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Archive for September, 2009

Membrane with Controllable Porosity Could Improve Drug Delivery

Wednesday, September 30th, 2009

A team of researchers led by Daniel Kohane of Harvard Medical School has created a hydrogel-based membrane that responds to magnetic flux. The ability to remotely ’switch on and off’ the membrane’s porosity could lead to membrane-based implants that can release doses of such drugs as anesthetics on demand.

Poly (N-isopropylacrylamide), or PNIPAM, served as the basis for the membrane. “The researchers embedded nanoscale particles of PNIPAM-based gels in an ethyl cellulose membrane so that clumps of the particles spanned the width of the membrane. They also entrapped magnetite nanoparticles within the membrane matrix,” according to a recent article in Chemistry World.

By exposing the thermosensitive membrane to an oscillating magnetic field, the researchers were able to cause the particles to collapse, which increased porosity. In turn, the researchers discovered that they could restore the material to its natural swollen state by removing the magnetic flux, thereby closing the channels.

The team anticipates that this ability to manipulate porosity remotely could enable the development of novel drug-delivery mechanisms that allow for controlled release of predetermined doses.

Parmatech Acquires MIM Business from Morgan Advanced Ceramics

Tuesday, September 29th, 2009

Parmatech-Proform Corp. (Petaluma, CA), a wholly owned subsidiary of ATW Cos. (Warwick, RI), announced today that it has acquired the metal injection molding (MIM) business of Morgan Advanced Ceramics (MAC; New Bedford, MA). The acquisition serves to strengthen Parmatech’s MIM capabilities for a variety of industries, including the medical device market.

Through the acquisition, Parmatech will build on its experience with fabricating metal injection-molded components and capitalize on MAC’s proprietary MIM process to reinforce its offerings in the field. In addition, the acquisition will enable Parmatech to increase prominence on the East coast, expand production capacity, and ensure quality.

“We anticipate the combination of our businesses will prove beneficial by empowering us to serve our customers better,” comments Peter C. Frost, president of ATW. “This change in ownership will strengthen our relationships with customers and enhance the high level of service we provide.”

Algae Enables Battery Breakthrough

Monday, September 28th, 2009
Four views of an algae-based battery show algae's structure, a schematic diagram of the battery's construction, and a finished prototype.

Four views of an algae-based battery show algae's structure, the battery's construction, and finished prototypes.

When people think of algae, they often picture the green film that forms on the surface of swimming pools. But now, researchers in the Nanotechnology and Functional Materials Department of Engineering Sciences at the Ångström Laboratory of Uppsala University (Sweden) have found another use for these photosynthetic organisms: batteries.

Constructed primarily from algae, paper, and salt-water, the thin and flexible batteries use thin mats of tangled cellulose fibers as electrodes and a saline solution as an electrolyte. A potentially inexpensive and environmentally friendly alternative to conventional lithium batteries, these algae-based batteries may eventually be used to power cheap medical diagnostic devices. Potential applications include a variety of low-power portable devices, such as wireless sensors and medical implants.

Despite extensive efforts in recent years to develop new cellulose-based coating substrates for battery applications, satisfactory charging performance proved elusive. However, Maria Strømme, professor of nanotechnology and leader of the Uppsala research group, and fellow researcher Albert Mihranyan saw the possibility of using algae for energy-storage applications because of the organism’s large surface area.

Consisting of a nanostructure of algal cellulose coated with a 50-nm layer of polypyrrole, their invention represents an entirely new electrode material for energy-storage applications. Batteries based on this material can store up to 600 mA per cm³, with only 6% loss through 100 charging cycles. “You don’t need advanced equipment to make the batteries,” explains Strømme.

“Our success in obtaining a much higher charge capacity than was previously possible with batteries based on advanced polymers is primarily due to the extreme thinness of the polymer layer,” says Gustav Nyström, a PhD student involved in the project.

“We have long hoped to find some sort of constructive use for the material from algae blooms and have now shown this to be possible,” Strømme says. “The battery research has a genuinely interdisciplinary character and was initiated in collaboration with chemist professor Leif Nyholm. Cellulose pharmaceutics experts, battery chemists, and nanotechnologists have all played essential roles in developing the new material.”

TPU Manufacturer Unveils New Facility

Friday, September 25th, 2009
Argotec has opened its new headquarters and manufacturing facility in Greenfield, MA.

Argotec has opened its new headquarters and manufacturing facility in Greenfield, MA.

Argotec Inc. (Greenfield, MA), a supplier of thermoplastic polyurethane (TPU) film and sheet to medical device manufacturers, has opened a new 95,000-sq-ft headquarters and manufacturing plant. The addition of the new facility increases the company’s total operations to more than 150,000 sq ft.

The added capacity will benefit the production not only of existing ArgoMed films for medical device and wound-care products customers but will also provide the company with flexibility to explore new markets and applications, says president and CEO Bruce Wilby. “It will create greater efficiencies throughout our entire production process, letting us focus more of our resources on research and development.”

The new plant houses two blown-film and nine flat-die extrusion lines. Seven of the flat-die lines are housed in an 8000-sq-ft hard-walled cleanroom, with each individual line enclosed in its own Class 10,000 soft-walled cleanroom environment. All seven extruders, along with the raw resin handling equipment, are positioned outside the cleanroom. Only the final heated polymer passes through the wall to the flat die and winding apparatus.

“Add to that our cleanroom operator certification program, the separate changing rooms and gowning requirements we’ve instituted, and the interlocking entrance and exit doors to guarantee no one enters the cleanroom until the first of the two doors is securely shut behind them, and the net result is an exceptionally clean product,” Wilby remarks.

Laser Deposition Method May Revolutionize Fabrication of Joint Implants

Thursday, September 24th, 2009

Team members review data using a laser deposition system. The system works by depositing layers of a powdered mixture of metal and ceramic materials, melting the powder with a laswer, and then solidifying each layer to form parts.

Members of the laser research team at Purdue University review data using a laser deposition system. The system works by depositing layers of a powdered mixture of metal and ceramic materials, melting the powder with a laser, and then solidifying each layer to form parts.

With the demand for artificial hips in people under the age of 40 expected to reach 40 million annually by 2010 and 80 million by 2030, scientists are hard at work developing methods to expedite their manufacture, reduce their cost, and increase their durability. Take Yung Shin, professor of mechnical engineering and director of the Center for Laser-Based Manufacturing at Purdue University (West Lafayette, IN). “We have 200,000 total hip replacements in the United States,” he remarks. “They last about 10 years on average. That means if you receive an implant at 40, you may need to have it replaced three or four times in your lifetime.”

Shin is pioneering technologies that use lasers to create longer-lasting medical implants and arterial stents. One of his techniques involves depositing layers of a powdered mixture of metal and ceramic materials, melting the powder with a laser, and then immediately solidifying each layer to form parts. Known as “functionally gradient coating,” this technique for forming parts one layer at a time is suitable for coating titanium implants with ceramic materials that mimic the characteristics of natural bone, Shin explains.

“Titanium and other metals do not match either the stiffness or the nature of bones, so you have to coat it with something that does,” Shin said. “However, if you deposit ceramic on metal, you don’t want there to be an abrupt change of materials because that causes differences in thermal expansion and chemical composition, which results in cracks. One way to correct this is to change the composition gradually so you don’t have a sharp boundary.”

Researchers have used this laser deposition process to create a porous titanium-based surface and a calcium phosphate outer surface, both designed to better match the stiffness of bone than conventional implants. By creating a strong bond between the material being deposited and the underlying titanium, steel, or chromium, the method can create a bond that is at least seven times as strong as that required by industry standards.

In addition, the process enables the fabrication of parts with complex shapes that are customized for each patient. “These are not like automotive parts,” Shin says. “You can’t make a million that are all the same.” He envisages a time when medical imaging scans will be sent to laboratories where implants will be made using laser deposition. “Instead of taking 30 days like it does now because you have to make a mold first, we could do it in three days. You reduce both the cost and production time.”

Additional research is needed before the techniques will be ready for commercialization. Future work will involve studying shape-memory materials that are similar to bone and also have a self-healing capability for longer-lasting implants.

Testing Service Expands Analytical Chemistry, Materials Characterization Department

Wednesday, September 23rd, 2009

NAMSA (Northwood, OH) has opened an expanded analytical chemistry and materials characterization facility. The new facility houses three laboratories, including a wet chemical lab, an instrumental services lab, and a volatile analysis lab. By doubling it chemistry testing capacity, the company plans to introduce new testing capabilities such as inductively coupled plasma spectrometry and volatiles analysis USP 467.

“We believe this move positions us to provide enhanced turnaround time, better work flow to increase our testing workload, and more efficiencies,” remarks Joe Grappin, NAMSA’s chemistry manager. “With the renovated and expanded space, we are able to add equipment and personnel to meet the increasing needs of materials analysis required by medical devices and combination products.”

In addition to achieving better turnaround times and increased speed to market, NAMSA’s R&D team will also have increased capabilities to develop additional materials characterization assays. Given these improvements, the company’s decision to expand the chemistry lab was an easy one to make, according to NAMSA’s president John Gorski.

“We continue to invest in our people, facilities, equipment, and clients because we believe that developing relationships and trust is the right thing to do. It has been a key to over 40 years of success,” comments Gorski. “Even during this economic downturn, NAMSA is committed to providing the best possible medical device testing services by growing our business and expanding our capabilities.”

Controlling Nanoparticles in Biological Systems

Tuesday, September 22nd, 2009

Nano- and microscale particle systems have become a key component in biomedical applications such as drug-delivery systems. Their small size and potential for modification and functionalization make them suitable for performing specific tasks in the body. Yet, controlling these materials at the structural level to create particles capable of complex interactions with biological systems remains a challenge.

Joerg Lahann, associate professor in the chemical engineering department at the University of Michigan (Ann Arbor), and his team of researchers are rising to that challenge. Using a microscale fluid manipulation system dubbed electrohydrodynamic cojetting, an electrospinning process in which thin fibrous strands are drawn from a liquid using high voltage, they believe that they can control nanoparticles’ interactions with biological systems.

As reported in the materials science journal Advanced Materials, Lahann’s team utilizes this system to synthesize dual-compartment, biologically compatible polymer particles with the ability to selectively self-associate with human endothelial cells found in the lining of blood vessels. When they are incubated with these cells, the particles display a strongly specific binding pattern because one of their compartments has been modified with the protein streptavidin, which interacts strongly in biological systems. As a result of this selective funcationalization process, one hemisphere of a particle exhibits strong affinity with a cell surface while another does not, leading to spatial control at the cellular level. Since only one side of each particle is attracted to the cells, they form into layers, just one particle thick, on the cell surface.

Having demonstrated the fundamental concept of selective particle control, Lahann and his cothinkers hope to build more-sophisticated multicompartmented building blocks suitable for use in more-complex biohybrid designs. Finer control over the particle architecture, they believe, will allow for the creation of different particle morphologies and functionalities, paving the way for the design of novel, complex systems for use in areas such as regenerative medicine, medical imaging, and diagnostics.

White Paper Highlights Microbial Control for Device Manufacturing

Monday, September 21st, 2009

Environmental testing and monitoring programs are essential elements in medical device manufacturing facilities. Companies must understand industrial sterilization and contamination control procedures to bring products to market on time and on budget. A new white paper titled “Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers” reviews the key elements of a best-practice environmental testing program for medical device manufacturing.

Authored by Steven Wieczorek, head of environmental testing, monitoring, and certification groups at Microtest Laboratories (Agawam, MA) , the white paper spotlights sterilization standards, FDA requirements, and the critical factors for maintaining controlled environments. Topics include what is required, viable versus nonviable particulates, sampling plans, validation management, sterilization programs, cost and product savings, critical factors, and the benefits of experience. The paper also discusses how these challenges can be met with the assistance of an update-to-date testing laboratory.

In attempting to meet regulatory demands from sources such as the FDA, the greatest challenge for medical device manufacturers can be determining what is required to achieve compliance. How must manufacturers design, implement, certify, and maintain correct sterilization and environmental monitoring programs? Unfortunately, there is no single reference document that U.S. manufacturers can rely on to help them design, validate, and demonstrate room-class compliance. The purpose of this white paper is to contribute to manufacturers’ knowledge about compliance requirements.

Gold Nanoparticles With a Nose for Cancer

Thursday, September 17th, 2009

A team of scientists at Technion, the Israel Institute of Technology (Haifa), are building an electronic ‘nose’ that could help physicians detect lung cancer in its initial stages. Using gold nanoparticles, the scientists have created sensors with unprecedented sensitivity for sniffing out compounds present in the breath of lung-cancer patients.

While other efforts to devise a cancer-sniffing gold nanoparticle–based sensor have been promising, the resulting devices must detect a higher concentration of volatile organic compounds (VOCs), metabolic products present in the vapors that we breathe out, than the Israeli device. However, VOCs occur in such small amounts that researchers using the other devices have had to find ways to increase their concentrations before testing. Now, Hossam Haick and his colleagues have built sensors using an array of gold nanoparticles that can detect VOCs in their natural concentrations and under the humid conditions characteristic of human breath.

Other devices used for breath tests depend on expensive means of VOC detection, such as optical sensors, mass spectrometry, and acoustic sensors. In contrast, gold nanoparticle sensors have the potential to be small and inexpensive. One sticking point, however, was getting the VOCs to stick to the gold. “It was quite a lot of work to get them to stick,” says Haick. “We’re the first to do so, as far as I know.”

Using breath samples from 40 healthy volunteers and 56 lung-cancer patients, the group used the sensors to identify which biomarkers would collectively act as an accurate lung-cancer signature. After training the sensors to identify the signature and testing it again, Haick and his colleagues found that their device could reliably differentiate between cancerous and healthy breath. They are now testing the device on a larger group of people in various stages of the disease and believe they’ll be ready to start clinical trials within two or three years.

Preliminary tests indicate that the gold-nanoparticle sensors are capable not only of differentiating among stages of lung cancer, but they can also detect distinct signatures for other ailments, such as liver failure. Haick’s group has even tested the electronic nose above colonies of cells grown in culture. This study found that while the sensor was able to sniff out compounds already known to be in breath, other lung-cancer-associated VOCs were not detected. “Obviously, something is going on in the body to metabolize and create additional VOCs,” Haick states. He is now attempting to determine  precisely what that is in the hopes that the information may provide new insight into lung cancer and how to treat it.

Revised Standard Details Cytotoxicity Testing of Materials

Wednesday, September 16th, 2009

A revised standard from the Association for the Advancement of Medical Instrumentation (AAMI) provides medical device manufacturers with information on how to improve the safety of medical device materials. An update of the 1999 edition of ANSI/AAMI/ISO standard 10993-5:2009, Biological Evaluation of Medical Devices—Part 5: Tests for in vitro Cytotoxicity advises manufacturers on how to use in vitro cytotoxicity testing to cost-effectively and efficiently evaluate medical device materials for potential harm.

In vitro cytotoxicity testing involves placing a device or material in a solvent at a certain temperature for a period of time. While the solvent is usually a serum-supplemented cell culture medium, other types of solvents such as saline can be used. “That wash of the device/material is applied to cell cultures, and those cell cultures are examined to determine whether the cells are still living,” remarks Lisa Olson, vice president and general manager of WuXi AppTec Inc. (St. Paul, MN) and co-chair of the AAMI biological evaluation working group 05, which played an active role in the development of the international standard. “If the cells are living, that is a good thing. It indicates that there is nothing in the device that is actively killing them off.”

The revised standard contains new information to promote more-objective testing. “An important change in the standard is the emphasis placed on quantitative methods of cytotoxicity testing that generate actual values related to the viability of the cells, whereas previously, qualitative means that microscopically evaluated morphological changes were primarily relied upon,” says Vana S. Poolava, manager of standards development and communication for Philips Healthcare (Bothell, WA) and co-chair of the AAMI biological evaluation working group 05.

Extraction testing, for example, requires visual examination of a cell line in the culture and evaluations of the cells’ health. “It is subjective, Olson says. “We wanted to get into more quantitative methodologies so it doesn’t matter if it is person A or B, and come up with an actual number.”

Olson believes that as companies develop materials and processes, many of them will use the standard as a simple check before they commence with animal studies.