| High efficiency manufacture of solid dose | | | | tooling. |
| pharmaceuticals requires the use of high performance | | | | Nitride hardcoatings can also be deposited by a low |
| tooling, including tablet punches, dies, tamping pins and | | | | temperature ion beam enhanced deposition (IBED) |
| compacting rolls. Since the tooling is in intimate | | | | process. Coating temperature does not exceed 200 |
| contact with formulation powders during tableting, | | | | degrees Fahrenheit, which is low enough to eliminate |
| the properties of the tooling surfaces can have a | | | | the danger of dimensional distortion or bulk softening |
| significant impact on both tablet properties and | | | | of the punch. Coating adhesion is guaranteed by first |
| manufacturing efficiency. Wear and corrosion of the | | | | forming a layer (termed a case layer) in the surface |
| working surfaces of the tooling results in picking, | | | | of the punch, and then growing the coating out from |
| sticking and capping which requires the tableting press | | | | the case layer. |
| to be stopped and tooling to be removed for | | | | Maintenance of the pre-coated surface finish is also |
| cleaning and polishing. Tablet quality is degraded, | | | | an important factor to be considered when choosing |
| manufacturing productivity is reduced, and revenues | | | | a coating and coating process. Electroplated and PVD |
| lost. | | | | coatings grow with large crystalline grain structures. |
| Precision coatings, if properly chosen and applied to | | | | This degrades the surface finish originally present on |
| tableting tooling, can dramatically reduce surface wear | | | | tooling surfaces, which requires that the surface be |
| and corrosion, and significantly improve manufacturing | | | | re-polished after coating. IBED coatings are |
| efficiency and tablet quality. There are a variety of | | | | amorphous in nature and replicate the surface finish |
| wear- and corrosion-resistant coatings available for | | | | exactly, thus eliminating the need for post-coating |
| use on pharmaceutical tableting tooling. Additionally, | | | | re-polishing. |
| there are a variety of coating processes used to | | | | FDA Regulation of Precision Metal Coatings - |
| deposit these coatings. Choice of the correct coating, | | | | All equipment, including precision tooling, used in the |
| and the correct coating process, are the keys to | | | | manufacture of pharmaceutical and nutritional |
| success in obtaining improved performance for | | | | products is regulated by the Food and Drug |
| tableting tooling. | | | | Administration. FDA regulations specific to equipment |
| The various coatings available are deposited by either | | | | used in the manufacture of solid dosage tablets is |
| electroplating or by advanced vacuum deposition | | | | found in 21CFR211.65 which states, "equipment shall |
| processes. Metallic coatings such as nickel and | | | | be constructed so that surfaces that contact |
| chromium are deposited by electroplating. Materials | | | | components, in-process materials, or drug products |
| such as Boron (B), and Teflon (PTFE), can be added | | | | shall not be reactive, additive, or absorptive so as to |
| to enhance plated coating hardness, and coating | | | | alter the safety, identity, strength, quality, or purity |
| lubricity, respectively. Processing temperatures during | | | | of the drug product beyond the official or other |
| metal plating are below 200 degrees Fahrenheit, but | | | | established requirements." Thus any coating applied to |
| the coated tool must be baked post-plating at higher | | | | the working surface of punches and dies cannot |
| temperatures (375 degrees Fahrenheit) to prevent | | | | react with, wear off into, or absorb any ingredient of |
| hydrogen embrittlement. | | | | the formulation being tableted. This is an important |
| Hard refractory nitride coatings such as Titanium | | | | consideration when choosing a metal coating and |
| Nitride and Chromium Nitride are usually deposited by | | | | precision coating process. |
| physical vapor deposition (PVD) processes. In order | | | | Wear and corrosion on tableting tooling can be |
| to insure sufficient adhesion and optimum coating | | | | significantly reduced by choosing the correct coating |
| properties, the PVD processing temperature must be | | | | and precision coating process. Benefits include |
| done at 900 degrees Fahrenheit or above. At these | | | | improved tablet quality and manufacturing |
| temperatures the bulk tool material will soften, | | | | productivity, both of which fall right to the bottom |
| distorting the crucial precision dimensions of the | | | | line - better profitability. |