EVAM® Mono-Chamber EVA Bags

EVAM^® Mono-Chamber - Drug Delivery Bags

Integrity of the Nutrition Mixture

The EVAM^® ethylene vinyl acetate film used for the manufacturing of Sartorius Stedim Biotech bags is in conformance with ISO and USP Biocompatibility Standards and is covered by a Drug Master File (DMF) on record with the FDA.
EVAM film has an ultra low level of extractibles (USP <88> Plastic Class VI Test & ISO 10993-1) and contains no plasticizers.
Full transparency is a major advantage for the visual inspection of both the empty bag and the solution.
Each bag is air leak tested with filtered (0.2µm) compressed air (580g / cm2).

Quality Assurance

Sartorius Stedim Biotech's Quality System is ISO 9001 and ISO 13485 (EN 46001) certified.
CE Marking is in conformity with the 93/42/EEC Medical Device Directive.
Sartorius Stedim Biotech is a registered device manufacturer with the FDA.

Exhaustive Range of Products

Mono chamber bags are offered in nominal capacities ranging from 50ml up to 1L.
Bags are available with a 3-port tube connection: filling port, administration port and sampling/additive port.

Film Material

EVAM^®Ethylene Vinyl Acetate Co-Polymer

Film characteristics

Range of bag sizes

Description

Film Mechanical Typical Values

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

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

H₂O_vap 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

Method of Sterilization

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.