Material Weigh Up of Tablet Ingredients
Ingredients are brought into a weigh room where they are weighed
according to a written formula for a predetermined number of tablets
specified in the Manufacturing Batch Record (MBR).
Raw Material Parameters for
raw material characteristics make tableting difficult, we use wet
granulation procedures which involves blending the raw materials
with purified water, air drying the mixture, mill sizing the
particles and then blending the resulting granules for tableting.
of Tablet Ingredients
are blended according to predetermined written
instructions specified in the Manufacturing Batch Record (MBR).
the blending process is completed, the blended ingredients are placed
in drums and transported to the tablet room for tableting.
Tablet Machine Setup
Using engineered dies and
punches, the size and shape specified in the
Manufacturing Batch Record (MBR), our production staff
sets up the tablet machine. The operator has Quality Control approve the
setup, fills the
hopper with raw material and starts the machine to begin
production of the batch.
Cee's high-speed tableting
machines operate at speeds up to 150,000 tablets per hour. The
operator continuously monitors and controls key functions such as
die filling, compression of raw materials and tablet ejection.
stainless steel construction assures optimum manufacturing
Process Testing of Tablets
Tablets are tested at the beginning of each batch and the beginning
of each shift to ensure that they meet USP <2091> requirements for weight conformity.
USP <2040> requirements for disintegration and USP
<12167> requirements for friability, hardness and thickness.
Every 15 minutes during
operation, a random sample of ten tablets is weighed, compared to
specification, and the average weight is recorded.
Disintegration Time and
USP <2040>, our tablets are required to disintegrate in a minimum of 5 to a maximum
of 30 minutes.
Our tableted products
(except chewables and sublingual) are coated with a vegetable cellulose
to enhance appearance, make them
easier to swallow and improve their stability by protecting them
from oxidation and moisture.
Each tablet machine operator is responsible for assuring that the
tablets they manufacture meet the exact specifications in the Manufacturing Batch Records (MBR). Each
step of the manufacturing
process is monitored by supervisory personnel and verified by quality control.
Finished Goods Inspection
As each batch is completed,
a representative sample is tested in the laboratory. Manufacturing Batch Record (MBR) and finished goods
thoroughly reviewed and verified for accuracy before the product is
given a final stamp of approval and released for packaging and