pall,颇尔,采用 Ultipor N66 膜的 Kleenpak 囊式过滤器,

pall,颇尔,采用 Ultipor N66 膜的 Kleenpak 囊式过滤器

颇尔 Kleenpak sterilizing-grade capsule filters with intrinsically hydrophilic Ultipor N66 membrane are self-contained sanitary filters designed for convenient small-batch sterile filtration of most biopharmaceutical solutions.Rugged, compact design ensures reliability.

特色及优点

100% integrity and pressure tested
0.2 micron NFP sterilizing-grade
0.1 micron NTP sterilizing-grade for bacteria and mycoplasma removal
Low filter extractables
Excellent solvent compatibility
Sanitary vent and drain valves with non-twist hose barbs
Low hold-up volumes (< 1 mL)
Gamma-irradiatable, autoclavable, and pre-sterilized versions available for maximum flexibility
Autoclavable versions can be repeatedly autoclaved
Manufactured for use in conformance with cGMP
ISO 9000 certified Quality system
Pharmaceutical P optimized
Certificate of test provided

Quality and Bio-Safety Biological Tests

Integrity
（正直诚信）

Every filter tested during manufacture.Test correlated to microbial 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 Sterile Purified Water

Autoclave Resistance

Lot samples multi-cycle autoclave challenged

* Per lot sample or rinse-flush aliquots.

材料成分


膜	尼龙 6,6
Support and Drainage	聚酯
Core and Cage	Autoclavable Version: 聚丙烯 G and S Grades: 聚酯
End Caps and Shell	聚酯
Vent and Drain Valve O-ring	Ethylene Propylene (EPDM)

Microbial Removal Ratings¹


NF	0.2 µm, sterilizing-grade, Brevundimonas diminuta
NT	0.1 µm, sterilizing-grade,²Brevundimonas diminuta

¹ Assembly lot samples retain > 10⁷ cfu/cm² of Brevundimonas diminuta per modified ASTM F838-83 and FDA guidelines.
² Also retains > 10⁷ cfu/cm² Acholeplasma laidlawii mycoplasma.

Nominal Filter Areas


Size Code	KA1	KA2	KA3	KA4
NF	0.05 m² (0.53 ft²)	0.1 m² (1 ft²)	0.2 m² (2.1 ft²)	0.5 m² (5.3 ft²)
NT	0.045 m² (0.4 ft²)	0.08 m² (0.8 ft²)	0.2 m² (2.1 ft²)	0.4 m² (4 ft²)

Nominal Dimensions


Size Code	KA1	KA2	KA3	KA4
Maximum Diameter of Bowl (including Valves)	94 mm (3.7 in.)	94 mm (3.7 in.)	109 mm (4.2 in.)	109 mm (4.2 in.)
Length (including Sanitary Connection* [Code 1 and 8])	117 mm (4.6 in.)	158 mm (6.2 in.)	174 mm (6.8 in.)	286 mm (11.2 in.)

* Sanitary connection is Tri-Clamp compatible.Tri-Clamp is a trademark of Alfa Laval, Inc

Operating Conditions³


Maximum Pressure and Temperature	5.2 barg (75 psig) to 40 °C
Maximum Differential Pressure	4.1 bard (60 psid) at 40 °C

³Using compatible liquids.Recommended maximum 3.5 barg (50 psig) in continuous air and gas service.KA*NT filters may be forward flow tested at 5171 mbar (75 psig) at ambient temperature.

Typical Liquid Flow Rates⁴

⁴Typical initial clean ∆P; water at 20 °C, 1 cP.Values shown are for 38 mm (1½ in.) sanitary flange connections.Values with other connections are available on request.For assistance, contact 上海羽令.

Aqueous Extractables (NVR)⁵


Size Code	KA1	KA2	KA3	KA4
Non irradiated	7 mg	10 mg	12 mg	20 mg
Pre-sterilized	6 mg	12 mg	22 mg	不可用

⁵ Water at 20 – 25 °C after autoclaving.
N/A = Filter not available

Steam Autoclaving⁶ (Non G and S Grades)


Cumulative Autoclave Time	16 hours at 125 °C 4 hours at 140 °C

⁶ Laboratory tests (1-hour cycles) establish multi-cycle.Filters should be qualified in actual use.Contact 颇尔 for recommended procedures
Warning:Kleenpak filters must not be steam-sterilized in situ by passing steam through under pressure.

Sterilization


Gamma-irradiation Maximum Dosage (G Grade)	50 kGy

注意事项：
S and G grades available in KA1 and KA2 with inlet and outlet options 1 and 2; KA3 with with inlet and outlet options 1 and 6.
Autoclavable grades available in KA1 and KA2 with inlet and outlet options 1 and 2; KA3 and KA4 with with inlet and outlet options 1 and 6.