Features and Benefits
- 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
- Every filter tested during manufacture. Test correlated to microbial retention
- Meets USP Biological Reactivity test, in vivo, for Class VI-121 °C Plastics
Effluent Quality Tests*
- Meets Cleanliness per USP Particulates in Injectables
- 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
- Lot samples multi-cycle autoclave challenged
* Per lot sample or rinse-flush aliquots.
Materials of Construction
|Support and Drainage||Polyester|
|Core and Cage||Autoclavable Version: Polypropylene
G and S Grades: Polyester
|End Caps and Shell||Polyester|
|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|
2 Also retains > 107 cfu/cm2 Acholeplasma laidlawii mycoplasma.
Nominal Filter Areas
|Maximum Diameter of Bowl (including Valves)||
|Length (including Sanitary Connection* [Code 1 and 8])||117 mm
|Maximum Pressure and Temperature||5.2 barg (75 psig) to 40 °C|
|Maximum Differential Pressure||4.1 bard (60 psid) at 40 °C|
Typical Liquid Flow Rates4
4 Typical 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 your local Pall representative.
Aqueous Extractables (NVR)5
|Non irradiated||7 mg||10 mg||12 mg||20 mg|
|Pre-sterilized||6 mg||12 mg||22 mg||N/A|
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
Warning: Kleenpak filters must not be steam-sterilized in situ by passing steam through under pressure.
|Gamma-irradiation Maximum Dosage (G Grade)||50 kGy|
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.