Keywords
Elastômeros
controle de qualidade
análise
equipamentos odonto-médico-hospitalares
controle de qualidade
análise
equipamentos odonto-médico-hospitalares
How to Cite
1.
Cecília Rosa Depieri Nunes M, Rosa da Silva de Alcantara M, Sadocco Pascuet N, Rosa Ribeiro E, Tieco Fukushima Murata L, Braghini Neto C. Elastomeric materials dental-medical-hospital equipment use: quality control and Methodology evaluation. Rev Inst Adolfo Lutz [Internet]. 1996 Dec. 30 [cited 2024 May 20];56(2):47-52. Available from: https://periodicos.saude.sp.gov.br/RIAL/article/view/36604
Abstract
Twenty-two samples of elastomeric materiais for dental-medical-hospital equipment use were analyzed, according to tests from three norms: Brazilian legislation-Portaria 23/64 that establishcs standard tests to evaluate the quality of general pharmaceuticals and clinical equipment; German norm - OlN 58367 and United States Pharmacopeia which establish specific tcst for elastomeric materiaIs. Respectively, 18,2 %,31,8 % and 13,6 % ofthe samples were approved bythetests from these regulations. The 10wlevels ofappoval show an unsatisfactory quality ofthese materiaIs. The purpose ofthis study is to show the quality ofthese types of materiaIs and also suggest that the qualified official agency issue a norm related to this malter.
References
1. ALEMANHA, Deutsches Institute fur Normung. Transfusion, infusion, injection, elastomeric parts: requirements, test. Berlin, DIN 58367, parte I, 1986.
2. AMERICAN SOCIETY FOR TESTING AND MATERIALS. - 1994 Annual book of ASTM standards. Philadelphia, ASTM, c 1994. V. 8. 01, p.211. (Designation 883-93).
3. BOURNE, H.G. ; YEE, H.T.; SEFERIAN, S. - The toxicity of rubber additives, Arch.Environ. Health, Chicago, 16: 700-5, 1968.
4. BRASIL, Leis, decretos, etc. - Portaria N° 23 de 30 de outubro de 1964, do Serviço Nacional de Fiscalização da Medicina e Farmácia. Diário Oficial, Rio de Janeiro, 13jan. 1965. Seç. I, pt. I, p.409.
5. BRYDSON, .T.A. - Rubber Chemistry . Barking, Esscx, Applied Science, 1978. 462 p.
6. COOPER, J. - Récipients en matiére plastique pour les preparations phannaceutiques. Essai et contrôle . Geneve, OMS, 1974. 205 p.
7. DE ROECK-HOLTZHAUER, Y - Action des liquides phannaceutiques sur les matiéres plastiques et Ies caoutchoes. Prod. Probo Pharm., Paris, 19: 58-63, 1964.
8. FARMACOPÉIA BRASILEIRA IV ed. São Paulo, Atheneu Editora São Paulo Ltda. V. 3.2, 1988.
9. GUESS, WL.& O'LEARY,R.K. - Toxicity ofa rubber accelerator. Toxicol.Appl. Pharmacol., London, 14: 221-31, 1969.
10. JELINEK,J.; STEPAN, J.;CINATL,1. - Toxicology testing of some polymeric and rubber materiaIs for tissue cuItures. Cesk. Farm., Praga, 29: 100-2, 1980.
11. KOSYREVA, N.S.; LOGINOVA,C.I.; SHEN-FIL.L.Z.; BOVENKO'y'N.- Buty1 rubber stoppers sealing bott1es containing blood substitutes and injection solutions. Farm atsyi a, Moscow, 4: 49-51, 1978.
12. LEONI, V - Una rassegna critica sue requisit delle materie plastiche da impiegarsi per il confezio-namento di farmiaci e proposte per una normativa dei settore. Farmaco. Ed. Prat., Pavia, 30: 3-30, 1975
13. MILES, D.C.& BRISTON, J.H. - Tecnologia dos polímeros. São Paulo, EDUSP/ PoIígono, 1975. 365 p.
14. PINTO, A.T.J. - Controle de qualidade de produtos médico-hospitalares: Característica de blocompatibilidade em materiais poliméricos. São Paulo, 1984. [Dissertação (mestrado) - Faculdade
de Ciências Farmacêuticas, USP].
15. PREGNOLATTO, N.P. et al, - Análise de materiais plásticos empregados em recipientes de envasamento de produtos farmacêuticos e em equipamento de uso clínico. Rev. Inst. Adolfo Lutz, 40(1): 55-57, 1980.
16. REEPMEYER, J.C. & JUHL, YH. - Contamination of injectable solutions with 2-mercaptobenzothiazole leached frorn rubber c1osures. 1. Pharm.
Sci., Washinton, 72: 1302-5, 1983.
17. SANOTSKII, LV. & SHUMSKAYA, N.I. - Standardization of toxic substances in water extracts from rubbers. Gig. Sanit., Moscow, 8: 79-
82, 1975.
18. SAUNDERS, K.J. - The identification of plastic and rubbers. London, Chapman and Hall, 1970. p.2.
19. STANKEVICH, v.v., SHURUPOVA, E.A.; PINCHUK, L.M. - Means of higienic assessment of rubber containing tetramethyIthiuran disulfide and intend for contact with food products. Gig. Sanit., Moscow, 1: 22-4, 1976.
20. UNITED STATES PHARMACOPEIA Elastomeric closures for injections. XXII ed. Rockville, Md., USP, 1990. p. 1533-34.
21. YENIA, A.A. et al. - Rubbcr vulcanizates in relation to their suitability as closure material for liquid pharmaceutical preparations. Effect of filIers and antioxidants. Pharm. Ind., Aulindorf, 40: 27781, 1978.
2. AMERICAN SOCIETY FOR TESTING AND MATERIALS. - 1994 Annual book of ASTM standards. Philadelphia, ASTM, c 1994. V. 8. 01, p.211. (Designation 883-93).
3. BOURNE, H.G. ; YEE, H.T.; SEFERIAN, S. - The toxicity of rubber additives, Arch.Environ. Health, Chicago, 16: 700-5, 1968.
4. BRASIL, Leis, decretos, etc. - Portaria N° 23 de 30 de outubro de 1964, do Serviço Nacional de Fiscalização da Medicina e Farmácia. Diário Oficial, Rio de Janeiro, 13jan. 1965. Seç. I, pt. I, p.409.
5. BRYDSON, .T.A. - Rubber Chemistry . Barking, Esscx, Applied Science, 1978. 462 p.
6. COOPER, J. - Récipients en matiére plastique pour les preparations phannaceutiques. Essai et contrôle . Geneve, OMS, 1974. 205 p.
7. DE ROECK-HOLTZHAUER, Y - Action des liquides phannaceutiques sur les matiéres plastiques et Ies caoutchoes. Prod. Probo Pharm., Paris, 19: 58-63, 1964.
8. FARMACOPÉIA BRASILEIRA IV ed. São Paulo, Atheneu Editora São Paulo Ltda. V. 3.2, 1988.
9. GUESS, WL.& O'LEARY,R.K. - Toxicity ofa rubber accelerator. Toxicol.Appl. Pharmacol., London, 14: 221-31, 1969.
10. JELINEK,J.; STEPAN, J.;CINATL,1. - Toxicology testing of some polymeric and rubber materiaIs for tissue cuItures. Cesk. Farm., Praga, 29: 100-2, 1980.
11. KOSYREVA, N.S.; LOGINOVA,C.I.; SHEN-FIL.L.Z.; BOVENKO'y'N.- Buty1 rubber stoppers sealing bott1es containing blood substitutes and injection solutions. Farm atsyi a, Moscow, 4: 49-51, 1978.
12. LEONI, V - Una rassegna critica sue requisit delle materie plastiche da impiegarsi per il confezio-namento di farmiaci e proposte per una normativa dei settore. Farmaco. Ed. Prat., Pavia, 30: 3-30, 1975
13. MILES, D.C.& BRISTON, J.H. - Tecnologia dos polímeros. São Paulo, EDUSP/ PoIígono, 1975. 365 p.
14. PINTO, A.T.J. - Controle de qualidade de produtos médico-hospitalares: Característica de blocompatibilidade em materiais poliméricos. São Paulo, 1984. [Dissertação (mestrado) - Faculdade
de Ciências Farmacêuticas, USP].
15. PREGNOLATTO, N.P. et al, - Análise de materiais plásticos empregados em recipientes de envasamento de produtos farmacêuticos e em equipamento de uso clínico. Rev. Inst. Adolfo Lutz, 40(1): 55-57, 1980.
16. REEPMEYER, J.C. & JUHL, YH. - Contamination of injectable solutions with 2-mercaptobenzothiazole leached frorn rubber c1osures. 1. Pharm.
Sci., Washinton, 72: 1302-5, 1983.
17. SANOTSKII, LV. & SHUMSKAYA, N.I. - Standardization of toxic substances in water extracts from rubbers. Gig. Sanit., Moscow, 8: 79-
82, 1975.
18. SAUNDERS, K.J. - The identification of plastic and rubbers. London, Chapman and Hall, 1970. p.2.
19. STANKEVICH, v.v., SHURUPOVA, E.A.; PINCHUK, L.M. - Means of higienic assessment of rubber containing tetramethyIthiuran disulfide and intend for contact with food products. Gig. Sanit., Moscow, 1: 22-4, 1976.
20. UNITED STATES PHARMACOPEIA Elastomeric closures for injections. XXII ed. Rockville, Md., USP, 1990. p. 1533-34.
21. YENIA, A.A. et al. - Rubbcr vulcanizates in relation to their suitability as closure material for liquid pharmaceutical preparations. Effect of filIers and antioxidants. Pharm. Ind., Aulindorf, 40: 27781, 1978.
This work is licensed under a Creative Commons Attribution 4.0 International License.
Copyright (c) 1996 Instituto Adolfo Lutz Journal
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