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Identification & Functionality
Liveo™ Pharma 50 Tubing Features & Benefits
- Excellent flexibility
- Low extractables
- Contains no peroxide by-products, chlorophenyls or PCBs
- No organic plasticizers, phthalates or latex additives
- Easily sterilized
- Stable over a wide temperature range
- High resiliency
- No impaired taste or odor
- Non-wetting (hydrophobic) surface
- Made from BioMedical Grade elastomer that exceeds United States Pharmacopeia (USP®) Class VI Plastics Test Requirements
- Meets European Pharmacopeia monograph 3.1.9. “Silicone elastomer for closures and tubing”
- Manufactured to the principles of FDA 21 CFR 210/211 cGMPs for Pharmaceutical products
- Produced in an FDA-registered (CFN 1816403) and inspected healthcare facility
- High purity quality (USP 788 Particulate matter for Injection, USP 85 Bacterial Endotoxins, ISO 11737-1 Bioburden)
- FDA 21 CFR 177.2600 and USP 661 Physico-chemical tests - Plastics
- Reduces risk of contaminating ultra-pure liquids
- Complete traceability
- Consistent performance
- Rigorous change control
Applications & Uses
How to Use
Information from “Chemical Resistance Guide For Elastomers IV”, published by Compass Publications, La Jolla, California, can be used as a reference. It is however recommended that the DuPont product be evaluated in the real conditions of use.
Limitations
This product is neither tested nor approved for any hospital or patient care use such as for temporary insertion or any in vivo procedures. This product is not to be used in human implantation, or human contraceptive, reproductive, obstetrical or gynecological applications. The user shall hold DuPont harmless from any and all damages resulting from use of this product. It is the sole responsibility of the user to determine the safety and efficacy of this product for any specific use. This product is not tested for specific pharmaceutical or medical device use(s). Should you wish to use this product in a specific pharmaceutical or medical device application, please contact DuPont to discuss such potential use. It remains the User’s responsibility to ensure the safety, efficacy and legal and regulatory compliance in each relevant jurisdiction (including targeted geographic regions of manufacture and supply) of these materials for its intended uses. DuPont makes no representation concerning the suitability of these products for any particular medical or pharmaceutical application. Under no circumstances should these materials be considered for implantation into the human body for periods that exceed 30 days in duration.
Safety Warning
Before handling, please consult the corresponding material safety data sheets.
Properties
Value | Units | Test Method / Conditions | |
Modulus (at 200% Strain) ¹ | 2 | MPa | ASTM D 412 |
Elongation (at Break) | min. 300 | % | ASTM D 412 |
Hardness (Shore A) | 50 | - | ASTM D 2240 |
Tensile Strength | 9 | MPa | ASTM D 412 |
Tear Strength (Die B) | 47 | kN/m | ASTM D 624 |
- [1]: tested on tubes with die D
- [2]: tested on tubes
- [3]: from the date of manufacture when stored in the original unopened containers
Regulatory & Compliance
Technical Details & Test Data
Sterilization Methods
- Ethylene Oxyde
- Autoclave Steam (30min at 120°C)
- Gamma Radiation (50 kGy)