产品说明
一般描述
Device Configuration: Cartridge
特点和优势
Rated for aerosol retention of a total challenge of 108–1010 plaque forming units of ΦX-174 virus particles at 85 Nm3/h (50 SCFM) per cartridge.
包装
Double Easy-Open bag
质量
Retains Brevundimonas diminuta liquid aerosol for 21 days at a minimum challenge of 10⁷ CFU/cm²
制备说明
Sterilization Method
150 (100 forward/50 reverse) SIP cycles of 30 min @ 145 °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).
分析说明
Gravimetric Extractables: after 24 hours in a 70/30% IPA/water mixture at controlled room temperature
HydroCorr: ≤0.75 mL/min @ 2.6 bar (38 psig) per 10 in cartridge
Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
其他说明
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.
法律信息
AERVENT is a registered trademark of Merck KGaA, Darmstadt, Germany
ASTM is a registered trademark of American Society for Testing and Materials
基本信息
| eCl@ss | 32031690 |
产品性质
| 质量水平 | 400 |
| 物料 | PTFE polypropylene polypropylene support silicone seal |
| 特点 | hydrophobic |
| manufacturer/tradename | Aervent® |
| 参数 | ≤24 mL/min nitrogen diffusion at 970 mbar (14 psig) and 23 ℃ (in 70/30% IPA/water) 1.7 bar max. inlet pressure (25 psi) at 80 ℃ 1.8 bar max. differential pressure (25 psid) at 80 ℃ (Forward) 4.1 bar max. differential pressure (60 psid) (Reverse; intermittent) 4.1 bar max. inlet pressure (60 psi) (Reverse; Intermittent) 5.5 bar max. differential pressure (80 psid) at 25 ℃ (Forward) 5.5 bar max. inlet pressure (80 psi) at 25 ℃ (Forward) |
| cartridge nominal length | 10 in. (25 cm) |
| 直径 | 6.9 cm (2.7 in.) |
| 过滤面积 | 0.65 m2 |
| 总尺寸 | 10 in. |
| 杂质 | <0.25 EU/mL USP bacterial endotoxins (LAL test, aqueous extraction) |
| gravimetric extractables | ≤35 mg/cartridge |
| 基质 | Aervent® |
| 孔径 | 0.2 μm pore size |
| input | sample type gas |
| bubble point | ≥1100 mbar (16 psig), nitrogen with 70/30% IPA/water at 23 ℃ |
| cartridge code | Code 7 |
