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Equipment Optimization

  This involves a lot more than turning up the speed.  Increasing productivity isn’t effective if machines get worn out or worse, damaged. Yet, that is what we often see.  We can help evaluate the product, environment, equipment setup and operation to maximize performance reducing downtime and changeover time. Address:   2917 E 79th St Cleveland Ohio 44104 Phone Number:   (216) 658-8038 Website URL:   http://techceuticals.com ADDITIONAL DETAILS  Hours: Mon-Fri 8:30am-5:30pm Payment Method : Cash, Cheque, Mastercard, Visa, American Express, Discover
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Tablet Pro — Part 3

Tablet Testing — We need to test tablets as they are being made to assure that we are in control. Tablet weight is critical as is thickness, hardness, friability, disintegration, dissolution and visual inspection.
Thickness is an important physical attribute. On the press thickness variation may mean there is a variation in weight and hardness or both. On the packaging floor, Bottle filling; thickness is important to allow for accuracy of count. A tablet that is too thick may not fit into the counting device, a tablet that is too thin may break, double-up and may also cause count accuracy issues.
Blister packaging machinery requires very tight tolerances in tablet thickness to achieve and maintain accurate filling, count and sealing of the blister. Thickness is one of the main control features of a tablet press, the other is weight control and speed. Tablet thickness is a critical attribute and should be controlled with accuracy.
Tablet Hardness
Tablet hardness is the second most important physical attribute. A tablet that is too hard may not break up and dissolve into solution before it passes through the body. A tablet that is too soft may break apart, not handle well, and can create other defects in manufacturing.
A soft tablet may not package well or may not stay together in transit. Hardness changes over time. Tablet hardness off the tablet press and hardness 24 hours later may be entirely different due to the energy from compression. It is important the measure and monitor hardness changes on the manufacturing floor and over time.
Disintegration Testing
Tablets must disintegrate before they dissolve. A disintegration tester will suspend tablets in a solution bath for visual monitoring of the disintegration rate.
The time it takes a tablet to break apart in solution is the first part of the objective. The other issue is how consistent are all tablets throughout the batch. In some companies the tablet press operators are required to run this test, in others QA performs this duty.
Dissolution
Tablet dissolution is an important test to make certain that the API goes into solution. The granulation process often uses coatings that will sustain dissolution. A common defect is that some of the particle are coated and the solution cannot penetrate the barrier. A dissolution test is basically taking water samples over time to determine the active is available for absorption into the body.
Tablet Defects
Tablet defects can come from many places. Contaminated raw materials, poor cleaning techniques, operating machinery incorrectly, and just plain old poor formulation are all common issues. The most common defects are tablet weight, hardness and thickness.
Also, some common visual defects include: capping, laminating, sticking & picking, black or grey spots and chipped tablets. Many defects can come from process, manufacturing, packaging and poor handling. Criteria boards with acceptable and unacceptable examples should be used to assure product quality.
Lubricant
A lubricant is a very small part of the overall formula but a very valuable part of the performance of the product and tablet. A poorly lubricated formula will not flow well, it will allow particles to stick to the punches and pick out the lettering and numbers on the tablet. Materials will extrude and create flash and gum up the punch tips.
The tablet press is the report card for everything that happens up stream. A poorly blended product is often not discovered until it reaches the tablet press. An experienced operator can adjust for changes in the granulation, but there are only so many things they can do.
Michael D Tousey, Technical Director/CEO

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