In the pharmaceutical and related industries, ingredient integrity must be assured and proper dosage maintained. It is the responsibility of the manufacturer to ensure the proper level of quality is guaranteed in a product. Process validation involves the experimental design and work performed to assure that key product quality parameters are consistently met under the processing conditions and limits outlined for the production process.
Coating Place is prepared to perform process validation for any product produced. Our process validation begins by identifying the key products and process parameters to create a batch record that outlines these parameters, and a validation protocol to define the requirements of validation. Validation requirements will vary with industry and application; however, every phase of a pharmaceutical product must be validated including Wurster fluid bed coating steps. A typical validation process will include assessing the product parameter ranges, assay or release uniformity, residual solvents verification and particle size distribution.
Once the work outlined in the protocol has been performed and acceptable results have been achieved, a final validation report is compiled and the procedure is validated for production manufacturing. Coating Place has the staff and resources to perform every aspect of a process validation including development of a process validation protocol, execution of validation batches, generation of analytical data under GLP guidelines, and creation of the final process validation report.
Coating Place has been in the Wurster coating industry since its founding in 1976 with the original Wurster patent and prototype equipment from Dr. Dale Wurster. Our extensive experience allows us to guarantee efficient and effective manufacturing processes, creating optimal and high quality services for our customers.
Our proprietary oral delivery technology is brought to you through our Oradel™ Platform. Our customers are offered extensive experience in the areas of modified release technology, multilayer coating and ion resin technology.
Coating Place, Inc. 200 Paoli Street PO Box 930310 Verona, WI 53593 Phone: (608) 845-9521 Fax: (608) 845-9526