Featured Articles
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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...
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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...
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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.
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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.
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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.
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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.
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Influence Of Concentration And Fill Depth On Product Resistance Of Sucrose During Freeze Drying
The objective of the study described in this article was to characterize product resistance as a function of dry layer thickness for various sucrose solutions using SMART Freeze-Dryer technology.
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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
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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
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Scale‐Up Of Freeze‐Drying Cycles
Laboratory scale freeze dryers are used for lyophilization of small amounts of product, either for simple preparation of relatively robust materials or for cycle development and subsequent transfer to a larger scale. If the lyophilization process developed is to be scaled up later on, it is beneficial if the freeze dryers employed on the various scales are constructed similarly. By Stefan Schneid, Ph.D. Freeze-Drying Focus Group University of Erlangen, Germany