特色及优点
- 3 Log Titer Reduction (LTR) for 20 nm viruses
- 6 log LTR for 50 nm viruses
- Robust size exclusion mechanism
- Narrow pore-size distribution
- Low binding for high protein yields
- Inherently water wettable
- Very low extractables
- Autoclavable or steamable in situ
- Gamma-irradiatable
- 100% integrity-tested
- Individually serialized
- Manufactured for use in conformance with cGMP
- Pharmaceutical P optimized with certificate of test provided
- Clear housing for easy venting
-
New design sanitary valves:
- Non-removable for safety
- Non-threaded for cleanliness
Quality and Bio-Safety Biological Tests
Integrity
(正直诚信)
- Every 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 Water Conductivity per USP Purified Water, pH per USP Sterile Purified Water
Autoclave Resistance
- Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics
* Per lot samples soak or rinse-up flush aliquots
Products in this datasheet may be covered by one or more patents including :
US 7,273,550
EP 0 998 343
材料成分
Filter Medium | Hydrophilic polyvinylidenefluoride (PVDF) |
Support and Drainage | 聚酯 |
Core, Cage and Endcaps | 聚丙烯 |
Housing Shell | Polyetherimide |
O-rings¹ | Silicone |
¹ Other polymers available
Nominal Dimensions
CLM05DV20 | C3DV50 | |
Length | 84 mm (3.3 in.) | 157 mm (6.18 in.) |
Diameter | 123 mm (4.8 in.) | 123 mm (4.8 in.) |
Nominal Filter Area | 0.07 m² (0.75 ft²) | 0.4 m² (4 ft²) |
Inlet and Outlet
26 – 38 mm (1 – 1½ in.) sanitary flange |
除病毒
DV20 |
TR > = 10³ for 25 nm PP7 bacteriophage TR > = 106 for 53 nm PR772 bacteriophage |
DV50 | TR > = 106 for 53 nm PR772 bacteriophage |
Operating Conditions
Recommended Operating Pressure | 1 – 2 bard (15 – 29 psid) |
Maximum Differential* Pressure | 3 bard (43.5 psid) |
* Note:Maximum assembly pressure is 6.0 bard (90 psid) for short-term integrity testing
Aqueous Extractables (NVR)
< 5 mg/capsule (Deionized water at 20 °C [68 °F]) |
Flow/Pressure (Water, 25 °C [77 °F])
23 mL/min at 2 bar (29 psi) for CLM05DV20P1G |
0.3 L/min @ 2 bar (29 psi) for CL3DV50P1G |
Sterilization
Autoclavable and Steamable in situ for 3 x 1-hour cycles at up to 125 °C (257 °F) (non-irradiated product only).Gamma-irradiatable² |
² Contact 颇尔 for recommended procedures
Effluent Quality Tests (P 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 USP Sterile Purified waters
Part Number | 介质 | Type Rating |
CLM05DV20P1G | Hydrophilic PVDF | For viruses ≥ 20 nm |
CL3DV50P1G | Hydrophilic PVDF | For viruses ≥ 50 nm |