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PDA Journal of Science & Technology

2009 PDA/FDA Joint Regulatory Conference

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

  • PDFVol. 63, No. 3 Editorial
    The PDA Journal and PDA Technical Reports: Separate and Equal
    Richard Levy and Walter Morris

  • Members OnlyVol. 63, No. 3 Research
    Indomethacin-loaded Poly(butylcyanoacrylate) Nanoparticles: Preparation and Characterization
    Haiyan Liu and Jinchun Chen

  • Members OnlyVol. 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

  • Members OnlyVol. 63, No. 3 Research
    Solubility and Stability Enhancement of Atorvastatin by Cyclodextrin Complexation
    Chinna Reddy Palem, Shweta Patel, and Varsha B. Pokharkar

  • Members OnlyVol. 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

  • Members OnlyVol. 63, No. 3 Research
    Formulation Design of Ranitidine Hydrochloride To Reduce its Moisture Absorption Characteristics
    Shagufta Khan, Praful Giradkar, and Pramod Yeole

  • Members OnlyVol. 63, No. 3 Technology/Application
    Critical Influences of Particles, Pores, and Prefilters in Sterilizing Filtration
    Russell E. Madsen and Theodore H. Meltzer

  • Members OnlyVol. 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

  • Members OnlyVol. 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



  • Members OnlyVol. 63, No. 2 Commentary
    Revisiting the Moist Heat Sterilization Myths
    J. Agalloco, J. Akers and R. Madsen

  • Members OnlyVol. 63, No. 2 Commentary
    Formulation Optimization of Serratiopeptidase-loaded PLGA Microspheres Using Selected Variables
    S. Saraf, D. Singh, V.K. Dixit and S. Saraf

  • Members OnlyVol. 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

  • Members OnlyVol. 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

  • Members OnlyVol. 63, No. 2 Research
    Double Loading of Cyclosporine A in Liposomes Using Cyclodextrin Complexes
    B. Malaekeh-Nikouei and N. Davies

  • Members OnlyVol. 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

  • Members OnlyVol. 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

  • Members OnlyVol. 63, No. 2 Technology-Application
    Leachables Evaluation for Bulk Drug Substance
    V. Tsui, M.S. Somma and L.A. Zitzner

  • Members OnlyVol. 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


  • Members OnlyVol. 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

  • Members OnlyVol. 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

  • Members OnlyVol. 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

  • Members OnlyVol. 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

  • Members OnlyVol. 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

  • Members OnlyVol. 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

  • Members OnlyVol. 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

  • Members OnlyVol. 63, No. 1 Research
    Polymeric Micelles of Ammonium Palmitoyl Glycol Chitosan and Solubilization of Camptothecin
    Nazar M. Ranjha

 
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