PDA Journal of Science & Technology
May/June 2009 PDA Journal: Real-Time Environmental Monitoring
This issue includes a two-article evaluation of BioVigilant™ IMD-A™ and its novel optical spectroscopy technology for the continuous and real-time monitoring of viable and nonviable particles. The first article, written by Michael Miller, Horatio Lindsay, Rene Valverde-Ventua, Michael J. O’Conner, provides a review of the technology and comparative studies with conventional methods. The second article, co-authored by Michael Miller, Michael Walsh, Jerry Shrake, Randall Dukes and Daniel Hill, is a case study involving the use of the technology fore environmental monitoring during aseptic filling, intervention assessments and glove integrity testing in manufacturing isolators.
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PDA Journal, Vol. 63 – Members Only Access
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Vol. 63, No. 3 Editorial
The PDA Journal and PDA Technical Reports: Separate and Equal
Richard Levy and Walter Morris
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Vol. 63, No. 3 Research
Indomethacin-loaded Poly(butylcyanoacrylate) Nanoparticles: Preparation and Characterization
Haiyan Liu and Jinchun Chen
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Vol. 63, No. 3 Research
Carvedilol-loaded Mucoadhesive Buccal Tablets: Influence of Various Mucoadhesive Polymers on Drug Release Behavior
Shunmugaperumal Tamilvanan, Ganesh Shesrao Bangale,
Jesudoss Jeya Ananthi, Vellaichamy Sivakumar, Ganesan Vinothapooshan,
Madasamy Palanivelu, and Mabepalli Byrappagowbu Viswanathan
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Vol. 63, No. 3 Research
Solubility and Stability Enhancement of Atorvastatin by Cyclodextrin Complexation
Chinna Reddy Palem, Shweta Patel, and Varsha B. Pokharkar
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Vol. 63, No. 3 Research
Reverse-Phase, High Performance Liquid Chromatographic Method for the Determination of Tolterodine Tartrate in Routine Quality Control Samples
V. S. N. Murthy Dwibhashyam, P. Keerthi, J. Vijaya Ratna, and A. N. Nagappa
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Vol. 63, No. 3 Research
Formulation Design of Ranitidine Hydrochloride To Reduce its Moisture Absorption Characteristics
Shagufta Khan, Praful Giradkar, and Pramod Yeole
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Vol. 63, No. 3 Technology/Application
Critical Influences of Particles, Pores, and Prefilters in Sterilizing Filtration
Russell E. Madsen and Theodore H. Meltzer
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Vol. 63, No. 3 Technology/Application
Evaluation of the BioVigilant_ IMD-A™, A Novel Optical Spectroscopy Technology for the Continuous and Real-time Environmental Monitoring of Viable and Nonviable Particles. Part I. Review of the Technology and Comparative Studies with Conventional Methods
Michael J. Miller, Horatio Lindsay, Rene Valverde-Ventura, and Michael J. O’Conner
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Vol. 63, No. 3 Technology/Application
Evaluation of the BioVigilant_ IMD-A™, A Novel Optical Spectroscopy Technology for the Continuous and Real-time Environmental Monitoring of Viable and Nonviable Particles. Part II. Case Studies in Environmental Monitoring during Aseptic Filling, Intervention Assessments, and Glove Integrity Testing in Manufacturing Isolators
Michael J. Miller, Michael R. Walsh, Jerry L. Shrake, Randall E. Dukes,
and Daniel B. Hill
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Vol. 63, No. 2 Commentary
Revisiting the Moist Heat Sterilization Myths
J. Agalloco, J. Akers and R. Madsen
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Vol. 63, No. 2 Commentary
Formulation Optimization of Serratiopeptidase-loaded PLGA Microspheres Using Selected Variables
S. Saraf, D. Singh, V.K. Dixit and S. Saraf
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Vol. 63, No. 2 Research
Formulation Optimization of Long-acting Depot Injection of Aripiprazole by Using D-optimal Mixture Design
T.R. Saini and T. Nahata
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Vol. 63, No. 2 Research
Evaluation of Disinfecting Procedures for Aseptic Transfer in Hospital Pharmacy Departments
J. Smith, M. Mehmi, L.J. Marshall, and P.A. Lambert
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Vol. 63, No. 2 Research
Double Loading of Cyclosporine A in Liposomes Using Cyclodextrin Complexes
B. Malaekeh-Nikouei and N. Davies
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Vol. 63, No. 2 Research
Distribution of Silicone Oil in Prefilled Glass Syringes Probed with Optical and Spectroscopic Methods
Z. Wen, A. Vance, F. Vega, X. Cao, B. Eu and R. Schulthesis
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Vol. 63, No. 2 Research
Polymyxin E Sulfate-Loaded Liposome for Intravenous Use: Preparation, Lyophilization, and Toxicity Assessment In Vivo
D.K. Wang, L. Kong, J. Wang, X. He, X. Li and Y. Xiao
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Vol. 63, No. 2 Technology-Application
Leachables Evaluation for Bulk Drug Substance
V. Tsui, M.S. Somma and L.A. Zitzner
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Vol. 63, No. 2 Technology-Application
Comparative Study of the Swabbing Properties of Seven Commercially Available Swab Materials for Cleaning Verification
D. Corrigan, S. Piletsky and S. McCrossen
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Vol. 63, No. 1 Commentary
Reverse Osmosis as a Means of Water for Injection Production: A Response to the Position of the European Medicines Agency
T. H. Meltzer, R. C. Livingston, R. E. Madsen, M. W. Jornitz, R. M. Johnson,
and M. W. Mittelman
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Vol. 63, No. 1 Commentary
Risk Management, cGMP, and the Evolution of Aseptic Processing Technology
James Agalloco, James Akers, Hal Baseman, Richard Boeh, Russell Madsen,
Steven Ostrove, and Anthony Pavell
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Vol. 63, No. 1 Research
Use of Cool Water Packs to Prevent Freezing During Vaccine Transportation at the Country Level
Umit Kartoglu, Serge Ganivet, Stephane Guichard, Venkat Aiyer,
Peter Bollen, Denis Maire, and Birhan Altay
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Vol. 63, No. 1 Research
Effect of High Calcium and Phosphate Concentrations on the Physicochemical Properties of Two Lipid Emulsions Used as Total Parenteral Nutrition for Neonates
Sonia Driss Chaieb, Jean-Claude Chaumeil, Sami Jebnoun, Naima Khrouf,
Abderrazek Hedhili, and Souad Sfar
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Vol. 63, No. 1 Research
Total Organic Carbon (VCSN and VWP) and HPLC Analysis for Cleaning Validation in a Pharmaceutical Pilot Plant
M. Queralt, E. García-Montoya, P. Pérez-Lozano, J. M. Suñé-Negre, M. Miñarro, and J. R. Ticó
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Vol. 63, No. 1 Research
Development of Modified Dosage Form for Enhancement of Dissolution Rate through Amalgamation of Solid Dispersion and Cube Sugar or Sintering Technology Using Famotidine as a Model Drug
Vishal Gupta, Meenal Gupta, and Anil Kumar Madan
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Vol. 63, No. 1 Research
Some Observations on Airborne Particles in the Critical Areas of a Blow-Fill-Seal Machine
Stefan Sundström, Bengt Ljungqvist,, and Berit Reinmuller
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Vol. 63, No. 1 Research
Polymeric Micelles of Ammonium Palmitoyl Glycol Chitosan and Solubilization of Camptothecin
Nazar M. Ranjha