S71 Multilayer Mono-Chamber Bag - Drug Delivery

  • 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.  

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

FDB102011

DDS S71 Bag 50 mL 

50

FDB102014

DDS S71 Bag 150 mL   

50

FDB102016

DDS S71 Bag 250 mL   

50

FDB102069

DDS S71 Bag 500 mL   

50

FDB102018

DDS S71 Bag 1000 mL   

50