Pharmaceutical products process simulation

In the chemical industry, chromatographic separation process is an emerging technology for the separation of pharmaceutical products, food and fine chemicals. To improve the economic viability, a continuous countercurrent operation is often desirable but the actual movement of the solid leads to a serious operating problem. Therefore, the simulated moving bed (SMB) process is an interesting alternative option. 

Pharmaceutical Drug Association. Technical Report No 22. Process Simulation Testing for Aseptically Filled Products Pharmaceutical Drug Association Inc. Bethesda, MD, 1996. 

Petrides D P, Koulouris A, Lagonikos P T (2002). The role of process simulation in pharmaceutical processes development and product commercialization. Pharmaceut. Engin. 22 1-8. 

A substantial number of chemical, food, pharmaceutical and metallurgical industry rely on batch-wise production processes. The dynamic and complicated character of the recipe steps and the equipment can lead the process to reach unsafe conditions. The accurate and appropriate modeling of the batch process and the recipe is the focus of this research. In particular, the goal of this paper is to present the modeling for simulation and optimization of safety constraints related to a polymer batch process. 

Batch process simulation is a computer modeling technique used for the design, analysis, and optimization of batch manufacturing processes. Batch process manufacturing is practiced in industries that produce low-volume, high-value products such as pharmaceuticals, fine chemicals, biochemicals, food, consumer products, etc. Most batch manufacturing facihties are multiproduct plants that produce a variety of products. 

Batch Plus (now called Aspen Batch Process Developer), a recipe-driven simulator that targeted batch pharmaceutical processes. Around the same time, Intelligen (Scotch Plains, NJ) introduced SuperPro Designer. The initial focus of SuperPro Designer was on bioprocessing. Over the years, its scope has been expanded to support modeling of fine chemicals, pharmaceuticals, food processing, consumer products, and other types of batch/semi-continuous processes. 

The purification of value-added pharmaceuticals in the past required multiple chromatographic steps for batch purification processes. The design and optimization of these processes were often cumbersome and the operations were fundamentally complex. Individual batch processes requires optimization between chromatographic efficiency and enantioselectivity, which results in major economic ramifications. An additional problem was the extremely short time for development of the purification process. Commercial constraints demand that the time interval between non-optimized laboratory bench purification and the first process-scale production for clinical trials are kept to a minimum. Therefore, rapid process design and optimization methods based on computer aided simulation of an SMB process will assist at this stage. 

Enzymatic Processes for Fine Chemicals and Pharmaceuticals Kinetic Simulation for Optimal /2-Phenylacetylcarbinol Production... 

At present, the purification by chromatographic processes is the most powerful high-resolution bioseparation technique for many different products from the laboratory to the industrial scale. In this context, continuous simulated moving bed (SMB) systems are of increasing interest for the purification of pharmaceuticals or specialty chemicals (racemic mixtures, proteins, organic acids, etc.).This is particularly due to the typical advantages of SMB-systems, such as reduction of solvent consumption, increase in productivity and purity obtained as well as in investment costs in comparison to conventional batch elution chromatography [1]. 

Westerhoff P, Yoon Y, Snyder S, Wert E (2005) Fate of endocrine-disruptor, pharmaceutical, and personal care product chemicals during simulated drinking water treatment processes. Environ Sci Technol 39 6649-6663... 

The volume for each media hll is listed in the data summary. The practice at (ABC Pharmaceutical Industries) has been to simulate production by using the 50% volume of the container (dehned as the practical hll capacity of the container by the manufacturer) for the media hll. This method simulates the hlling process utilized in normal production. 

Continuous processes are more efficient than batch processes, as the use of stationary phase is optimized and the amount of eluent needed for the purification is significantly reduced. The concentration of feed mixture inside the column can be much higher than it is in the case of a batch process. As a consequence, productivity is multiplied by a factor of two to five, less manpower is required, usage of stationary phase is optimized, and the amount of solvent used is reduced by a factor of two to ten. Two multicolumn continuous chromatography processes have been commercially implemented at commercial scale for pharmaceutical chiral separahons, these being the simulated moving bed (SMB) process and the Varicol process [15-17]. 

---