Additional chapters feature key aspects of the technology, including formulation requirements, process variables, process scale up, troubleshooting, new development, safety, and process evaluation. 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. Nov 11, 2019 at the end of the coating process, the coated particles were dried for 20 min at 25c in situ. Critical design parameters include chamber geometry, air velocity and mass flow ratio of air to product.
Pellet coating is traditionally carried out using the wurster coater, a bottomspray fluid bed coater 1,3. Fluid bed wurster hs coating systems chemical online. The variables studied were the inlet air temperature and the coating suspension flow rate. Scaleup is easily achieved by including multiple partitions within the wurster processing insert.
Our proprietary equipment is designed for linear scalability allowing a smooth transition to commercial production in the 18, 32 and 46 wurster units. Jun 20, 2012 there are various theories about how to scale up a solid dosage coating operation in a pan coater. The first is that of the raw materials to be used and how their variations will affect any scaleup. The first is that of the raw materials to be used and how their variations will affect any scale up. The innovative, creative spirit at coating place is ready to take on wurster coating applications and associated upstream and downstream processing. 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. Out with the old and in with the new european commission. Numerical simulation of twophase flow in a wurster.
In mixing applications, scaleup is indeed concerned with increasing the. Differential air streams move the bed of particulate upward inside the chamber as it is coated with a material to create a coreshell structure. 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. Computational fluid dynamicsdiscrete element method modeling. Wurster coating scle up and scale out fluidization. Innovations in pharmacy and pharmaceutical technology. Pilot scale equipment is available at glatts ramsey new jersey process development laboratory for testing and customer inspection. Removal of mill scale is virtually impossible by hand. Explanation of scaleup principles and procedures using case studies. Oct 08, 2019 successful scale up of wurster based coating process at commercial 11. The wurster process coating place specialty chemical. Nowadays usfda also demanding for a scientific approach for scale activity based on development batches. Film coating of nifedipine extended release pellets in a. In this paper, electrical capacitance tomography ect is applied to reconstruct the solids distribution in a lab scale wurster fluidised bed for coating pellets and the measurements are used in a control loop of the process.
Jan 21, 2014 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. We offer wurster spray nozzles for laboratory size machine to plant size macines. Computational fluid dynamics cfd simulations and experimental measurements of laboratoryscale wurster coating were performed. Mar 30, 2014 the purpose of this work was to develop a practical scale up model for a solventbased pan coating process. This might be due to some spray dried coating material wet through filter bag and not considered in the calculation of percentage fines. Investigation of hydrodynamic behavior of alginate aerogel. Scribd is the worlds largest social reading and publishing site. Click the link to view an interactive pdf with the following data for 53992 topspray granulating lance. The coating process was studied using a complete experimental design of two factors at two levels for each polymer. 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. This animation shows the wurster coating process within a fluid bed. A feasibility study on pellet coating using a highspeed quasi.
Implementation of these rules does not require complex experimentation or prediction of model parameters. In this paper, electrical capacitance tomography ect is applied to reconstruct the solids distribution in a labscale wurster fluidised bed for coating pellets and the measurements are used in a control loop of the process. Particulate coating is a form of fluidized bed coating involving the coating of solid. Wurster coating job work, wurster coating machine manufacturers. The quality of film coat applied can be controlled by monitoring key process and product variables. Application of failure mode effect analysis in wursterbased pelletization technology. 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. Numerical simulation of twophase flow in a wurster coating. The entire process of drying, granulation, and wurster pellet coating occurs in a single container. All mill scale need to be removed to present a uniform and clean surface of the substrate steel for any application of any coating on the steel. Wurster based coating process at commercial scale is a challenging task. In the center over the plate the wursterpipe is installed, and inside of the wursterpipe the nozzle is placed.
Wurster coating, synonymous with fluid bed microencapsulation, is the encapsulation of discrete particles in a fluidized bed using bottom spray application. Fluid bed spray agglomeration is also often in colloquial. Cfd simulations were performed in a 2d axisymmetric space using the twofluid model. On the optimization of the fluidized bed particulate. Control of pellets coating in a wurster fluidised bed by. Larger scale batches must be monitored carefully, as any mistake could result in costly product waste. When scaling up the fluid bed process, a major requirement is to produce fluidization behavior on the larger machines equivalent to that used on the scale that provided the basis for process development.
She is a coordinator and an active contributor on various committees within american association of pharmaceutical scientists. Summary of technical and process parameters to be considered in scaleup procedures. Glatt wurster hs coating process in a fluidized bed youtube. Every thing about wurster coating process parameters, principle and scale up will be covered here.
Discussion of technical design options for fluidized bed equipment. Sep 08, 2019 so out off whole coating assembly, wurster column is a functional area for quality coating. After 10 min of drying, 1 g of silicon dioxide was added to the coating column through the external feeding port to separate particles that were stuck in the column non free flowing particles nffp, eq. How to optimize fluid bed processing technology 1st edition. In wurster processing, the big step in scale up is from laboratory equipment 6. Explanation of scale up principles and procedures using case studies. Aqueous polymeric coatings for pharmaceutical dosage forms, edited by. The proposed scale up rules are based on a macroscopic evaluation of the coating process. Wurster coaters are particularly suited to scaleup from labscale to production systems.
Each partition contains its own wurster accelerator spray gun and diverting system. The pellets were coated in wurster and characterized for assay, dissolution. Additional chapters feature key aspects of the technology, including formulation requirements, process variables, process scaleup, troubleshooting, new development, safety, and process evaluation. The proposed scaleup rules were tested by conducting coating scaleup and scaledown experiments on 24inch and 52inch vector hicoaters. Fluid bed wurster hs coating systems from glatt air techniques source. So out off whole coating assembly, wurster column is a functional area for quality coating. The purpose of this work was to develop a practical scaleup model for a solventbased pancoating process. Coating over mill scale mill scale is a thin layer on mild steel. Successful scale up of wurster based coating process at commercial scale is a challenging task. Scaleup using response surface methodology peter dybdahl hede 1, poul bach 1, and anker d. Wurster fluid bed coating coating place specialty chemical. 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. 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.
The partitions move in unison through the use of a center lift device. Freundvector corporation wurster bottom spray coating animated demo. This video gives an indepth explanation on the glatt wurster hs process. The wurster column coating process of pharmaceutical solids has been studied for many years and a considerable body of literature has been produced covering various aspects of the process. Wurster coating company ankleshwar gujarat and mumbai maharashtra, india. Fluid bed wurster hs coating systems from glatt air techniques. Every thing about wurster coating process parameters, principle and scale up. For chemical characterization, assay is the best test to conclude quality of coating, which is another cqa.
Chen has extensive experience in the development and scale up of beads coating process using wurster coating technology for different types of products from lab to commercial scales. Shetty and others published wurster coating scale up and scale out find, read and cite all the research you need on researchgate. Several sets of experiments were conducted by varying wurster tube diameter, wurster tube length, batch volume and partition gap height. The wurster process fluid bed coating is widely used and has become a primary method for the microencapsulating of particles. In one of the usfdas guide to inspections report prepost approval issues explained the expectations of regulatory authority on scale up activity saidit is important. 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. It is generally formed on metal surfaces through chemical oxidation of iron combined with oxygen at high temperature during the rolling process. The optimization performed to decide level of x2 and x3 for fines and agglomerated free process. Fludized bed wurster spray coating spray nozzle manufacturers. Wurster coaters are particularly suited to scale up from lab scale to production systems. Wurster process bottomspray the bottomblown fluidbed air is distributed by an perforated bottom plate.
Production size wurster coaters with multiple coating partitions have two very critical process challenges to overcome. Computational fluid dynamics cfd simulations and experimental measurements of laboratory scale wurster coating were performed. The effects of design and operating parameters on the superficial velocity at the onset of circulatory motion and the residence time of alginate aerogel particles in a laboratory scale wurster fluidized bed were investigated. To achieve uniform active coating content is one of the key interests for the pharmaceutical manufacturing industry. Fluid bed technology international journal of pharmaceutical. Additionally, it shows the key technical elements glatt wurster hs coating process in a fluidized bed on vimeo. This article provides a basic process understanding and scale up theory based on first principles. Process variables involved in wursterbased coating process medium risk. Practical scaleup rules to determine the key parameters pan load, pan speed, spray rate, air flow required to control the process are proposed.
Modeling and simulation of a wurster column for particulate. Development, optimization, and scaleup of process parameters. There are various theories about how to scale up a solid dosage coating operation in a pan coater. Wurster coating scle up and scale out free download as pdf file. Fluid bed wurster beadcoating, layering and encapsulation. Packed with all the features of a productionscale machine, gpcg 1. Scale up is easily achieved by including multiple partitions within the wurster processing insert. Our inhouse fluid bed coating, layering and encapsulation expertise, from pilot to full scale, allows for a successful techtransfer process into commercial production. The fluidbed process often is used for coating and powdered layering pelletizing. Coating place remains privately held with ownership actively involved 24 hrsday, 56 days per week. Just like the variables remaining same in pilot scale also, the same process control will apply.
Pellet coating is commonly performed in a fluid bed coater such as a wurster coater. Combined population balance and thermodynamic modelling of the batch topspray fluidised bed coating process. Steps in a scale up of the many variables involved there are at least two aspects of scaling up a coating process, from the bench to a production operation, that require additional consideration. Jan 31, 20 ever wondered how the wurster process works. Wurster fluid bed contract manufacturing services are the foundation of coating place business. The coating process shown in figure 1 has multiple, simultaneous, ongoing exchange processes. The objective of this work was to study the coating process of nifedipine extended release pellets using opadry and opadry ii, in a fluid bed coater with a wurster insert. Given its discussion of theoretical principles and practical solutions, this is a goto resource for all those scientists and new researchers.
Overall, the coating zone increases from lab to pilot scale. Wurster coating scle up and scale out humidity free 30day trial. The flow regime is identified from the ect images using a simple but efficient approach. Oct 29, 2012 the wurster column coating process of pharmaceutical solids has been studied for many years and a considerable body of literature has been produced covering various aspects of the process. Mar 30, 2014 the proposed scale up rules are based on a macroscopic evaluation of the coating process. The wurster process is recognized as the technology for precision application of a film coating onto particulate materials such as powders, crystals, or granules, and other solid ingredients with diameters ranging from 30 m to several centimeters. Click here to download the fluid bed wurster hs coating system brochure in pdf format. Successful scaleup of wurster based coating process at commercial 11. The proposed scale up rules were tested by conducting coating scale up and scale down experiments on 24inch and 52inch vector hicoaters. However, our gpubased dem code can currently model up.
Summary of technical and process parameters to be considered in scale up procedures. In wurster processing, the big step in scaleup is from laboratory equipment 6. 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. This article provides a basic process understanding and scaleup theory based on first principles. Get the latest industry news, insights, and analysis. Pelagia research library the tackiness of the coating being applied. Individual particles may make repeated cycles typically from 10 to through the tube, allowing very large agglomerates to be built up. In scale up of pellets, physical and chemical parameters reproduced based on. Practical scale up rules to determine the key parameters pan load, pan speed, spray rate, air flow required to control the process are proposed. Scale up factors in fluid bed processing wurster coating a. New surface treatment stops scale buildup mit news. Additionally, it shows the key technical elements that are required to.
Largescale fluid bed coating operations using wurster coaters are common in the pharmaceutical in. Nov 20, 2017 this animation shows the wurster coating process within a fluid bed. The proposed scaleup rules are based on a macroscopic evaluation of the coating process. Largerscale batches must be monitored carefully, as any mistake could result in costly product waste. Due to an higher number of holes in the center of the bottom plate an higher airflow here appears, with two effects. 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. Wurster coating scale up and scale out researchgate.
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