Advertisement

Pharmaceutisch weekblad

, Volume 3, Issue 1, pp 342–354 | Cite as

The use of reverse osmosis water for the production of parenterals in the hospital pharmacy

  • Ph. Jacobs
Article

Abstract

Only theUnited States Pharmacopeia has included reverse osmosis as an approved process for producing ‘Water for Injection’ to date. In the author's hospital pharmacy water for the production of large volume parenterals is being produced by means of an installation containing the Du-Pont Permasep ® hollow fiber permeator. Technical details and chemical background of this system are discussed. The permeator is fed by mixed bed deionised water of very low solids content. The main advantages of such a system, which does produce water conforming to pharmacopoeial specifications, are the small initial investment and running costs as compared with a distillation unit; the fact that no heat energy is required and that the production rate of pyrogen free water is as high as 300 l/h and upwards, thus obviating the need for storage.

Disadvantages are the need for a variety of monitoring arrangements to control correct membrane function, especially membrane integrity and the possible leakage past gaskets; the necessity of regular sanitisation with formaldehyde, which is not without its own inherent difficulties; and the fact that an absolutely sterile product water cannot be consistently guaranteed. Some of these aspects are also discussed with respect to the recent CGMP/LVP proposals of FDA.

Keywords

Total Dissolve Solid Product Water Hollow Fiber Reverse Osmosis Feed Water 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. Astm Standard D 3736–79 (1979)Annual Book of ASTM Standards, part 31.Google Scholar
  2. Astm (1980) Recommended practice for detecting leaks in reverse osmosis devices; under development by ASTM Committee D-19 on Water.Google Scholar
  3. Banes, D. (1978)J. Parent. Drug Assoc. 32, 105.Google Scholar
  4. Bangham, A. D., andM. W. Hill (1972)Nature 237, 408.CrossRefGoogle Scholar
  5. Caracciolo, V. P., N. W. Rosenblatt andV. J. Tomsic (1970) In:Reverse Osmosis (Sourirajan, S., Ed.). Academic Press, New York, 347.Google Scholar
  6. Cooper, J. F., andM. E. Neely (1980)Pharmac. Technology 4, 72.Google Scholar
  7. Elste, U. (1974)Die Krankenhausapotheke 24, 41.Google Scholar
  8. Fassbinder, W., U. Frei andK.-M. Koch (1979)Klin. Woch.schr. 57, 673.CrossRefGoogle Scholar
  9. Fda (1976)Federal Register 41, nr. 106.Google Scholar
  10. Frith, C. F., F. W. Dawson andR. L. Sampson (1976)Bull. Parenteral Drug Assoc. 30, 118.Google Scholar
  11. Hendriks, W. D. H. (1980) Private communication.Google Scholar
  12. Jacobs, Ph. (1981)Pharm. Weekblad 116, 145.CrossRefGoogle Scholar
  13. Jacobs, Ph., and M. A. H.Driessen (1980) Personal communication.Google Scholar
  14. Juberg, D. L., W. A. Pauli andD. H. Artiss (1977)Bull. Parenteral Drug Assoc. 31, 70.Google Scholar
  15. Klink, A. E., andD. H. Artiss (1978)J. Parenteral Drug Assoc. 32, 226.Google Scholar
  16. Klumb, G. H. (1975)Bull. Parenteral Drug Assoc. 29, 261.Google Scholar
  17. Kunz, A. L. (1973)Bull. Parenteral Drug Assoc. 27, 266.Google Scholar
  18. Lowén, B. (1978) In:Large Volume Patenterals, a seminar held in Oslo June 1978. EFTA Secretariat, Geneva, 13.Google Scholar
  19. Marcus, St., C. Anselmo andJ. Luke (1960)J. Am. Pharm. Assoc. Sci. Ed. 49, 616.CrossRefGoogle Scholar
  20. Mascoli, C. G. andM. E. Weary (1979)J. Parenteral Drug Assoc. 33, 81.Google Scholar
  21. Otten, G. (1972)American Laboratory, July, 25.Google Scholar
  22. Otten, G., and G. D.Brown (1973)American Laboratory, December, 3.Google Scholar
  23. Paradiso, S. J. (1974)Bull. Parenteral Drug Assoc. 28, 78.Google Scholar
  24. Poll, M. A. P. C. van de, andH. H. Harmsen (1981)Pharm. Weekblad 116, 317.CrossRefGoogle Scholar
  25. Saunders, L., W. F. Lorch and M. H.Hassell (1970)Ion Exchange in the Process Industries. Conference 16/18 July 1969, Soc. of Chem. Industry London, 410.Google Scholar
  26. Sourirajan, S. (1970)Reverse Osmosis. Academic Press, New York.Google Scholar
  27. Wüthrich, M., and H.Mauch (1975)Techn. Mitteil. der Schweizer. PTT-Betriebe, Bern, 252.Google Scholar

Copyright information

© Bohn, Scheltema & Holkema 1981

Authors and Affiliations

  • Ph. Jacobs
    • 1
  1. 1.Apotheker en Klinisch ChemicusZiekenhuis EudokiaRotterdam

Personalised recommendations