0.1µm AseptiCap^® KS-γ 5", 10", 20", 30"

LKSX5436EEXX101 LKSX5436EEXX301 LKSX5436EERX101LKSX5436IEXX101 LKSX5436IEXX301 LKSX5436IERX101LKSX5436EQXX101 LKSX5436EQXX301 LKSX5436EQRX101LKSX5436IQXX101 LKSX5436IQXX301 LKSX5436IQRX101LKSX5436QQXX101 LKSX5436QQXX301 LKSX5436QQRX101LKSX5436IIXX101 LKSX5436IIXX301 LKSX5436IIRX101LKSX5436EEXT101 LKSX5436EEXT301 LKSX5436EEXT101LKSX5536EEXX101 LKSX5536EEXX301 LKSX5536EERX101LKSX5536IEXX101 LKSX5536IEXX301 LKSX5536IERX101LKSX5536EQXX101 LKSX5536EQXX301 LKSX5536EQRX101LKSX5536IQXX101 LKSX5536IQXX301 LKSX5536IQRX101LKSX5536QQXX101 LKSX5536QQXX301 LKSX5536QQRX101LKSX5536IIXX101 LKSX5536IIXX301 LKSX5536IIRX101LKSX5536EEXT101 LKSX5536EEXT301 LKSX5536EEXT101LKSX5636EEXX101 LKSX5636EEXX301 LKSX5636EERX101LKSX5636IEXX101 LKSX5636IEXX301 LKSX5636IERX101LKSX5636EQXX101 LKSX5636EQXX301 LKSX5636EQRX101LKSX5636IQXX101 LKSX5636IQXX301 LKSX5636IQRX101LKSX5636QQXX101 LKSX5636QQXX301 LKSX5636QQRX101LKSX5636IIXX101 LKSX5636IIXX301 LKSX5636IIRX101LKSX5636EEXT101 LKSX5636EEXT301 LKSX5636EEXT101LKSX5336EEXX101 LKSX5336EEXX301 LKSX5336EERX101LKSX5336IEXX101 LKSX5336IEXX301 LKSX5336IERX101LKSX5336EQXX101 LKSX5336EQXX301 LKSX5336EQRX101LKSX5336IQXX101 LKSX5336IQXX301 LKSX5336IQRX101LKSX5336QQXX101 LKSX5336QQXX301 LKSX5336QQRX101LKSX5336IIXX101 LKSX5336IIXX301 LKSX5336IIRX101LKS15436EEXX101 LKS15436EEXX301 LKS15436EERX101LKS15436IEXX101 LKS15436IEXX301 LKS15436IERX101LKS15436EQXX101 LKS15436EQXX301 LKS15436EQRX101LKS15436IQXX101 LKS15436IQXX301 LKS15436IQRX101LKS15436QQXX101 LKS15436QQXX301 LKS15436QQRX101LKS15436IIXX101 LKS15436IIXX301 LKS15436IIRX101LKS15436EEXT101 LKS15436EEXT301 LKS15436EEXT101LKS15536EEXX101 LKS15536EEXX301 LKS15536EERX101LKS15536IEXX101 LKS15536IEXX301 LKS15536IERX101LKS15536EQXX101 LKS15536EQXX301 LKS15536EQRX101LKS15536IQXX101 LKS15536IQXX301 LKS15536IQRX101LKS15536QQXX101 LKS15536QQXX301 LKS15536QQRX101LKS15536IIXX101 LKS15536IIXX301 LKS15536IIRX101LKS15536EEXT101 LKS15536EEXT301 LKS15536EEXT101LKS15636EEXX101 LKS15636EEXX301 LKS15636EERX101LKS15636IEXX101 LKS15636IEXX301 LKS15636IERX101LKS15636EQXX101 LKS15636EQXX301 LKS15636EQRX101LKS15636IQXX101 LKS15636IQXX301 LKS15636IQRX101LKS15636QQXX101 LKS15636QQXX301 LKS15636QQRX101LKS15636IIXX101 LKS15636IIXX301 LKS15636IIRX101LKS15636EEXT101 LKS15636EEXT301 LKS15636EEXT101LKS15336EEXX101 LKS15336EEXX301 LKS15336EERX101LKS15336IEXX101 LKS15336IEXX301 LKS15336IERX101LKS15336EQXX101 LKS15336EQXX301 LKS15336EQRX101LKS15336IQXX101 LKS15336IQXX301 LKS15336IQRX101LKS15336QQXX101 LKS15336QQXX301 LKS15336QQRX101LKS15336IIXX101 LKS15336IIXX301 LKS15336IIRX101 Capsule filters, filters, asepticap

Consistent and Reliable Quality:	AseptiCap® capsule filters are produced with ISO 9001 certified quality management systems.
Regulatory Compliance:	Meet all pharmacopeial and compendia requirements and are registered with USFDA DMF #015554
Low Protein Binding:	Results in increased overall product yield
High Throughputs:	Translates to lower filtration costs, less number of filter changes and overall economy of operations.
Low Extractables:	Mean less addition to impurity profile of the biological product from the filters.

Construction
Membrane	0.1 µm Hydrophilic PES
Prefilter Membrane	0.2 µm or 0.45 µm Hydrophilic PES
Support Layers	Polyester
Plastic parts	Gamma Stable Polypropylene
Size
Size	5" 10" 20" 30"
Effective Filtration Area (Nominal)	3000cm² 6000cm² 12000cm² 18000cm²
Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Hose Barb Outlet	212 mm 334 mm 620 mm 870 mm
Dimension (End to End) - ¾" Sanitary Flange I/O	214 mm 335 mm -- --
Dimensions (End to End) Inline Capsule Filters - 1½" Sanitary Flange I/O	205 mm 330 mm 600 mm 855 mm
Dimensions (End to End) Inline Capsule Filters - ½" Single Step Hose Barb I/O	218 mm 336 mm 630 mm 890 mm
Dimension (End to End) - 1" Hose Barb I/O	-- 405 mm 635 mm 895 mm
Operational Radius (with Vent/ Drain)	78 mm 78 mm 78 mm 78 mm
Clean Water Flow Rate @ 10 psi with 1½" Sanitary Flange Connection	8 lpm 17 lpm 28 lpm 45 lpm
Vent and Drain	¼" Hose Barb with Silicone "O" rings
Integrity Testing / Retention
Max. Air Diffusion Flow (@ 50psi (3.51 Kg/cm²) with water	< 15 ml/min < 29 ml/min < 58 ml/min < 87 ml/min
Microbial Retention	LRV > 7 for Acholeplasma laidlawii ATCC 23206 per cm² of filter area
Operational
Max. Operating Temperature	80 °C @ < 30 psi (2 Kg/cm²)
Max. Differential Pressure	60 psi (4 Kg/cm²) @ 30 °C
Bubble Point	> 26 psi (1.82 Kg/cm²) with 50% IPA > 65 psi (4.56 Kg/cm²) with Water
Sterilization By Irradiation	Gamma Irradiatiable up to 50 kGy. These filters should not be autoclaved or in-line steam sterilized.
Shelf Life	2 years after gamma sterilization
Assurance
Toxicity	Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics
Cytotoxicity	Passes Biological Reactivity Tests, In Vitro, USP <87> for cytotoxicity
Bacterial Endotoxin	Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test
Bioburden	Bioburden level is < 1000 cfu/filter device as per ISO 11737-1 : 2018
Non Fiber Releasing	Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(6) for fiber release
TOC and Conductivity	Meets the WFI requirements of USP for TOC <643> and Conductivity <645> after a 10 liter flush for 5” capsule filters and 20 liter flush for 10” capsule filters
Indirect Food Additive	All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520
Extractables with WFI	Passes NVR test as per USP <661>
Good Manufacturing Practice	These products are manufactured in a facility which adheres to Good Manufacturing Practices.
Oxidizable Substances	Within limits as specified in USP <1231>
Particle Shedding	Passes USP test for particulates in injectables
Quality Management System	ISO-9001 Certified
USFDA	DMF No. 015554
pH Compatibility	Compatible with pH range of 1-10

Type AseptiCap® KS-γ (0.2 μm Upstream) LKS1 AseptiCap® KS-γ (0.45 μm Upstream) LKSX

Size Size Code 5" 53 10" 54 20" 55 30" 56

Pore Size Pore Size Code 0.1µm 36

I/O Connection Connection Code 1½" Sanitary Flange E 3/4” Sanitary Flange*** S 3/8” Hose Barb I Single Step ½”Hose Barb Q 1” Hose Barb Z

Radiation Sterilizable Code Yes R No* X

Inline/T-line Code Inline X T-line** T

Sterility Code Non Sterile 1 Gamma Sterile 3

Pack Size Pack Size Code 1 01

*Gamma sterilized filters cannot be gamma irradiated again

**T-line is not available in 5" Capsule filter

**T-line Capsule Filter are available with 1½” Sanitary Flange I/O Connection only

***3/4" Sanitary Flange end connection is available only in 5" and 10" capsule filters

Example:

LKSX

54

36

EE

R

X

1

01

Example for Non Sterile: LKSX5336EERX101          Example for Gamma Sterile: LKSX5336EEXX301

Datasheet	Download
Certificate of Quality	Download