KTGRA02TT3

Aervent^® 0.2 µm, Opticap^® XL Capsule

Opticap^® XL 2, inlet connection diam. 1.5 in., pore size 0.2 μm, cartridge nominal length 5.6 in. (14.3 cm)

• 동의어(들): Opticap Sterilizing Grade XL2 Aervent 0.2 µm 1-1/2 in. TC/TC
• UNSPSC 코드: 23151806
• eCl@ss: 32031690

속성

• material: PTFE ; polypropylene ; polypropylene housing; polypropylene support; polypropylene vent cap; silicone seal
• Quality Level: 400
• 무균: non-sterile
• 멸균 적합성: autoclavable compatible
• 제품 라인: Opticap^® XL 2
• 특징: hydrophobic
• 제조업체/상표: Opticap^®
• 파라미터: 1.0 bar max. differential pressure (15 psid) at 80 °C (Forward); 1.0 bar max. inlet pressure (15 psi) at 80 °C; 2.8 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 23 °C; 80 psig max. inlet pressure
• 기술: gas filtration: suitable
• 길이: 14.3 cm (5.6 in.)
• 너비: 3.3 in.
• 카트리지 공칭 길이: 5.6 in. (14.3 cm)
• 직경: 8.4 cm (3.3 in.)
• 여과 면적: 0.1 m²
• 입구 연결 직경: 1.5 in.
• 입구에서 출구 너비(W): 14.3 cm (5.6 in.)
• 출구 연결 직경: 1.5 in.
• 불순물: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• 중량 추출물: ≤15 mg
• 기질: Aervent^®
• 공극 크기: 0.2 μm pore size
• 버블 포인트(bubble point): ≥1100 mbar (16 psig), nitrogen with 70/30% IPA/water at 23 °C
• 피팅: 1/4 in. drain/vent hose barb (with double O-ring Seal); inlet sanitary flange; outlet sanitary flange; (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

설명

일반 설명

Device Configuration: Capsule

포장

Double Easy-Open bag

결합

Replaces: KTGR04TC3

제조 메모

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).

분석 메모

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

HydroCorr: ≤0.12 mL/min @ 2.6 bar (38 psig)

기타 정보

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.

법적 정보

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

면책조항

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.