Manufacturers frequently step over dollars to pick up dimes by using low-quality lubricants to protect expensive machines, and often fail to provide regular maintenance service.
Understanding what regulations require is the first step in identifying the appropriate lubricants. In essence, two zones exist on capsule filling machines, and a table separates the two halves:
The Code of Federal Regulations (CFR) Title 21, Part 178.3570 provides the rules for lubricants used in areas where incidental contact may occur. It identifies the ingredients in lubricants that manufacturers can use in these areas and states the limits on the amounts of these ingredients that may be present.
An easy way to recognize lubricants safe for the above-the-table area is to find lubricants that conform to the H1 category of NSF standards, which derive from US Department of Agriculture (USDA) standards for food grade lubricants. Before you commit to any H1 or other lubricant, you should qualify it for performance on your equipment. Some equipment manufacturers recommend specific brands of lubricant for their machines, but most don’t. Always ask for data that demonstrates the effectiveness of the lubricant. One popular measure is examination of the size of wear particles extracted from the lubricant at the end of a maintenance cycle. Large wear particles, although still microscopic, can reach 60 microns and can indicate rapid component failure.
In support of the quality lubricant you will use, it is critical to develop a schedule for maintaining your machine, and stick to it. Frequency of maintenance services should be fine-tuned to your specific operation. Below the table are cams, gears, and actuating arms, each requiring cleaning, inspection and lubrication. Under good operating conditions, a service below the table of filling machines may last several weeks. Above the filling table, cams, linear ball bushings and shafts have greater exposure to product and more frequent maintenance is generally required.
To establish preventative maintenance intervals for above and below table areas, make routine checks after your maintenance service, while keeping track of operating time. When lubrication is starting to turn black or is drying out, it is time to clean parts and re-lubricate. Repeat the process of tracking your operating conditions a few times and you will soon learn how long each service type will last under your operating conditions. For areas above the table, you will find that maintenance intervals will need to be adjusted when running sticky or abrasive formulations.
When cleaning parts, inspect cam followers and other bearings for smooth movement; linear ball bushings can be checked using a dental type pick. When applying new lubricant, do not use more than is necessary, as excessive amounts attract unwanted powder, and can also contaminate finished product.
Finally, establish measures to protect areas where lubricant is applied from powder and other contaminants:
In addition, machine design also plays a role. In the last decade, suppliers of capsule filling machines have improved the protection of areas above the filling table. Many areas that were exposed, such as the top cam, are now better contained and operate almost free of product.
Stephen W. Lee is technical service manager at CapsCanada®, 1893 SW Third St; Pompano Beach, FL 33069. Tel 800 440 6470 E-mail: Stevelee@capscanada.com. For 15 years, he has worked in the dietary supplement and pharmaceutical manufacturing industries specializing in making and filling two-piece capsules. Steve holds a Bachelor of Science in business management from the University of Redlands, Redlands, CA and is a member of Tablets and Capsules’ Technical Advisory Board.