Scale-up of a pan-coating process pdf

The purpose of this work was to develop a practical scaleup model for a solventbased pancoating process. In the pharmaceutical tablet film coating process, we clarified that a difference in exhaust. Department of chemical engineering and technology, royal institute of technology, stockholm, sweden. Statistical evaluation of tablet coating processes. For instance, the development is initially from lab scale to bench scale then move to pilot. N o one can deny that materials developers ultimately have their eye on commercial uses. Scale up of a pan coating process pdf abstract the purpose of this work was to develop a practical scaleup model for a solventbased pancoating process. Tablet scaleup troubleshooting coating studies bioavailability and dissolution studies who should attend this course is designed for contract pharmacists, formulators, managers, pharmaceutical engineersand those who want to better understand the tablet manufacturing process. A quality by design approach for coating process parameter optimization film coating is a thin polymer layer applied on to a solid dosage form. Give a brief note on scaleup of biotechnologyderivedproducts and parenteral solutions. Mcconville process design for scaleup process development strategies importance of engineering in pd scaleup an overview role of the pilot plant overview of scaleup issues technology transfer issues batch reactors typical plant operations and equipment. Scale up of pan coating process using quality by design principles. Abstract in this article the authors, based on the visimix software, the experience of visimix users and personal.

After successful process development and optimization of your process at lab scale, in your or our lab, your process is ready for scaleup. Think process before scaling up tom mroz, director of technology at thermal processing company harper international, explains the importance of considering scaleup requirements for thermal processing early for successful commercialisation of new materials. Practical scaleup rules to determine the key parameters pan load, pan speed, spray rate, air flow required to control the process are proposed. A key unit operation required unusually severe conditions high temperature, high pressure, andor high corrosivity. Secondly, always allow time for finetuning even after the scaleup seems complete. Scale up of a pan coating process pdf semantic scholar. Second edition, revised and expanded, edited by allen cato, lynda sutton, and allen cato iii 121. However, limitation of using t mix as scale up criteria is that it increases markedly with the. The number of process variables and their interdependence in a pan coating process can make it a rather complex scale. Practical scaleup rules to determine the key parameters pan load, pan speed, spray rate. Up of pan coating process using microenvironmental control pandey, preetanshu. By this approach, the comparison between a laboratory and a production coating spray gun with respect to scale up was determined using a statistical model and surface plots. The coating of solid dosage forms, such as capsules.

We have spent considerable time evaluating both pumps and nozzles to find those which give us the best performance in comparison to the smaller test units. This article provides a basic process understanding and scaleup theory based on first principles. Scale up methodology for the fine chemical industry the. Scaling up a film coating process pharma ima group. Outline the pilot plant operation and give brief note oneach. Scale up of pan coating process using wiley online library.

Nonlinear scaleup is the number one challenge to pilot plant scaleup and is the cause behind the other seven challenges. Pandey 5 has developed a practical scaleup model for a 58 solventbased pancoating process, based on a macroscopic evaluation of the coating process 59 to determine the key parameters required to control the process. Any change in the guntobed distance will change the drying time for the spray droplets and thus alter the quality of the coating. The proposed scaleup rules are based on a macroscopic evaluation of the coating process.

There are various theories about how to scale up a solid dosage coating operation in a pan coater. Process development, engineering and economics by edi d. Scaleup approach for fermentation process of production. Key factors for bioprocess technology selection, scaleup and engineering of new facilities biocatalyst raw materials process technologies products scale economics s cale e conomics b.

Company founder werner glatt with the first fluid bed granulator and pan coater contents pan coating systems 2 glatt gc smart 3 processing 4 air processing 5 spraying system 6. A commentary on scaleup of pan coating process using. A central composite design was chosen by considering independent. Equipment specified for a unit operation was a prototype in terms of size or application. Implementation of these rules does not require complex experimentation or prediction of model parameters. The full text of this article is available as a pdf 378k. The formulation factors that can affect the pan coating process and product at tributes on scaleup are excipient type and levels, volatility of the. Up of pan coating process using microenvironmental control a commentary on scale. To scale up the coating process with any degree of confidence, the spray rate must be determined using the same guntobed distance used in the larger coating pan.

In scale up of bioreactors mixing time is often used as criteria. The number of process variables and their interdependence in a pan coating process can make it a. Secrets of batch process scaleup a 3 day course given by francis x. On the optimization of the fluidized bed particulate coating process 1998. The proposed scaleup rules were tested by conducting coating scaleup and scaledown experiments on 24inch and 52inch vector hicoaters. Mixing time t mix, defined as the period of time required for the homogeneous distribution of a small volume of pulsating material in the bulk of the liquid, was used for scale up to adjust proper mixing conditions in large vessels.

Due to the larger size and scale of industrial fermentation setups it is vital to succeed beforehand studies of possible complications, due to increase in scale, and to sort out ways to tackle them. The number of process variables and their interdependence in a pan coating process can make it a rather complex scaleup problem. As in pan coating, the performance of nozzles, pumps, and other support equipment may become a limiting factor in scale up. Scaleup approach for fermentation process of production of bacillus thuringiensis var kenyae based biopesticide r g muley, s sarkar, b l bhan, arunkumar,m narayanan and s r aik rescarch and development, hinuustan antibi otics limited, pi mpri. Scaleup involves the development of culture systems in stages from small scale laboratory to large scale industry. This also includes our comprehensive service, which has become our trademark and which you can expect from us in the future as well. A novel scale up model for prediction of pharmaceutical film. The scaleup process is divided into two categories.

Bio base europe pilot plant is an experienced partner for the scaleup of your biobased process or product. A quality by design approach for coating process parameter. National essential drug list october 6 september 34. Scaling up of film coating processes can be critical as the technology is very complex. Although significant progress had been made in developing general scaleup rules for an aqueous pancoating process, there are often scenarios where smallscale experiments are not found to be truly reflective of what may be observed at the large scale. Experimental information such as the tablet location, circulation time distribution, velocity distribution, projected surface area, and spray dynamics was the main input to. Dermatological and transdermal formulations, edited by kenneth a. Technology development benefits from stage gates at which. What is the difference between pilot scale and scaleup. Reference number6 various differing types of models exist, each suited to different situations in scaleup fundamental modelsany model based on a theoretical understanding of the process mechanismsused to describe the system from first principles of thermodynamics, phase equilibrium, and kineticsresidence time distribution models are used to treat continuous, steady state.

Secondly, and probably more significantly, it strongly affects the fluidization pattern. Modeling weight variability in a pan coating process using. An easy to use procedure for creating temperature and. Abstract different aspects that influence the fluidized bed particulate coating process have been investigated. Scale up of pan coating process using quality by design. It should be noted that atomization air volume is the key variable, but it often is gauged by atomization air pressure. Process air volume is also a key factor in scaleup, providing three major functions. Tablet coating checklist since spraying, coating distribution, and drying take place at the same time, tablet coating is a dynamic, complex process that is affected by many variables. First, it delivers heat to the product, for evaporation and removal of the coating application medium. The primary objective of the current study was to investigate process variables affecting weight gain mass coating variability cv m in pan coating devices using novel videoimaging techniques and monte carlo simulations. Pan coating, scaleup, scaledown, similarity, solvent coating, drug release, opacity.

Scale up of pan coating process is of high importance to the pharmaceutical and food industry. Choose from a wide variety of coating materials including pure metals, metallic alloys, metallic blends, carbides and selffluxing materials, tailored to gas or liquid fuel systems. This article will focus mostly on scaleup aspects of aqueousbased pan coating process. Scale up methodology for the fine chemical industry the influence of the mixing in the process moshe bentolila visimix ltd. The coating process shown in figure 1 has multiple, simultaneous, ongoing exchange processes. On the optimization of the fluidized bed particulate.

Due to our strict confidentiality policy, we cannot further comment on the content of the scaleup projects performed so far on a bilateral basis. Pharmaceutical process scaleup, edited by michael levin 119. Product and process development for scaling up is typically move in small steps. A chemical plant is an industrial process plant that manufactures or otherwise processes chemicals, usually on a large scale. Scaleup definition act of using results obtained from laboratory studies for designing a prototype and a pilot plant process. Pilotscale testing was incomplete or was conducted with nonrepresentative samples. Think process before scaling up harper international. Nonlinear scaleup basically means you cannot take a chemical process in the lab and drop it into a pilot plant by simply increasing the chemicals and equipment involved in. Pdf scale up of pan coating process using quality by. Technology development benefits from stage gates at which the viability of the technology can be assessed before continuing with the scale up scaling up step by step t he recommended approach for scaling bioenergy and biofuels technology follows a similar stage gate process to that used in traditional chemical process industry cpi processes.