Scientific papers

  1. Bradley, A., Probert, S., Sinclair, C. S., and A. Tallentire, Airborne Microbial Challenges of Blow-Fill-Seal Equipment: A Case Study, J. of Parenteral Science and Technology, 45(4), 187 (1991)
  2. Farquharson G., Clean rooms and associated controlled environments, Pharm. Tech. Europe, Feb. issue (2002)
  3. Jones, D., Topping, P., and J. Sharp, Environmental Microbial Challenges to an Aseptic Blow-Fill-Seal Process - A Practical Study, J. Pharm. Science and Technology, 49(5), 226-234 (1995)
  4. Jornitz M. W., Agalloco J. P., Akers J. E., Madsen R. E., Meltzer T. H., Considerations in Sterile Filtration – Part I: The changed role of filter integrity testing, PDA Journal of Pharm. Sci. and Tech., 56(1), 4-10 (2002)
  5. Leo, F., Chapter in Aseptic Pharmaceutical Manufacturing - Technology for the 1990s, Editor: Olson and Groves, Interpharm Press.
  6. Prout, G. (editor), The Use of Process Simulation Tests in the Evaluation of Processes for the Manufacture of Sterile Products, Technical Monograph No. 4, Parenteral Society, June (1993)
  7. PDA Special Scientific Forum: Blow-Fill-Seal Technology, March 30, 1994.
  8. PDA Asian Symposium and Exhibit, November 14-16, 1994, Schoenbuch Sabou Congress Hall, Tokyo, Japan, Further Steps Towards Particle Reduction-Experiences with Blow-Fill-Seal Machines with Component Separation.
  9. Price, J., Blow-Fill-Seal Technology; Part I. A Design for Particulate Control, Pharm Technol., 22(2), 62-72 (1998)
  10. Price, J., Blow-Fill-Seal Technology; Part II. Design Optimization of a Particulate Control System, Pharm Technol., Feb. issue, 42-52 (1999)
  11. Roberts et al, Australia-wide Epidemic of P. pickettii bacteria due to Contaminated “Sterile” Water for Injection,” Medical Journal of Australia, volume 152, June 18, 1992
  12. Sharp, J. R., Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology, Pharmaceutical Journal, 239 (1987)
  13. Sharp, J. R., Validation of a New Form-Fill-Seal Installation, Manufacturing Chemist, Feb., p.22 (1988)
  14. Sharp, J. R., Aseptic Validation of a Form-Fill-Seal Installation: Principles and Practices, J. of Parenteral Science and Technology, Vol 44 (5), Sept/Oct, (1990)
  15. Sinclair, C. S., and A. Tallentire, Predictive sterility assurance for aseptic processing, in R. F. Morrisey, Ed. Sterilization of Medical Products VI, Polyscience Publ., Montreal, 97-114 (1993)
  16. Sinclair, C. S., and A. Tallentire, Performance of Blow-Fill-Seal Equipment Under Controlled Airborne Microbial Challenges, J. of Pharmaceutical Science and Technology, Volume 49(6), 294 (1995)
  17. Sundaram S., Eisenhuth J., Howard Jr. G., Brandwein H., Method for qualifying microbial removal performance of 0.1 micron rated filters – Part I: Characterization of water isolates for potential use as standard challenge organisms to qualify 0.1 micron rated filters, , PDA Journal of Pharm. Sci. and Tech., 55(6), 346-372 (2001)
  18. Sundaram S., Eisenhuth J., Stevens M., Howard Jr. G., Brandwein H., Method for qualifying microbial removal performance of 0.1 micron rated filters – Part II: Preliminary characterization of Hydrogenophaga (formerly Pseudomonas) pseudoflava for use as standard challenge organisms to qualify 0.1 micron rated filters, , PDA Journal of Pharm. Sci. and Tech., 55(6), 373-392 (2001)
  19. Sundaram S., Eisenhuth J., Lewis M., Howard Jr. G., Brandwein H., Method for qualifying microbial removal performance of 0.1 micron rated filters – Part III: Bacterial challenge tests on 0.2/0.22 and 0.1 micron rated filter cartridges with Hydrogenophaga (formerly Pseudomonas) pseudoflava, PDA Journal of Pharm. Sci. and Tech., 55(6), 393-416 (2001)
  20. Whyte, W., Matheis, W., Mark D-N., Edwards, A., Airborne contamination during blow-fill-seal pharmaceutical production, PDA Journal of Pharm. Sci. and Tech., 52(3), 89 (1998)
  21. Zimmerman, L., Technical Measures for Aseptic Packaging of Liquids with the Bottlepack Assembly System, Drugs Made in Germany, 41 (2), p. 56, 1084

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