AseptiVent TF- 1", 2", 5", 8"


	Consistent and Reliable Quality:	AseptiVent 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
	Air Flow rates/ Hydrophobicity	Translates to lower filtration costs, less number of filter changes and overall economy of operations.

Fermentor exhaust
Sterile air for cell factories
Venting of sterile collection vessels
Cleaning sterile surfaces

Construction
Final Filter Pore Size		0.2µm		0.45µm
Membrane		Hydrophobic PTFE
Support Layers		Polypropylene
Body and Core		Polypropylene
Integrity Testing / Retention
Bubble Point		> 22psi (1.55Kg/cm²) (with 70% IPA Wetted)		> 10psi (0.7Kg/cm²) (with 70% IPA Wetted)
Microbial Retention (LRV >7 for)		Brevundimonas diminuta (ATCC 19146) per cm²		LRV >7 for Serratia marcescens (ATCC 14756) per cm²
Size
Size		1"	2"	5"	8"
Effective Filtration Area (Nominal)		250cm²	500cm²	1000cm²	2000 cm²
Dimension (End to End)	1½" Sanitary Flange I/O	93 mm	111 mm	161 mm	213 mm
	½" Hose Barb I/O	91 mm	113 mm	164 mm	215 mm
	Quick Connector	101 mm	121 mm	167 mm	218 mm
	¼" SHB	94 mm	121 mm	173 mm	231 mm
	¾" Sanitary Flange I/O	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 @ < 2 Kg/cm² (30 psi)
Max. Differential Pressure (Forward)		< 4 Kg/cm² (60 psi) @ 30 °C
Sterilization	By Gas	Sterilizable by Ethylene Oxide
	By Autoclave	Autoclavable at 121 °C for 30 minutes. 50 Cycles. Can not be in-line steam sterilized.
Assurance
Toxicity		Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics
Microbial Bacterial Retention		Validated as per ASTM F 838-05
Bioburden		Bioburden level is < 1000 cfu/filter device as per ANSI/AAMI/ISO 11737-1 : 1995
Bacterial Endotoxin		AAqueous extracts exhibit < 0.5 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 and 210.3 (b)(6) for fiber release
Oxidizable Substances		Within limits as specified in USP
Particle Shedding		Passes USP test for particulates in injectables
Indirect Food Additive		All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520
Good Manufacturing Practice		These products are manufactured in a facility which adheres to Good Manufacturing Practices
Quality Management System		ISO-9001:2008 Certified
		ISO-13485 : 2003 for Medical Devices Only
USFDA		DMF Type V No. 15554

Type
AseptiVent TF	DTLX

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

Pore Size
Pore Size	Code
0.2µm	01
0.45µm	02

I/O Connection
Connection	Code
¼" SHB	A
¼" MNPT	B
½"MNPT	C
½”Hose Barb	D
1½" Sanitary Flange	E
¾" Sanitary Flange	S
Quick Connector	J
Single Step ½" Hose Barb	Q

XX

Sterility
	Code
Non Sterile	1
EO Sterile	2

Pack Size
Pack Size	Code
1	01

DTLX

53

01

DD

XX

1

01

Check for End Connection Availablity for Different Sizes