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Biocompatibility Testing

Validation, Testing, and Regulatory Consulting Services

June 17, 2014 12:39 am | by MDT Staff | Nelson Laboratories, Inc. | Product Releases | Comments

Nelson Laboratories announced the expansion of its services with the addition of a dedicated Technical Consulting Services group for MedTech companies. Technical Consulting Services encompasses product development...

LISTED UNDER: Regulatory Affairs | Biocompatibility Testing | Clinical Testing

MED-5440: TRANSLUCENT FLUOROSILICONE ELASTOMER FOR MEDICAL IMPLANT APPLICATIONS

April 29, 2013 10:52 am | NuSil Technology | Products

Carpinteria, California — NuSil Technology LLC, a global leader in silicone materials for the healthcare, pharmaceutical and drug delivery industries, introduces MED-5440, a medical-grade 100 mol % fluorosilicone elastomer that resists swell caused by dimethyl fluids and most solvents or oils. In addition, this product offers the following: rapid cure with heat; compatibility with liquid injection molding equipment; wide range of application feasibility; and translucent appearance. Some typical applications for MED-5440 include O-rings, gaskets, seals, and precision molded parts for implant applications requiring silicones of medium durometers that resist swell.

LISTED UNDER: Silicone | Biocompatibility Testing

MED-9050: SILICONE GEL WITH UNIQUE GREASE-LIKE PROPERTIES

April 29, 2013 10:48 am | NuSil Technology | Products

Carpinteria, California — NuSil Technology LLC, a global leader in silicone materials for the healthcare, pharmaceutical and drug delivery industries, unveils MED-9050, a high-viscosity, crosslinked silicone gel blend designed to be used primarily as a formulary ingredient for topical applications. Its unique, grease-like properties make it ideal for skin care and scar management therapies. MED-9050 is designated as “restricted” and may be considered for use in external devices or short-term implant applications of 29 days or less.

LISTED UNDER: Silicone | Biocompatibility Testing
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MED-6731: HIGH-CONSISTENCY FLUOROSILICONE GREASE

April 29, 2013 10:40 am | NuSil Technology | Products

Carpinteria, California— NuSil Technology LLC, a global leader in silicone materials for the healthcare, pharmaceutical and drug delivery industries, introduces MED-6731, a low-flow, high-consistency fluorosilicone grease that resists swell. As a lubricant, MED-6731 will not absorb into or swell dimethyl silicone components. A fluorosilicone fluid may be used for applications in which dimethylpolysiloxane grease has compatibility issues with silicone rubber components. MED-6731 provides an added benefit where migration is a concern. This solvent-resistant grease may be used as a high-vacuum grease around glass, ceramic and ground glass joints.

LISTED UNDER: Silicone | Biocompatibility Testing

VERSASIL LINE: THREE NEW DUROMETERS ADDED

April 26, 2013 5:59 pm | NuSil Technology | Products

Carpinteria, California — NuSil Technology LLC, a global leader in silicone materials for the healthcare, pharmaceutical and drug delivery industries, adds three new products to the VersaSil line, which is now a series of six high-consistency elastomers designed for optimal performance in a wide range of healthcare applications. Featuring high tear strength; wide processing parameters; and translucent, non-tacky surfaces, the new additions are available in unvulcanized base stock that can be cured through either a peroxide catalyst or platinum-cure masterbatch. The base stock, available in 25- or 1,000-pound kits, produces tough, durable elastomers with nominal Type A durometers of 40, 60 and 80.

LISTED UNDER: Silicone | Biocompatibility Testing

MED-6671: LOW COEFFICIENT OF FRICTION SILICONE COATING FOR HEALTHCARE APPLICATIONS

April 26, 2013 5:19 pm | NuSil Technology | Products

Carpinteria, California — NuSil Technology LLC, a global leader in silicone materials for the healthcare, pharmaceutical and drug delivery industries, announces the release of MED-6671, a room temperature curable coating that significantly decreases the coefficient of friction of cured silicone surfaces. Silicone elastomers inherently have a tendency for blocking (sticking to themselves by virtue of chemical affinity). Once cured, MED-6671 chemically bonds to the silicone elastomer substrate, mimicking its mechanical properties and covering this surface tack. The result is a smooth finish with a durable, yet flexible coating that resists abrasion from moving, sliding and rubbing parts.

LISTED UNDER: Silicone | Biocompatibility Testing

MED-6219: OPTICALLY CLEAR, HIGH-DUROMETER ELASTOMER

April 26, 2013 4:17 pm | NuSil Technology | Products

Carpinteria, California — NuSil Technology LLC, a global leader in silicone materials for the healthcare, pharmaceutical and drug delivery industries, announces the release of MED-6219, an optically clear, high-durometer elastomer. MED-6219 suits a wide variety of healthcare applications because of its rheology, optical clarity, and adjustable cure schedule. Its transparent appearance lends it for use in potting and encapsulating electronic devices or for making molded parts. Because it can be vulcanized at both high and low temperatures, this elastomer is particularly suitable for temperature-sensitive substrates or for use in environments with fluctuating temperatures.

LISTED UNDER: Silicone | Biocompatibility Testing

MED-6613-X: HEALTHCARE SILICONE INKS

April 26, 2013 2:46 pm | NuSil Technology | Products

Carpinteria, California — NuSil Technology LLC, a global leader in silicone materials for the healthcare, pharmaceutical and drug delivery industries, announces the launch of a new heat-cure colored inks series, MED-6613-X. The newly released colors — red, white, green, bright blue and dark blue — vastly expand the company’s color palette and provide more vibrant, creative marking options. The two-part, addition-cure inks can be used in pad-printing and silk-screening processes for marking or coloring silicone rubber parts, such as catheters. Designated unrestricted, they may be considered for long-term implant applications (29 days or longer).

LISTED UNDER: Silicone | Biocompatibility Testing
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Deburring PEEK Implants With Micro-Abrasive Blasting

November 24, 2010 5:19 am | Product Releases | Comments

Comco Inc.’s micro-abrasive blasting equipment can be used to deburr PEEK implants. Though PEEK’s biocompatibility and chemical resistant nature make it an ideal choice for medical implants, it creates challenges to the manufacturing process.

LISTED UNDER: PEEK, PEK | Micromachining | Biocompatibility Testing

Complete Range of Testing Services

October 5, 2010 7:12 am | Geneva Laboratories, Inc. | Product Releases | Comments

For over 35 years, the company provides clients with the respect they deserve and offers testing to meet customers' needs in the areas of microbiology, chemistry, toxicology/biocompatibility, and stability/accelerated aging.

LISTED UNDER: Biocompatibility Testing | Microbiology/Chemical Testing | Medical Device Testing

UltraSafe Passive Needle Guard Utilizes High-productivity Medical Grade of Polycarbonate Resin

March 23, 2010 9:59 am | Product Releases | Comments

To manufacture its UltraSafe Passive Needle Guards, Safety Syringes Inc. needed to find a material that was not only robust and transparent, but also offered improved flow, lubricity, and easy release characteristics.

LISTED UNDER: Resin | Injection Molding | Biocompatibility Testing

No-Drip Medical Adhesive Designed for Bonding Vertical Surfaces

December 2, 2009 4:28 am | Master Bond, Inc. | Product Releases | Comments

The EP42HT 2 ND 2 has a paste like consistency and facilitates the adhesive's application when bonding vertical surfaces. This no-run two part epoxy fully complies with the testing requirements for USP Class VI biocompatibility.

LISTED UNDER: Epoxy | Biocompatibility Testing | Microbiology/Chemical Testing

USP Class VI Approved Medical Adhesive Has Quick Set Time

December 5, 2008 7:04 am | Master Bond, Inc. | Product Releases | Comments

This low viscosity medical epoxy—EP41SMED—has a handling time of as little as 10-15 minutes and forms resistant bonds to cold sterilants such as EtO and gamma radiation as well as water, oil, and many organic solvents.

LISTED UNDER: Epoxy | Biocompatibility Testing

Facing Double Jeopardy in the Testing of Combination Products

October 13, 2006 9:50 am | Microtest Laboratories, Inc. | Product Releases | Comments

Combination products can cause twice as many problems for companies in the testing of these devices since they require expertise in two highly regulated specialties—medical devices and pharmaceuticals. This article offers a number of areas manufacturers of these devices will have to consider.

LISTED UNDER: Medical Device Testing | Cylinders | Biocompatibility Testing

Silicone Is the Stone That Kills Two Birds

October 13, 2006 9:50 am | Product Releases | Comments

Silicone has emerged as one of the most researched biomaterials available to pharmaceutical makers and medical device manufacturers. As such, it readily lends itself to being an ideal choice for use in combination products where these two industries merge.

LISTED UNDER: Silicone | Injection Molding | Micro Molding

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