默克密理博NovaSeptumzei高无菌等级的无菌取样装置

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Milli-Q无菌试验隔离, 整合了默克密理博旗下NovAseptic和NovaSeptum二大品牌的无菌取样方式，适用于不同取样体积。它们有一个共同......

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NovaSeptum®Sterile Sampling Units
	High Purity Flat Bag	Autoclavable Flat Bag	Bottle
Sampling Unit Volume	50 mL to 1000 mL	50 mL to 1000 mL	60, 125, 250, and 500 mL
Maximum Pressure Conditions (at 25°C )	0.50 bar (7.25 psi) up to 250 mL	0.30 bar (4.35 psi)	0.50 bar (7.25 psi) 0.30 bar for the multi-sampling unit
Maximum Pressure Conditions (at 25°C )	0.30 bar (4.35 psi) for 1000 mL and multi sampling
Temperature Range	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)
Materials of Construction
Trigger
Septum:	Medical Grade platinum-cured silicone
Body:	Polyester
Cannula:	ASTM 316L Stainless steel
Sampling Bag:	Polyethylene film (PureFlex film)	Polypropylene film	Polyethylene Terephtalate Glycol
Fluid Contact Layer:	Polyethylene film (PureFlex film)	Polypropylene film	Polyethylene Terephtalate Glycol
Tubing:	Polyethylene	Silicone	Polyethylene
Drainage Bag (valid for Multi-Sampling Application):	Polyethylene film (PureFlex film)	Not Applicable	Polyethylene film (PureFlex film)
Fittings
Inlet Tubing:	Septum with a 1 mm or a 2 mm needle
Outlet Tubing:	Tubing: 3-piece Luer, containing a male, female and an injection site	Tubing: Male Luer with Female cap	Tubing: Male Luer Fitting and Female to Female Luer
Autoclaving*	Not autoclavable	Autoclavable	Not autoclavable
USP <88> Class VI	All components in contact with sampling liquid conform with USP <88> Class VI.
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
Sterilization	The sampling units are sterilized by beta irradiation at ≥ 25 kGy according to ISO 11137		The sampling units are sterilized by gamma irradiation at ≥ 25 kGy according to ISO 11137
Bacterial Endotoxin	Aqueous extraction contains
* Autoclaving can only be performed on empty bags.

NovaSeptum® Sterile Sampling Units and Transfer System
	Syringe	Bag Transfer System	Tube Transfer System
Sampling Unit Volume	5 mL and 20 mL	250 mL	Not applicable
Maximum Pressure Conditions (at 25°C)	0.50 bar (7.25 psi)
Temperature Range	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)	-80° (When used with a NovaSeptum Case) to 50 °C (-112 to 122 °F)	Polyethylene: -20 to 50 °C (-4 to 122 °F) Silicone : -50 to 95 °C (-58 to 203 °F)
Materials of Construction
Trigger
Septum:	Medical Grade platinum-cured silicone
Body:	Polyester
Cannula:	ASTM 316L Stainless steel
Sampling Bag:	Not Applicable	Polyethylene film (PureFlex film)	Not applicable
Fluid Contact Layer:	Polycarbonate, medical grade platinum-cured silicone, medical silicone fluid	Polyethylene film (PureFlex)	Not applicable
Tubing:	Silicone	Polyethylene	Polyethylene or Silicone
Drainage Bag (valid for Multi-Sampling Application):	Polyethylene film (PureFlex film)	Not Applicable	Not Applicable
Fittings
Inlet Tubing:	Septum with a 1 mm or a 2 mm needle
Outlet Tubing:	Tubing: male and female luer	Septum Unit with a 1 mm or 2 mm needle	3-piece Luer, containing a male, female and an injection site
Autoclaving*	Single : autoclavable Multi : Not autoclavable	Not autoclavable	Not Autoclavable
USP <88> Class VI	All components in contact with sampling liquid conform with USP <88> Class VI.
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
Sterilization	The sampling units are sterilized by beta irradiation at ≥ 25 kGy according to ISO 11137
Bacterial Endotoxin	Aqueous extraction contains
* 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® Single-Use holder, TC 1.5 / 2“, 2 mm
Holder and Magazine	PEI Black
Locking ring	PEI Orange
Screw	A2-A4
Environmental
Design Temperature, TC holder	Steam in place cycle at up to 134 °C (273 °F) or Autoclave during 1 hour at up to 134 °C (273 °F) (when applicable)
Traceability	The product and packaging label includes the catalogue number, lot number and expiration date.
Sterilization	Gamma irradiation between 25 kGy and 40 kGy
Component Material Toxicity	All wetted components comply with USP USP <88> Class VI.
Endotoxin level	< 2.15 EU/device for all wetted components
Assembly	This product is manufactured in a clean room environment complying with class 8 according to ISO® 14644-1.
Packaging	Each Single use pre-loaded holder is double packed.