pall,颇尔,应用在 Kleenpak Nova囊式过滤器中的Supor EX Grade ECV膜,

pall,颇尔,应用在 Kleenpak Nova囊式过滤器中的Supor EX Grade ECV膜

Supor EX grade ECV filters are high capacity, high flow rate 0.2um sterilizing grade filters validated for the retention of B.diminuta (ATCC 19146) at a challenge level of 10⁷ cfu per cm² membrane.A unique polyethersulfone (PES) membrane pairing ensures Supor EX grade ECV filters deliver highly efficient filtration of cell harvest material, process intermediates, growth media, buffers and final bulk biological process fluids.Supor EX grade ECV filters also deliver unrivalled efficiency with more viscous process streams.

Kleenpak Nova capsules are designed for use in medium-to-large-scale production environments (50 L to > 1000 L).Kleenpak Nova 囊式过滤器通常可提供使用清洁型法兰或软管倒钩配件的“在线型”(NP) 或“T”型 (NT) 入口/出口配置。
 

Key Features and Benefits

• Available as 5-inch, 10-inch, 20-inch and 30-inch filter capsules for coverage of a broad range of fluid volumes
• Encapsulated format for minimized cleaning and low installation costs
• Easy integrity testing through Staubli vent valve
• Asymmetric PES membrane for excellent flow rates and high capacity per unit membrane
• Laid-over pleat filter construction with narrow core design maximizes available area per capsule for high device throughputs
• Low protein and preservative binding
• Fluid compatibility over a broad pH range for use in multiple applications

Quality Standards

A Certificate of Test provided with every filter documents the following:

• Filters are manufactured in a controlled environment
• Manufactured for use in conformance with cGMP
• Filters’ materials of construction meet USP Biological Reactivity Test in vivo for Class VI-121 °C plastics
• Q.C. lot release tests
• Fabrication Integrity - each filter has successfully passed a Forward Flow integrity test correlated to bacterial retention per modified ASTM F838-05
• Lot sample bacterial retention tests with Brevundimonas diminuta (ATCC 19146) at a challenge level of 10⁷ CFU/cm ²
• Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens per USP standard methods

材料成分

Filter Membrane	Dual Layer Hydrophilic PES
Support/Drainage	聚丙烯
Core/End Caps/ Fin/Adaptor	聚丙烯
Cage	Polypropylene with TiO2 whitener¹
O 型圈	Silicone elastomer
Sealing Technology	Thermal bonding without adhesives
Housing Bowl	聚丙烯
Housing Head	Polypropylene with TiO2 whitener

¹ TiO₂ is an insoluble inorganic mineral filler that does not contribute to organic extractables

Operating Parameters ²

Maximum Operating Temperature	40 °C
最大操作压力	3 bar (43.5 psi) at 40 °C
Maximum Differential Pressure	3 bar (43.5 psi) at 40 °C

² In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction.

Sterilization ³

Autoclave (G option only)	3 x 60 minutes at 125 °C
Gamma Irradiation (G option only)	Maximum of 50 kGy

³ Pre-sterilized Kleenpak Nova capsules must not be re-sterilized.Kleenpak Nova capsules must not be sterilized in-situ by passing steam under pressure

Typical Non Volatile Residue (NVR) Extractables in Water at 20 °C*

• < 150 mg NVR after 24 hours extraction (per 10 in. capsule)

* Tested on elements without pre-flushing after one 60 minute autoclave cycle at 125°C or after gamma-irradiation at 50 kGy

Nominal Dimensions

同轴的	NP5	NP6	NP7	NP8
Maximum Diameter including valves	154 mm (6.1 in.)	154 mm (6.1 in.)	154 mm (6.1 in.)	154 mm (6.1 in.)
Length with hose barb inlet/outlet	275 mm (10.8 in.)	397 mm (15.6 in.)	644 mm (25.4 in.)	895 mm (35.2 in.)
Length with sanitary inlet/outlet	213 mm (8.4 in.)	332 mm (13.1 in.)	584 mm (23.0 in.)	834 mm (32.8 in.)

T-style	NP5	NT6	NT7	NT8
Maximum Diameter including valves	不可用	240 mm (9.5 in.)	240 mm (9.5 in.)	240 mm (9.5 in.)
Length	不可用	349 mm (13.7 in.)	598 mm (23.5 in.)	848 mm (33.4 in.)

Nominal Effective Filter Area (EFA) and Clean Water Flow Rates

Capsule Size	Capsule Length (inches)(mm)	EFA (ft2) (m2)	Clean Water Flow at 100 mbar DP (L/min)
5	5 (127)	5.6 (0.52)	8.5
6	10 (254)	11.2 (1.04)	17
7	20 (508)	22.4 (2.08)	34
8	30 (762)	33.6 (3.12)	51

Integrity Test Values (Air test gas, water wet)**

Values for 10 in. capsule at 20°C
Max. allowable Forward Flow	21 mL/min at 2760 mbar (40 psi)

** Contact 颇尔 for multi-element integrity test values and recommended test procedures

Part Number Construction

N + (Style Code) + (Filter Size Code) + UECVP + (Connection Option Code) + (Shipping Format Code) + (Vent/Drain Option Code)

Example Part Number:NP6UECVP1G
(Kleenpak Nova Capsule with Supor EX Grade ECV Membrane, in-line style, 10-inch filter, 1 - 1½ in. sanitary flange inlet and outlet, supplied non-sterile gamma irradiatable/autoclavable)

Codes

Styles

Code	描述
P	同轴的
T	T-Style

Filter Sizes

Code	描述
5L*	5 inch (125mm)
6	10 inch (254 mm)
7	20 inch (508 mm)
8	30 inch (762 mm)

Connection Options

Code	描述
1	1 – 1½ inch sanitary flange inlet and outlet
9	1 inch (25 mm) single barb hose barb inlet and outlet
19	1 – 1½ inch sanitary flange inlet and 1 inch (25 mm) single barb hose barb outlet
6*	½ inch (13 mm) single barb hose barb inlet and outlet
16*	1 – 1½ inch sanitary flange inlet and ½ in. (13 mm) single barb hose barb outlet
1H**	1 – 1½ inch sanitary flange inlet and outlet, with ½ inch sanitary port on inlet
1H9**	1 – 1½ inch sanitary flange inlet and 1 inch (25 mm) single barb hose barb outlet, with ½ inch sanitary port on inlet

* For In-Line style only
** For T-style only

样式

Code	描述
Blank	Non-sterile autoclavable
G	Non-sterile gamma irradiatable/autoclavable
S	Pre-sterilized using gamma irradiation

Vent/Drain Options

Code	描述
Blank	Staubli vent and stepped hose barb drain
A	Staubli vent and drain

pall,颇尔,应用在 Kleenpak Nova囊式过滤器中的Supor EX Grade ECV膜