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Life Sciences Guidebook: Best Practices for FDA Compliance Solutions

In a market where high-demand causes organizations to seek software systems that will fit into their complex business infrastructure, the pressure to find the right system often causes angst to many. Learn some of the key elements to spotting a good FDA Compliance solution, techniques for achieving GMP Compliance, and how to ensure that Quality and Compliance are met in the Life Science industry.

Posted in: White Papers, White Papers, FDA Compliance/Regulatory Affairs, Software

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Evaluation of Platelet Aggregation on Commonly-Used Blood-Contacting Medical Polymers

The blood compatibility of polymers used for medical devices which facilitate the movement or storage of blood is critical, particularly in devices whose applications where device-contacting blood will be re-introduced into a patient (dialyzer housings, storage vessels, IV components, etc.). Standard biocompatibility testing conducted in accordance with the ISO 10993 series of standards for these materials includes various tests for hemocompatibility1, including platelet interactions, but direct microscopic examination of platelet adhesion and activation is less common. This white paper presents the results of a scanning electron microscopic (SEM) examination of human platelet adhesion on polymeric materials, which shows that CYROLITE® materials may be less likely to aggregate and activate platelets than some other commonly-used blood-contacting materials.

Posted in: MDB, White Papers, White Papers, Medical

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How the Laser, Optic, & Photonic Industries Benefit from Electropolishing

Improve precision and cleanliness with an enhanced surface finish. Like other industries that utilize electropolishing to finish metal components, there are many benefits associated with electropolishing metal components used in photonics, optics or laser applications.

Posted in: White Papers, Coatings & Adhesives, Materials, Medical, Optics, Photonics

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Computer-Controlled Solid-State Lighting Assembly to Emulate Diurnal Cycle and Improve Circadian Rhythm Control

John F. Kennedy Space Center, Florida The Lighting System to Improve Circadian Rhythm Control was designed and built to help regulate the sleep cycles of astronauts working on the International Space Station (ISS) and during long-duration spaceflight. In space, the lack of a true diurnal cycle of sunlight, encompassing the same range of color temperatures and intensities of sunlight experienced on Earth, is one of the potential causes of sleep disorders among the crew aboard ISS. The production of melatonin, a hormone that helps regulate sleep cycles, can be inhibited by light, especially cool white light (with its large blue light component). To help regulate sleep cycles and improve the quality of sleep for the crew, control of the melatonin production cycle through the use of light is key. On Earth, this technology can be used to help treat many sleep disorders, including jet lag, shift work sleep disorder, delayed sleep phase syndrome, advance sleep phase syndrome, and non-24-hour sleep/wake disorder (frequently affects those who are totally blind since the circadian clock is set by the light-dark cycle over a 24-hour period).

Posted in: Briefs, Medical

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Capillary Driven Microorganism Cultivation Platform for Human Life Support

SABR is a novel microbial cell cultivation platform that mimics the way vascular plants use transpiration to deliver nutrients to their cells. Ames Research Center, Moffett Field, California The high water-to-biomass ratio characteristic of conventional algae cultivation systems requires large energy inputs for pumping and mixing the culture during cultivation, as well as for dewatering and harvesting the resultant biomass. In light of this challenge, the Surface- Adhering BioReactor (SABR) cultivates micro-organisms as densely packed biofilms rather than in suspension, leading to an approximately 100-fold reduction in the water-to-biomass ratio of the system. Moreover, the mechanism of nutrient delivery to the cells is completely passive, eliminating the need for a pump. This mechanism is also independent of gravitational and inertial forces, making it an ideal candidate for human life support in space. The SABR is ideally suited for cultivating shear-sensitive cells, which can be product-secreting candidates due to their potential lack of cell walls. It reduces the number of steps in the cascade of cultivation, harvesting, dewatering, and extraction, favorably impacting the energetic and economic sustainability.

Posted in: Briefs, Medical

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Device and Method for Healing Wounds

The electroactive bandage is a slim, self-contained alternative to electrical stimulation devices. Langley Research Center, Hampton, Virginia This technology is a device that uses electrical activity to facilitate the wound healing process while protecting the wound. The bandage is made of an electroactive material (see figure) that is stimulated by the heat of the body and the pressure of cell growth, thus no external power source is required.

Posted in: Briefs, Medical

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Portable Acoustic Holography Systems for Therapeutic Ultrasound Sources

Lyndon B. Johnson Space Center, Houston, Texas High-intensity focused ultrasound (HIFU) is a rapidly developing medical technology that relies on focusing acoustic waves to treat remote tissue sites inside the body without damaging intervening tissues. HIFU can be used to treat benign and malignant tumors, dissolve blood clots, enhance drug delivery to specific sites, and ablate brain tissue causing essential tremors. While standard practices for characterizing diagnostic ultrasound are well established, the lack of analogous metrology techniques for therapeutic ultrasound remains an impediment to broader clinical acceptance of HIFU.

Posted in: Briefs, Medical

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