Fluorodyne EX grade EDF filters are 0.2 micron rated high capacity, low protein binding sterilizing grade filters.Incorporating a built-in prefiltration layer and validated to retain B. diminuta at a challenge level of 107 cfu/ cm2 of membrane, Fluorodyne EX grade EDF filters are ideal for the sterile filtration of cell harvest material and challenging intermediate and final bulk biological process fluids..
Mini Kleenpak™ capsules are compact filters used in the laboratory for volumes of 2 L to 50 L in process development, and in pilot and manufacturing scale operations if processing requirements do not demand a large filter.These filters are the smallest capsule filters in the UpScaleSM Program range to utilize a pleated membrane, and are excellent for modeling filter performance at large production scale.
Key Features and Benefits
- Encapsulated format for higher flexibility, minimized cleaning and low installation costs
- Minimal hold up volume
- Ideal for scaling trials
- Asymmetric, built-in prefilter layer for highest dirt-holding capacity
- Validated for retention of B. diminuta when challenged with a minimum concentration of 107 CFU/cm² EFA
- High flow rate
- Low protein and preservative binding
- Low extractables
- Designed for autoclaving or SIP under wet or dry conditions
Quality Standards
- Manufactured for use in conformance with cGMP
- 100% integrity tested
- ISO 9000 Certified Quality System
- Meets USP Biological Reactivity Test in vivo for Class VI-121 °C plastics
- Every filter tested during manufacture.Test correlated to microbial retention
-
Certificate of Test provided includes:
- Fabrication Integrity
- Bacterial Retention
- Materials of construction
- Effluent quality for cleanliness, TOC and Water Conductivity, pH and Pyrogens
延伸阅读
海报：Scale Up of Direct Flow Membrane Filters 文章：Bacterial Penetration of 0.2 μm Sterilizing-Grade Filters with a Cholesterol Liposome Carrier:A Comparison of Data材料成分
| Filter Membrane |
Prefilter Layer: Hydrophilic asymmetric PES Final Filter Layer: Hydrophilic PVDF |
| Support/Drainage | 聚丙烯 |
| Capsule Shell, Core and Endcaps | 聚丙烯 |
| Filling Bell | 聚碳酸酯 |
| Sealing Technology | Thermal bonding without adhesives |
Operating Parameters¹
| Maximum Operating Temperature | 40 °C |
| Maximum operating pressure | 4.1 bar (60 psi) at 38 °C |
Sterilization²
| Autoclave | 3 x 30 minutes at 135 °C |
| Gamma Irradiation | Maximum of 50 kGy |
Typical Extractables in Water at 20 °C
| < 5 mg for the non-irradiated filter capsule |
Nominal Dimensions
| Maximum diameter including valves | 53 mm (2.1 in.) |
|
Length - Code 2 Length - Code 8 |
105 mm (4.1 in.) 73 mm (2.9 in) |
Nominal Effective Filter Area (EFA)
| 230 cm² (0.25 ft²) |
Removal Rating³
| 0.2 微米 |
| 项目 | Part Number* |
|
Mini Kleenpak™ Capsule with Fluorodyne® EX EDF Membrane ¼ in - ½ in (6 mm - 13 mm) hosebarb, supplied non sterile, gamma irradiatable/autoclavable |
KA02EDFP2G |
|
Mini Kleenpak™ Capsule with Fluorodyne® EX EDF Membrane ¼ in - ½ in (6 mm - 13 mm) hosebarb, supplied pre-sterilized using gamma irradiation |
KA02EDFP2S |
|
Mini Kleenpak™ Capsule with Fluorodyne® EX EDF Membrane ½ in - ¾ in (13 mm - 19 mm) sanitary flange, supplied non sterile, gamma irradiatable/autoclavable |
KA02EDFP8G |
|
Mini Kleenpak™ Capsule with Fluorodyne® EX EDF Membrane ½ in - ¾ in (13 mm - 19 mm) sanitary flange, supplied pre-sterilized using gamma irradiation |
KA02EDFP8S |
