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Product Sheets | Vitrification Brochure - Irvine Scientific

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Quality Testing<br />

Each lot receives a complete laboratory evaluation<br />

including mouse embryo testing, endotoxin level,<br />

pH, osmolality and sterility testing. All results are<br />

provided in a lot-specific Certificate of Analysis.<br />

<strong>Irvine</strong> <strong>Scientific</strong>’s commitment to excellence<br />

is demonstrated by its products’ performance<br />

and adherence to the industry’s highest quality<br />

standards. <strong>Irvine</strong> <strong>Scientific</strong> was the first ART<br />

manufacturing company in the USA to receive<br />

ISO 13485:2003 quality systems certification, the<br />

rigorous international quality assurance standard<br />

designed specifically for Medical Devices.<br />

<strong>Product</strong>s manufactured by <strong>Irvine</strong> <strong>Scientific</strong> are<br />

produced in accordance with the Guidelines for<br />

Manufacture of In Vitro Diagnostic <strong>Product</strong>s and<br />

the Good Manufacturing Practices (GMPs) for<br />

Medical Devices.<br />

References<br />

1. Conaghan et al., (2010), Human blastocyst <strong>Vitrification</strong> and<br />

Warming: 3 Years Experience Using the CryoTip®<br />

2. Tucker M, Liebermann J, (2007), <strong>Vitrification</strong> in Assisted<br />

Reproduction. United Kingdom. Informa Healthcare<br />

3. Smith et al., (2010), Prospective randomized comparison of human oocytes cryopreservation<br />

with slow-rate freezing or vitrification, Fertility and Sterility, Feb 18 2010<br />

4. Cobo et al., (2008), Effect of different cryopreservation protocols on the metaphase II<br />

spindle in human oocytes, Reproductive BioMedicine Online, Volume 17, 16 July<br />

5. Kartberg A-J et al., (2008), <strong>Vitrification</strong> with DMSO protects embryo membrane integrity better<br />

than solution without DMSO, Reproductive BioMedicine Online, Volume 17, 3 September<br />

6. Data on file.<br />

7. Data on file.<br />

North America Headquarters<br />

<strong>Irvine</strong> <strong>Scientific</strong><br />

2511 Daimler Street, Santa Ana, CA 92705<br />

USA<br />

Phone: 1 (949) 261-7800<br />

Toll Free: 1 (800) 437-5706<br />

Fax: 1 (949) 261-6522<br />

www.irvinesci.com<br />

2012 <strong>Irvine</strong> <strong>Scientific</strong> P/N 10034R Rev.11<br />

Europe Headquarters<br />

<strong>Irvine</strong> <strong>Scientific</strong><br />

Unit 31, Newton Business Center, Block D<br />

Newtownmountkennedy<br />

County Wicklow<br />

Ireland<br />

Phone: +353 1 281 99 20<br />

Fax: +353 1 281 99 28<br />

Asia Headquarters<br />

<strong>Irvine</strong> <strong>Scientific</strong><br />

3-17-35 Niizo-Minami<br />

Toda-Shi<br />

335-0026 Saitama<br />

Japan

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