Product Description
Check this product with a package size of C03-660cm² / 0.1/0.1μm / 19 mm (3/4") Sanitary Flange on Iright. 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
Filtration Area
C01-180cm²C02-420cm²C03-660cm²
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
Low adsorption
Applications
Mycoplasma removal application
Mycoplasma removal from buffer
Intermediate product filtration
Stock solution filtration
Terminal product filtration
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.
Typical Log Reduction Value (LRV) >7 of Acholeplasma laidlawii (ATCC 23206) 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