bar) at 25 °C (Reverse); 5.5 bar max. inlet pressure (80 psi) at 25 °C; 60 L process volume; 80 psi max. differential pressure (5.5 bar) at 25 °C (Forward)
• テクニック: sterile filtration: suitable
• L: 4.3 in.
• W: 3.0 in.
• filter filtration area: 300 cm²
• 不純物: <0.25 EU/mL USP bacterial endotoxins (LAL test, per device; aqueous extraction); <0.25 EU/mL bacterial endotoxins (LAL test, per device; aqueous extraction)
• マトリックス: Durapore^®
• ポアサイズ: 0.22 μm pore size
• 泡立ち点: ≥50 psi (3450 mbar), air with water
• フィッティング: (38 mm (1 1/2 in.) Sanitary Flange Inlet and 13 mm (1/2 in.) Hose Barb Outlet)

詳細

詳細

Device Configuration: Capsule

包装

Double Easy-Open bag

調製ノート

Sterilization Method: Device integrity and retention was maintained after 3 autoclave cycles of 90 minutes at 126  °C. Devices can withstand a dose ≤40  kGy gamma exposure.

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), validated based on large volume parenteral specifications as detailed in USP 788 Particulate Matter in Injections

アナリシスノート

Bacterial Grow-Through: Quantitative retention of 1 x 10⁷ CFU/cm² Brevundimonas diminuta ATCC^® 19146 per ASTM^® F838 methodology.

その他情報

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 general guidelines section of user guide shipped with this product
• Storage Statement: Please refer user guide shipped with this product
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

These products are manufactured in a facility which is certified to ISO 9001:2015 Quality Management Systems.

法的情報

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

ATCC is a registered trademark of American Type Culture Collection

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

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