- 商品介绍
- 规格参数
- 包装参数
General description
Device Configuration: 取样皿滤膜
包装
Double Easy-Open bag
Other Notes
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 installation section of OPTICAP® XL Capsules and OPTICAP® XLT Capsules user guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.
Preparation Note
Sterilization Method
3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
This product was manufactured with a Millipore Express membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
Analysis Note
Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
TOC/Conductivity
After sterilization and a controlled water flush of 9.5 L, samples exhibited less than 500 ppb TOC per USP
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L
法律信息
ASTM 为以下机构的注册商标: American Society for Testing and Materials
Disclaimer
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.
Quality Level | 400 |
material | polyethersulfone membrane |
polypropylene | |
polypropylene housing | |
polypropylene support | |
polypropylene vent cap | |
polysulfone | |
silicone seal | |
reg. compliance | meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials) |
product line | Emprove® Filter |
feature | hydrophilic |
mfr. no. | Millipore Express® |
parameter | ≤13.3 mL/min air diffusion at 2.8 bar (40 psig) and 23 °C ( in water) |
1.0 bar max. differential pressure (15 psid) at 80 °C (Forward) | |
1.0 bar max. inlet pressure (15 psi) at 80 °C | |
100 psi max. differential pressure (6.9 bar) (intermittent) | |
2.1 bar max. differential pressure (30 psid) at 25 °C (Reverse; intermittent) | |
2.75 bar max. inlet pressure (40 psi) at 60 °C | |
25 °C max. inlet temp. | |
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward) | |
5.5 bar max. inlet pressure (80 psi) at 23 °C | |
6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent) | |
6.9 bar max. inlet pressure (100 psi) at 25 °C (intermittent) | |
80 psi max. differential pressure (5.5 bar) (continuous) | |
80 psig max. inlet pressure | |
L | 21.6 cm (8.5 in.) |
cartridge nominal length | 5 in. (12.5 cm) |
diam. | 10.7 cm (4.2 in.) |
filtration area | 0.23 m2 |
inlet connection diam. | 1-1/2 in. |
inlet to outlet W | 21.6 cm (8.5 in.) |
outlet connection diam. | 1-1/2 in. |
overall size | 5 in. |
impurities | ≤0.25 EU/mL (LAL test, Aqueous extraction) |
<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction) | |
matrix | Millipore Express® SHC |
pore size | 0.2 μm pore size |
0.5 μm pore size | |
bubble point | ≥4000 mbar (58 psig), air with water at 23 °C |
fitting | 1/4 in. drain/vent hose barb (with double O-ring seal) |
inlet sanitary flange | |
38 mm (1 1/2 in.) inlet/outlet sanitary flange | |
outlet sanitary flange |
长度(mm) | |
宽度(mm) | |
高度(mm) | |
重量(kg) |