Microspheres Online

Everything about microspheres and research utilizing precision spherical particles.

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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Silica Microspheres – 6 micron mean Diameter

Silica is a chemically stable inorganic synthetic material. It has the benefit of providing no irritation to human skin. Silica is essentially transparent, colorless and promote a high degree of slip in products. The skin feel is generally lubricious in nature. Spherical silica imparts exceptional lubricity to loose and pressed powder products. The effect is increased ‘play time’ and a luxurious feel. Spherical products with mean particle size between 3 to 10 micron will scatter light on the surface of its particle, ie which are transparent, but give natural coverage.

Microspheres in Cosmetics – Solid Polymer Microspheres for Color Effects

A recent article on microspheres in Cosmetics & Toiletries magazine describes the use Solid Polyethylene Mirospheres for Effects in Color Cosmetics. Microspheres have been used in cosmetics for some time, primarily as fillers and exfoliators. Most recently scientists started to utilize light reflecting properties of microspheres for creating unique optical effects, such as optical blurring … Read more

What is a Microsphere? Definition and Explanation.

Sourcing Microspheres - Monodisperse Silica
Conductive Bondline Spacer - Silver-Coated Silica Spheres
Conductive Bondline Spacer – Silver-Coated Silica Microspheres (Cospheric Product ID: SiO2MS-Ag)

Definition of a Microsphere:

There is a lot of confusion and uncertainty in the academic community as well as the industry on exactly what is a microsphere. Below is the definition of “microsphere” that we use, because it is clear and straight-forward:

Microsphere is a term used for a small solid spherical particle, with diameter in the micrometer range (typically 1 micron to 1000 micron (1mm)).

What a Microsphere is Not:

A microsphere is not the same as a microcapsule, because microcapsules typically consist of a flexible (deformable) shell encapsulating a fluid, which might be liquid or gas. Microspheres always have a solid shell. Even if the microsphere is technically hollow (containing gas inside), its shape is not significantly flexible or deformable.

A microsphere is not the same as a microparticle, because microparticle is a general term that refers only to the size of the granular material and does not provide information on the shape. Microspheres are always round and spherical. There are no sharp edges, oblong shapes, or debris.

What are Nanospheres? Silica Nanospheres
Monodisperse Silica Nanospheres (Cospheric Product ID: SiO2MS)

A microsphere is not the same as a nanopshere, because nanospheres have diameters on the nanoscale (typically between 1 nanometer and 1000 nanometers (1 micron)). Nano-diameters present a complete different characteristics, behaviors, and functionalities.

What are Microsphere Materials:

Microspheres are manufactured from various natural and synthetic materials. Glass microspheres, polymer microspheres, and ceramic microspheres are commercially available. Solid and hollow microspheres vary a lot in density and, therefore, are used for different applications. Hollow microspheres are typically used as additives to lower the density of a material. Solid microspheres have numerous applications depending on what material they are constructed of and what size they are.

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