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MANUFACTURING ENVIRONMENT
DOW CORNING Pharma Tubing is manufactured under quality control guidelines.The Healthcare Industries Materials Site in Hemlock, Michigan, is dedicated to the production of silicone materials for healthcare applications.lt is registered with the U.S. Food and Drug Administration (FDA) as a Drug Establishment (CFN 1816403).The site quality system is based on principles of current Good Manufacturing Practices for both Bulk Pharmaceutical Products and Medical Devices.The site is
ISO 9001-registered.
QUALITY ASSURANCE
Dow Corning manufactures DOW CORNING Pharma Tubing in a totally integrated process from raw materials to the final extruded tubing. The tubing is manufactured in an ISO registered facility, requiring appropriate documentation and traceability.Critical properties are controlled all along the complete manufacturing process, to provide quality of the raw materials, the elastomer, and the finished tubing.
STERILIZATION CONSIDERATIONS
It is the user's responsibility to validate a sterilization process for silicone tubing.The user should conduct testing if sterilization conditions vary and/or if minor property changes could affect application performance.Common sterilization procedures include:
Autoclave (Steam Sterilization)
Silicone tubing can be effectively sterilized by steam in an autoclave. Silicone materials are more difficult to heat than materials such as thermo-plastics because they have thermal insulating properties.Steam sterilization has been accomplished in a standard gravity steam sterilization cycle (30 minutes at 1 bar /15 psi and 121°C/250°F) and in a high-speed flash steam sterilization cycle (15 minutes at 2 bar/30 psi and 132°C/270°F).
ORDERING
DOW CORNING Pharma Tubing is available direct from Dow Corning or through many pharmaceutical or laboratory distributors.For order information or to discuss specific requirements, please contact Dow Corning at 1-800-248-2481 (USA) or +44-(0)1676-528000 (Europe & Middle East) or consult www.dowcorning.com.
HEALTH AND ENVIRONMENTAL INFORMATION
To support Customers in their product safety needs, Dow Corning has an extensive Product Stewardship organization and a team of Product Safety and Regulatory Compliance (PS&RC) specialists available in each area.
For further information, please see our website, www.dowcorning.com or consult your local Dow Corning representative.
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Gamma Radiation Sterilization
Gamma radiation studies of the effects on the physical properties of the silicone elastomer used to produce DOW CORNING Pharma Tubing have shown that doses of radiation up to 2.5 Mrad (25kGy) do not adversely affect durometer, elongation, modulus, tensile or tear strength.Repeated gamma sterilization or processing at higher doses of radiation and for longer dosing periods may change some of the physical properties of the elastomer.
Ethylene Oxide Sterilization
Ethylene oxide (ETO) has been used to sterilize silicone tubing with no degradation of physical properties. Sterilization by this method is only recommended if procedures allow sufficient time for complete out-gassing of residual ETO and ETO by¬products.
REGULATORY STATUS
DOW CORNING Pharma Tubing is manufactured using SILASTIC BioMedical Grade silicone elastomer that meet or exceed the test requirements of USP Class VI Plastics (87> and (88>.
DOW CORNING Pharma Tubing meets the requirements of 21 CFR 177.2600 and USP<661> (Physico-chemical Tests - Plastics), and its elastomer stock complies with selected 3-A Sanitary Standards.The tubing meets the requirements of European Pharmacopoeia (Ph.Eur. or "EP") 3.1.9. "Silicone elastomer for closures and tubing."
To support use in validated processes, contact Dow Corning to obtain a Qualifications Guide for Dow Corning Pharma Tubing.This manual summarizes key tubing performance and regulatory data.
LIMITED WARRANTY INFORMATION - PLEASE READ CAREFULLY
The information contained herein is offered in good faith and is believed to be accurate.However, because conditions and methods of use of our products are beyond our control, this information should not be used in substitution for customers' tests to ensure that Dow Coming's products are safe, effective, and fully satisfactory for the intended end use.Suggestions of use shall not be taken as inducements to infringe any patent.
Dow Corning's sole warranty is that the product will meet the Dow Corning sales specifications in effect at the time of shipment.
Your exclusive remedy for breach of such warranty is limited to refund of purchase price or replacement of any product shown to be other than as warranted.
DOW CORNING SPECIFICALLY DISCLAIMS ANY OTHER EXPRESS OR IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE OR MERCHANTABILITY.
DOW CORNING DISCLAIMS LIABILITY FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES.
We help you invent the future.™
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USABLE LIFE AND STORAGE
When stored in the original unopened containers, DOW CORNING Pharma Tubing has a usable life of 36 months from the date of production.
TUBING SIZE CAPABILITIES AND PACKAGING
To serve our customers better, we can provide DOW CORNING Pharma Tubing in a variety of dimensions, including the most commonly used sizes shown in Table 1.Standard package is a 15-meter (50 foot) coil, double bagged in separately sealed polyethylene bags contained in a cardboard box.
SPECIAL NEEDS
Dow Corning has the capabilities to customize products to your specifications.Customization includes sizes, tolerances, cut lengths, bulk packaging and spooling.For easy identification, DOW CORNING Pharma Tubing is also available marked with product name and size. Please contact your Dow Corning representative to discuss your specific requirements.
LIMITATIONS
This product has not been tested or 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 Dow Corning 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.
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