BioCompatability of Metal Coated Spheres

For those scientists who are looking to use silver coated materials such as silver coated microspheres in biomedical applications, it is important to understand whether they are bio-compatable.  A selection of abstracts and article references related to the biocompatability of silver follow:

The Biocompatibility of Silver²

The experiments reported have referred to some of the characteristics of the biocompatibility of Ag. Silver has been shown to display interactions with albumin, as an example of a plasma protein, quite different from those of most metals. Such studies shed further light on the complex issue of protein adsorption on biomaterials. It has also been demonstrated that Ag at concentrations < 1 ppm exerts a considerable influence on the activity of lactate dehydrogenase, this effect being reversed in the presence of albumin. A significant but transient increase in blood levels of Ag following intramuscular implantation of the metal has been observed. This is not reflected in any raised urine level. It is proposed that the richly vascular tissue immediately surrounding the implant in the acute phase of the response gives rise to the transient increase, but a subsequent decrease in vascularity reduces this possibility. It appears that Ag released from implants following this initial period substantially remains in the local area.²

Lack of toxicologocial side-effects in silver-coated megaprostheses in humans¹

Deep infection of megaprostheses remains a serious complication in orthopedic tumor surgery. Furthermore, reinfection gets a raising problem in revision surgery of patients suffering from infections associated with primary endoprosthetic replacement of the knee and hip joint. These patients will need many revision surgeries and in some cases even an amputation is inevitable. Silver-coated medical devices proved their effectiveness on reducing infections, but toxic side-effects concerning some silver applications have been described as well. Our study reports about a silver-coated megaprosthesis for the first time and can exclude side-effects of silver-coated orthopedic implants in humans. The silver-levels in the blood did not exceed 56.4 parts per billion (ppb) and can be considered as non-toxic. Additionally we could exclude significant changes in liver and kidney functions measured by laboratory values. Histopathologic examination of the periprosthetic environment in two patients showed no signs of foreign body granulomas or chronic inflammation, despite distant effective silver concentrations up to 1626 ppb directly related to the prosthetic surface. In conclusion the silver-coated megaprosthesis allowed a release of silver without showing any local or systemic side-effects.¹

Specific Article References for the biocompatability of silver are below: See the References

FDA-Approved Microspheres

What makes a microsphere FDA-approved?

In order to tell whether the microsphere can be used in cosmetics, food, or medical devices it is important to look at the raw materials that are incorporated into the microsphere during manufacturing process.  For example, unpigmented or clear polyethylene microspheres supplied by Cospheric in sizes from 10 micron to 1000 micron meet the quality requirements of the US FDA as specified in 21 CFR 172.888 and 21 CFR 178.3720.  Specific grade of polyethylene used in manufacturing of these microspheres is  FDA-approved for food applications in chewing gum base, on cheese and raw fruits and vegetables, and as a defoamer in food.

Color additives are subject to a strict system of approval under U.S. law (FD&C Act), sec. 721; 21 U.S.C. 379e. Color additive violations are a common reason for detaining imported cosmetic products offered for entry into this country. If a product contains a color additive, by law [FD&C Act, Sec. 721; 21 U.S.C. 379e; 21 CFR Parts 70 and 80] you must adhere to requirements for:

• Approval. All color additives used in cosmetics (or any other FDA-regulated product) must be approved by FDA. There must be a regulation specifically addressing a substance’s use as a color additive, specifications, and restrictions.
• Certification. In addition to approval, a number of color additives must be batch certified by FDA if they are to be used in cosmetics (or any other FDA-regulated product) marketed in the U.S.
• Identity and specifications. All color additives must meet the requirements for identity and specifications stated in the Code of Federal Regulations (CFR).
• Use and restrictions. Color additives may be used only for the intended uses stated in the regulations that pertain to them. The regulations also specify other restrictions for certain colors, such as the maximum permissible concentration in the finished product.

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Microspheres for Medical Devices – MDDI Magazine – January 2011

The Microsphere of Influence

Published: January 2011, MDDI

Find more content on: Feature, Nano and Microtechnology, Technology, Testing and Inspection

Microspheres come in many different grades and sizes, and are usually solid particles that are composed of polymers, glass, and ceramics. All images courtesy of COSPHERIC LLC

Microspheres are round microparticles that typically range from 1 to 1000 μm in diameter. In the pharmaceutical and cosmetics industry, microspheres are well known for their ability to deliver active materials. This process usually involves the microencapsulation of a drug or an active cosmetic ingredient to protect it from the deteriorating effects of the environment or for optimal release and performance in the final product. Active ingredients are released by dissolution of the capsule walls, mechanical rupture (rubbing, pressure, or impact), melting, or digestion processes. Solid microspheres are widely used as fillers and spacers in a variety of industries.

Microspheres used to manufacture and test medical devices are typically solid particles that are made from robust and stable raw materials such as polymers, glass, and in some cases, ceramics. Different types and grades of microspheres are available and selected based on specific application requirements.

They are often used as tracers and challenge particles in medical devices. In these situations, it is beneficial to use larger microspheres with sphere diameters greater than 50 μm that are vividly colored (red, blue, black, yellow, or green), since they provide contrast with the background material and visibility to the naked eye in daylight. Colored microspheres are typically used in the testing of filtration media and systems, vial and container cleaning evaluations, flow tracing and fluid mechanics, centrifugation and sedimentation processes, pharmaceutical manufacturing, and contamination control.

Fluorescent microspheres are recommended for applications that require the use of particles that emit distinctive colors when illuminated by UV light and offer additional sensitivity for observation through the use of microscopes, lasers, and other analytical methods. Examples include microcirculation and biological research, imaging, and flow cytometry. Fluorescent microspheres can be excited and detected by a wide range of methods and are useful as experimental particles for acoustical and optical analytical systems.

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Density Marker Beads – Microspheres with Specific gravity of 1.065 and 1.075

Product Announcement:

Red 1.065 g/cc Spheres

In the biomedical industry researchers are sometimes looking for cells having targeted specific gravities.  In order to locate these cells in test tubes it is useful to have colored marker beads which will show where the delineation between specific densities occurs.  Two microsphere products having densities of 1.065 g/cc and 1.075 g/cc were recently released.

Blue 1.075g/cc Spheres

These spheres are offered with density tolerances of ±0.005 g/cc enabling excellent stratification, and bright blue and red coloration for high visibility with the unaided eye.

R&D Quantities are in stock and ready to purchase in sizes from 10um to 600um, larger 1kg+ quantities can be made to order to existing specifications or made to your custom color and density requirements. For more information visit:  Blue Density Marker Beads 1.075g/cc,  Red Density Marker Beads 1.065g/cc

Some Materials which have densities close to these markers are¹:

Source:
1 – Courtesy of Amersham Biosciences

Microspheres: Technologies and Global Markets

An extensive market research report titled Microspheres: Technologies and Global Markets was recently published by BCC Research marketing firm. The microspheres report examines the spherical microparticles used as components in many advanced materials and composites, in the healthcare and personal care industries, and in many specialty research and development applications. The report estimates the size of the microsphere industry worldwide and makes predictions on a 5-year compound annual growth rate of the microsphere market.

The global market for microspheres in 2010 is estimated to be $2 billion and growing at a 5–year compound annual growth rate (CAGR) of 11.6%, reaching global sales of $3.5 billion by 2015.