SureFlex™ process container film
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| Disinfection control |
| Safe Solvents Handling |
Categorias
| Biopharmaceutical Manufacturing > Downstream Processing > Single-use Manufacturing |
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.