SureFlex™ process container film
Recommended Products
-
106059 Supelco Methyl benzoate -
103830 Supelco HPLC-bottle adapter with 3 tube connections ID 3.2 mm, solvents supply -
102183 Supelco Charcoal activated -
69967 Sigma-Aldrich pT7Blue DNA (uncut) - Novagen -
370656 Sigma-Aldrich Guanosine 3ʹ,5ʹ-cyclic Monophosphate, Sodium Salt - CAS 40732-48-7 - Calbiochem -
MAB8727 Sigma-Aldrich Anti-Rabies Antibody, Glycoprotein, clone 24-3F-10 -
670111 Millipore UDP-α-D-Galactose, Disodium Salt - CAS 137868-52-1 - Calbiochem -
AP4007000 Millipore Glass Fiber Filter without binder -
104091 SAFC Glycerol 85% -
476475 Sigma-Aldrich PKC Inhibitor, EGF-R Fragment 651-658, Myristoylated - Calbiochem
개요
사양
주문 정보
Documentation
관련 제품 및 어플리케이션
관련 제품: Application Facete
| Disinfection control |
| Safe Solvents Handling |
카테고리
| 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.