|PureFlex™ Single-Use Process Container Films|
PureFlex™ Single-use process container films are flexible, robust and chemical resistant materials used in the construction of our single-use process containers, including Mobius® assemblies and NovaSeptum® sterile sampling products.
Single-use containers made with PureFlex™ films are employed throughout the biopharmaceutical production process and are free of animal derived components.
PureFlex film is a high purity, medical grade, coextruded film designed to provide strength, flexibility (with maximum resistance to flex-crack), excellent gas barrier performance and inert contact. The fluid contact material is made of ultra low density polyethylene (ULDPE). The gas barrier is made of polyethylene vinyl alcoholcopolymers (EVOH). The outer layers are made of ethylene vinyl acetate (EVA) and ULDPE. PureFlex film contact layers comply with the Food and Drug Administration (FDA) regulation 21 CFR 177.1520.
For particularly demanding applications often encountered in large volume operations (>500L), additional robustness may be required to assure single-use process container integrity. PureFlex™ Plus film is constructed with a tough, linear low density polyethlene (LLDPE) outer layer. This rugged outer layer increases the film's resistance to leak formation through abrasion, puncture, stretching, and tearing. The inner layers, including the product contact layer, are identical to PureFlex™ film, maintaining the same extractables profile and gas barrier properties.
The Emprove® Program
The Emprove® Program complements the product portfolio through
- Comprehensive documentation to support qualification, risk assessment and process optimization needs.
- Consolidation of product specific testing, quality and regulatory information to simplify compliance requirements.
- Convenient 24/7 access to up-to-date product information.
|Physical Data (Post gamma irradiation)|
|Properties||Tests||PureFlex Average Values1||PureFlex Plus Average Values2|
|Tensile Strength||ASTM D882||2700 psi (18.6 Mpa)||2245 psi (15.4 Mpa)|
|Yield Strength||ASTM D882||1360 psi (9.4 Mpa)||2000 psi (13.7 Mpa)|
|Secant Modulus||ASTM D882||37 kpsi (255 Mpa)||39 kpsi (269 Mpa)|
|Toughness||ASTM D882||9100 in-Lbf/in3 (63 M J/m3)||10500 in-Lbf/in3 (73 M J/m3)|
|Seam Strength||ASTM D882||18 Lbf/in (32 N/cm)||20 Lbf/in (36 N/cm)|
|02 Transmission Rate||ASTM F1307 at 23°C||0.063 cc/100 in2/24 hrs (0.98 cc/m2/24 hrs)||0.017 cc/100 in2/24 hrs (0.26 cc/m2/24 hrs)|
|C02 Transmission Rate||ASTM F2476 at 23°C||0.13 cc/100 in2/24 hrs (92 g/m2/24 hrs)||<0.065 cc/100 in2/24 hrs (<46.02 g/m2/24 hrs)|
|MVTR||ASTM F1249 at 23°C||0.034 g/100 in 2/24 hrs (0.53 g/m2/24 hrs)||0.067 g/100 in2/24 hrs (1.1 g/m2/24 hrs)|
|Glass Transition Temperature||ASTM D5026||-15˚F (-26°C)||-13°F (-25°C)|
|Film Thickness||ASTM D374||0.01 in (0.25 mm)||0.012 in (0.30 mm)|
|Operating Temperature Range3||-112 - 140°F (-80 - 60°C)||-112 - 140°F (-80 - 60°C)|
|1PureFlex film values reported after gamma irradiation at >45 kGy.|
|2PureFlex Plus film values reported after gamma irradiation at 25 - 40 kGy.|
|3Freezing requires the film to be supported.|
|Biocompatibility Data for PureFlex™ and PureFlex™ Plus Films (Post gamma irradiation at ≥ 40 kGy)|
|USP Class VI||USP <88>||Passed|
|Bacterial Endotoxin||USP <85>||Passed|
|Heavy Metals||USP <661>||Passed|
|Buffering Capacity||USP <661>||Passed|
|Non-volatile Residuals||USP <661>||Passed|
|Residue on Ignition||USP <661>||Passed|
|Acidity and alkalinity||EP 220.127.116.11||Passed|
|Reducing Substances||EP 18.104.22.168||Passed|
|Particulate Matter||USP <788>||Passed|