All raw materials, components, packaging, and labeling materials are received through the same controlled entrance to “receiving area”in 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 materials are held in our "quarantine" area until they are sampled, tested, and stamped to be released by our "quality control” department. The sampling is performed according to specific procedures under cGMP codes from NSF & NPA by trained personnel. The procedures are designed to prevent any type of contamination and cross contamination. Every raw material, component, packaging, and labeling material has its own test procedure and specification in writing on batch record. When the test result is documented and passed against each specification, those containers are allowed to exit quarantine area and moved into the main warehouse.
The first step of processing every product is weighing the raw materials to their proper weights indicated on the "batch record". The technician identifies each raw material by its name and code number. Then each raw material is weighed using a calibrated scale. The technician document the completion of each raw material weighed and checked against the "batch 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 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. Maximum capacity is 1,800kg/day.
SUN TEN Laboratories offers extensive skills and abilities in tablet manufacturing. There is a strong and knowledgeable group of scientists that can meet your demand. After production, each batch is carefully monitored by quality control department to ensure the correct size, weight, hardness, friability and dissolution are maintained. Our maximum capability is approximately 4,200 units per minute.
The encapsulation department is where common dry powders or granulations take shape into a capsule. SUN TEN state-of-the-art facility is equipped with both high-speed automatic and semi-automatic encapsulating machines with capabilities to produce two-piece hard shell gelatin and vegetarian capsules in sizes of 0, 00, 1 and 3. Each unique product has their own setting and quality control tests are performed before & after the set up. Everything will be handled and noted in the “batch record” according to cGMP codes. Maximum capability for encapsulation is 3,000 units per minute. After completion, samples are taken and submitted to the quality control department for testing along with the “batch record”.
At SUN TEN we provide tea bagging service which set us apart from other contract manufacturer. Even the teas are handled under the 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 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. 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, 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. Samples of finished, packaged product are tested for stability to allow for determination of expiration dating.
At SUN TEN, quality is built directly into our processes and is an essential component of all business activities.
The released products are stored in the “Finished Product Storage Room”for shipping. If required, our shipping department can help arrange for special shipping by customers as requested.