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FREQUENTLY ASKED QUESTIONS

FREQUENTLY ASKED QUESTIONS. Regarding SIGMA TECH/ DOE. SIGAM TECH. SAWROOP TECH. CONSULTANCY PLOT NO.39, Phase-2, SAKET, Kapra, ECIL:Post, Hyderabad-500062. Phone no. 91-040-2714 1290 Cell no. 9849 379 750 E-mail: bhadra40@yahoo.com Web site: www.swarooptechindia.com .

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FREQUENTLY ASKED QUESTIONS

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  1. FREQUENTLY ASKED QUESTIONS Regarding SIGMA TECH/ DOE

  2. SIGAM TECH • SAWROOP TECH. CONSULTANCY • PLOT NO.39, Phase-2, SAKET, Kapra, ECIL:Post, Hyderabad-500062. • Phone no. 91-040-2714 1290 • Cell no. 9849 379 750 • E-mail: bhadra40@yahoo.com • Web site: www.swarooptechindia.com

  3. 1.What is SIGMA TECH ? • SIGMA TECH is a software package deigned by SWAROOP TECH. CONSULTANCY for the application of DOE in process development.

  4. 2.DOE stands for what? • DOE stands for "Design Of Experiments." DOE helps you to design an experiment that will provide you with the most information possible with the minimum experimental work. • Everyone wants to perform experiments that provide a lot of valuable information with as little work as possible. DOE provides all such information.

  5. 3.Who are the people who can get benefitted by using it ? • The Scientists and Engineers who are engaged in the process/product developmental work, Quality Assurance , Analytical Research , Process / product Research , Pilot Plant studies, scale up design etc. will get benefitted by use of DOE.

  6. 4.Why do we need to go for DOE for process development? • The challenge facing corporations is to cut design and development time while producing low-cost quality products that are ready to perform. Many organizations are being challenged to cut delivery time in half or more. • By understanding and applying Experimental Designtechniques, scientists, researchers, and engineers typically obtain a 50% reduction in the time cycle required to conduct experiments . This translates into enhanced understanding of technologies, reduced design and development time, and decreased costs.

  7. Contd. • Among the regulatory authorities, cGMP, FDA(a), PAT(b), ICH(c) etc have recommended for the use of DOE for process development and the data submissions for their approvals. • Now a days in contract research work, even the customers are asking to submit the results by use of DOE methods . • In regulated industry like drugs and pharmaceutical industry, automobile industry, medical equipment manufacture etc. the regulatory authorities have strongly recommended the use of DOE for the development of process/ product.

  8. Some of the references are sighted here for the details if the users would like to have the details. Ref: (a) www.fdagv/cder/guidance/pv.htm, (b) EMEA /INS/277260/ www.emea.eu.int (c) The pharmaceutical journal ( vol 272) 5th June 2004 P 718.

  9. 5.What happens if we do not use the DOE in processdevelopment? • While developing the process quite often a large number of variables say about 7 to 10 are confronted with which the process has to be developed. • Usually the scientists with the available information, try to use OFAT method ( one factor at a time approach) in developing a process. • Since the number of variables are quite large and adoption of OFAT method needs large number experimental trials and time and resources , some of the variables are considered as not significant to the best of their knowledge and with only 3 or 4 variables the process development is tried and studied.

  10. Contd. • This approach does not guarantee the results. Even some variables are not significant their interactions with other variables might be significant in influencing the results. • Added to this the conventional methods as followed in process development can not establish the consistency and reproducibility of the results. • The interactions of the process variables are quite strong in many processes and they create a havoc in the process leading to inconsistent results.

  11. Contd. • Further among the process variables, some will influence the average performance and some other will influence the variation in the results. • Due to the inability of the OFAT method, the factors affecting the average performance and the variation in the results can not be established and hence consistent and cost optimal results can not be achieved. What ever it is achieved with OFAT the cost optimization can not be proved.

  12. 6.why DOE is not being followed in many Indian Industries? • In the past in many Universities these DOE methods were not part of the curriculum and never taught. Further even after some appreciation courses rendered during academic sessions, due to its detailed mathematical calculation procedures, the scientists and engineers were not ready to use DOE. • Since a better way was not taught the same good old method ie. OFAT method had been in use. • Latter on even some software packages were made available, by and large they were not user friendly. The sequence in which the soft ware is prepared is totally away from the sequence of the process development, adding the difficulty to the scientist and engineers in using these methods.

  13. Contd. • SIGMA TECH software is a user friendly and can be used easily with little training. • Hence Swaroop Tech.Consultancy has been trying to spread these DOE methods at Industry, Professional Institutions and academy level by conducting various seminars/ work shops through SIGMA TECH software and guiding the Research Scholars through the use of SIGMA TECH software in completing their project works.

  14. 7.What are the advantages of using the DOE in process development? • The process development time cycle and resources can be reduced to 50% by using DOE when compared to the OFAT. • The interactions can be identified which influence the results significantly and there by improving the results. • The factors affecting the variation in the results can be identified and a consistent / robust process can be designed which can guarantee the quality. • The cost effective optimal solution can be achieved .

  15. Contd. • When large number of factors are confronted, they can be screened to find out with few ( say n + 1 where n is the number of variables ) experiments , the most and few significant factors that matter for achieving the desired results

  16. 8. Which are the Organizations using the DOE methods for process development. • While multinational companies like Hoecshst Celanese, Glaxo, Pfizer, ICI, etc have institutionalized DOE methods , in India some of the reputed organizations like Divis laboratories, Ranbaxy labs, Dr.Redys labs, Hindustan livers, Sudarshan Chemicals, Crompton & Grieves etc have been using these DOE methods in process/product development.

  17. 9.what is the pay back period for the SIGMA TECH software package? • Just with the application of SIGMA TECH in one project , the cost of the software is paid back and it will result in the recurring savings subsequently as it is used.

  18. 10.what are the savings affected by the application of the DOE methods in practice ?

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