S71 Multilayer Mono-Chamber Bag

  • The S71 bag offers extremely low oxygen permeability, due to its high gas barrier properties.  
  • Oxygen permeability of the S71 bag is approximatively 70 times lower than standard EVA bags.  
  • These high gas barrier properties are important for hospital pharmacies and compounding centers who produce bags for intermediate storage and where longer shelf-life is necessary.  

Film material


S71 : Multi layer high gas barrier Film

Film characteristics

  • EVAM® fluid contact layer
  • Conformance with ISO and USP Biocompatibility Standards
  • Excellent clarity
  • Sterilization by Gamma

Main applications

  • Drug delivery
  • Parenteral nutrition
  • Ideal for O2 sensitive drugs

 

 

Range of bag sizes : 50mL – 5L

Description

  • S71 is a multi layer robust high gas-barrier film containing Ethylene Vinyl Acetate (EVA) copolymer as a fluid contact layer (EVAM® layer) and Ethylene Vinyl Alcohol Copolymer (EVOH) as gas barrier layer minimizing transmission of gases such as 02 and CO2 accross the film.
  • The film is manufactured in our class ISO 7 cleanroom (Class 10000 or Grade C).

Film mechanical properties

The values given are "reference values". They have been obtained by testing different irradiated batches between 25-45 kGy of S71 film (thickness 360µ)

  • Ultimate tensile strengh (ISO 527, MPa)

      Machine Direction:

26

      Transverse Direction:

19
  • Elongation at break (ISO 527, %)

 

 Machine Direction:

608

      Transverse Direction:

793

Operating temperatures
The mechanical properties of the S71 film have been validated between -70°C and 45°C. The use of S71 bags at temperatures outside this range cannot be guaranteed.

 

Permeability to gases and water vapor results

 

  • O2 Transmission Rate at 23ºC – RH= 50% on the external side, RH= 90% on the internal side (ASTM D3985)

 

 

      (cc3 l m2 per 24 hours) 300 µm Film

12

      (cc / m2 / per 24 hours / 1 atm) 360 µm Film

8

      

 

 

  • Water vapor transmission rate at 23ºC, RH= 0% on the external side, RH= 100% on the internal side (ASTM F1249)

 

 

      (g / m2 per 24 hours) 300 µm Film

< 2,5

      (g / m2 per 24 hours) 360 µm Film

< 2,4

Method of Welding: Radio Frequency

Method of Sterilization: Gamma Irradiation

Regulatory Information

  • Drug Master File No. 13014 on bags manufactured with S71 is available for registration dossiers.
  • Registered device manufacturer with the FDA - Class II medical devices.
  • The EVAM® contact layer meets the requirements of the European Pharmacopoeia chapter 3.1.7
    [Ethylene-vinyl-acetate copolymer for containers and tubing for total parenteral nutrition preparations].

Environmental Impact

  • S71 film disposal may be done in an approved landfill or preferably by incineration under locally approved conditions.
  • At temperatures above 238ºC, S71 film will release decomposition products, which may include acetaldehyde, crotonaldehyde, acetone, acetic acid, carbon monoxide and dioxide, hydrocarbons.

Ordering Information


Order code

Description

Qty/Box

FNB102221

Nutripoche® High Gas Barrier 250 mL (Luer Lock)

50

FNB103377

Nutripoche® High Gas Barrier 500 mL (Luer Lock)

50

FNB103339

Nutripoche® High Gas Barrier 1L (Luer Lock)  

50

FNB103428

Nutripoche® High Gas Barrier 2L (Luer Lock)  

25

FNB103635

Nutripoche® High Gas Barrier 3L (Luer Lock) 

25

FNB102368

Nutripoche® High Gas Barrier 4L (Luer Lock)

25