0.2µm AseptiCap DKLO


	Consistent and Reliable Quality:	AseptiCap capsule filters are produced with ISO 9001-2008 certified quality management systems.
	Regulatory Compliance:	Meet all pharmacopeial and compendia requirements and are registered with USFDA DMF #15554
	Low Protein Binding:	Results in increased overall product yield with biological streams.
	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.

For sterile filtration of alkaline fluid streams such as pH adjusters for Microbial fermentation processes.

Construction
Pore size		0.2µm
Membrane		Hydrophilic PES
Size		1"	2"	5"	8"
EFA (Effective Filtration Area)		230cm²	500cm²	1000cm²	2000cm²
Support Layers		Polypropylene
Dimension (End to End)	1½" Sanitary Flange	93 mm	111 mm	161 mm	213 mm
	Quick Connector	101 mm	121 mm	167 mm	218 mm
	¼" SHB	94 mm	121 mm	173 mm	231 mm
	½" HB	91 mm	113 mm	164 mm	215 mm
	¾" Sanitary Flange	91 mm	113 mm	164 mm	215 mm
Operational Radius (with Vent/ Drain)		30 mm	65 mm	65 mm	65 mm
Vent and Drain		1/4" Hose Barb with double Silicone "O" rings
Operational
Max. Operating Temperature		80 °C @ < 30 psi (2 Kg/cm²)
Max. Differential Pressure		60 psi (4 Kg/cm²) @ 30 °C
Bubble Point		> 50psi (3.52Kg/cm²) with Water
Sterilization	By Gas	Sterilizable by Ethylene Oxide
	By Autoclave	Autoclavable at 121°C for 30minute, 25 Cycles. Can not be steam sterilized
Assurance
Toxicity		Passes Bioreactivity test, In Vivo, as per USP for Class VI plastics
Cytotoxicity		Passes Biological Reactivity Tests, in vitro, USP <87> for cytotoxicity
Bacterial Retention		LRV> 7 for B. diminuta per cm² of filter area as per ASTM F 838-05
Bacterial Endotoxin		Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test
Non Fiber Releasing		Passes test as per USP and comply with USFDA 21 CFR Part 211.72 for fiber release
pH Compatibility		Compatible with pH range of 1 - 14
Extractables with WFI		Passes test as per USP
Fractional Dissolution		Comply with USFDA 21 CFR Part 177.1520
Oxidizable Substances		Within limits as specified in USP
Quality Management System		ISO-9001:2008 Certified
USFDA		DMF Type V No. 15554

Type
DKLO	DKLO

Size
Size	Code
1"	51
2"	52
5"	53
8"	57

Pore Size
Pore Size	Code
0.2µm	01

I/O Connection
Connection	Code
1/4” SHB	A
½”Hose Barb	D
1½" Sanitary Flange	E
3/4" Sanitary Flange	H
Quick Connector	J

X

Bell
	Code
Yes	B
No Bell	X

Sterile/ Non Sterile
	Code
Non Sterile	1

Pack Size
Pack Size	Code
1	01

DKLO

57

01

DD

X

1

01