TY  - JOUR
AU  - Boltić, Zorana
AU  - Ružić, Nenad Lj.
AU  - Jovanović, Mica
AU  - Mihajlović, Marina
AU  - Jovanović, Jovan
AU  - Petrović, Slobodan
PY  - 2013
UR  - http://TechnoRep.tmf.bg.ac.rs/handle/123456789/2519
AB  - The aim of the article is to present a case study related to implementation of cleaner production (CP) process with the concept of minimizing emissions versus the end of pipe (EOP) approach within pharmaceutical industry. The idea is to move beyond simple pollution control by technology improvement and prevention of organic solvents emission into the atmosphere. Furthermore, cost-effectiveness of the suggested approach is evaluated compared to traditional concepts of polluted air treatment, ensuring both environmentally friendly and effective production of film coated tablets. Technological changes to improve the impact on the environment have been applied already in many industries as well as in pharmaceutical manufacturing. However, more effort is to be made in order to further decrease particularly VOCs emission into the atmosphere. An analysis is provided to stimulate a proactive approach in this field towards completely eliminating the use of organic solvents from film-coating systems in the production of the pharmaceutical solid dosage forms. The new way of addressing the costs actually associated with embracing cleaner technologies, which are mostly related to regulatory aspects in pharmaceutical industry, is aimed to promote the change in culture, as well as to be applied in the decision making process for other pharmaceutical facilities still using organic solvents based coatings in the manufacturing of tablets. The significance of the small scale projects is additionally emphasized considering the magnitude of the world generic market.
PB  - Elsevier Sci Ltd, Oxford
T2  - Journal of Cleaner Production
T1  - Cleaner production aspects of tablet coating process in pharmaceutical industry: problem of VOCs emission
EP  - 132
SP  - 123
VL  - 44
DO  - 10.1016/j.jclepro.2013.01.004
ER  - 

@article{
author = "Boltić, Zorana and Ružić, Nenad Lj. and Jovanović, Mica and Mihajlović, Marina and Jovanović, Jovan and Petrović, Slobodan",
year = "2013",
abstract = "The aim of the article is to present a case study related to implementation of cleaner production (CP) process with the concept of minimizing emissions versus the end of pipe (EOP) approach within pharmaceutical industry. The idea is to move beyond simple pollution control by technology improvement and prevention of organic solvents emission into the atmosphere. Furthermore, cost-effectiveness of the suggested approach is evaluated compared to traditional concepts of polluted air treatment, ensuring both environmentally friendly and effective production of film coated tablets. Technological changes to improve the impact on the environment have been applied already in many industries as well as in pharmaceutical manufacturing. However, more effort is to be made in order to further decrease particularly VOCs emission into the atmosphere. An analysis is provided to stimulate a proactive approach in this field towards completely eliminating the use of organic solvents from film-coating systems in the production of the pharmaceutical solid dosage forms. The new way of addressing the costs actually associated with embracing cleaner technologies, which are mostly related to regulatory aspects in pharmaceutical industry, is aimed to promote the change in culture, as well as to be applied in the decision making process for other pharmaceutical facilities still using organic solvents based coatings in the manufacturing of tablets. The significance of the small scale projects is additionally emphasized considering the magnitude of the world generic market.",
publisher = "Elsevier Sci Ltd, Oxford",
journal = "Journal of Cleaner Production",
title = "Cleaner production aspects of tablet coating process in pharmaceutical industry: problem of VOCs emission",
pages = "132-123",
volume = "44",
doi = "10.1016/j.jclepro.2013.01.004"
}

Boltić, Z., Ružić, N. Lj., Jovanović, M., Mihajlović, M., Jovanović, J.,& Petrović, S.. (2013). Cleaner production aspects of tablet coating process in pharmaceutical industry: problem of VOCs emission. in Journal of Cleaner Production
Elsevier Sci Ltd, Oxford., 44, 123-132.
https://doi.org/10.1016/j.jclepro.2013.01.004

Boltić Z, Ružić NL, Jovanović M, Mihajlović M, Jovanović J, Petrović S. Cleaner production aspects of tablet coating process in pharmaceutical industry: problem of VOCs emission. in Journal of Cleaner Production. 2013;44:123-132.
doi:10.1016/j.jclepro.2013.01.004 .

Boltić, Zorana, Ružić, Nenad Lj., Jovanović, Mica, Mihajlović, Marina, Jovanović, Jovan, Petrović, Slobodan, "Cleaner production aspects of tablet coating process in pharmaceutical industry: problem of VOCs emission" in Journal of Cleaner Production, 44 (2013):123-132,
https://doi.org/10.1016/j.jclepro.2013.01.004 . .

TY  - JOUR
AU  - Boltić, Zorana
AU  - Ružić, Nenad Lj.
AU  - Jovanović, Mica
AU  - Petrović, Slobodan
PY  - 2010
UR  - http://TechnoRep.tmf.bg.ac.rs/handle/123456789/1721
AB  - This article presents experience from the practice of a successful pharmaceutical company related to design and implementation of performance measures (PMs) for deviation management linked to the analysis of impact on the production cost for the selected product. Case study focuses on PMs within good manufacturing practice (GMP) processes related to quality assurance (QA) and quality management, with the aim of complying with its future requirements proposed by the European Commission. Critical areas were identified based on data gathered from the industrial deviation database. Implementation of the suggested corrective actions showed significant improvement in terms of reducing their number for more than 50% per selected deviation category. The results obtained in the course of this practice-oriented study contribute to further improvement of deviation management in the pharmaceutical industry and performance measurement of other GMP processes. The suggested performance measurement concept and problem-solving techniques may serve both practitioners and the decision-makers within QA and quality control (QC) in order to improve their processes by implementing relevant regulatory requirements for quality management and maintain compliance.
PB  - Springer, New York
T2  - Accreditation and Quality Assurance
T1  - Measuring the performance of quality assurance processes: pharmaceutical industry deviation management case study
EP  - 636
IS  - 11
SP  - 629
VL  - 15
DO  - 10.1007/s00769-010-0709-2
ER  - 

@article{
author = "Boltić, Zorana and Ružić, Nenad Lj. and Jovanović, Mica and Petrović, Slobodan",
year = "2010",
abstract = "This article presents experience from the practice of a successful pharmaceutical company related to design and implementation of performance measures (PMs) for deviation management linked to the analysis of impact on the production cost for the selected product. Case study focuses on PMs within good manufacturing practice (GMP) processes related to quality assurance (QA) and quality management, with the aim of complying with its future requirements proposed by the European Commission. Critical areas were identified based on data gathered from the industrial deviation database. Implementation of the suggested corrective actions showed significant improvement in terms of reducing their number for more than 50% per selected deviation category. The results obtained in the course of this practice-oriented study contribute to further improvement of deviation management in the pharmaceutical industry and performance measurement of other GMP processes. The suggested performance measurement concept and problem-solving techniques may serve both practitioners and the decision-makers within QA and quality control (QC) in order to improve their processes by implementing relevant regulatory requirements for quality management and maintain compliance.",
publisher = "Springer, New York",
journal = "Accreditation and Quality Assurance",
title = "Measuring the performance of quality assurance processes: pharmaceutical industry deviation management case study",
pages = "636-629",
number = "11",
volume = "15",
doi = "10.1007/s00769-010-0709-2"
}

Boltić, Z., Ružić, N. Lj., Jovanović, M.,& Petrović, S.. (2010). Measuring the performance of quality assurance processes: pharmaceutical industry deviation management case study. in Accreditation and Quality Assurance
Springer, New York., 15(11), 629-636.
https://doi.org/10.1007/s00769-010-0709-2

Boltić Z, Ružić NL, Jovanović M, Petrović S. Measuring the performance of quality assurance processes: pharmaceutical industry deviation management case study. in Accreditation and Quality Assurance. 2010;15(11):629-636.
doi:10.1007/s00769-010-0709-2 .

Boltić, Zorana, Ružić, Nenad Lj., Jovanović, Mica, Petrović, Slobodan, "Measuring the performance of quality assurance processes: pharmaceutical industry deviation management case study" in Accreditation and Quality Assurance, 15, no. 11 (2010):629-636,
https://doi.org/10.1007/s00769-010-0709-2 . .

TY  - JOUR
AU  - Ružić, Nenad Lj.
AU  - Petrović, Slobodan
PY  - 2002
UR  - http://TechnoRep.tmf.bg.ac.rs/handle/123456789/458
AB  - 2-lmidazolines are components of many products, used in industry and households. 1-(Stearamidoethyl)-2-heptadecyl-2-imidazoline is a surface active compound, which after quaternization with dimethyl sulfate, is used in lubricants, detergents, shampoos, softeners and cosmetics products. Due to its importance, it was essential to establish the exact reaction pathway for obtaining this compound. Diethylene triamine and stearic acid were used as the starting components. Using titrimetric analysis, and IR and 1H NMR spectros-copic analysis, as well as UV-Vis spectrophotometry it was established that the main intermediate was the 1,3-diamide bis(stearamidoethyl)amine. Earlier investigations conducted by some authors, using exclusively titrimetric analysis, showed that the main intermediate was the 1,2-diamide. In this paper it was proved that the assumption of these authors that salicylaldehiyde would react only with the primary and not the secondary amine groups was wrong. 1,2-Diamide is the main product of the hydrolysis of 1-(stearamido-ethyl)-2-heptadecyl-2-imidazoline. It was shown, in this paper that the reaction of diethylene triamine with stearic acid in xylene at the reflux temperature, yields the salt of 1-(stearamidoethyl)-2-heptadecyl-2-imidazoline and stearic acid.
AB  - 2-imidazolini su jedinjenja koja ulaze u sastav velikog broja proizvoda koji se koriste u Industriji i domaćinstvima. 1-(2-stearamidoetil)-2-heptadecil-2-imidazolin je površinski aktivno jedinjenje, koje se posle kvaternizacije dimetilsulfatom, koristi kao aditiv lubrikansima, deterdžentima, šamponima, omekšivačima i kozmetičkim proizvodima. U raduje dat dokaz reakcionog puta do-bijanja 1-(2-stearamidoetil)-2-heptadecil-2-imidazolina. Do rezultata se došlo praćenjem reakcije između stearlnske klseline i dietilentriamina volumetrijskom metodom titracije i savremenim metodama IR i 1W NMR spektroskopije i UV-Vis spektrofotometrije. Utvrđeno je da je glavni intermedijer u reakciji dobijanja 1-(2-stearamidoetil)-2-heptadecil-2-imidazolina 1,3-diamid bis(stearamido-etil)amin. Pokazano je da je glavni proizvod reakcije dietilentriamina i stearin-ske kiseline u ksilenu, pod uslovima refluksa, so 1-(stearamidoetil)-2-hepta-decil-2-imidazolina istearinske kiseline.
PB  - Association of Chemical Engineers of Serbia
T2  - Hemijska industrija
T1  - Confirmation of the reaction pathway for obtaining 1-(stearamidoethyl)-2-hepta-decyl-2-i midazoline
T1  - Dokaz reakcionog puta dobijanja 1-(2-stearamidoetil)-2-heptadecil-2-imidazolina
EP  - 49
IS  - 2
SP  - 43
VL  - 56
DO  - 10.2298/HEMIND0202043R
ER  - 

@article{
author = "Ružić, Nenad Lj. and Petrović, Slobodan",
year = "2002",
abstract = "2-lmidazolines are components of many products, used in industry and households. 1-(Stearamidoethyl)-2-heptadecyl-2-imidazoline is a surface active compound, which after quaternization with dimethyl sulfate, is used in lubricants, detergents, shampoos, softeners and cosmetics products. Due to its importance, it was essential to establish the exact reaction pathway for obtaining this compound. Diethylene triamine and stearic acid were used as the starting components. Using titrimetric analysis, and IR and 1H NMR spectros-copic analysis, as well as UV-Vis spectrophotometry it was established that the main intermediate was the 1,3-diamide bis(stearamidoethyl)amine. Earlier investigations conducted by some authors, using exclusively titrimetric analysis, showed that the main intermediate was the 1,2-diamide. In this paper it was proved that the assumption of these authors that salicylaldehiyde would react only with the primary and not the secondary amine groups was wrong. 1,2-Diamide is the main product of the hydrolysis of 1-(stearamido-ethyl)-2-heptadecyl-2-imidazoline. It was shown, in this paper that the reaction of diethylene triamine with stearic acid in xylene at the reflux temperature, yields the salt of 1-(stearamidoethyl)-2-heptadecyl-2-imidazoline and stearic acid., 2-imidazolini su jedinjenja koja ulaze u sastav velikog broja proizvoda koji se koriste u Industriji i domaćinstvima. 1-(2-stearamidoetil)-2-heptadecil-2-imidazolin je površinski aktivno jedinjenje, koje se posle kvaternizacije dimetilsulfatom, koristi kao aditiv lubrikansima, deterdžentima, šamponima, omekšivačima i kozmetičkim proizvodima. U raduje dat dokaz reakcionog puta do-bijanja 1-(2-stearamidoetil)-2-heptadecil-2-imidazolina. Do rezultata se došlo praćenjem reakcije između stearlnske klseline i dietilentriamina volumetrijskom metodom titracije i savremenim metodama IR i 1W NMR spektroskopije i UV-Vis spektrofotometrije. Utvrđeno je da je glavni intermedijer u reakciji dobijanja 1-(2-stearamidoetil)-2-heptadecil-2-imidazolina 1,3-diamid bis(stearamido-etil)amin. Pokazano je da je glavni proizvod reakcije dietilentriamina i stearin-ske kiseline u ksilenu, pod uslovima refluksa, so 1-(stearamidoetil)-2-hepta-decil-2-imidazolina istearinske kiseline.",
publisher = "Association of Chemical Engineers of Serbia",
journal = "Hemijska industrija",
title = "Confirmation of the reaction pathway for obtaining 1-(stearamidoethyl)-2-hepta-decyl-2-i midazoline, Dokaz reakcionog puta dobijanja 1-(2-stearamidoetil)-2-heptadecil-2-imidazolina",
pages = "49-43",
number = "2",
volume = "56",
doi = "10.2298/HEMIND0202043R"
}

Ružić, N. Lj.,& Petrović, S.. (2002). Confirmation of the reaction pathway for obtaining 1-(stearamidoethyl)-2-hepta-decyl-2-i midazoline. in Hemijska industrija
Association of Chemical Engineers of Serbia., 56(2), 43-49.
https://doi.org/10.2298/HEMIND0202043R

Ružić NL, Petrović S. Confirmation of the reaction pathway for obtaining 1-(stearamidoethyl)-2-hepta-decyl-2-i midazoline. in Hemijska industrija. 2002;56(2):43-49.
doi:10.2298/HEMIND0202043R .

Ružić, Nenad Lj., Petrović, Slobodan, "Confirmation of the reaction pathway for obtaining 1-(stearamidoethyl)-2-hepta-decyl-2-i midazoline" in Hemijska industrija, 56, no. 2 (2002):43-49,
https://doi.org/10.2298/HEMIND0202043R . .