Abstract
The sterilization requirements for medical/pharmaceutical applications are traditionally based on an extensive overkill. In the past few years, however, an evolution towards bioburden related sterilization processes has been started (F0 theory). Especially manufacturers of large volume parenterals have — forced by the thermolability of the product — contributed to this development.
In this paper both philosophies are combined, resulting in a concept in which the bacteriological and physical bases of the sterilization process are mathematically related by using the F0 theory and by introducing an Imaginary Micro-Organism (imo). Theimo concept provides the opportunity for anyone in the field of sterilization to raise the quality control level, which can be achieved by:
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selecting optimum sterilization conditions without performing pre-sterilization counts;
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step by step introducing the pre-sterilization count which results in even more favourable sterilization conditions.
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References
Akers, M.J. (1979)J. Parenteral Drug Assoc. 33, 372–383.
Akers, M.J., I.A. Attia andK.E. Avis (1978)Pharm. Techn., May, 31–35;Ibidem (1979)J. Parenteral Drug. Assoc. 33, 195–202.
Alderton, G., andN. Snell (1963)Biochem. Biophys. Res. Commun. 10, 139–143;Ibidem (1969)Science 163, 1212–1213.
Anderson, R.A., andW.T. Friesen (1974)Pharm. Acta Helv. 49, 295–298.
Association for the Advancement of Medical Instrumentation (1980)Aami st i. Arlington (usa).
Barbeito, M.S., andE.A. Brookey (1976)Appl. Environ. Microbiol. 32, 671–678.
Beal, R.W. (1980)Anaesth. Intens. Care 8, 172–177.
Beck, W.C. (1978)Hepatitis controversy, AAMI, Arlington (USA), 55–58.
Boom, F.A., andA.C.A. Paalman (1979)Pharm. Weekbl. 114, 157–165.
Bowie, J.H. (1955)Pharm. J., June 11, 473–476.
Bowman, F.W. (1969)J. Pharm. Sciences 58, 1301–1307.
Brown, M.R.W., andP. Gilbert (1977)J. Pharm. Pharmacol. 29, 517–523.
Burrell, R.L., R.Z. Wein andA.N. Paris (1979)J. Parenteral Drug Assoc. 33, 363–370.
Caputo, R.A., T.E. Odlaug, R.L. Wilkinson andC. C. Mascoli (1979)J. Parenteral Drug Assoc. 33, 214–221.
Caputo, R.A., K.J. Rohn andC.C. Mascoli (1980)J. Parenteral Drug Assoc. 34, 394–397.
Cerf, D. (1977)J. Appl. Bacteriol. 42, 1–19.
Cook, A.M., andM.R.W. Brown (1965)J. Appl. Bacteriol. 28, 361–364.
Cook, A.M., andR.J. Gilbert (1968a)J. Pharm. Pharmacol. 20, 626–629;Ibidem (1968b)J. Food Technol. 3, 295–302.
Costin, I.D., andJ. Grico (1974)Zentr. Bakteriol. Parasitenk., Abt. I Orig. A 227, 483–521.
Department of Health and Social Security (1980)Health Technical Memorandum, nr. 10. London.
Dobberkau, H.J., E. Steiger andM. Nagel (1980)Z. Ges. Hyg. 26, 717–721.
Dorpema, J.W., andA.S. Tolman (1980)Pharm. Weekbl. 115, 149–155.
Everall, P.H., andC.A. Morris (1975)J. Clin. Pathol. 28, 664–669.
Finley, N., andM.L. Fields (1962)Appl. Microbiol. 10, 231–236.
Fleming, C.R., D.J. Witzke andR.W. Beart (1980)Ann. Surg. 192, 593–599.
Franchi, G., andE. Lencioni (1978)Boll. Chim. Farm. 117, 620–626.
Frieben, W.R., R.A. Kreiger, D.L. Juberg andR.M. Enzinger (1978)J. Parenteral Drug Assoc. 32, 249–257.
Halleck, F.E., S. Mizuba, B.S. Zimmer andJ. Woodrow (1979)Medical Instrumentation 13, 168–171.
Han, Y.W. (1975)Can. J. Microbiol. 21, 1464–1467.
Hodges, N.A., J. Melling andS.J. Parker (1980)J. Pharm. Pharmacol. 32, 126–130.
Horakova, V., andE. Buriankova (1974)IAEA-SM-192/ 10, 15–24.
Hoskins, H.T. (1979)J. Pharm. Pharmacol. 31, 101.
Hoskins, H.T., andB.L. Diffey (1978)Med. Biol. Eng. Comput. 16, 330–333.
Irving, A.D. (1980)Int. Roy. Coll. Surg. Edinburgh, 25, 23–25.
Kelsey, J.C. (1958)Lancet I, 306–309;Ibidem (1961)J. Clin. Pathol. 14, 313–319.
Keogh, E.J., andB.E. Hopkins (1973)Australian N.Z. J. Med. 3, 389–392.
Kereluk, K. (1976) In:Quality in Microbiology (Prier, J.E., J. Bartola andH. Friedman, Eds.). University Park Press, Baltimore-London-Tokyo, 25–39.
Konold, F., U. Ullmann, C.P. Schrader andG. Kieninger. (1974)Deut. Med. Woch.schr. 99, 1009–1013.
Korczynski, M.S. (1980)J. Parenteral Drug Assoc. 34, 277–285.
Korczynski, M.S., C.L. Peterson andC.C. Loshbaugh (1974)Bull. Parenteral Drug Assoc. 28, 270–277.
Lee, C.H., T.J. Montville andA.J. Sinskey (1979)App. Environ. Microbiol. 37, 1113–1117.
Lim, J.C. (1979)Am. J. Hosp. Pharm. 36, 1202–1204.
Lumini, E., C. Brambini andA. Merlini (1978)Boll. Chim. Farm. 117, 627–637.
Marshall, B.J., W.G. Murrell (1970)J. Appl. Bact. 33, 103–120.
Melichar, M., H. Podstatova andJ. Pokorny (1980)Pharmazie 35, 547–549.
Mikolajcik, E.M., andK.T. Rajkowski (1980)J. Food Protection 43, 799–804.
Myers, R.B. (1978)J. Parenteral Drug Assoc. 32, 216–225.
Norris, J.R., andD.W. Ribbons (1971)Methods Microbiol. 6A, 327–381.
Parenteral Drug Association (1978)Inc. Techn. Monogr. no. I, 1–35.
Ph. Ned. Ed. VIII (1978) 344–347.
Propper Manufacturing Co., Inc. (1980) 20th ed.Excerpts from US Pharm. National Formulary. Long Island City (USA).
Puleo, J.R., M.S. Faverno, G.S. Oxborrow andC.M. Herring (1975)Appl. Microbiol. 30, 786–790.
Reich, R.R., J.E. Whitbourne andA.W. Mcdaniel (1979)J. Parenteral Drug Assoc. 33, 228–234.
Report of the Working Group on Sterilizing Dose.aami, Arlington (usa) (1976) Meeting of theaami Subcommittee on radiation sterilizing dose.
Riv (1980)Steriliseran en Steriliteit. Handleidingen Serie no. 1, Bilthoven.
Schramm, G., andM. Schmidt (1974)Pharm. Acta Helv. 49, 243–248.
Selman, A.C., andK.C. Hignett (1979)Hospital Engineering, Jan.–Febr., 6–16.
Seyfarth, H. (1975)Zentr. Bakteriol. Parasitenk., Abt. I Orig. B 160, 432–442.
Sinatra, A., andL. Giannalia (1980)Min. Anest. 46, 1117–1121.
Smith, G.M., I.J. Pelug andP.A. Chapman (1976)Appl. Environ. Microbiol. 32, 257–263.
Spicher, G. (1973)Zentr. Bakteriol. Parasitenk., Abt. I Orig. A 224, 527–553.
Spicher, G., andJ. Peters (1978)Zentr. Bakteriol. Parasitenk., Abt. I Orig. B 167, 63–82.
Srimani, B., andM. Loncin (1980)Lebensm. Wiss. Technol. 13, 190–192.
Tjoeng, M.M., andE.W. De Flines (1979)Pharm. Weekbl. 114, 604–607.
Tolman, A.S., andJ.W. Dorpema (1980)Pharm. Weekbl. 115, 155–161.
Wallhäusser, K.H. (1980)Pharm. Ind. 42, 917–925.
who (1973) Expert Committee on Biological StandardsWHO/BS/73.1062. WHO/Pharm/73.474.
Wolff, A. (1975)Deut. Apotheker-Ztg. 115, 247–251.
Wyatt, L.R., andW.M. Waites (1975)J. Gen. Microbiol. 89, 337–344.
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Van Asten, J., Dorpema, J.W. A new approach to sterilization conditions. The IMO concept. Pharmaceutisch Weekblad Scientific Edition 4, 49–56 (1982). https://doi.org/10.1007/BF01963661
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DOI: https://doi.org/10.1007/BF01963661