Role of automation-Pharmaceutic automation-Pharmaceutical al industry
Submitted by
J.S.R Moorthy
[email protected]
Prasun bheri
[email protected]
Y.N.V.K.M Subbarao
[email protected]
Progressive Engineering College
Role of automation-Pharmaceutical industry
Abstract Abstract - In the health care segment, pharmaceutical industry plays an important role by providing appropriate drugs to combat the diseases. In order to cope up with the ever increasing demands of the health care segment, pharmaceutical industry is constantly looking for optimal solutions. Automation helps in achieving these goals.
Introduction – The quest to improve the drug discovery process, to find new drugs demands demands stringent stringent quality standards which are difficult difficult to achieve achieve in manual processes. processes. These results in poor performance of the research labs, which is measured by the number of products found by a lab for the investment in infrastructure and associated recurring revenue expenditure. Automation is the solution to overcome these drawbacks. Automa Automatio tion n helps helps in syste systemat matizi izing ng the proces processes ses,, improv improving ing the quality quality along along with with reducing the time frames. This results in consistent, accurate, valid and repeated results in the following fields: • • •
Drug discovery process. Drug manufacturing process. Inspection and quality control.
Drug discovery process Robots are employed in all aspects of drug development activities viz., synthesizing large verities of potentially viable chemical combinations conceived by researchers, producing and documenting these in the lab and conducting the field trials to check the performance of the candidate combinations.
The actual process of drug discovery begins with scientific research to discover new pro produ duct ctss and and to impr improv ovee or modi modify fy exis existi ting ng ones ones.. The The R&D R&D depa depart rtme ment ntss in pharmaceutical and medicine manufacturing firms start this process by seeking new chemical compounds by selecting few of the possible candidates from a collection of potential potential combinations combinations which usually usually run in to few hundreds hundreds of thousands. thousands. Automation Automation helps in choosing a right combination by associating a mathematical model comprising of weight age factors. This has resulted in new disciplines like combinatorial chemistry, computer modeling and simulation in the Parma research domain.
Atomization - drug discovery Drug discovery involves iterative testing of the specimen with different samples .This laborious process can be automated by b y using the following schema:
Take the specimen along with reactants in a sterilized specimen tray.
Place the specimen in reactants jar.
Tabulate the initial reaction status
Catalyze the compound
Take the parametrical readings of the reaction
Mobilize the specimen for further analysis if necessary or halt the process
Create the record of positively identified elements
Identify the cell with positive reaction
End of process
fig-1: Typical schema representing the process flow.
A typical implementation of the above schema is presented below:
Fig-2 Xantus state of the art flexible automated XYZ pipetting and robotic workstation
Atomization – drug manufacturing In spit spitee of the the econ econom omic ic hard hardsh ship ipss face faced d beca becaus usee of slow slow grow growth th rate rate,, drug drug manufacturing industry is aggressively heading towards automation of the plants to reap the benefits like quality products, minimal wastage, consistent production schedules and associated cost benefits. benefits. This This has resulted in promotion of many robot vendors, system integr integrato ators rs and proces processs automa automati tion on consul consultan tants ts to provid providee end to end soluti solutions ons for manufacturing, material handling and quality control applications.
Fig-3 A leading pharmaceutical company’s fully automated system that would increase productivity, meet extremely tight repeatability specification and achieve high dot placement density.
Atomization – drug testing This phase is highly important and must be give special attention .The main objective of this stage is to prevent spurious drugs to enter the market. Absence of this phase may lead to disaster to human life. This process is a long one and high technology is used perform this task. Atomization provides a safer and accurate way of inspecting. Drug inspection involves tests for contaminants which range from biological agents to microscopic dust particles. Tracing these these impurities impurities is a challenging process. All these processes can be accomplished in one stage by a systematic atomized process. Automated drug testing machines or DNA decoders use robot arms to fill thousands of miniscule wells on a single plate. Each well may represent six months of work on a single drug compound.
Fig-4 Demonstration of a robotic arm performing a visual inspection on the on the chemical samples on a conveyer belt
Case study - EPSON Robotics has implemented automation in a Shunt manufacturing industry. The application called for sorting the needles into three categories based on thei theirr leng length ths. s. A comb combin inat atio ion n of visu visual al insp inspec ecti tion on and and a sort sortin ing g robo robott have have been been successfully integrated to determine the size and orientation of the needle and feed the needles into the injection molding machine. This has resulted in seamless integration and automation of plastic shunt manufacturing unit. Statutory Statutory Requirements Requirements - In each each and ever every y coun countr try y the the gover governm nment ent cont contro rols ls and and regulates Parma industry to protect the life of the citizens. Stringent laws are enacted and implemented to steam line manufacturing and quality norms. This helps in prevention of spurious drugs entering the market. All the above objectives are easily achieved by implem implement enting ing automa automatio tion n soluti solutions ons.. This This also also reduces reduces cost cost of manufa manufactu cturin ring g and improves the profitability of company. Parma industry is looking for most of these produc products ts which which are subjec subjectt to strict strict Food Food and Drug Drug Admini Administr strati ation on rules rules regard regarding ing validation, documentation and manufacturing practices, such as 21 CFR parts 11. At the same same time, time, manufa manufactu cturin ring g proces processes ses are typica typically lly subjec subjectt to Class Class 100 cleanr cleanroom oom specifications set out in ISO 14644-1. Because of these strict regulations and the time along with the costs of validating each product, they typically have longer lifetimes.
Advantages – Preventing the spurious drugs entering the market • Records are managed properly • The results obtained are reliable and veracious •
Conclusion - A few years ago many of the robots used in lab automation applications were very light duty. Today, duty cycles are going up rapidly, even though in many cases, cases, the speeds are relatively relatively minimal. minimal. When duty cycles are high, a poor up-time up-time can rapidly take the yield out of the system, so the industry is becoming more and more interested in reliability. In order to meet the current day requirements more sophisticated technology should be adopted. Though lot of advancements have taken place small and medium scale industries have not adapted this technology because of cost effective tailor made solutions for this specific processes we intend to work in this field by offering affordable solutions. We thank Dr.K.Ravindra principal Progressive Engineering college, Dr Rama krishna H.O.D (c.s.e), Devaraj Naidu H.O.D (e.e.e). Our special thanks to Prof.G.Krishna Murthy for motivating and guiding us in preparation of this paper.
