LAGR04TP6

Aervent^® 0.2 µm, Optiseal^® Cartridge

pore size 0.2 μm, OptiSeal^® 4 in., filtration area 0.18 m², matrix Aervent^®

• 동의어(들): Optiseal Aervent Cartridge Filter 0.2 µm hydrophobic
• UNSPSC 코드: 23151806
• eCl@ss: 32031690

속성

• material: PTFE ; polypropylene ; polypropylene support; silicone seal
• Quality Level: 400
• 무균: non-sterile
• 멸균 적합성: steam-in-place compatible
• 제품 라인: OptiSeal^® 4 in.
• 특징: hydrophobic
• 제조업체/상표: OptiSeal^®
• 파라미터: ≤6 mL/min nitrogen diffusion at 965 mbar (14 psig) and 23 °C (in 70/30% IPA/water); 0.35 bar max. differential pressure (5 psid) at 135 °C (Forward); 0.35 bar max. inlet pressure (5 psi) at 135 °C (Forward); 1.7 bar max. differential pressure (25 psid) at 80 °C (Forward); 1.7 bar max. inlet pressure (25 psi) at 80 °C (Forward); 4.1 bar max. differential pressure (60 psid) (Reverse); 4.1 bar max. inlet pressure (60 psi) (Reverse;); 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward); 5.5 bar max. inlet pressure (80 psi) at 25 °C (Forward)
• 기술: gas filtration: suitable
• 길이: 4 in.
• 카트리지 공칭 길이: 4 in. (10 cm)
• 여과 면적: 0.18 m²
• 불순물: ≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction); <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• 중량 추출물: ≤10 mg/cartridge
• 기질: Aervent^®
• 공극 크기: 0.2 μm pore size
• 입력: sample type liquid
• 버블 포인트(bubble point): ≥1100 mbar (16 psig), nitrogen with 70/30% IPA/water at 23 °C
• 카트리지 코드: not applicable

설명

일반 설명

Device Configuration: Cartridge

포장

Double Easy-Open bag

기타 정보

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.

제조 메모

Sterilization Method
80 (40 forward/40 reverse) SIP cycles of 30 min @ 135 °C; 80 autoclave cycles of 30 min @ 135 °C

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: ≤0.20 mL/min with water @ 2.6 bar (38 psig)

법적 정보

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

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

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