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NovaSeptum^® GO Sterile Sampling Systems

A secure and flexible system for sampling fluids throughout sterile and aseptic processes More

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Overview

Specifications

Ordering Information

NovaSeptum^® GO Conical TubesClear Sorting & Filtering Show Filter Hide Filter
Catalogue Number	Description	Pack Size
EC71-80015	NovaSeptum GO; Conical Tube; 15ml - Single	40
EC74-80015	NovaSeptum GO; Conical Tube; 5x15ml	8

NovaSeptum^® GO High Purity Flat BagsClear Sorting & Filtering Show Filter Hide Filter
Catalogue Number	Volume	Device Configuration	Needle Size	Pack Size
E711-10050	50 mL	Single sampling	2.0 mm	50
E711-10100	100 mL	Single sampling	2.0 mm	50
E711-10250	250 mL	Single sampling	2.0 mm	50
E711-11000	1 L	Single sampling	2.0 mm	50
E714-10050	5*50 mL	Multi-sampling	2.0 mm	5
E714-10100	5*100 mL	Multi-sampling	2.0 mm	5
E714-10250	5*250 mL	Multi-sampling	2.0 mm	5

NovaSeptum^® GO BottlesClear Sorting & Filtering Show Filter Hide Filter
Catalogue Number	Volume	Device Configuration	Needle Size	Pack Size
E871-80060	60 mL	Single sampling	2.0 mm	40
E871-80125	125 mL	Single sampling	2.0 mm	25
E871-80250	250 mL	Single sampling	2.0 mm	20
E871-80500	500 mL	Single sampling	2.0 mm	12
E874-80060	5*60 mL	Multi-sampling	2.0 mm	5
E874-80125	5*125 mL	Multi-sampling	2.0 mm	4
E874-80250	5*250 mL	Multi-sampling	2.0 mm	3

NovaSeptum^® GO Autoclavable Bags Clear Sorting & Filtering Show Filter Hide Filter
Catalogue Number	Volume	Device Configuration	Needle Size	Pack Size
E221-00215	50 mL	Single sampling	2.0 mm	40
E221-00216	100 mL	Single sampling	2.0 mm	40
E221-C0243	250 mL	Single sampling	2.0 mm	40
E221-C0244	1 L	Single sampling	2.0 mm	40

NovaSeptum^® GO Accurate Volume SyringesClear Sorting & Filtering Show Filter Hide Filter
Catalogue Number	Volume	Device Configuration	Needle Size	Pack Size
E461-90005	5 mL	Single sampling	2.0 mm	50
E461-90020	20 mL	Single sampling	2.0 mm	40
E464-90005	5*5 mL	Multi-sampling	2.0 mm	5
E464-90020	5*20 mL	Multi-sampling	2.0 mm	5

NovaSeptum^® GO Transfer UnitsClear Sorting & Filtering Show Filter Hide Filter
Catalogue Number	Needle Size	Tubing Material	Length	Fitting Outlet	Pack Size
E511-10014	2.0 mm	Medical grade, Thermoplastic elastomer (TPE)	500 mm	3-piece Luer	50
E521-10014	2.0 mm	Medical grade, platinum-cured silicone	500 mm	3-piece Luer	50
E541-00020	2.0 mm	C-Flex® elastomer	1000 mm	3-piece Luer	50

NovaSeptum^®GO Holders - TC HolderClear Sorting & Filtering Show Filter Hide Filter
Catalogue Number	Description	Pack Size
ET12/2-3D0	NovaSeptum^® GO holder, 1-port TC 25	1
ET52/5-3D0	NovaSeptum^® GO holder, 5-port TC 50,5	1
ET92/6-3D0	NovaSeptum^® GO holder, 9-port TC 64	1

NovaSeptum^® GO High Purity Flat Bags - Pre-loadedClear Sorting & Filtering Show Filter Hide Filter
Catalogue Number	Volume	Device Configuration	Needle Size	Pack Size
E5SU711-10050	50 mL	5 Single sampling	2.0 mm	8
E5SU711-10100	100 mL	5 Single sampling	2.0 mm	8
E5SU711-10250	250 mL	5 Single sampling	2.0 mm	7
E5SU711-11000	1 L	5 Single sampling	2.0 mm	6
E9SU711-10050	50 mL	9 Single sampling	2.0 mm	3
E9SU711-10100	100 mL	9 Single sampling	2.0 mm	3
E9SU711-10250	250 mL	9 Single sampling	2.0 mm	3
E9SU711-11000	1 L	9 Single sampling	2.0 mm	3

NovaSeptum^® GO Bottles - Pre-loadedClear Sorting & Filtering Show Filter Hide Filter
Catalogue Number	Volume	Device Configuration	Needle Size	Pack Size
E5SU871-80060	60 mL	5 Single sampling	2.0 mm	6
E5SU871-80125	125 mL	5 Single sampling	2.0 mm	4
E5SU871-80250	250 mL	5 Single sampling	2.0 mm	3
E5SU871-80500	500 mL	5 Single sampling	2.0 mm	2
E9SU871-80060	60 mL	9 Single sampling	2.0 mm	3
E9SU871-80125	125 mL	9 Single sampling	2.0 mm	2
E9SU871-80250	250 mL	9 Single sampling	2.0 mm	1

NovaSeptum^® GO Autoclavable Bags - Pre-loadedClear Sorting & Filtering Show Filter Hide Filter
Catalogue Number	Volume	Device Configuration	Needle Size	Pack Size
E5SU221-00215	50 mL	5 Single sampling	2.0 mm	8
E5SU221-00216	100 mL	5 Single sampling	2.0 mm	8
E5SU221-C0243	250 mL	5 Single sampling	2.0 mm	7
E5SU221-C0244	1 L	5 Single sampling	2.0 mm	6
E9SU221-00215	50 mL	9 Single sampling	2.0 mm	3
E9SU221-00216	100 mL	9 Single sampling	2.0 mm	3
E9SU221-C0243	250 mL	9 Single sampling	2.0 mm	3
E9SU221-C0244	1 L	9 Single sampling	2.0 mm	3

NovaSeptum^® GO Accurate Volume Syringes - Pre-loadedClear Sorting & Filtering Show Filter Hide Filter
Catalogue Number	Volume	Device Configuration	Needle Size	Pack Size
E5SU461-90005	5 mL	5 Single sampling	2.0 mm	6
E5SU461-90020	20 mL	5 Single sampling	2.0 mm	4
E9SU461-90005	5 mL	9 Single sampling	2.0 mm	3
E9SU461-90020	20 mL	9 Single sampling	2.0 mm	2

NovaSeptum^® GO Pre-loaded Starter kitsClear Sorting & Filtering Show Filter Hide Filter
Catalogue Number	Description	Pack Size
EAT52/5-3D0	NovaSeptum^® base/nut, 5-port TC 50,6	1
EAT92/6-3D0	NovaSeptum^® base/nut, 9-port TC 64	1

NovaSeptum^® GO AccessoriesClear Sorting & Filtering Show Filter Hide Filter
Catalogue Number	Description	Pack Size
E202	NovaSeptum^® GO Port plug	100
ENSTAG	First actuation locking tag	100
ET-BAGRACK-KIT	NovaSeptum^® GO bagrack fixture kit for Tri-Clamp holders	1
A100	NovaSeptum Crimping tool	1
A104	NovaSeptum Manual Crimping Tool Spare Part Kit	1
NSTP-3X6	Crimped Tube Protector Caps	100

Volume Indicator RulerClear Sorting & Filtering Show Filter Hide Filter
Catalogue Number	Description	Pack Size
NSRULER-10050	Volume Indicator Ruler, 50 mL	50
NSRULER-10100	Volume Indicator Ruler, 100 mL	50
NSRULER-10250	Volume Indicator Ruler, 250 mL	50
NSRULER-11000	Volume Indicator Ruler, 1000 mL	50

Documentation

Material Qualification Dossier

Title	Version
EMPROVE® Material Qualification Dossier for NovaSeptum^® GO Sterile Sampling Systems	7.0

Quality Management Dossier (Open Access)

Title
EMPROVE® Quality Management Dossier for NovaSeptum^® GO Sterile Sampling Systems

Related Products & Applications

C213427A secure and flexible system for sampling fluids throughout sterile and aseptic processes

Benefits

Sampling actuation evidence and control, ensures process integrity and a representative sample
Closed, easy to use and validate, the system improves operational efficiency and reduces risk of contamination
Presterilized, eliminating the need for cleaning and/or sterilization between samples
Preconfigured or configure on site
Accommodates a wide range of holders and sampling configurations for adaptable, flexible sampling throughout your process

To demonstrate the safety and integrity of your product, you need a standard-setting sampling solution that provides the flexibility to sample throughout your entire process. It is critical that samples are consistently representative. Therefore the method used should be designed to protect against the risk of potential cross contamination in both your formulation and sample. Our NovaSeptum^® GO sterile sampling system addresses these requirements.

A closed, sterile sampling method can significantly reduce your sampling risk and is recommended by regulatory bodies.
Ideal for sampling from aseptic and sterile processes, the NovaSeptum^® GO sterile sampling system is designed with your needs in mind. The innovative, closed design ensures your sample will be isolated from point of sample to analysis, reducing the risk of losing valuable product while maintaining the integrity of your fluid samples. NovaSeptumm^® GO security capabilities also provide an extra level of confidence in your risk mitigation strategy by allowing the device to be locked and containers sealed when not in use, keeping your sample safe and process under control.

NovaSeptum^® GO Sterile Sampling Units
	Conical Tube	High Purity Bag	Autoclavable Bag	Bottle	Syringe	Tube transfer
Sampling Unit Volume	15 mL and 50 mL	50 mL to 1000 mL	50 mL to 1000 mL	60, 125, 250, and 500 mL	5 mL and 20 mL	Not applicable
Maximum Pressure Conditions (at 25°C )	0.50 bar for the single unit 0.30 bar for the multi-sampling unit with drainage bag	0.50 bar (7.25 psi) up to 250 mL 0.30 bar (4.35 psi) for 1000 mL and multi sampling	0.30 bar (4.35 psi)	0.50 bar (7.25 psi) 0.30 bar for the multi-sampling unit	0.50 bar (7.25 psi)	0.50 bar (7.25 psi)
Temperature Range	8 to 60°C (46° to 140°F)	50 mL to 250 mL: -80° (when used with a NovaSeptum Case) to 50 °C (-112 to 122 °F) 1000 mL: -20° to 50 °C (-4 to 122 °F)	-20 to 125 °C (-4 to 257 °F)	-80 to 50 °C (-112 to 122 °F)	Single 5ml : -80 to 134 °C (-112 to 273 °F) Single 20ml : -80 to 121 °C (-112 to 250 °F) Multi: -20 to 50°C (-4 to 122 °F)	Thermoplastic elastomer (TPE): -20 to 50 °C (-4 to 122 °F) Silicone : -50 to 95 °C (-58 to 203 °F) C-Flex®: -73 to 132 °C (-99 to 270 °F)
Materials of Construction
Trigger		Septum: Platinum-cured silicone; Body: Polyester; Cannula: ASTM^® 316 L Stainless steel
Sampling Bag:	N/A	Polyethylene film (PureFlex film)	Polypropylene film	N/A	N/A	N/A
Fluid Contact Layer:	Polystyrene (15 mL) Polypropylene (50 mL)	Polyethylene film (PureFlex film)	Polypropylene film	Polyethylene Terephtalate Glycol	Polycarbonate, platinum-cured silicone, medical silicone fluid	N/A
Tubing:	Medical grade Thermoplastic Elastomer	Thermoplastic elastomer (TPE)	Silicone	Thermoplastic elastomer (TPE)	Silicone	Thermoplastic elastomer (TPE), silicone or C-Flex® tube
Drainage Bag (valid for Multi-Sampling Application):	Polyethylene film (PureFlex film)	Polyethylene film (PureFlex film)	N/A	Polyethylene film (PureFlex film)	Polyethylene film (PureFlex film)	N/A
Bottle cap	N/A	N/A	N/A	Polypropylene	N/A	N/A
Fittings
Inlet Tubing:		Septum with a 2 mm needle
Outlet Tubing:	Tubing: 3-piece Luer-Lok™, containing a male, female and an injection site	Tubing: 3-piece Luer-Lok™, containing a male, female and an injection site	Tubing: Male Luer-Lok™ with female cap	Cap	Female and male Luer-Lok™	3-piece Luer-Lok™, containing a male, female and an injection site
Autoclaving*	NO	Not autoclavable	Autoclavable	Not autoclavable	Single: Yes Manifold: No	Not autoclavable
USP 88Class VI	All component materials, in contact with sampling liquid, meet the criteria for Class VI testing based on USP <88> Biological Reactivity, in vivo.
Integrity Testing	Units are integrity tested at regular intervals during manufacturing.
Assembly	Assembled under ISO^® Clean Room Class 8 conditions in a facility certified to ISO® 14644-1 standards.
Sterilization	Gamma irradiation at ≥ 25kGy according to ISO® 11137	Beta irradiation at ≥ 25kGy according to ISO^®11137	Beta irradiation at ≥ 25kGy according to ISO^®11137	Gamma irradiation at ≥ 25kGy according to ISO^® 11137	Beta irradiation at ≥ 25kGy according to ISO^® 11137	Beta irradiation at ≥ 25kGy according to ISO^® 11137
Bacterial Endotoxin	Aqueous extraction contains < 2.15 EU per device as determined using the Limulus Amebocyte Lysate (LAL) test.
* Autoclaving can only be performed on empty bags.

NovaSeptum^® Case
Compatible with Sampling Unit Volume	50 mL, 100 mL and 250 mL
Maximum Pressure Conditions (at 25°C)	0.50 bar (7.25 psi) up to 250 mL
Operating Temperature	-80 to 37 °C (-112 to 98.6 °F)
Materials of Construction	APET (Amorphous Polyethylene Terephthalate) noble
Sterilization	Non-sterile

NovaSeptum^® GO Holder
Materials of Construction
Wetted Materials	Stainless steel 316L, EN 1.4435
Magazine	GF reinforced Polysulfone (PSU) for 5 and 9 shot TC holders. Polyphenylene sulfide (PPS) for 1 shot TC, Ingold^®, and in-line holders.
Safety ring	Polysulfone for 5 and 9 shot TC holders. Polyester for 1 shot TC, Ingold^®, and in-line holders.
Autoclavable/Steam-in-Place	Yes
Tube Standards
TC and Ingold®	N/A
In-line TC, Butt-end	ASTM^® A270, DIN 11850 (Part 2)
Design Pressure:	6 bar(g) (87 psi)
Design Temperature:	-80°C to 150°C (-112°F to 302°F)

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