This review on the radiation effects on pharmaceutical materials, with a view to their sterilization by gamma radiation, attempts to cover all the pertinent literature published over the period 1975 to 1992.
Get full access to this article
View all access options for this article.
References
1.
1. Gopal, N. G. S.1978. "Radiation Sterilization of Pharmaceuticals and Polymers,"Radiat. Phys. Chem., 12:35-50.
2.
2. Jacobs, G. P.1985. "A Review: Radiation Sterilization of Pharmaceuticals,"Radiat. Phys. Chem., 26:133-142.
3.
3. 1960. Association of the British Pharmaceutical Industry, Use of Gamma Radiation Sources for the Sterilization of Pharmaceutical Products. London: ABPI.
4.
4. Wills, P. A.1963. "Effects of Ionizing Radiation on Pharmaceuticals,"Aust. J. Pharm., 44:550-557.
5.
5. Geue, P. J.1973. Radiosterilization of Pharmaceuticals, A Bibliography, 1962-1972. Lucas Heights: Australian Atomic Energy Commission.
6.
6. Trutnau, H., W. Bogl and K. Stockhausen. 1978. Der Einfluss der Strahlenbehandlung auf Artzneimittel und Hilfsstoffe. Eine Literaturstudie, Teil l. Bericht des Instituts fuer Strahlenhygiene des Bundesgesundeitsamtes. Berlin: Dietrich Reimer Verlag.
7.
7. Schuttler, C., W. Bogl and K. Stockhausen. 1979. Der Einfluss der Strahlenbehandlung auf Artzneimittel und Hilfsstoffe. Eine Literaturstudie, Teil II. Bericht des Instituts fuer Strahlenhygiene des Bundesgesundeitsamtes. Berlin: Dietrich Reimer Verlag.
8.
8. Schuttler, C., W. Bogl and K. Stockhausen. 1979. Der Einfluss der Strahlenbehandlung auf Artzneimittel und Hilfsstoffe. Eine Literaturstudie, Teil III. Bericht des Instituts fuer Strahlenhygiene des Bundesgesundeitsamtes. Berlin: Dietrich Reimer Verlag.
9.
9. Schuttler, C. and W. Bogl. 1982. Der Einfluss der Strahlenbehandlung auf Artzneimittel und Hilfsstoffe. Eine Literaturstudie, Teil IV Bericht des Instituts fuer Strahlenhygiene des Bundesgesundeitsamtes. Berlin: Dietrich Reimer Verlag.
10.
10. Schuttler, C. and W. Bogl. 1982. Der Einfluss der Strahlenbehandlung auf Artzneimittel und Hilfsstoffe. Eine Literaturstudie, Teil V Bericht des Instituts fuer Strahlenhygiene des Bundesgesundeitsamtes. Berlin: Dietrich Reimer Verlag.
11.
11. Schnell, R. and W. Bogl. 1982. Der Einfluss der Strahlenbehandlung auf Artzneimittel und Hilfsstoffe. Eine Literaturstudie, Teil VI. Bericht des Instituts fuer Strahlenhygiene des Bundesgesundeitsamtes. Berlin: Dietrich Reimer Verlag.
12.
12. Schnell, R. and W. Bogl. 1984. Der Einfluss der Strahlenbehandlung auf Artzneimittel und Hilfsstoffe Eine Literaturstudie, Teil VII. Bericht des Instituts fuer Strahlenhygiene des Bundesgesundeitsamtes. Berlin: Dietrich Reimer Verlag.
13.
13. Zalewski, Ch., C. Schuttler, and W. Bogl. 1988. Der Einfluss der Strahlenbehandlung auf Artzneimittel und Hilfsstoffe. Eine Literaturstudiie, Teil VIII. Bericht des Instituts fuer Strahlenhygiene des Bundesgesundeitsamtes. Berlin: Dietrich Reimer Verlag
14.
14. Bogl, W. 1983. "Chemical Changes of Pharmaceuticals During Radiation Sterilization," in Proceedings of the 3rd International Conference of Pharmaceutical Technology, Paris. Chatenay Molabry, France: Association de Pharmaceit Galenique Industrielle, pp. 318-326.
15.
15. Phillips, G. O.1973. "Medicines and Pharmaceutical Base Materials," in Manual on Radiation Sterilization of Medical and Biological Materials, Vienna: International Atomic Energy Agency, pp. 207-228.
16.
16. Jacobs, G. P., M. Donbrow, E. Eisenberg and M. Lapidot. 1977. "The Use of Gamma Irradiation for the Sterilization of Water for Injections and Normal Saline Solution for Injection,"Acta Pharm. Suec., 14:287-292.
17.
17. Jacobs, G. P. and E. Eisenberg. 1981. "The Reconstitution of Powders for Injection with Gamma-Irradiated Water,"Int. J. Appl. Radiat. Isotopes, 32:180-181.
18.
18. Gopal, N. G. S., S. Rajogopalan and G. Sharma. 1975. "Feasibility Studies on Radiation Sterilization of Some Pharmaceutical Products," in Radiosterilization of Medical Products 1974, Vienna: International Atomic Energy Agency, pp. 387-402.
19.
19. Power, D. M.1978. "Physico-Chemical Changes in Irradiated Drugs:" in Sterilization of Medical Products by Ionizing Radiation, Vol. II, E. R. L. Gaughran and A. J. Goudie, eds., Montreal: Multiscience, pp. 237-246.
20.
20. Phillips, G. O., D. M. Power and C. Robinson. 1973. "Chemical Changes Following Gamma-Irradiation of Benzylpenicillin in Aqueous Solution,"J. Chem. Soc. Perkin. Trans 2, pp. 575-582.
21.
21. Tsuji, K., J. F. Goetz and W. Vanmeter. 1979. "Effect of 60Co-Irradiation on Penicillin G Procaine in Veterinary Mastitis Product,"J. Phar. Sci.68:1075-1080.
22.
22. Tsuji, K., P. D. Rahn and K. A. Steindler. 1983. "60Co-Irradiation as an Alternate Method for Sterilization of Penicillin G, Neomycin, Novobiocin, and Dihydrostreptomycin,"J. Pharm. Sci., 72:23-26.
23.
23. Dziegielewski, J., B. Jesowska-Trzebiatowska, E. Kalecinska, I. Z. Siemion, J. Kalecinski and J. Nawojska. 1973. "Gamma-Radiolysis of 6-Aminopenicillanic Acid and Its Derivatives,"Nukleonika, 18:513-523.
24.
24. Hayashi, N., S. Kato and H. Morimoto. 1977. "Effect of Gamma Irradiation on Disodium Alpha-Sulfobenzylpenicillin in Solid State,"Int. J. Appl. Radiat. Isotopes, 28:723-726.
25.
25. Fleurette, J., S. Madier and M. J. Transy. 1975. "Activite Bacteriostatique de Differents Antibiotiques Apres Irradiation Par Rayons Gamma," in Radiosterilization of Medical Products 1974. Vienna: International Atomic Energy Agency, pp. 247-251.
26.
26. Bor, C.1981. "Gamma Radiation Sterilization of Pharmaceutical Active Ingredients, Adjuvants and Packaging Materials,"Zfl-Mitt. B, 43:445-458.
27.
27. Gupta, K. G., K. K. Vyas and N. S. Sekhon. 1973. "Effect of Radiation on Activity of Antibiotics,"J. Pharm. Sci., 62:841-842.
28.
28. Sekules, G., S. de Leo, S. Fantelli and E. Zannini. 1975. "Possibilita di Sterilizzazione di Antibiotiki con Raggi Gamma,"Boll. Chim. Farm., 114:217-226.
29.
1976, quoted in Chem. Abs., 85, 112734d.
30.
30. Jacobs, G. P.1979. "The Radiation Sterilization of Semi-Synthetic Penicillins,"Int. J. Appl. Radiat. Isotopes, 30:417-421.
31.
31. Jacobs, G. P.1977. "The Gamma Irradiation of Four Semi-Synthetic Penicillins,"Trans. Israel Nucl. Soc., 5:165-167.
32.
32. Jacobs, G. P.1980. "The Effect of Gamma-Rays on Semi-Synthetic Penicillin Powders,"Int. J. Pharmaceut., 4:299-307.
33.
33. Jacobs, G. P.1979. "The Effect of Gamma-Irradiation on Carindacillin, Epicillin, Mecillinam and Nafcillin,"Trans. Israel Nucl. Soc., 7(IV):20-22.
34.
34. Jacobs, G. P.1980. "The Sterilization of Five New Anti-Pseudomonal Semi-Synthetic Pencillins by Gamma Rays,"Drug Dev. Ind. Pharm., 6:547-568.
35.
35. Jacobs, G. P. 1982. "Effect of Radiation on Drugs," in Proceedings of the PMA Seminar on Radiation Sterilization, G. W. Whitaker and R. F. Morrissey, eds., Washington, DC: Pharmaceutical Manufacturers' Association, pp. 139-150.
36.
36. Jacobs, G. P., L. Dobrilovic, R. Coombes and N. Raghavan. 1986. "HPLC Analysis of Gamma Irradiated Beta-Lactam Antibiotics,"Int. J. Pharmaceut., 32:151-158.
37.
37. Jacobs, G. P.1984. "Gamma-Radiolysis of Sodium Ampicillin and Its Esters,"Int. J. Appl. Radiat. Isotopes, 35:1023-1027.
38.
38. Diding, N., O. Flink, S. Johansson, B. Ohlson, G. Redmalm and B. Ohrner. 1978. "Irradiation of Drugs with Co-60 and Electrons," in Sterilization of Medical Products by Ionizing Radiation, Vol. II, E. R. L. Gaughran and A. J. Goudie, eds., Montreal: Multiscience, pp. 216-231.
39.
39. Casas Medina, F., D. Carriazo Tobar, M. del C. Esteban Garcia and F. Jimeno de Osso. 1976. "Estabilidad de la Ampicilina Frente a Dosis Esterilizantes de Radiacion Gamma,"Ann. R. Acad. Farm., 42:349-385.
40.
40. Sharma, G., R. Zaman, L. Varshney, N. Balan and N. G. S. Gopal. 1989. "Effect of Ethylene Oxide and Gamma Radiation on Ampicillin Sodium,"Ind. J. Pharm. Sci., 51:35-38.
41.
41. Basova, L. V., V. A. Gromov, T. R. Klimova, N. D. Konevskaya, V. I. Panin and A. F. Usatyi. 1978. "Physical and Chemical Studies on Some Irradiated Drugs," in Sterilization of Medical Products by Ionizing Radiation, Vol. II, E. R. Gaughran and A. J. Goudie, eds., Montreal: Multiscience, pp. 232-236.
42.
42. Rhee, K. S., K. J. Chun and K. S. Kim. 1977. "Radiosterilization of Medical Products. III. Effect of Gamma Irradiation Cobalt-60 on Activity of Antibiotics,"Misaengmul Hakhoe Chi, 15:154-158.
43.
43. Dziegieleswki, J. O.1975. "Gamma-Radiation Decomposition Yields in Dehydrated and Hydrated Aminobenzylpenicillin, and Basic Radiation Chemical Processes,"Int. J. Radiat. Phys. Chem., 7:507-518.
44.
44. Jacobs, G. P., L. Dobrilovic, R. Coombes and N. Raghavan. 1987. "A Note on the Effect of Gamma-Rays on Cefamandole and Oxacillin,"Appl. Radiat. Isotopes, 38:71-73.
45.
45. Jacobs, G. P.1980. "The Radiation Sterilization of Cephalosporins,"Int. J. Appl. Radiat. Isotopes, 32, 91-95.
46.
46. Jacobs, G. P.1979. "Cephalosporin Powders Sterilized by Gamma-Rays,"J. Pharm. Pharmacol., 31:56P.
47.
47. Jacobs, G. P.1978. "The Gamma-Irradiation of Cephalosporins,"Trans. Israel Nucl. Soc., 6:14E-16E.
48.
48. Jacobs, G. P.1981. "The Radiation Sterilization of Cefoxitin Sodium,"Int. J. Pharmaceut., 7:279-283.
49.
49. Jacobs, G. P., L. Dobrilovic, R. Coombes and N. Raghavan. 1986. "Analysis of Gamma-Irradiated Beta-Lactam Antibiotics by High Performance Liquid Chromatography,"Trans. Israel Nucl. Soa, 13:195-198.
50.
50. Jacobs, G. P.1983. "Stability of Cefazolin and Other New Cephalosporins Following Gamma Irradiation,"Int. J. Pharmaceut., 17:29-38.
51.
51. Gopal, N. G. S. and S. Rajagopalan. 1981. "Effect of Gamma Radiation and Ethylene Oxide on Neomycin Sulphate,"Int. J. Pharmaceut., 9:359-360.
52.
52. Ovcharova, G., A. Boteva and R. Ovcharov. 1981. "Effect of High Doses of Gamma-Radiation on the Properties of Gentamicin Sulfate,"Farmatisiya (Sofia), 31:40-45.
53.
53. Moroz, A. F., S. V. Kataev, I. I. Samoilenko, A. L. Komissarova and V. S. Yakubovich. 1981. "Use of Ionizing Radiation for the Sterilization of Alginate Coatings Containing Various Antibacterial Drugs,"Antibiotiki, 26:92-96.
54.
1975, quoted in Chem. Abs., 85, 68209k.
55.
1975, quoted in Chem. Abs., 83, 93159k.
56.
56. Varshney, L. and V. K. Iya. 1989. "Effect of 6OCo Gamma Irradiation on Chloramphenicol,"Ind. J. Pharm. Sci., pp. 25-29.
57.
57. Tsuji, K. and J. H. Robertson. 1975. "Improved High Performance Liquid Chromatographic Method for Polypeptide Antibiotics and Its Application to Study the Effects of Treatments to Reduce Microbial Levels in Bacitracin Powder,"J. Chromatogri, 112:663-672.
58.
58. Jacobs, G. P.1977. "The Sterilization of Tetracycline Hydrochloride by Gamma Rays,"Pharma. Acta Helv., 52:302-304.
59.
59. Jacobs, G. P.1976. "The Radiation Sterilization of Tetracycline Hydrochloride,"J. Pharm. Pharmacol., 28:7P.
60.
1976, quoted in Chem. Abs.84, 169634e.
61.
61. Chen, C.-C., Y.-K. Fu, C.-M. Thai and S.-C. Wu. 1982. "The Effect of Radiation, Autoclave and Dry Meat on Tetracycline-HCl Sterilization,"Natl. Sci. Counec Monthly, ROC, 10:890-898.
62.
1976, quoted in Chem. Abs., 84, 65221b.
63.
63. Jezowska-Trzebiatowska, B., J. Dziegielewski, J. Kuduk-Jaworska, E. Kalecinska, J. Kalecinski and J. Nawojska. 1975. "Radiation and Chemical Processes Occurring in Viomycin Sulphate Under the Influence of Radiation,"Nukleonika, 20:247-261.
64.
64. Phillips, G. O., D. M. Power and M. C. G. Sewart. 1971. "Effects of Gamma-Irradiation on Sodium Sulphacetamide,"Radiat. Res., 46:236-250.
65.
65. Phillips, G. O., D. M. Power and M. C. G. Sewart. 1973. "Effects of Gamma-Irradiation on Sulphonamides,"Radiat. Res., 53:204-215.
66.
66. Trigger, D. J. and A. D. S. Caldwell. 1968. "Studies on Some Radiation-Sterilized Single-Dose Ophthalmic Preparations,"J. Hosp Pharm., pp. 269-272.
67.
67. Moore, D. E. and B. J. Wilkins. 1990. "Common Products from Gamma Radiolysis and Ultraviolet Photolysis of Metronidazole,"Radiat. Phys. Chem., 36:547-550.
68.
68. Antoni, F.1973. "The Effect of Ionizing Radiation on Some Molecules of Biological Importance," in Manual on Radiation Sterilization of Medical and Biological Materials. Vienna: International Atomic Energy Agency, pp. 13-35.
69.
69. Kawakishi, S., Y. Kito and M. Namiki. 1973. "Deoxy Sugars Produced by Gamma-Irradiation of Hexoses in Oxygen-Free, Aqueous Solution,"Carbohydr. Res., 30:220-222.
70.
70. Kawakishi, S. and M. Namiki. 1972. "Spectral Changes of the Gamma-Irradiated Glucose Solution,"Agr. Biol. Chem., 36:2017-2019.
71.
71. Kawakishi, S., Y. Kito and M. Namiki. 1975. "Gamma-Radiolysis of D-Glucose in Aerated, Aqueous Solution,"Carbohydr, Res., 39:263-269.
72.
72. Kawakishi, S. and M. Namiki. 1973. "The Formation of 2-Deoxy-D-Arabino-Hexono-1,4-lactone from D-Glucose by Gamma-Radiolysis,"Carbohydr. Res., 26:252-254.
73.
1976, quoted in Chem. Abs., 85, 80012y.
74.
1976, quoted in Chem. Abs., 85, 65053u.
75.
1976, quoted in Chem. Abs., 85, 34944f.
76.
76. Mucchielli, A. and J. Fretton. 1976. "Physiological Behaviour Escherichia coli Cultured in the Presence of Extracts of Irradiated Starch. III. Influence of Irradiated Starch Treatments,"Eur. J. Appl. Microbiol., 3:55-61.
77.
77. Gupta, B. L.1975. "Chemical and Biological Effects of Radiation Sterilization of Medical Products," in Radiosterilization of Medical Products 1974. Vienna: International Atomic Energy Agency, pp. 175-190.
78.
78. Rasero, L. J. and D. M. Skauen. 1967. "Effect of Gamma Radiation on Selected Pharmaceuticals,"J. Pharm. Sci., 56:724-728.
79.
79. Jacobs, G. P. and R. Simes. 1979. "The Gamma Irradiation of Tragacanth: Effect on Microbial Contamination and Rheology,"J. Pharm. Pharmacol., 31:333-334.
80.
80. Adams, I., S. S. Davis and R. Kenshaw. 1972. "Formulation of a Sterile Surgical Lubricant,"J. Pharm. Pharmacol., 24:178P.
81.
81. Hartman, A. W., R. U. Nesbit, F. M. Smith and N. O. Nuessle. 1975. "Viscosities of Acacia and Sodium Alginate After Sterilization by Cobalt-60,"J. Pharm. Sci., 64:802-805.
82.
82. McCarthy, T. J.1978. "The Effect of Gamma Irradiation on Selected Aqueous Preservative,"Pharm. Weekbl., 113:698-700.
83.
83. Achmatowicz-Szmajke, T., T. Bryl-Sandelewska and M. Galazka. 1979. "Radiation Sterilization of Some Cosmetic Raw Materials and Preparations,"Radiochem. Radioanal. Lett., 38:5-14.
84.
84. Bachman, S., S. Galant, Z. Gasyna, S. Witkowski and H. Zegota. 1974. "Effects of Ionizing Radiation on Gelatin in the Solid State," in Proceedings of a Panel for the Improvement of Food Quality by Irradiation. Vienna: IAEA, pp. 77-94.
85.
85. Hayden, G. A., S. C. Rogers and F. Friedberg. 1966. "Radiation Degradation of Polyamino Acids in the Solid State,"Arch. Biochem. Biophys., 113:247-250.
86.
86. Patel, K. K., M. Tantry, G. Sharma and N. G. S. Gopal. 1979. "Effect of Dry Heat, Ethylene Oxide and Gamma Radiation on Gelatin and Gelatin Capsules,"Ind. J. Pharm. Sci., 41:209-213.
87.
87. Fassihi, A. R. and M. S. Parker. 1988. "Influence of Gamma Radiation on the Gel Rigidity Index and Binding Capability of Gelatin,"J. Pharm. Sci., 77:876-879.
88.
88. Jacob, B. P. and K. Leupin. 1974. "Irradiation of Drugs,"Pharm. Acta Helv., 49:12-20.
89.
89. Diding, N., G. Redmalm, G. Samuelsson, L. Frigren, B. M. Yman and I. van Katjwik. 1973. "Studies on the Effect of Gamma Irradiation of Crude Drugs,"Sven. Farm. Tids., 77:622-630.
90.
90. Fu, Y.-K.1988. "Current Status and Prospects of Radiation Processing Studies in Taiwan, R.O.C.,"Radiat. Phys. Chem., 31:293-300.
91.
91. Reisch, J., G. Henke and R. Schildgen. 1971. "Uber die Einwirkung Energiereicher Strahlen auf Einige Analgetica I,"Sci. Pharm., 39:247-255.
92.
1978, quoted in Chem. Abs.89, 204191k.
93.
93. Mathews, R. W. and D. F. Sangster. 1965. "Measurement by Benzoate Radiolytic Decarboxylation of Relative Rate Constants for Hydroxyl Radical Reactions,"J. Phys. Chem., 69:1938-1946.
94.
1977, quoted in Chem. Abs.87, 141258y.
95.
95. Schuttler, C. and K. W. Bogl. 1992. "Influence of Radiation Treatment on Pharmaceuticals. Part I. Morphine Derivatives and Other Alkaloids,"J. Radiat. Sterilization, 1:43-82.
96.
96. Jacobs, G. P.1976. "Sterilization of Barbiturates by Gamma-Radiation,"Pharm. Acta Helv., 51:313-314.
97.
97. Haak, R. A. and B. W. Benson. 1976. "Free Radicals in Pyrimidines: ESR Studies of Irradiated Amobarbital (5-Ethyl-5-Isoamylbarbituric acid),"Radiat. Res., 687:381-389.
98.
98. Werner, I. A., H. Altorfer and X. Perlia. 1990. "Effects of Various Scavengers on the Gamma Irradiated Methanolic Solutions of Medazepam, Int. J. Pharmaceut., 63:155-162.
99.
99. Altorfer, H. and X. Perlia. 1975. "Uber den Einfluss Von Gamma-Strahlen auf Diphenhydraminhydrochlorid,"Pharm. Acta Helv., 50:329-336.
100.
1980, quoted in Chem. Abs.93, 173679b.
101.
101. Morimoto, K., S. Kimura, Y. Inamori and K. Morisaka. 1980. "Stability of Enzyme Preparations on Radiosterilization,"Chem. Pharm. Bull., 28:1304-1306.
102.
1979, quoted in Chem. Abs.90, 127525.
103.
1976, quoted Chem. Abs.85, 89411k.
104.
1977, quoted in Chem. Abs.87, 141259z.
105.
105. Bussey, D. M., M. P. Kane and K. nuji. 1982. "Sterilization of Corti-costeroids by 6OCo Irradiation,"J. Parenter: Sci. Technol., 37:51-54.
106.
1977, quoted in Chem. Abs.87, 122772v.
107.
107. Hayes, R., G. Fletcher and D. J. G. Davies. 1980. "The Effect of Ionizing Radiation on Beclomethazone Dipropionate,"J. Pharm. Pharmacol., 32:48P.
108.
1976, quoted in Chem. Abs.85, 89408q.
109.
109. Kimura, K., T. Miwa and M. Imamura. 1970. "The Radiolysis and Photolysis of Methanolic Solutions of Eosin. I. The Gamma-Radiolysis of Neutral and Alkaline Solutions,"Bull. Chem. Soc. Jpn., 43:1329-1336.
110.
110. Blackburn, R., B. Iddon, J. S. Moore, G. O. Phillips, D. M. Power and T. W. Woodward. 1975. "Radiation Sterilization of Pharmaceuticals and Biomedical Products," in Radiosterilization of Medical Products 1974. Vienna: International Atomic Energy Agency, pp. 351-363.
111.
111. Jooyandeh, F., J. S. Moore, R. E. Morgan and G. O. Phillips. 1971. "Chemical Effects of Gamma-Irradiation of Aqueous Solutions of Heparin and Keratan Sulphate,"Radiat. Res., 45:455-461.
112.
112. Balazs, E. A. and R. W. Jeanloz. 1966. The Amino Sugars. New York: Academic Press.
113.
113. Soboleva, N. N., A. I. Ivanova, V. L. Talrose, V. I. Trofimov and V. P. Fedotov. 1981. "Radiation Resistivity of Frozen Insulin Solutions and Suspensions,"Int. J. Appl. Radiat. Isot., 32:753-756.
114.
1980, quoted in Chem. Abs.93, 137941x.
115.
115. Rainey, H. B.1978. "Ionizing Radiation in the Preparation of Vaccines and Antigens," in Sterilization of Medical Products by Ionizing Radiation, Vol. II, E. R. L. Gaughran and A. J. Goudie, eds., Montreal: Multiscience, pp. 200-215.
116.
116. Tumanyan, M. A.1973. "Radiosterilization of Prepared Vaccines," in Manual on Radiation Sterilization of Medical and Biological Materials. Vienna: International Atomic Energy Agency, pp. 291-292.
117.
117. Gopal, N. G. S., K. M. Patel and G. Sharma. 1987. "Effect of Heat, Ethylene Oxide and Gamma Radiation on Psyllium Husk,"Ind. J. Pharm. Sci., 49:75-76.
118.
118. Nakazawa, T., S. Nagatsuka and T. Sakuria. 1981. "Radiation-Induced Changes of Liposomes and Lecithin in Non-Aqueous Media,"Int. J. Radiat. Biol., 40:365-373.
119.
119. Hangay, G.1978. "On the Theoretical and Practical Aspects of the Use of Radiation Sterilization and Radiation Pasteurization in the Pharmaceutical and Cosmetic Industry," in Sterilization of Medical Products by Ionizing Radiation, Vol. 11, E. R. L. Gaughran and A. J. Goudie, eds., Montreal: Multiscience, pp. 247-263.
120.
120. Sprinz, H., U. Frank, Z. V. Kuropteva and H. Schaefer. 1989. "NMR Studies on Irradiated Lecithin Systems,"Radiat. Phys. Chem., 34:383-385.
121.
121. Galatzeanu, I. and F. Antoni. 1967. "Effets des Rayons Gamma (Cobalt-60) sur La Vitamine B6 et 1-Acide Folique," in Radiosterilization of Medical Products. Vienna: International Atomic Energy Agency, pp. 33-48.
122.
122. Colovos, G. C. and B. W. Churchill. 1957. "The Electron Sterilization of Certain Pharmaceutical Preparations,"J. Phar. Assoc Sci. Ed., 46:580-583.
123.
123. Rao, K. N., P. N. Moorthy and K. Kishore. 1978. "Radiation Sterilization of Vitamins-Studies on the Radiolysis and Radiation Protection of Vitamins in Aqueous Systems and the Solid State,"INIS Atomindex, 9, Abstract No. 404840.
124.
124. Kishore, K., P. N. Moorthy and K. N. Rao. 1976. "Radiation Protection of Vitamins in Aqueous Systems, Part II. A Comparative Study in Fluid and Frozen Aqueous Systems,"Radiat. Effects, 29:165-170.
125.
125. L'vova, M. Sh., N. P. Belkina, S. Ya. Erman and E. I. Kozlov. 1980. "Action of Gamma-Irradiation of Solutions of Ascorbic Acid for Injection,"Khim.-Farm. Zh., 14:81-84.
126.
126. Barelko, E. V., G. S. Babakina, I. V. Berezovskaya, V. S. Degilova, L. A. Piruzyan, N. V. Pormotseva, I. P. Solyanina, V. V. Sukhanov, V. L. Tal'roze, E. A. Tyrina and M. I. Tsibulskaya. 1977. "Stabilization of Cyanocobalamin with Radiation Sterilization of its Solution in Freezing Conditions,"Khim.-Farm. Zh., 11:94-100.
127.
1981, quoted in Chem. Abs.95, 175765s.
128.
1981, quoted in Chem. Abs95, 156451v.
129.
129. Barelko, E. V., G. S. Babakina, G. A. Rakitskaya, I. P. Solyanina, V. L. TIlroze, V. I. Trofimov and M. I. Tsibul'Skaya. 1980. "Radiation Stability of Aqueous Solutions of Vitamin B3,"Khim.-Farm. Zh., 14:77-79.
130.
1980, quoted in Chem. Abs.92, 116329t.
131.
131. Wilska-Jeszka, J.1977. "Comparative Studies on the Resistance of Group B Vitamins to Gamma-Irradiation,"Nukleonika, 22:1011-1019.
132.
132. Chingpaisal, P., G. Fletcher and D. J. G. Davies. 1977. "The Effect of COTAB on the Radiation Sensitivity of Benzocaine to Hydrated Electrons and Hydroxy Radicals in Aqueous Solution,"J. Pharm. Pharmacol., 29:47P.
133.
133. Grossweiner, L. I., A. F. Rodde, G. Sandberg and J. Chrysochoos. 1966. "Pulse Radiolysis of Aqueous Eosin,"Nature, 210:1154-1156.
134.
134. Dziedzic-Goclawska, A.1978. "Effect of Radiation Sterilization on Biostatic Tissue Grafts and Their Constituents," in Sterilization of Medical Products by Ionizing Radiation, Vol. II, E. R. L. Gaughran and A. J. Goudie, eds., Montreal: Multiscience, pp. 156-187.
135.
135. Komender, J. and A. Komender. 1978. "Evaluation of Radiation Sterilized Tissues in Clinical Use," in Sterilization of Medical Products by Ionizing Radiation, Vol. II, E. R. L. Gaughran and A. J. Goudie, eds., Montreal: Multiscience, pp. 188-199.
136.
136. Triantafylou, N. and P. Karatzas. 1975. "Effects of Sterilizing Doses of Ionizing Radiation on the Mechanical Properties of Various Connective Tissue Allograpts," in Radiosterilization of Medical Products 1974. Vienna: International Atomic Energy Agency, pp. 215-223.
137.
137. Feher, I., S. Pellet, E. Unger and G. Petranyi. 1975. "Organization and Immunological Qualities of Lyophilized and Radiosterilized Extrasynovial Dog-Tendon Preparations," in Radiosterilization of Medical Products 1974. Vienna: International Atomic Energy Agency, pp. 225-237.
138.
138. Bochkarev, V. V., V. T. Kharlamov, A. K. Pikaev, L. P. Shubnyakova, Z. M. Potapova and E. P. Pavlov. 1975. "Radiation Sterilization of Radiopharmaceutical Preparations," in Radiosterilization of Medical Products 1974. Vienna: International Atomic Energy Agency, pp. 365-373.
139.
139. Gopal, N. G. S. and K. A. Sundaram. 1975. "Discussion on Presentation: Radiation Sterilization of Radiopharmaceutical Preparations," in Radiosterilization of Medical Products 1974. Vienna: International Atomic Energy Agency, pp. 373-378.
140.
140. De La Paz, L. R.1977. "The Effect of Radiation on Some Salicylates. 1. Steady State Studies,"INIS Atomindex 1977, 8: Abstract No. 298467.
141.
141. Loyaux, D., P. Bone, C. Granier, A. M. Krstulovic and G. Mompon. 1987. "Gamma-Radiolysis of Acetylsalylicylic Acid in the Solid State Gas Chromatographic-Mass Spectrometric and High Performance Liquid Chromatographic Identification and Quantification of the Radiolytic Products,"J. Chromatog, 387:434-441.
142.
1981, quoted in Chem. Abs.94, 180594u.
143.
1978, quoted in Chem. Abs.89, 169023h.
144.
144. Gopal, N. G. S., K. K. Patel, S. Rajagopalan, G. Sharma and M. Tantry. 1980. "Gamma Ray Sterilization of Urea,"Ind. Drugs, 18:49-54.
145.
145. Goyal, G. C. and D. A. Armstrong. 1976. "Product Yields and Mechanism of Penicillamine Radiolysis at pH 5,"Can. J. Chem., 54:1938-1947.
146.
146. Phillips, M.R. P. Agarwal, R. J. Brodeur, V. F. Garagusi and K. L. Mossman. 1985. "Stability of an Injectable Disulfiram Formulation Sterilized by Gamma Irradiation,"Am. J. Hosp Pharm., 42:343-345.
147.
147. Chipault, J. R. and G. R. Mizuno. 1965. "Effect of High Energy Radiations on Antioxidants and on the Stability of Fats:"Abstr. Pap Am. Chem. Soc., 150:19A-20A.
148.
148. Hangay, G., G. Hortobagyi and G. Muranyi. 1967. "Sterilization of Hydrocortisone Eye-Ointment by Gamma-Irradiation, I. Physical and Chemical Aspects," in Radiosterilization of Medical Products. Vienna: International Atomic Energy Agency, pp. 55-62.
149.
149. Hickman, J. R.1965. "Acute Toxicity of Radiation-Sterilized Propylene Glycol,"J. Pharm. Pharmacol., 17:255-256.
150.
150. Jayson, G. G., G. Scholes and J. Weiss. 1957. "The Chemical Action of Ionizing Radiations in Solution. Part XX. Actions of X-Rays (200 kV) on Ethanol in Aqueous Solution,"J. Chem. Soc, 1957:1358-1368.
151.
151. Allan, T. J., E. M. Hayon and J. Weiss. 1959. "The Chemical Action of Ionizing Radiations in Solution. Part XXIII. The Action of 6OCo-Gamma-Rays on Aqueous Solutions of Ethanol in the Liquid and Frozen State,"J. Chem. Soc., 1959:3913-3919.
152.
152. Hayon, E. M. and J. Weiss. 1961. "The Chemical Action of Ionizing Radiations on Simple Aliphatic Alcohols. Part I. Irradiation of Ethanol in the Liquid and in the Solid State and in the Presence of Solutes,"J. Chem. Soc., 1961:3962-3970.
153.
153. Ausloos, P. and J. F. Paulson. 1958. "Radiolysis of Simple Ketones,"J. Am. Chem. Soc, 80:5117-5121.
154.
154. Astudillo, M. D., E. Funes and F. Sanz. 1968. "Efectos de la Radiacion Sobre el Aceite de Oliva,"Anales Real Soc. Espanola Fis. Quim., Ser B. Quim., 64:787-789.
155.
1976, quoted in Chem. Abs.84, 88088c.
156.
1976, quoted in Chem. Abs.84, 178426r.
157.
157. Stamatov, St. D. and St, A. Ivanov. 1976. Seifen, Ole, Fette, Wachse, 102:261, quoted in Reference 1.
158.
158. Wu, G. S. and D. R. Howton. 1975. "Gamma-Radiolysis of Stearic Acid: Studies of Nongaseous Products,"Radiat. Res., 61:374-392.
159.
159. Haraszti, M., K. Czeh and G. Hangay. 1967. "Sterilization of Hydrocortisone Eye-Ointment by Gamma-Irradiation, 11. Bacteriological Aspects," in Radiosterilization of Medical Products. Vienna: International Atomic Energy Agency, pp. 63-68.
160.
160. Chang, B.-L., W. G. Haney and N. O. Nuessle. 1974. "Sterilization of Selected Colorants by Cobalt-60,"J. Pharm. Sci., 63:758-763.
161.
161. Prince, H. N. and M. A. Welt. 1971. "Microbiological Studies on Pressed Powders and Sterilizing Effect of Gamma Irradiation,"Am. Perfum. Cosmet., 86:49-53.
162.
162. 1974. Report of the B.A.R.C. 737, Bhaba Atomic Research Centre, India.
163.
163. Jacobs, G. P.1981. "Gamma Radiation Decontamination of Cosmetic Raw Materials,"Cosmet. Toiletries., 96:51-55.
164.
164. Jacobs, G. P.1984. "Gamma-Radiation Decontamination of Cosmetic Raw Materials," in Cosmetics and Drug Preservation: Principles and Practice, J. J. Kabara, ed., New York: Marcel Dekker, pp. 223-233.
165.
165. Ahrgren, L., A. N. de Belder, T. Malson and S. Marksroem. 1977. "The Radio-Sterilisation of a Wound-Cleansing Agent Based on Cross-Linked Dextran Beads (Debrisan),"Acta Phars. Suec., 14:(Supplement):68.
166.
1975, quoted in Chem. Abs.82, 7597b.
167.
167. Bhalla, H. L., M. R. Menon and N. G. S. Gopal. 1983. "Radiation Sterilization of Polyethylene Glycol Ointment Bases,"Ind. J. Pharm. Sci., 45:203-206.
168.
168. Chapiro, A.1962. Radiation Chemistry of Polymeric Systems. New York: John Wiley.
169.
169. Charlesby, A.1960. Atomic Radiation and Polymers. New York: Pergamon Press.
170.
170. Wilski, H.1987. "The Radiation Induced Degradation of Polymers,"Radiat. Phys. Chem., 29:1-14.
171.
171. Clough, R. L.1988. "Radiation Resistant Polymers," in Encyclopedia of Polymer Science and Engineering, Vol. 13, 2nd Edition, H. F. Mark, N. M. Bikales, C. G. Overberger and G. Menges, eds., New York: John Wiley, pp. 667-708.
172.
172. Landfield, H."Radiation Effects on Device and Packaging Materials, Med. Dev. Diag Ind., 1980:45-48.
173.
173. Ley, F. J.1976. "The Effect of Irradiation on Packaging Materials,"J. Soc. Cosmet. Chem., 27:483-489.
174.
174. Sharma, G. and N. G. S. Gopal. 1980. "Effect of Gamma Radiation on Soft PVC Tubing,"Plastics News, 1980:30-34.
175.
175. Skiens, W. E.1980. "Sterilizing Radiation Effects on Selected Polymers,"Radiat. Phys. Chem., 15:47-57.
176.
176. Williams, J. L. and T. S. Dunn. 1980. "Radiation Stability of Polypropylene,"Radiat. Phys. Chem., 15:59-68.
177.
177. Eisenberg, E. and G. P. Jacobs. 1981. "The Development of a Formulation for Radiation Sterilizable Urea Broth,"J. Appl. Bacteriol., 58:21-25.
178.
178. Eisenberg, E., B. Bogokowsky and G. Altmann. 1981. "Bacterial Growth on Mueller-Hinton Medium Sterilized by Gamma-Radiation,"Int. J. Appl. Radiat. Isotopes, 32:891-893.
179.
179. Altmann, G., E. Eisenberg and B. Bogokowsky. 1979. "Radiation Sterilization of Triple Sugar Iron Agar,"Int. J. Appl. Radiat. Isotopes, 30:527-529.
180.
180. Stotland, A., J. Bahar, E. Eisenberg and S. Rubinfeld. 1992. "Development of Radiation-Sterilized Mannitol Salt Agar Dip Slide Kits,"J. Radiat. Steril., 1:5-10.
181.
181. Darbord, J. C. and J. Laizier. "A Theoretical Basis for Chosing the Dose in Radiation Sterilization of Medical Supplies,"Int. J. Pharmaceut., 37:1-10.
182.
182. Davis, K. W., W. E. Strawderman and J. L. Whitby. 1984. "The Rationale and a Computer Evaluation of a Gamma Sterilization Dose Determination Method for Medical Devices Using a Substerilization Incremental Dose Sterility Test Protocol,"J. Appl. Bacteriol., 57:31-50.
183.
183. Ley, F. J. and A. Tallentire. 1964. "Radiation Sterilization—The Choice of Dose,"Pharm. J., 195:216-218.
184.
184. Tallentire, A. and A. A. Khan. 1975. "Tests for the Validity of a Model Relating Frequency of Contaminated Items and Increasing Radiation Dose," in Radiosterilization of Medical Products 1974. Vienna: International Atomic Energy Agency, pp. 3-14.
185.
185. van Asten, J. and J. W. Dorpema. 1982. "A New Approach to Sterilization Conditions; the IMO Concept,"Pharm. Weekblad, Sci. Ed., 4:49-57.
186.
186. Jacobs, G. P.1990. "Choice of Dose for Radiation Sterilization, in Frontiers in Radiation Biology, E. Riklis, ed., Weinheim: VCH, pp. 699-702.
187.
187. 1989. The United States Pharmacopeia XXII. Rockville, MD, United States Pharmacopeial Convention, Inc. pp. 1707-1708.
188.
188. Association for the Advancement of Medical Instrumentation. 1992. Guideline for Gamma Radiation Sterilization, Arlington, VA: AAMI.
189.
published as a Supplement to J. Parent. Sci. Technol., 42.
190.
190. International Organization for Standardization (ISO). 1994. Sterilization of Health Care Products-Requirements for Validation and Routine Control Radiation Sterilization, ISO 11137, Geneva: ISO.
191.
191. Jacobs, G. P.1991. "Radiation in the Sterilization of Pharmaceuticals," in Sterile Pharmaceutical Manufacturing-Applications for the 1990's, Vol. 1, M. J. Groves, W. P. Olson and M. H. Anisfeld, eds., Buffalo Grove: Interpharm, pp. 57-78.
192.
192. Jacobs, G. P.1992. "Gamma Radiation Sterilization," in Encyclopedia of Pharmaceutical Technology, Vol. 6, J. Swarbrick and J. C. Boylan, eds., New York: Marcel Dekker, pp. 305-332.
193.
193. Williams, J. L. and T. S. Dunn. 1979. "Radiation Sources-Gamma,"Radiat. Phys. Chem., 14:185-201.
194.
194. McKinnon, R. G.1988. "Safety Considerations in the Design of Gamma Irradiation Facilities and the Handling of Cobalt-60 Sources,"Radiat. Phys. Chem., 31:563-568.
195.
195. Beers, E. W.1979. "Innovations in Irradiator Design,"Radiat. Phys. Chem., 35:539-546.
196.
196. International Atomic Energy Agency. 1990. Guidelines for Industrial Radiation Sterilization of Disposable Medical Products (Cobalt-60 Gamma Irradiation), IAEA-TECDOC-539. Vienna: IAEA.
197.
197. United Kingdom Panel on Gamma and Electron Irradiation. 1989. "Code of Practice for the Validation and Routine Monitoring of Sterilization by Ionizing Radiation,"Radiat. Phys. Chem., 33:245-249.
198.
198. 1976. Code of Good Manufacturing Practice for Therapeutic Goods, Appendix A, Radiation Sterilisation. Canberra City, Australia: National Biological Standards Laboratory.
199.
199. 1990. Guidelines for Radiation Sterilization. Jerusalem, Israel: Ministry of Health.
200.
200. International Atomic Energy Agency. 1981. High-Dose Measurements in Industrial Radiation Processing, IAEA Technical Reports Series, No. 205. Vienna: IAEA.
201.
201. International Atomic Energy Agency. 1991. High Dose Dosimetry for Radiation Processing, Vienna: IAEA.
202.
202. McLaughlin, W. L.1990. "New Dosimetry Systems,"Radiat. Phys. Chem., 35:693-698.
203.
203. Spinks, J. W. T. and R. J. Woods. 1976. An Introduction to Radiation Chemistry, 2nd Edition. New York: John Wiley.
204.
204. Puite, K. J. and K. V. Ettinger. 1982. "Lyoluminescence Dosimetry Part II. State of the Art,"Radiat. Phys. Chem., 33:1139-1157.
206. Tallentire, A., J. Dwyer and F. J. Ley. 1971. "Microbiological Quality Control of Sterilized Products: Evaluation of a Model Relating Frequency of Contaminated Items with Increasing Radiation Treatment,"J. Appl. Bact., 34:521-534.
207.
207. Alper, T.1979. Cellular Radiobiology. Cambridge: Cambridge University Press.
208.
208. Dwyer, J., F. R. Fitch, P. T. Doolan, V. M. Dwyer, N. A. Halls and A. Tallentire. 1985. "Towards Microbiological Quality Assurance in Radiation Sterilization Processing: The Limiting Case Model Applied to a Microbial Population Having a Distribution of Radiation Response,"J. Appl. Bacteriology, 58:189-194.
209.
209. Fitch, F. R., P. T. Doolan, J. Dwyer, V. M. Dwyer, N. A. Halls and A. Tallentire. 1985. "Towards Microbiological Quality Assurance in Radiation Sterilization Processing: Simulation of the Radiation Inactivation Process,"J. Appl. Bacteriology, 58:307-313.
210.
210. Dam, A., L. G. Gazso and P. Grigorova. "Microbiological Investigations for Radiation Treatment of Pharmaceuticals,"Radiat. Phys. Chem., 35:396-399.
211.
211. Berezovskaya, I. V., V. L. Tal'roze and V. I. Trofimov. 1983. "Toxicological Study of Radiosterilized Medicinal Preparations,"Khim. Farm. Zh., 17:443-450.
212.
212. World Health Organization. 1981. Wholesomeness of Irradiated Foods, Report of a Joint FAO/IAEA/WHO Expert Committee, Technical Report Series 659. Geneva: WHO.
213.
213. Swinwood, J. F. and B. K. Wilson. 1989. "Sterilization of Pharmaceuticals by Gamma Radiation; An Update on a North American Product Testing Project (1989-1992)," Presentation at the Seventh International Meetings on Radiation Processing, Noordwijkerhout, The Netherlands.