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SureFlex™ process container film

Designed to provide strength, flexibility (with maximum resistance to flex-crack), excellent gas barrier performance and inert contact.

Overview

Merck process containers are single-use flexible containers designed specifically for bioprocessing, storage and transport of biopharmaceutical fluids in sterile conditions. They are free of animal derived components.

Product Description

SureFlex process container film are manufactured utilizing a high purity, medical grade composite film designed to provide strength, flexibility (with maximum resistance to flex-crack), excellent gas barrier performance and inert contact. The fluid contact material is ethylene vinyl acetate (EVA). The gas barrier is made of polyethylene vinyl alcoholcopolymers (EVOH). The outer layer is made of LLDPE.

Physical Data (Post gamma irradiation at ≥ 25 kGy)
Properties Tests Units Typical Values
Tensile Strength* ASTM® D638 psi MD - 3100, TD - 3100
Elongation* ASTM D638 % MD - > 650, TD - > 650
Tear Strength* ASTM D-1004 g/mils MD - 550, TD - 560
Modulus at 100% Elongation* ASTM D638 psi TM - 1100, TD - 1000
Port Seal Strength* Air Pressure psi 40
Puncture Resistance* FTMS 101B Lbf 22.4
Leak Testing
• Leak Test Air Pressure 20 in. H2O/60 s Passed
Barrier Testing Testing performed at 25 °C
• Oxygen Transmission (O2) ASTM D-3985 mL/100 in2/24 h 0.28
• Carbon Dioxide (CO2) ASTM D-1434 mL/100 in2/24 h 0.58
• Moisture Permeability E-96-80 g/100 in2/24 h 0.11
Extractables Test European Pharmacopeia (3.1.5) Passed
Simulated Transit Testing
(Filled bag chamber) ASTM D-4169 (Level II) Passed
Operating Temperature Range** Nelson Labs °C -70 to 70
Gamma Irradiation AAMI VDMax 10-6 SAL @ 25 kGy
Specific Gravity ASTM-792 g/mL 0.96
* Data pre-gamma irradiation.
** Freezing requires the film to be supported.
Biocompatibility Data (Post gamma irradiation at ≥ 25 kGy)
Properties Tests Units Typical Values
Testing performed on freshly
gamma irradiated film (25–40 kGy)
Intracutaneous Toxicity USP Class VI Passed
Acute Systemic Toxicity USP Class VI Passed
Muscle Implantation USP Class VI Passed
Cytotoxicity Study MEM Elution Method (MG023) Passed
Bacterial Endotoxin LAL EU/device less than 5.0
Physicochemical USP <24> Passed
Hemolysis USP <24> - In Vitro % 0.41

Note: These are typical data for SureFlex film. Typical values are with a 95% confidence interval.