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2 sterility
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4 pyrogen
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Mycoscience

http://www.mycoscience.com/environmentals.html

Mycoscience offers the highest quality environmental testing of airborne, surface, and water microbial levels. We provide testing, certification, and monitoring of viable and non-viable particulates in both medical device and pharmaceutical environments. We also offer training programs for environmental control and can assist you with establishing appropriate environmental limits. Mycoscience works with you to develop a concise, cost-effective sampling strategy. Water Testing and Water System Validations.

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Mycoscience

http://www.mycoscience.com/manufaturing.html

Customized Development Programs From Conception through FDA Approval. Our expertise with environmental control makes Mycoscience a logical choice for cleanroom contract manufacturing. We specialize in environmentally controlled, low volume, clinical production of diagnostics, pharmaceuticals and devices. We offer a variety of cleanroom options from Class 100 to Class 100,000. Our facilities include a Class 100 syringe filling suite, with the capacity to fill thousands of syringes per hour.

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Mycoscience

http://www.mycoscience.com/about-us.html

A World of Experience. When it comes to meeting medical device, pharmaceutical, and in-vitro diagnostic regulations we have a world of experience, not only with FDA standards but with EN and ISO requirements as well. Visit our modern facility conveniently located along the I-84 corridor between Boston and New York and meet our dedicated professionals. We have the training, experience, and quality standards you require, and we deliver the level of service you deserve.

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Mycoscience

http://www.mycoscience.com/consulting.html

The consequences of non-compliance with FDA, ISO, or EN regulations can be disastrous to a company's reputation and profitability. The Mycoscience consulting team can help you avoid costly regulatory pitfalls and market delays. Our expertise with FDA regulations, combined with extensive laboratory skills, enable us to analyze your product line and plot a comprehensive, economical course for your products from development through manufacturing. 510K, IDE, PMA Submissions. QA Systems and Design Review.

5

Mycoscience

http://www.mycoscience.com/laboratory.html

The lab personnel at Mycoscience have decades of microbiological experience and training. Mycoscience offers a modern laboratory with state of the art equipment. Our quality and service are unparalleled in the medical industry. Your tests go on line, on time, guaranteed. We'll fax you a report at no extra charge. Moreover, we will meet or beat competitors' pricing. That's the kind of service you deserve. Sterilization and Sterility Assurance. Sterilization Validations: ETO, Radiation, and Steam.

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