Product Description
Check this product with a package size of C01-260cm² / 31 mm (1 1/4") Sanitary Flange / Sterile Breathable Bag Packed on Iright. Hydrophilic Sterilizing-Grade Filter with High Throughput and Low Protein Adsorption.
Specifications
Materials
Membrane
Hydrophilic polyvinylidene fluoride(PVDF)
Support
Polypropylene(PP)
Core/Cage/End Cap
Polypropylene(PP)
Capsule Housing
Polypropylene(PP)
Capsule Vent O-rings
Silicone
Pore Size
0.2 μm
Filtration Area
C01-260cm²C02-600cm²C03-940cm²
Operating Conditions
Max. Operating Temperature
80°C
Max. Differential Pressure (Forward)
0.55 MPa @25°C0.10 MPa @80°C
Max. Differential Pressure (Reverse)
0.21 MPa @25°C
Quality Standards
Integrity
100% Integrity testing
Traceability
Each filter with a unique serial number
QMS
ISO 9001:2015
Sterility
Delivery Condition
Non-sterile
Sterilization Method
Can be autoclaved 25 cycles for 30 minutes at 130°C (Can not be steam sterilized in-line)
Package
Pack Size
1/pk
Packaging
Double PE bag
*Note: Cobetter also provides filters with different sterilization methods:
1. Gamma compatible filters: can be sterilized by gamma irradiation at 25-45 kGy or can be autoclaved 5 cycles for 60 minutes at 126 °C. (Can not be steamed in-line);2. Pre-sterilized filters by gamma irradiation at 25-45 kGy (Gamma-sterilized products cannot be re-sterilized with gamma irradiation or steam sterilization);3. Pre-sterilized filters by autoclaved for 30 minutes at 121°C (Packed in sterile breathable bags).
Features
High flow rate, high loading capacity
Low leachables
Low adsorption
Applications
Buffer filtration
Pre-column/ultra-filtration protection
Filtration of intermediate products/stock solutions
Filtration of serum and blood products, sterile filtration of terminal products
Filtration of colloidal or viscous liquids
Regulatory Compliance
Effluent meets the USP<788> requirement of particulate matter in large volume injection.
Component materials meet the criteria for a “Non-fiber-releasing filter”as defined in 21 CFR 210.3(b)(6).
Retention of 10⁷ cfu/cm² Brevundimonas diminuta(ATCC 19146) according to ASTM F838.
Aqueous extraction from a cartridge contains less than 0.25EU/ml as determined by Limulus Amebocyte Lysate (LAL), meeting requirements of USP<85>.
Components meet the requirement of USP <87> In Vitro Biological Reactivity Test.
Components meet the criteria of the USP <88> Biological Reactivity Test for Class V-121 °C plastics.
Components meet the FDA indirect Food Additive requirements cited in 21 CFR177-182.
Based on the current information from our suppliers, all components used in the manufacture of this product are animal-free.
*Contact us for more specification details.
Order Guidelines
1. Price & Stock Available on Request. Click to send email to: service@iright.com
2. Please DO NOT make payment before confirmation.
3. Minimum order value of $1,000 USD required.
Collaboration
Tony Tang
Email: Tony.Tang@iright.com
Mobile/WhatsApp/Wechat: +86-17717886924