Our high sheer granulators can create a wet cake of material that has uniform distribution of ingredients. In general, this wet mass is then used in our extruder to form elongated threads of material, which is then run through a spheronizer to form uniform spheres for further drying and coating in a CPI Wurster fluid bed unit. This process allows otherwise incompatible formulations to be combined to create a core that can be uniformly coated with sustained release profiles.
We use our proprietary CPI Wurster fluid bed coaters to create a granular particle that will be dried upon exit from the single unit. This eliminates the numerous steps needed in the extrusion and spheronization process. In this process, a wet solution is sprayed into the fluid bed coater to agglomerate the primary powder together and create larger granules by suspending the particles inside the chamber through high velocity air. This material is then dried upon completion of the spraying by adding hot air to the unit. The particles will exit the chamber in spherical shapes due to the movement of the material in the chamber and through particle interaction.
Wet ball milling is useful when the particles are highly insoluble in your liquid suspension. In the ball milling process, the particles in the liquid suspension are broken down to increase their ability to mix into the solution and create a fluidized coating with an even viscosity. This can be done for a drug loaded suspension that is then spray coated onto a carrier particle inside a CPI Wurster unit. This then creates a smooth and uniform final product with desired release profiles within the system.
Coating Place has highly trained technicians who can determine the best particle engineering system for your product. Let us make your final product that best that it can be with our advanced Wurster fluid bed coating skills and our array of capabilities available to you.
Our capsule abilities include a single-bead, dual-bead, dual-bead and powder, or powder fillings. We use our Dott Bonapace IN-CAP and Bosch GKF 1400 capsule fillers to provide the highest quality products. These machines are capable of filling a wide range of capsule sizes allowing us to provide the most flexibility to our clients in their final product and dosage amounts. Encapsulation is useful in extending shelf-life, regulating reactivity or controlling release profiles during delivery.
Powdered material can be pressed into all different tablet sizes and shapes using a variety of tooling provided by our Manesty 16 Station and Korsch Model 400 tablet presses. Our multiple blending operation styles allow a uniform drug distribution throughout the tablet. With three tableting machines available, we can handle virtually any size project from research to commercial manufacturing. Pan coating is also available to coat pressed tablets to create a variety of release profiles.
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.
Process Scale Up
Scale-up from smaller research batches to commercial production may be necessary after formulation development is completed or during the technical transfer of a product. Our proprietary equipment is designed for linear scalability allowing a smooth transition to commercial production in the 18”, 32” and 46” Wurster units, reducing the number of demonstration batches needed. The highly experienced engineers and technicians at Coating Place will guide your project through the scale-up process to minimize risk and optimize product yield. Coating Place combines experience and expertise in engineering, development, and manufacturing to offer you efficiency in the movement of your project from the small-scale development phase to commercial manufacturing.
During the product transition, our knowledgeable chemists, engineers and technicians provide assistance and advice, allowing for a smooth transfer from other manufacturing locations and alternative coating equipment. With key parameters of the application identified and one or more test runs completed to optimize parameters, a process validation protocol can be generated to initiate the transfer. The technology transfer is complete upon meeting the acceptance criteria defined in the protocol and summarized in the validation report. Equipped with Wurster fluid bed units capable of batch sizes of up to 800 Kg, Coating Place can match current batch sizes and operating parameters as well as successfully scale-up products for commercial manufacturing. Our on-site GLP analytical laboratory is capable of generating all required analytical data necessary for your product transfer and continued production with assistance from our quality assurance department. From beginning to end, Coating Place can perform the technology transfer necessary for optimization of your product.
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