Scientific papers
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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)
- Farquharson G., Clean rooms and associated controlled environments, Pharm. Tech. Europe, Feb. issue (2002)
- 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)
- 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)
- Leo, F., Chapter in Aseptic Pharmaceutical Manufacturing - Technology for the 1990s, Editor: Olson and Groves, Interpharm Press.
- 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)
- PDA Special Scientific Forum: Blow-Fill-Seal Technology, March 30, 1994.
- 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.
- Price, J., Blow-Fill-Seal Technology; Part I. A Design for Particulate Control, Pharm Technol., 22(2), 62-72 (1998)
- Price, J., Blow-Fill-Seal Technology; Part II. Design Optimization of a Particulate Control System, Pharm Technol., Feb. issue, 42-52 (1999)
- 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
- Sharp, J. R., Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology, Pharmaceutical Journal, 239 (1987)
- Sharp, J. R., Validation of a New Form-Fill-Seal Installation, Manufacturing Chemist, Feb., p.22 (1988)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
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Zimmerman, L., Technical Measures for Aseptic Packaging of Liquids with the Bottlepack Assembly System, Drugs Made in Germany, 41 (2), p. 56, 1084