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 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. 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 or production.
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 production 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 production technician performs a double check to ensure that the information is correct and matches the requirements of the “batch production record”. The production 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 it is blended.
The proper handling of materials in any department is crucial to prevent any contamination or cross-contamination of the product. In the Blending 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 production technicians 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 production technician documents that the step has been completed and a second production technician verifies and documents that the step has been completed. Also, as each raw material is added to the batch, the production technician documents the addition and a second production technician verifies and documents the addition. Once all blending 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 unit along with the samples for in-process testing that will assure the proper specifications have been achieved.
The encapsulation department is where common dry powders take shape into a hard-shell 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 1,200 units per minute. After encapsulation, the “batch production record” is, again, reviewed. Samples are taken, and the samples and “batch production record” is submitted to the quality control unit for further testing.
6. Quality Control
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.