Process Defoaming

In general, concentrations of 1 to 50 parts per million (ppm) are sufficient to suppress foaming in most systems. It is suggested that a concentration within this range be used initially. Adjustments in concentration may be desirable to detennine the appropriate level to use for any particular process or product.

The height to which a foam will rise can be limited by applying Liveo™ Medical Antifoam A Compound to processing equipment. For example, the defoamer is often wiped on nozzles of bottle-filling machines to knock down foam as it rises in the neck of the bottle. Similarly, if applied to the rim of a processing container, foam overflow can be prevented.

Tableting

Medical Antifoam A Compound may be used in certain pharmaceutical applications by first applying it uniformly to an excipient such as sugar or starch. This mixture is then added directly to the batch according to normal processing procedures.

Liveo™ Medical Antifoam A Compound complies with all monograph requirements for Simethicone USP and is acceptable under Food and Drug Administration Regulation 21 CFR 332.10 as a safe and effective over-the-counter drug for use as an anti-flatulent to alleviate the symptoms of gas associated with heartburn, sour stomach and acid indigestion.

Liveo™ Medical Antifoam A Compound can also be used in non standardized foods in amounts up to 10 parts per million under FDA Regulation 21 CFR 173.340.

In any application involving the U.S. Food and Drug Administration or any other regulatory agency, it is the user's responsibility to ensure that use of the product complies with the requirements of these agencies.

This Simethicone formulation is qualification tested to requirements of the United States Pharmacopeia (USP). While this monograph can serve as a material screen, it is the user's responsibility to ensure the safety and efficacy of this product for each specific end-use pharmaceutical product, medical device or other application.

Silicone antifoam supplied as opaque gray liquid

Liveo™ Medical Antifoam A Compound is manufactured, tested and packaged imder strict quality control guidelines at the Healthcare Industries Materials Site (HlMS). The HIMS (Hemlock, Mich.) is dedicated to the production of silicone materials for healthcare applications. It is registered with the U. S. Food and Drug Adminis­tration (FDA) as a drug establishment (CFN 1816403), The site quality system for active pharmaceutical ingredients (APis) is in compliance with current Good Manufacturing Practices, for Bulk Pharmaceutical Products. The site is also ISO regisiered by BSI.

Liveo™ Medical Antifoam A Compound is supplied in 18 and 200 kg containers, net weight.

Some settling may occur during storage of Liveo™ Medical Antifoam A Compound. Therefore, containers should be thoroughly mixed prior to use or testing.