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1. Merck has as a corporate commitment and goal to eliminate the use of chloroform in all film coating formulations. To this end, they are pursuing active programs relating to new formulations and coating techniques. 2. The pressures of state and federal regulating agencies toward solvent emissions and personnel safety have caused them to concentrate on aqueous coatings. 3. Some economics are realized as a result of coating with aqueous systems. These savings are in the range of 1 to per 100 tablets. 4. They also stated that a disadvantage associated with aqueous coatings is their requirement for humidity control of the air system. This represents an expensive investment. At this time Merck is applying aqueous film coating to Aldomet tablets. One other product is on the market and next month another product will be on the market. Their long range goal is to apply aqueous film coatings to all their film-coated products. Merck has provided me with a few slides showing what goes on in the Elkton plant. In this facility they have four 24-inch Wurster units. Another manufacturer converted to aqueous film coating is the Shaklee Corporation in Hayward, California. I have to say that the management of Shaklee deserves a big bouquet of roses for their commitment to convert from solvents to aqueous. They converted in "cold turkey" fashion. They were operating with 32 coating pans 42 inch ; and 8 polishing pans on two shifts and replaced the solvent coating systems with two 46-inch Wurster Columns and aqueous film coating. If that doesn't show management commitment, I don't know what does--especially when we realize that the two 46-inch Wurster units are the first two manufactured for commercial use. Shaklee personnel told me that the reason they felt so secure in converting to aqueous systems was because of the advantages they saw in the Wurster columns. ADVANTAGES OF THE WURSTER COLUMNS Greater air volume provides increased drying capacity. Increased drying capacity results in: o Shorter cycle time o Greater flexibility in processing o Decision to go "aqueous" film coating Eliminated factors relating to solvent cost, handling, and emission control equipment. Scale-up 12-inch and 18-inch columns were valid for the larger units.
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GUIDELINES Review of Service Goals and Objectives It is essential for the home health agency to monitor the client's progress and assure the efficient utilization of services. The time frame for achieving short term goals is negotiable and may depend on the type of services being delivered, for example, itemiser. The Committee was concerned not to undermine the intercompany dialogue process through which Servier had given undertakings to cease use of the Diam8cron MR card, destroy all copies and send a corrective letter to doctors. However, it did consider the breaches of the Code should be taken seriously. The Committee resolved that Servier should take immediate action for the prompt withdrawal of the Diamicrpn MR card that had been found in breach and should permit no further appearance of it in its present form. The statements found in breach of the Code should not be used again in their present form or in a manner that conveys the same or similar meaning. In consideration that Servier had already sent a corrective letter to doctors, which the Committee would have required, it accepted that appropriate correction had been undertaken. The Committee resolved that Servier should be required to pay a fine of $5, 000 as they considered that the promotional item should have been reviewed more carefully by Servier prior to distribution.
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