Hoodia Diet Pills Manufacturing

Hoodia Gordonii Nutritional Manufacturing Profile Of Advanced Diets UK & USA

Hoodia Gordonii Based Weight Loss Supplement Manufacturers

BUILDING AND FACILITIES

The manufacturing area is designed to facilitate the operation from the time of receipt of raw materials to the time of shipping of the finished product. The areas are organized in a manner to prevent mix-ups and contamination of raw materials, packaging components and the products manufactured. The areas allocated to different operations are as follows:

1. Receiving and quarantine area

2. Warehouse for storage of raw materials and other components

3. Pharmacy and blending

4. Staging area for storage of in-process materials

5. Production area for encapsulation

6. Production area for tableting

7. Coating area

8. Packaging and labeling area

9. Area for storage of finished products

10. Quality control laboratory

Adequate lighting and ventilation is provided through the building and sanitation procedures are in place to ensure the building is maintained clean and free of rodents and other vermin. All manufacturing areas, including storage of finished products, are air conditioned. Individual dust collection units service the areas of pharmacy and blending, tableting, encapsulation and coating, in order to prevent build up of dust and microorganisms, and product contamination. Separate rooms and/or cubicles are employed for the performance of specific operations which are equipped with appropriate equipment and separate air handling system using negative air pressure for prevention of cross-contamination.

PRODUCTION AND PROCESS CONTROLS

Written procedures are strictly followed in production of nutritional products to ensure their identity, strength, quality and purity. In process controls have been established to assure that the product is made reproducibly and according to set specifications. Process control functions are documented at the time of performance and processing records are maintained throughout the manufacturing process.

Equipment used in the manufacture of a product are properly maintained and thoroughly cleaned according to written procedures to prevent malfunction and contamination of the product. Procedures are in-place for cleaning, set-up and operation of equipment as well as its inspection prior to use. A log of use, cleaning and maintenance is kept for each processing equipment.

To ensure batch uniformity and integrity of the product, procedures have been established for in-process testing. These control procedures include, where appropriate:

1. Appearance

2. Weight variation

3. Tablet thickness

4. Tablet hardness

5. Friability

6. Disintegration time

7. Dissolution time

In-process specifications are consistent with finished product specifications. The quality control unit may reject a product at any stage of the manufacturing process, if the purity or quality of the product is compromised. Rejected products are quarantined until an investigation of the problem is completed.

EQUIPMENT AND CAPACITIES

Equipment and Capacities are reviewed on an ongoing basis for upgrading due to more efficient available machinery and productivity needs.  Two 8 hour shifts are normally run with and third shift available for peak times.

1.  Granulation

Dry Granulation:  Chilsonatar (capacity of 1000 kilograms per Day)

Wet Granulation:  Standard Oven (capacity of 500 kilogram per Day)

Fluid Bed Dryer (capacity of 160 kilograms per Hour)

2.  Blending

2- 50 cubic feet Patterson Kelley V-Blenders

1- 75 cubic feet Patterson Kelley V-Blenders

3.  Tablet Compression

5- BB-2 Type High Speed Compression

7- D-Tooling Compression

capacity of approximately 150 million per month

4.  Encapsulation

4- Fully Automatic Encapsulators

6- Semi Automatic Encapsulators

capacity of approximately 45 million capsules per month

5.  Powder

Powder Filling Machine

6.  Coating

4- Conventional 48” Coating Pans

2- Excella Coaters (for Film Coating and Enteric Coating)

7.  Packaging

2- Fully Automatic Lines (including all standard bottle packaging services, such as filling, cottoning, capping, induction sealing, neck sealing, full body sealing, labeling)

2- King TB-4 Tablet Counters

Specialty Services:

Full Body Sealing

Square Bottle Filling

Induction Sealing

8.  Quality Control

Tablet/Capsule Inspection Lines allow for a visual approval of all products.  These lines are also equipped with metal detection.  New production is compared to earlier standard samples to ensure the ongoing consistancy of products.

A fully equipped QC Laboratory allows for a complete complement of tests ensuring that potencies fully match label requirements, proper disintegration occurs, tablet hardness is correct and all other aspects of the product meet specifications and standards.  Our QC Laboratory is equipped for USP and NF testing including the following:

High Pressure Liquid Chromatography

Spectrophotometer

Thin Layer Chromatography

Atomic Absorption

Friability

Disintegration

Dissolution

Hardness

Gas Chromatagraph

Full Microbiologic

RECORDS AND REPORTS

All production and analytical records associated with a batch of a product are retained for at least one year past the expiration date of the batch. Records are also maintained for all raw materials and other components for at least one year after the expiration date of the last lot of product incorporating any of these materials or components.

1.  Raw Materials: Raw materials and packaging components are purchased from reputable suppliers. A Certificate of Analysis is obtained from the supplier which is maintained by the Quality Assurance Group for at least one year past the expiration date of the product. All raw materials received are identified and checked for their physical characteristics, and identified according to the supplier label claim and the purchasing department. An inventory record is generated for each lot of material which is used by the pharmacy to maintain a log of material use. Samples are withdrawn and submitted to QC for testing according to specifications and Standard Operating Procedures (SOP's) set forth.

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