Featured Articles

71. White Paper: Applicability Of Manometric Temperature Measurement (Mtm) And Smart Freeze Dryer Technology To Development Of An Optimized Freeze Drying Cycle: Preliminary Investigation Of Two Amorphous Systems 10/24/2005

    Rational development of a freeze drying cycle for a given product is often a trial and error approach and as a result time consuming, even for highly skilled personnel...

72. Applicability Of Manometric Temperature Measurement (Mtm) And Smart Freeze Dryer Technology To Development Of An Optimized Freeze Drying Cycle: Preliminary Investigation Of Two Amorphous Systems 10/24/2005

    Rational development of a freeze drying cycle for a given product is often a trial and error approach and as a result time consuming, even for highly skilled personnel...

73. Banishing The Mysteries Of Evaporation

    A variety of sample concentration and evaporation methods are used in laboratories. This article will describe the basic theories of evaporation and concentration, and some of the commonly used techniques. By Dr Induka Abeysena and Rob Darrington BSc, Genevac Ltd

74. Terminal Sterilized Product: Validating PQ Of Manufacturing Equipment

    The introduction of a new rotary vial washer used in the process of manufacture of terminally sterilized products requires validation in accordance with GMP to ensure verification of performance. A PQ protocol was required to test the effectiveness of the machine with regard to the manufacture of terminally sterilized parenteral products.

75. Safe Technique For Rapidly Drying Oligonucleotides

    Research done at the Welcome Trust Centre for Human Genetics shows that the Genevac EZ-2 evaporator is an ideal tool for concentrating SNP and oligonucleotides in microplates when preparing samples for microarraying and for Sequenon analysis. Compared to traditional methods using the EZ-2 evaporator offers significant benefits.

76. Application Of Tunable Diode Laser Absorption Spectroscopy (TDLAS) To Monitoring Pharmaceutical Lyophilization

    This technical brief provides an overview of Tunable Diode Laser Absorption Spectroscopy (TDLAS) and its application for monitoring freeze drying processes. Through the combination of TDLAS measurements and a well-established heat and mass transfer model describing freeze drying, users can obtain information about Key Process Parameters (KPPs) affecting end product quality.

77. Advances In Sample Preparation For Metabolite Profiling

    A recent study carried out at Nerviano Medical Sciences in Milan has shown that the sample preparation steps employed can be just as important as the analytical steps in generating errors in the process, and require just as much attention when setting up the process. Critical to the process being established within Nerviano’s laboratory is the evaporation methodology used when preparing the samples.

78. Reducing The Risks Of Particles On The Outside Of Vials

    The pharmaceutical industry and safety regulators are putting more emphasis on using external washers to remove product particles from the outside of vials.

79. PAT For Freeze Drying: Cycle Optimization In The Laboratory

    Freeze drying is generally known to be a time consuming and therefore expensive process. In order to lower costs during manufacturing, the effective cycle time must be reduced. This goal can be achieved by optimising a freeze drying cycle in the laboratory – in particular the primary drying phase. Applying PAT in the laboratory can provide valuable information about product and process behaviour and may help to identify the critical process parameters during cycle development and optimisation. By Dr. Henning Gieseler, PhD., Department of Pharmaceutics, University of Erlangen-Nuremberg

80. Discussion Of Vial Closures And Stoppering Force In Pilot Freeze-Dryers

    To answer the often asked question "Can my system stopper a full tray of the vials and stoppers I have selected?,", it is important to be able to recognize the force needed for your particular container-closure system and to compare that to the stoppering pressure specification provided by the freeze dryer manufacturer. By Leslie Mather