1-800-251-8182
 

QUALITY CONTROL

In-House Laboratory

Our products are subjected to rigorous third-party testing by multiple independent laboratories. These tests ensure our capsules only contain 100% pure ingredients and also that they are completely free of dangerous heavy metal and all biological contaminants. Our Food scientist supervised tests include:

* Mositure Analysis

* Particle size

* Powder density

* PH testing

* Purified water testing

* Cleaning & sanitizing material testing


* Microbiology

* Physical evaluations

* Ingredient identity

* Stability testing

* Disintegration

* Hardness

* Friability

* Weight variation

 

 

 

 

 

 

 

In Process Checks

Quality assurance inspectors perform hourly, in-process testing of manufacturing lines to assure compliance with product specifications and government regulations.

 

 

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.

 

 

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.

 

 

 

 

TABLETING

 

Raw 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 Tablet Ingredients

When 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.

 

 

Blending of Tablet Ingredients

Ingredients are blended according to 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 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.

 

 

Tablet Machine Operation

Dee 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. Enclosed, stainless steel construction assures optimum manufacturing conditions.

 

 

In 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.

 

 

Tablet Disintegration Time and Dissolution Rate

Using USP <2040>, our tablets are required to disintegrate in a minimum of 5 to a maximum of 30 minutes.

 

 

 

Tablet Coating

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.

 

 

 

Quality

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 records are thoroughly reviewed and verified for accuracy before the product is given a final stamp of approval and released for packaging and shipment.

 

 

 

PACKAGING

 

Experience

Dee Cee's packaging staff is directed by industry professionals who know how to produce superior quality in appearance, package consistency and uniformity.

Training

Dee Cee's training procedures provide staff with the opportunity to expand their knowledge and responsibility as their experience increases. Outside training and professional development are encouraged and rewarded.

 

Versatility

Dee Cee's equipment is designed to efficiently handle a broad range of capsule and tablet sizes in a wide variety of container configurations.

Capacity

Superior staff and high speed equipment provide Dee Cee with the ability to manage very high packaging volumes.

Quality

Each line technician is responsible for assuring that every product is packaged to exacting specifications. Performance is monitored by supervisory personnel and verified by quality control.

 

 

 

 


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