Validation Documentation for C-Flex Formulation R Table of Contents. Biocompatibility Test Reports: Endotoxins (LAL)

Transcription

1 Validation Documentation for C-Flex Formulation R Table of Contents Biocompatibility Test Reports: USP Class VI Endotoxins (LAL) Cytotoxicity by MEM Elution Hemolysis Pyrogens Elastomeric Closures Technical References: Physicochemical Tests Animal Origin Statement (1088) C-Flex TOC Extractables (1083) Gas Permeability (1093) Saint-Gobain Performance Plastics Corporation th Avenue North Clearwater, Florida Tel: (800) Fax: (727)

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21 C-Flex and Materials of Animal Origin Since C-Flex is used primarily in the medical device and biopharmaceutical industries, many of our customers are concerned about the sources of the ingredients in our family of thermoplastic elastomers. All of the raw materials used to produce C-Flex are synthetic chemicals and are neither sourced from nor come in contact with animal products except one ingredient, polypropylene. The polypropylene resin used in many C-Flex formulations is itself a synthetic chemical produced from natural gas, but it contains calcium stearate, used as an acid scavenger and lubricant. Its concentration in C-Flex is typically no more than 128 parts per million. Calcium stearate is usually made from beef tallow using a series of aggressive chemical reactions. The European Union has been investigating the causes and prevention of BSE, TSE and related diseases since they became widely known and they publish the results of their studies in the Official Journal of the European Union, most recently in C24/6, 28.I Section 6.4 of the Note for guidance on minimizing the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products in this issue states: Tallow derivatives, such as glycerol and fatty acids, manufactured from tallow by rigorous processes are thought unlikely to be infectious such materials manufactured under the conditions at least as rigorous as those given below shall be considered in compliance for this note for guidance -trans-esterification or hydrolysis at not less than 200 C for not less than 20 minutes under pressure (glycerol, fatty acids, and fatty acid esters production) Our polypropylene suppliers have certified that the bovine tallow used is sourced only in North America and is produced using conditions that exceed these conditions. In addition, we have documentation on file that the calcium stearate they use has been granted Certificate No. RO-CEP Rev 01 confirming its suitability for use in the European Union. In September 2004, SGPPL introduced new C-Flex formulations that are certified to be free from any animal derived components. C-Flex R70-374, the ADCF equivalent to R A clear, is now commercially available. For additional information and references please contact the Technical Service department at SGPPL at Note: All recommendations and suggestions contained in our printed matter regarding end uses and methods of use are based upon laboratory studies, test results and experience available to us. However, as we cannot control the conditions and circumstances under which our products may be used, users of C-Flex products have sole responsibility for their use. SGPPL makes no other warranties, express or implied, and disclaims any warranty of merchantability and fitness for use. Effective Date: April 2, 2007 Revision: 1 DOC#: 1088 Saint-Gobain Performance Plastics Corporation th Avenue North Clearwater, Florida Tel: (800) Fax: (727)

22 Total Organic Carbon Extractables of C-Flex Tubing Tubing Type TOC (ppm) 72 hr./50º C 120 days/23º C C-Flex 50A Opaque (R70-001) C-Flex 50A Clear (R70-050) C-Flex 60A Clear (R70-082) C-Flex 60A ADCF Clear (R70-374) C-Flex 65A Opaque (R70-072) Notes: The differences between C-Flex samples are not considered significant. All specimens were sterilized by gamma irradiation with a dose of 50 kgy. Tests were performed in duplicate by a qualified testing laboratory according to the procedures defined in USP29 after conditioning in water for injection (WFI) for the time and temperature shown. Note: All recommendations and suggestions contained in our printed matter regarding end uses and methods of use are based upon laboratory studies, test results and experience available to us. However, as we cannot control the conditions and circumstances under which our products may be used, users of C-Flex products have sole responsibility for their use. SGPPL makes no other warranties, express or implied, and disclaims any warranty of merchantability and fitness for use. Effective Date: April 2, 2007 Revision: 2 DOC#: 1083 Saint-Gobain Performance Plastics Corporation th Avenue North Clearwater, Florida Tel: (800) Fax: (727)

23 Gas Permeability of C-Flex The gas transmission rate of films made with typical clear and opaque C-Flex formulations was measured along with platinum cured silicone rubber; results are shown in the table below. Material Gas Transmission Rate (cm 3 -mil/100 in hr.-atm.) Oxygen Nitrogen Carbon Dioxide C-Flex R x x x 10 3 C-Flex R x x x 10 3 Silicone Rubber 109 x x x 10 3 Tests were performed by a qualified independent laboratory on duplicate specimens at 23º C and 1 bar pressure. Note: All recommendations and suggestions contained in our printed matter regarding end uses and methods of use are based upon laboratory studies, test results and experience available to us. However, as we cannot control the conditions and circumstances under which our products may be used, users of C-Flex products have sole responsibility for their use. SGPPL makes no other warranties, express or implied, and disclaims any warranty of merchantability and fitness for use. Effective Date: April 2, 2007 Revision: 1 DOC#: 1093 Saint-Gobain Performance Plastics Corporation th Avenue North Clearwater, Florida Tel: (800) Fax: (727)