|
ENCAPSULATION
Raw
Material Weigh Up of Capsule Ingredients
Ingredients
are brought into a weigh room where they are weighed
according to a written formula for a predetermined number of
capsules specified in the Manufacturing Batch Record (MBR).
Raw Material Parameters for Capsule
Ingredients
Encapsulating machines
operate at extremely high speeds. Conformity from batch to batch in the filling
operation depends on the characteristics of the Raw Material such as particle size, shape, and size distribution. The
following parameters must be controlled:
*Particle size and shape
*Uniformity of particle
size *Homogeneity of the
mixture *Flow properties *Moisture content *Tap
density
Blending
of Capsule Ingredients
Ingredients
are blended according to another set of predetermined written
instructions specified in the Manufacturing Batch Record (MBR).
When
the blending process is completed, the blended ingredients are placed
in drums and transported to the capsule filling room for
encapsulation.
Capsule
Filling Machine Setup
Using precision engineered
tooling (dosing disk and tamping pins) the size specified in the
Manufacturing Batch Record (MBR), our production staff sets up the capsule
filling
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.
Capsule
Filling Machine Operation
Dee Cee's high speed
encapsulating machines fill up to 45,000 capsules per hour. The
operator continuously monitors and controls key functions such as
filling, tamping of the raw material and capsule ejection. Enclosed
stainless steel construction assures optimum manufacturing conditions.
In Process Testing
of Capsules
Capsules 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. Every 15 minutes during
operation, a random sample of ten capsules is checked for weight and
length compliance.
Disintegration Time and Dissolution
Rate of Capsules
Capsules
disintegrate and release contents within a period of 2 minutes up to
a maximum of 10 minutes. Capsules are recognized as having superior
disintegration properties compared to tablets.
Quality
Each capsule machine operator is responsible for assuring that the capsules
they manufacture meet the exact specifications in 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
records are
thoroughly reviewed and verified for accuracy before the product is
given a final stamp of approval and released for packaging and
shipment.
Dee
Cee Laboratories, Inc.
304 Dee Cee Court
White House, TN 37188
Office
Hours
8:05-4:25 Central Time
Monday - Friday
Phone: 1-800-251-8182
Fax: 1-615-672-4989
After Hours: 1-800-251-8182
|
