Chemical Properties and FDA Regulations
Ion Beam Enhanced Deposited (IBED) Coatings
BeamAlloy Technologies, LLC IBED coating technology allows deposition of precision high quality engineered hardcoatings on virtually any metal and metallic alloy surfaces. Operating at temperatures below 200° F, the process is highly controllable resulting in coatings with precise thickness and repeatable properties. The IBED coatings are first formed in the subsurface region of the part to be coated and then grown out to a thickness of 1 - 2 microns. This tight metallurgical bond guarantees excellent coating adhesion and eliminates the possibility of chipping and flaking of the coating during tool operation.
Chromium Nitride Chemical Properties
Chromium nitride (CAS #12053-27-9) is a metallic nitride compound having a chemical formula of Cr2N. It is a solid material exhibiting a metallic gray color and having no odor. It is non-volatile and non-flammable, insoluble in water and organic solvents, and only slightly reactive with strong inorganic acids (chromic acid) and strong oxidizing agents (potassium persulfates). It is hard (HKN 2800), highly resistant to abrasive wear and as such does not release wear debris. When deposited as a coating using the IBED process, chromium nitride is fully dense and void-free, and as such will not absorb or trap any powdered or liquid materials that it may come into contact with.
Chromium Nitride Health Effects
Chromium nitride is listed as not having any specific known health hazards, is not known to aggravate any known health conditions, and is not specifically listed as a carcinogen.
Chromium Nitride Coating Thickness and Mass
The typical thickness of chromium nitride coatings deposited on the working face of tableting punches is 1 micron (0.00004 inches). The total mass of chromium nitride deposited in a layer this thick on a 0.25-inch diameter punch face is approximately 32 micrograms.
FDA Regulatory Issues
The Food and Drug Administration (FDA) regulates the pharmaceutical and nutritional products manufacturing industry. Regulations governing the manufacture of pharmaceuticals in solid dosage form are found in the “Code of Federal Regulations: Title 21 – Food and Drugs.” The regulations specific to equipment used to manufacture solid dosage tablets is found in Part 211 “Current Good Manufacturing Practice for Finished Pharmaceuticals;” Subpart D “Equipment,” Section 211.65 “Equipment Construction.” As stated in 21CFR211.65:
“(a) Equipment shall be constructed so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.”
“(b) Any substances required for operation, such as lubricants or coolants, shall not come into contact with components, drug product containers, closures, in-process materials, or drug products so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.”
Clearly the IBED chromium nitride coatings applied to the working surfaces of tableting punches and dies, since they are non-reactive, non-absorptive, and non-additive, satisfy the FDA regulatory guidelines set forth in 21CFR211.65.
For more information, contact us.