Facility

All raw materials, components, packaging, and labeling materials are received through the same controlled entrance into our manufacturing plant. Their receipt is performed according to specific procedures by trained personnel who ensure that the integrity of each and every container has been protected during shipment. Each container is thoroughly checked, counted, and identified before it is allowed into the "quarantine" area.

All raw materials, components, packaging, and labeling materials are held in our "quarantine" area until they are sampled, tested and/or examined, and released for use by our "quality control laboratory". The sampling is performed according to specific procedures by trained personnel. The procedures are designed to prevent contamination of raw materials, components, and packaging materials. Every raw material, component, packaging, and labeling material has its own test procedure and specification in writing and on file. When the "quality control laboratory" receives the samples, the respective test procedure is followed and the results documented and matched against the specifications. Upon release, each container of each lot number of raw materials, components, packaging, and labeling materials receives a green "release" sticker. Only containers bearing this "release" sticker are allowed out of quarantine and into the main warehouse.

The first step of processing every batch of product is weighing the raw materials to their proper weights indicated on the "batch production record". Our highly skilled pharmacy technicians identify each raw material by its name and code number. Each raw material is weighed using a calibrated scale and placed into a clean poly-lined container that has been labeled to indicate the material, the weight, the raw material lot number, and the product name, code, and lot number of the batch being processed. A second pharmacy technician performs a double check to ensure that the information is correct and matches the requirements of the "batch production record". The pharmacy technicians document the completion of each raw material weighed and checked on the "batch production record". Upon completion of weighing all of the raw materials for a production batch, all documentation is rechecked and signed off before sending it to the Compounding/Blending department.

The proper handling of materials in any department is crucial to prevent any contamination or cross-contamination of the product. In the Blending/Compounding department it is most crucial due to the fine materials and the exposed surface area during processing. Each processing room is equipped with dust collection ports to create a negative room pressure and a positive airflow out of each room to minimize the chances of cross-contamination. Highly skilled material compounders identify each of the weighed raw materials and compare them to the requirements of the "batch production record". As each step in the processing procedures is performed, the material compounder documents that the step has been completed and a second material compounder verifies and documents that the step has been completed. Also, as each raw material is added to the batch, the material compounder documents the addition and a second material compounder verifies and documents the addition. Once all compounding steps have been completed, the uniform blend is discharged from the blenders into poly-lined, in-process, labeled containers. Samples are taken according to a written procedure. The "batch production record" is reviewed and submitted to the quality control laboratory along with the samples for in-process testing that will assure the proper specifications have been achieved.

The tablet compression/encapsulation department, or unit dosing, is where common dry powders or granulations take shape into a tablet or a hardshell capsule. Precision machines are set up to the specifications indicated on the "batch production record". Each product is fairly unique which demands that they are set up according to written procedures to achieve the desired finished results. Quality control tests are performed after the set up and before the actual production run on each lot of each product. During the production run, in-process tests are performed by trained operators every fifteen minutes until the completion of the process. Each of the performed tests are documented on the "batch production record". The various machines used, each, can produce varying amounts of output with a top speed of approximately 3,300 units per minute. Some of the tablets are further processed in our "coating" area. Applying a coating to the tablet adds to its stability and enhances the appearance of the tablets. Applying a coating to tablets is still very much an "art". It takes a coater years of experience to develop the skills necessary to perform this process. After tablet compression or encapsulation, and after coating, the "batch production record" is, again, reviewed. Samples are taken, and the samples and "batch production record" is submitted to the quality control laboratory for further testing.

Our diversity of provided services includes the manufacture of softgel capsules. Softgel manufacturing is a very specialized process. Each product is made up of two parts. One being the molten gelatin for the shell, and the other being the ingredients encapsulated by the gelatin. Again, the machines must be set up to exacting specifications for size, shape, and weight. In-process test are performed every fifteen minutes to ensure that the product produced is consistent and meets the specifications. Completed softgels are automatically transferred to tumblers to allow the gelatin shell to partially dry which shrinks the capsule around the filling which helps it retain its shape. Then the softgels are spread onto trays and placed in drying tunnels to continue the drying process. The tunnels, as well as the entire department, are supplied with clean, cool, dry air from a controlled air handling device specifically designed for the manufacture of the softgels. Once dried, the softgels are inspected and polished to achieve a shiny luster to enhance their appearance. Upon completion of the process, samples are taken, the paperwork is reviewed, and both are submitted to the quality control laboratory for further testing.

Another service that sets us apart from other contract manufacturers is tea bagging. Even the teas are handled under the same GMP guidelines that are used for drug products. After release from the quality control laboratory, the blended tea is fed from overhead containers into the tea bagging machines. These machines are set up to achieve results as specified on the "batch production record". The lead operators check the tea bag weights every fifteen minutes to ensure that they are within the specifications. The tea bags can be foil pouched or poly pouched then placed into a box. At the completion of each lot, samples are taken, the "batch production record" is reviewed, and both are delivered to the quality control laboratory for further testing.

Our packaging department is divided between two areas. Bottle filling handles the counting and filling of unit dose forms such as tablets, hardshell capsules, and softgel capsules. Powder filling handles the packaging of powder blends such as drink mixes. Both areas are controlled by written procedures designed to assure that the proper fill, components, and labeling is used on each packaging run. The "packaging record" provides all the necessary specifications and allows for all documentation of the packaging of the batch. The packaging record then becomes part of the "batch production record" which allows all of the processing and packaging information to be filed in one location within our document control department. Packaging runs are monitored constantly to ensure that the final product meets all of the customer's specifications. At the end of the packaging run, the "packaging record" and finished samples are submitted to the quality control laboratory for a final test and release for shipping.

The quality control department is responsible to ensure that all materials meet the established criteria throughout all phases of the process. Raw materials, components, and packaging and labeling are examined and tested according to a rigorous written program designed to assure uniformity from batch to batch. Every raw material received is tested for identity and conformance to specifications. Every bottle, cap, and label is examined to assure that they match the written specifications. During the manufacture of all batches of all products, in-process samples are tested and the results documented. If any results fall outside of the written specifications, the product is rejected and the information is submitted to the research and development group for evaluation and further disposition. Samples of finished, packaged product is tested for stability to allow for determination of expiration dating. Accelerated stability testing as well as real time stability testing is done concurrently to validate the results of the tests. When it comes to Quality, we teach each and every employee the same lesson… "Quality is not "inspected" into the product, it is "manufactured" into the product!"

The released products are stored in the Finished Good Area for shipping. If required, our shipping department can help arrange for special shipping requirements by customers.