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Equipment to solve the challenges of tablet and capsule production.
From a distance, tablets and capsules seem like a straightforward approach to nutrition. But what do you do when faced with cracked or crumbling tablets, leaking or oddly shaped capsules, and other issues that can occur in the manufacture of these delivery systems?
Luckily, industry is always providing solutions for the challenges facing tablets and capsules. Nutritional Outlook picks up on a few of the latest advances here, including some that were formally introduced at this year’s ACHEMA trade show in Frankfurt, Germany-a processing equipment show worth visiting if you haven’t been already.
Checkweighers ensure consistent tablet/capsule weight, from pill to pill. As more companies look to high-quality manufacture, demand for these machines is growing. Tomorrow’s checkweighers must answer the shortcomings of traditional models: manual operation and the limits of small batch sizes.
ACG North America (South Plainfield, NJ) addresses both of these concerns with the Accura 100, an automated machine that can weigh up to 100,000 capsules per hour. The Accura 100 also has a weighing accuracy within a range of ± 0.2 mg, significantly better than the industry standard of ±2.0 mg. What’s more, the machine is 21 CFR Part 11 compliant, meaning that data reports generated from this checkweigher can’t be altered (the machine prints data in PDF format). “That gives more confidence to the auditor and FDA, who come into your facility to review your practices,” says ACG head of sales Dolphy Machado. “If you give either party a record in PDF format, it does not appear as manipulated data.”
But what if your checkweigher could do more than just weigh pills and provide statistical data?
Enter the KKX 3900 Universal Capsule Inspection System. This checkweighing solution from Bosch Packaging Technology Inc. (Minneapolis) is perhaps the most innovative option on the market. The KKX 3900 is fitted with an X-ray camera that allows the machine to weigh capsules and even inspect them for foreign particles.
“What we’re doing is creating an X-ray image of a block of capsules,” says business development manager Thomas Mauritzen. “Our unit can detect anything that’s a different density from the product filled in the capsule, such as a piece of wood or plastic that might come off a pallet. These things can happen, and when they do, you have a big issue.”
The KKX 3900 can be used as a standalone unit or an in-line accessory capable of running in tandem with any capsule filler on the market. Your alternative for foreign-particle inspection would be purchasing individual units for each level of detection (e.g., a metal detector to detect only metal). That’s added cost and floor space. The KKX 3900 can inspect up to 220,000 capsules per hour. Reduced-speed models will be available soon.
Understanding moisture is key to manufacturing perfect softgels. Add too much moisture, and softgels can clump together. Skimp on moisture, and softgels could harden. Equally catastrophic outcomes.
To help attain (and keep a record of) that perfect point of moisture, industry is now familiar with hardness testers-because the moisture in a softgel can be correlated to hardness value: the amount of force required to expand a softgel.
The 6D(SG) softgel hardness tester from Dr. Schleuniger Pharmatron Inc. (Manchester, NH) gives R&D labs a hardness tester capable of both delicate testing and destructive testing. In it, the company combines both high and low load cell machines into one, available from a 50-newton load cell to an 800-newton load cell.
“If you’re going to use a machine for the release-to-pack environment, then you’re typically measuring at no greater than 30 newton of force,” says Brad Klements, Dr. Schleuniger Pharmatron product and applications specialist. “A higher load cell than this would be used in the R&D department when you would want to do more destructive testing.” For destructive testing, accessory bags are provided to capture bursting liquids from softgels. The bags are thin enough that they won’t alter test results.
The 6D(SG) hardness tester generates data-including statistics, graphics, and start dates and times-on up to 100 softgels without requiring computer assistance.
Small-scale operations and compounding pharmacies need not be burdened with high-priced automated capsule fillers. That’s why Capsugel (Morristown, NJ) offers the ProFill capsule filler line for 100-hole and 300-hole operations. In response to customer feedback, a new ProFiller series was introduced. Available in three different styles, each ProFiller is dishwasher-safe and smaller and lighter than its predecessor.
The GMP-compliant tabletop ProFillers can fill up to 9000 capsules per hour, depending on the model and operator’s skill level. And they’re suitable for virtually any type of capsule, including Capsugel’s new vegetarian Vcaps. For a space-restricted, lower-budget operation, ProFill 100-hole and 300-hole filling systems are a solid option. If you’re looking for semiautomatic and automatic machines, Capsugel has plenty of those, too.
Speaking of automatic machines, ACG North America’s new ZRO 200-T high-speed capsule filler is worth checking out for a certain patented technology that reduces raw ingredient dusting.
Dolphy Machado says that standard capsule fillers give off a yield of around 95%, meaning that 95% of your raw ingredient will make it into capsules and 5% will be lost as dust in the air or around the machine in the dust collectors. But with ZRO technology, ACG promises a reduction in ingredient dust by at least 2 or 3%. Over time, that’s a big increase in savings.
ACG can run comparative dusting tests on the ZRO 200-T and any high-speed capsule filler. For a closer look at the machine, check out the SupplySide West show this November.
No one likes rejection, but the tablet business is unfortunately full of it. When a tablet press determines that a tablet is not up to weight standards, that tablet gets rejected-but not without taking a few tablets with it. Rejecting perfectly good tablets is wasteful, and that’s why ACG is offering another little treat: the Destiny 8100, a tablet press designed to reject only the tablet at fault.
Numerous other tablet presses have launched in recent months, including the FE35 from Fette Compacting America Inc. (Rockaway, NJ). The machine is designed to be an equipment train of continuous manufacturing, maximized for efficiency in reduced setup and maintenance time.
For all of your tableting parts requirements, Natoli Engineering Co. (Saint Charles, MO) just updated its customer catalog. Available in print and online, the Natoli Catalog includes a slew of new products, including a disegment storage cabinet with lockable wheels, small digital microscopes for tooling inspection, new tablet totes, and much more.