Dual-Chamber EVA TPN Bags

A Major Step Forward in TPN

  • The Sartorius Stedim Biotech Dual- Chamber bag is a major step forward for the preparation and mixing of TPN solutions. The bag is designed for separated storage of the lipid emulsion until reconstitution of the mixture just before administration. Complete mixtures are easily obtained by simply removing the separation rod.  

Enhanced Quality Assurance

  • The design maintains the integrity of the lipid emulsion and reduces the risk of an emulsion separation. Addition of vitamins and trace elements in the binary mixture allows for a more thorough visual inspection and reduces the potential for any precipitate.  
  • Sartorius Stedim Biotech's Dual- Chamber bag is the recommended choice when longer shelf life is necessary such as in home healthcare applications.
  • The range of potential formulations is maximized (provided the compatibility of the different components is validated).  
  • Full transparency of the film allows for the visual inspection of the bag's contents before and after reconstitution.

Complete and Easy Mixture Reconstitution

  • Easy reconstitution of the mixture is performed either by the patient at home or the nurse at the hospital by removing the separation rod.  

A Full Range

  • Dual-Chamber bags are offered in nominal capacities ranging from 500mL up to 4L.  
  • Bags are designed for filling by gravity or by automated compounders.

Film Material


EVAM® Ethylene Vinyl Acetate Co-Polymer

Film characteristics

  • Conformance with ISO and USP Biocompatibility Standards
  • Mono or Dual-Chamber bags
  • No plasticizers
  • Excellent clarity
  • Sterilization by ETO or Gamma

Range of bag sizes

  • 50mL – 5L

Description

  • EVAM® is a monolayer film made of high purity ethylene vinyl acetate 18%.
  • The film is manufactured by blown extrusion in our class ISO 7 cleanroom.

Film Mechanical Typical Values

The following properties are typical values obtained on freshly irradiated film with a minimum dose of 25 kGy.

 

  • Tensile Strength (N / mm2):

 

 

      Machine Direction:

150

      Transverse Direction:

110

      

 

 

  • Elongation @ Break (%):

 

 

      Machine Direction:

500

      Transverse Direction:

670

      

 

 

  • Temperature Range:

 

-85°C to +45°C

 

 

Permeability to gases and water vapor

 

  • O2 Transmission Rate @ 23ºC – 65% RH (ASTM D3985)

 

 

      (cc / m2 per 24 hours / 1 atm)

1 080

      (cc / 100 inch2 per 24 hours / 1 atm)

69.7

      

 

 

  • CO2 Transmission Rate @ 23ºC – 65% RH (ASTM D3985)

 

 

      (cc / m2 per 24 hours / 1 atm)

10 320

      (cc / 100 inch2 per 24 hours / 1 atm)

665

      

 

 

  • H2Ovap Transmission Rate @ 37ºC – 90% RH (NF H00-044)

 

 

      (g / m2 per 24 hours)

2.9

      (g / 100 inch2 per 24 hours)

0.187

Method of Welding

  • Radio Frequency

Method of Sterilization

  • Ethylene oxide (ETO) sterilization
  • Gamma Irradiation

Regulatory Information

  • Drug Master File No. 12633 on bags manufactured with EVAM® is available for registration dossiers.
  • Registered device manufacturer with the FDA - Class II medical devices.
  • The EVAM® film meets the requirements of the European Pharmacopoeia 1998 chapter 3.1.7 [Ethylene-vinyl-acetate copolymer for containers and tubing for total parenteral nutrition preparations].

Environmental Impact

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

Bio-compatibility Testing

  • The following tests have been performed on freshly irradiated film with a minimum dose of 25 kGy according to USP <88> (Plastic Class VI) Test and ISO 10993 studies:

Cytotoxicity Study using ISO Elution method

ISO 10993-5

USP<87>

Actute Intracutaneous Reactivity Study in the rabbit

ISO 10993-10

USP<88>

Acute Systemic Toxicity in the mouse

ISO 10993-11

USP<88>

Muscle Implantation Study in the rabbit

ISO 10993-6

USP<88>

Sensitization Study in the guinea pig

ISO 10993-10

 

Subchronic Intravenous Toxicity Study in the rat

ISO 10993-11

 

Genotoxicity: Reverse Mutation Study

ISO 10993-3

 

Motagenicity

ISO 10993-3

 

Haemocompatibility Studies

ISO 10993-4

 

(Clotting Time, Hemolysis)

 

 
  • The following tests have been performed on 2 years artificially aged irradiated film according to USP <88> (Plastic Class VI) Test and ISO 10993 studies:

Cytotoxicity Study using ISO Evolution method

ISO 10993-5

USP<87>

Acute Intracutaneous Reactivity Study in the rabbit

ISO 10993-10

USP<88>

Acute Systemic Toxicity in the mouse

ISO 10993-11

USP<88>

Muscle Implantation Study in the rabbit

ISO 10993-6

USP<88>

Hemolys slides

ISO 10993-4

USP<88>
  • Film freshly irradiated at 50 kGy was tested and passed the USP<661> Physico-chemical tests for plastics.

Ordering Information


Order code

Description

Qty/Box

FNB103219

Nutripoche® EVAM® 2-Compartment 500 mL (Luer Lock)

50

FNB103218

Nutripoche® EVAM® 2-Compartment 1L (Luer Lock) 

50

FNB102397

Nutripoche® EVAM® 2-Compartment 2L (Luer Lock)  

50

FNB103592

Nutripoche® EVAM® 2-Compartment 3L (Luer Lock) 

50

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 TPN Dual-Chamber Bags