
特色及优点
- Sanitary direct flow cartridges
- 6 log Titer Reduction (TR) for 50 nm viruses (DV50 grade)
- Robust size exclusion mechanism
- PVDF microporous membranes
- Narrow pore-size distribution
- Inherently water wettable
- Low binding for high protein yields
- Very low extractables
- Steamable in situ
- 100% integrity-tested
- Individually serialized
- Manufactured for use in conformance with cGMP
- ISO 9000 Certified Quality System
- Pharmaceutical P optimized
- Certificate of Test provided
- Validation Guide available
-
Discs and mini-cartridges (SBF Junior Style) available
Quality and Bio-Safety Biological Tests
Integrity
(正直诚信)
- Every DV50 grade filter integrity tested during manufacture.Test correlated to viral (phage) retention.
Biological Tests
- Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics
Effluent Quality Tests*
- Meets Cleanliness per USP Particulates in Injectables
- Non-Fiber-Releasing
- Non-Pyrogenic per USP Bacterial
Endotoxins (< 0.25 EU/mL)
- Meets Total Organic Carbon and Conductivity per USP Purified Water; pH per Sterile Purified Water
Autoclave Resistance
- Lot samples multi-cycle autoclave challenged
* Per lot sample or rinse-flush aliquots
Products in this datasheet may be covered by one or more patents including :
EP 0 667 800
EP 0 982 061
EP 1 380 331
US 5,543,047
US 5,690,765
US 5,725,784
US 6,113,784
US 7,083,564
US 7,318,800
US 5,736,051
材料成分
膜 | Hydrophilic modified polyvinylidenefluoride (PVDF) |
Support and Drainage | 聚酯 |
Core, Cage and End Caps | 聚丙烯 |
Code 7 Adapter | Polypropylene with encapsulated stainless steel reinforcing ring for steaming in situ |
O 型圈 | Silicone¹ |
Removal Ratings
DVD | Sub-0.1 µm prefilter |
DV50 | TR 106 for 50 nm viruses² |
Configuration (AB Code 7)
Double 226 O-ring adapters, fin end with bayonet lock |
Nominal Dimensions
Lengths | 10 in. (254 mm), 20 in. (508 mm), 30 in. (762 mm), 40 in. (1016 mm) |
Diameter | 70 mm (2.75 in.) |
Nominal Filter Area³
DVD | 0.9 m² (9.5 ft²) |
UDV50 | 1.63 m² (17.5 ft²) |
Typical Flow Rate
Clear water flow is 1 L/min @ 2 bard (29 psid) |
Operating Conditions*
Maximum Differential Pressure during Integrity Testing | 6.0 bard (90 psid) |
Maximum Differential Pressure for Continuous Service | 3 bard (43.5 psid) |
Recommended Operating ∆P | 1-2 bard (15 – 29 psid) |
Autoclave and Steaming in situ**
Maximum Temperature | 125 °C (257 °F) |
Aqueous Extractables (NVR) per 10 in. (254 mm) Element***
< 25 mg after autoclaving (water wet) |
< 5 mg after installation integrity testing (30% IPA/water wet), water flush and autoclaving |
