The Manufacturing Process — Part 5

The Manufacturing Process — Part 5

Encapsulation — Commonly referred to as a capsule filler, the encapsulation machine has the ability to fill many different products. Powders, granulations, liquids, tablets and capsules can be filled into a two piece capsule.

Encapsulation machinery technology varies a great deal from one manufacturing to the next. Not all machines can fill a wide variety of products; most are designed to handle free flowing powders much like powders that are prepared for a tablet press.

The capsule filler must first position all of the incoming capsules into an upright position (rectification), separate the cap from the body (top from bottom), attain the proper fill volume (capsule weight), and then the product filled body is rejoined with the cap and ejected from the machine. Some capsule filling machines have the ability to compress or tamp the powder for proper filling volume and weigh control.

Encapsulators can be defined as 1) Hand operated 2) Semi Automatic 3) Automatic. The Hand Operated capsule filler requires the operator to organize the capsules in the correct position, separate the cap from the body, and fill & close the caps (basically the hand filler is a holder for the capsule body).

There are exceptions and some hand operated fillers assist the operator with separation and closing functions. The Semi automatic machine requires the operator to move rings (capsule holder rings) from the rectifier to the filling and closing stations allowing for production up to 25,000 capsule per hour.

Automatic machines with speeds up to 90,000 per hour can be divided into two categories: Continuous and Intermittent operation.

The intermittent motion machine is divided into segments. Each segment indexes from each machine function; rectify, fill, tamp, close and eject.

The automatic machine is a continuous operation somewhat comparable to a rotary tablet press in that the rotation is continuous and does not start and stop.

Capsule Care

Gelatin capsules that are old and improperly stored can dry out and become brittle; they have a rather high defect rate when compared, say, to finished tablets. Even with all the quality check points many capsules are unusable by the time they reach the production floor. Just ask any process operator and they will tell you about the impact that defective capsules have on production rates. Even on the semi-automatic model 8 machinery defective capsules can slow production rates significantly. Common Capsule defects include: Dented, cracked, split, over size caps, and empty capsules after the filling cycle.

Printing Technology

The principle of operation in printing is the successful transfer of the image from a surface to the object. In the case of tablets the transfer is made from the ink pot to the gravure (or design roll) roll, to the rubber roll to the tablet.

All offset printing, regardless of equipment manufacturer, is accomplished in this manner. Gravure rolls should be inspected for defects before they are used on the production floor. As an example, using a jeweler’s glass to inspect the ink retaining screens is recommended before the roll is placed in use. Rolls received with incomplete or missing screens will not be able to hold ink in the impression cavities and the image cannot be transferred to the rubber roll. If this occurs, you will have unknowingly introduced defectively printed tablets into the batch.

Most equipment manufacturers recommend using a 50-50 mix of n-butanol and isopropyl alcohol as both an ink thinning and cleaning agent. All ink manufacturers supply recommended specific gravity ranges for their inks.

Controlling the ink viscosity is critical throughout the entire batch.

-Michael Tousey, Techceuticals

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