(**) The mixture can be made manually, directly in the mortar or with the help of automatic blenders: this
is an important operation that ought to be validated. If white powders are 30 used, a small portion of
powdered food colouring can be added, to help us visualize the time necessary for the active ingredients to
be distributed evenly throughout the powder mixture.
Once the time and the method are standardised, colorant is no longer needed. It will be sufficient to follow
the standardized procedure. Once the mixture of powders prepared, the Optima® capsule filling system can
be used to open, fill and recap the capsules. Once the compounding is completed, uniformity of dosage units
must be sample-checked. The sample test is carried out weighing 10 full capsules selected at random among
those prepared; the resulting weight is then divided by the number of capsules, 10 in this case, to obtain the
average weight. Each capsule is then weighed individually. The average deviation admitted for each capsule,
by excess or default, is 10%, the compounder being to ensure that each unit shall be not less than 90% and
not more than 110% of the theoretically calculated weight for each unit. So, for instance, if the average
weight is 300 milligrams, the weight of the ten selected capsules will have to be between 270 and 330
milligrams.
3 GENERAL DESCRIPTION
The Optimatic 300 Semi-automatic capsule filling machine consists of a capsule filling unit mounted on a
base in which the vibrating support is installed.
Like other machines manufactured by Farmalabor Tech, the Optimatic 300 semi-automatic capsule filler can
process any type of hard gelatine capsules, from the format "000" to "5".
The capsule filling unit is equipped with a 300-capsule loading plate. In this group the capsules are opened,
filled and closed. The unit is equipped with a device for pressing the powder regulated by the operator
according to the type of powder treated (paragraph5.3.2.).
Furthermore, an electromagnetic vibrator ensures a uniform distribution of the substances inside the
capsules.