Dale wurster at university of wisconsin invented the wurster process way back in 1959. Scale up model for prediction of exhaust air relative humidity. This video gives an indepth explanation on the glatt wurster hs process. Scale up factors in fluid bed processing, fluid air inc. Fluid bed wurster hs coating systems from glatt air techniques source. We offer wurster spray nozzles for laboratory size machine to plant size macines. The coating of pharmaceutical, agricultural, and food products has been practiced for hundreds of years using techniques as diverse as applying coatings by hand to individual tablets to the application of millions of tablets using fluidized beds or rotating drum coating devices. The coating process was studied using a complete experimental design of two factors at two levels for each polymer. Film coating of nifedipine extended release pellets in a. Diagram flow diagram of fbe by pam glatt density of alloy granulation process in a pam glatt fbegranulation process in a pam glatt fbe. The quality of film coat applied can be controlled by monitoring key process and product variables.
Wurster fluid bed contract manufacturing services are the foundation of coating place business. Our inhouse fluid bed coating, layering and encapsulation expertise, from pilot to full scale, allows for a successful techtransfer process into commercial production. The original patents were filed in 19531 and, over time, the process has evolved into one of the most adaptable means of coating small particles. Wisconsin alumni research foundation, internal document. Successful scaleup of wurster based coating process at commercial 11. Glatt wurster hs coating process in a fluidized bed on vimeo. Coating place remains privately held with ownership actively involved 24 hrsday, 56 days per week. She is a coordinator and an active contributor on various committees within american association of pharmaceutical scientists. In the wurster process, a complete sealing of the surface can be achieved. Wurster coaters are particularly suited to scale up from lab scale to production systems. Wurster coating scle up and scale out fluidization. Scale forms in boilers due to the presence of various salts, which come out of the solution and are deposited because of the effects of temperature and density.
Additionally, it shows the key technical elements glatt wurster hs coating process in a fluidized bed on vimeo. New surface treatment stops scale buildup mit news. He has successfully led the development and secured the approval of more than 30 products approved in the us, eu, japan and china, including new drug applications. The wurster coating application having a longer column in the processor. Fluid bed bottom spray pellet with particle coating option. Wurster coaters are particularly suited to scaleup from labscale to production systems. The model was composed of fundamental flow types such as plug flow and wellmixed flow regions to describe phenomena including dead zone and side pass. A novel scale up model for prediction of pharmaceutical.
The problem with that approach, varanasi explains, is that these coatings can wear out, just as the coating on a nonstick frying pan often degrades with use. Implementation of these rules does not require complex experimentation or prediction of model parameters. Using proven gea fluid bed technology to achieve fluid bed granulation, drying and pellet coating or tablet coating in a single module, flexstream is a new multipurpose processor that addresses the current shortfalls of traditional fluid bed processing, including linear scaleup, fully contained loading and unloading, and superior product homogeneity for both lod and psd. The purpose of this document is to provide a brief guide for scaling up a fluid bed process. Largerscale batches must be monitored carefully, as any mistake could result in costly product waste. The variables studied were the inlet air temperature and the coating suspension flow rate. Glatt pharmaceutical services the glatt group has commercialized several improvements to the original wurster bottom spray fluid bed technology invented by dr. Each partition contains its own wurster accelerator spray gun and diverting system. Early versions of the wurster were used for tablet coating, particularly when coatings were.
Users have to know the crucial processing attributes which needs to be observed and evaluated in order. This coater employs a cylindrical product container with perforated plates. The majority of the studies reported in literature on scaleup concentrates only on the. Presenting the scaleup concept of particle coating using wurster technology as an example. This animation shows the wurster coating process within a fluid bed. A feasibility study on pellet coating using a highspeed. Overall, the coating zone increases from lab to pilot scale. Scribd is the worlds largest social reading and publishing site. The coating process shown in figure 1 has multiple, simultaneous, ongoing exchange processes. Innovations in pharmacy and pharmaceutical technology. Wurster coating, synonymous with fluid bed microencapsulation, is the encapsulation of discrete particles in a. The proposed scaleup rules were tested by conducting coating scaleup and scaledown experiments on 24inch and 52inch vector hicoaters.
Scaleup of particle coating in the fluidized bed understanding the process. Explaining the scaleup of the most important process parameters in detail. As a corrosion professional and a coating formulating chemist, i feel that i have the obligation to write this note mill scale, rust, and coating 101. Online moisture control as tool for process development, scale up activities and routine. Results obtained using a mini glatt wurster coater typically used for early productprocess development have been comparted with those obtained using a gea mp 1 machine fitted with a wurster insert. Every thing about wurster coating process parameters, principle and scale up. So out off whole coating assembly, wurster column is a functional area for quality coating. The scaleup of spray coating processes for granular. Practical scaleup rules to determine the key parameters pan load, pan speed, spray rate, air flow required to control the process are proposed. Wurster coating scle up and scale out fluidization humidity. Wurster coating company ankleshwar gujarat and mumbai maharashtra, india. Fluid bed wurster hs coating systems from glatt air techniques. Just like the variables remaining same in pilot scale also, the same process control will apply.
Chen has extensive experience in the development and scaleup of beads coating process using wurster coating technology for different types of products from lab to commercial scales. On the optimization of the fluidized bed particulate. Glatt air techniques the wurster hs processing insert, patented by glatt in 1992, provides significant improvements over conventional wurster coating technologies through increased productivity, high spray rates, increased yields and applications with fine particles. This might be due to some spray dried coating material wet through filter bag and not considered in the calculation of percentage fines. Fluid bed wurster beadcoating, layering and encapsulation. Critical design parameters include chamber geometry, air velocity and mass flow ratio of air to product. Researchscale granulator coater with three inserts and expan sion chambers for tangentialspray coating a, top. Patapplications in dry powder layering with rotor technology in fluid bed. Previous attempts to prevent or reduce scale formation have typically involved adding a coating such as teflon to a surface to prevent minerals from bonding to it. Pellet coating is traditionally carried out using the wurster coater, a bottomspray fluid bed coater 1,3. However, the wurster coater has been associated with problems of pellet agglomeration during the coating process. Process scale up scaleup from smaller research batches to commercial production may be necessary after formulation development is completed or during the technical transfer of a product.
Coating over mill scale mill scale is a thin layer on mild steel. This article provides a basic process understanding and scaleup theory based on first principles. The partitions move in unison through the use of a center lift device. The proposed scaleup rules are based on a macroscopic evaluation of the coating process. A profound understanding of the filmcoating processes itself is an essential prerequisite for upscaling. In the pharmaceutical process study during the development phase, the batch scale and coating equipment are. In wurster processing, the big step in scale up is from laboratory equipment 6. Production size wurster coaters with multiple coating partitions have two very critical process challenges to overcome. Shetty and others published wurster coating scale up and scale out find, read and cite all the research you need on researchgate. Scaleup is the transfer of a process from labscale to manufacturing scale.
Explanation of scaleup principles and procedures using case studies. Scale up factors in fluid bed processing fluid air. Crites and turton 2005 have developed a compartment based model to incorporate the cycle time distribution feature for the coating process in the wurster column coater. The theoretical scale up section describes how to theoretically. The scaleup of gassolid contacting equipment from bench to. There are various theories about how to scale up a solid dosage coating operation in a pan coater. Fludized bed wurster spray coating spray nozzle manufacturers.
Urs of mini glatt fluidizes bed processor was prepared by a coordinated approach among production, quality assurance, and engineering department of astron research ltd. The innovative, creative spirit at coating place is ready to take on wurster coating applications and associated upstream and downstream processing. Pellets containing venlafaxine hcl were coated with an ec film coating 10% weight gain. The wurster process fluid bed coating is widely used and has become a primary method for the microencapsulating of particles. Wurster coating scle up and scale out download as file pam glatt pharma technologies pvt ltd.
In wurster processing, the big step in scaleup is from laboratory equipment 6. In small machines, bed depth rarely exceeds 200 mm, and fluidization height substrate travel out of the partition is principally limited by machine dimensions to 1. The purpose of this work was to develop a practical scaleup model for a solventbased pancoating process. Scaleup is easily achieved by including multiple partitions within the wurster processing insert. Scale up factors in fluid bed processing wurster coating a. Wurster coating scle up and scale out free download as pdf file. Study of scale up parameters of fluidized bed coating imedpub. Particulate coating is a form of fluidized bed coating involving the coating of solid. Wurster coating scle up and scale out pdf document. Our proprietary equipment is designed for linear scalability allowing a smooth transition to commercial production in the 18, 32 and 46 wurster units. Successful scale up of wurster based coating process at commercial scale is a challenging task. 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. Wurster coating scale up and scale out researchgate. The wurster process coating place specialty chemical.
1451 1028 1029 1432 1565 257 1051 1481 823 456 196 1344 380 979 904 43 665 1063 1208 1428 570 493 1512 105 1495 799 976 309 1074 826 248 28 396 952 651 309 975 1314 941 444 1262 247 210 458 1376 277