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Maintaining a spore-free environment in the cleanroom

21 September 2007 | By Karen Rossington, Marketing and Development Manager, Shield Medicare Ltd.

The manufacture of sterile pharmaceutical products is governed in the European Union by the requirements of EU Good Manufacturing Practice for Medicinal Products. The GMP guide gives very specific details on the environmental and microbial requirements for aseptic processing. However, little or no guidance is given on how to create…

Cleanroom standards

27 March 2007 | By John Neiger, Technical writer and consultant

It is some years since the ISO 14644 and 14698 series of international cleanroom standards started taking over from national standards. Early parts are already undergoing their statutory five-year reviews; other parts have only recently been published and new parts are still being written.

Rapid microbiology: Solutions for the next stage

20 July 2006 | By Tim Lloyd, Editor, European Pharmaceutical Review

Rapid microbiology is an exciting field for the development of new technologies and applications. There are significant challenges to be overcome and in doing so, great prospects for microbiologists and the companies that provide cutting-edge equipment.

RS coupled to separations

24 March 2006 | By Cees Gooijer, Freek Ariese and Reyer J. Dijkstra, Dept. of Analytical Chemistry and Applied Spectroscopy, Laser Centre Vrije Universiteit

Currently, Raman spectroscopy (RS) is rapidly becoming a mature analytical technique in the pharmaceutical world. Thus far, it is used almost exclusively in a stand-alone mode, since coupling with liquid separation methods hardly seemed realistic in practice. However, as outlined in this article, recent developments are quite promising and such…

Co-operation through certification

24 March 2006 | By Bengt Ljungqvist, Ph.D. and Berit Reinmüller, Ph.D. KTH Stockholm

To verify that cleanroom and clean zones are adequately installed and functioning they are usually validated during three occupancy states. First, when the installation is complete with all services connected and functioning, as-built; secondly during at-rest conditions when equipment is installed and running in a manner agreed upon by customer…

In vitro safety pharmacology profiling

2 February 2006 | By Jacques Hamon, Kamal Azzaoui, Steven Whitebread, Laszlo Urban, Edgar Jacoby, Bernard Faller, Novartis Institutes for BioMedical Research

One major cause of the late failure of drugs in development (i.e. attrition) is the lack of clinical safety of the compounds (accounting for approximately 30% of failures together with toxicology)1. One of the key elements is the off-target effects of the compounds, causing adverse drug reaction (ADRs).

Applications in bioprocesses and biotechnology

11 November 2005 | By ,

Raman spectroscopy is a highly versatile tool that provides chemical fingerprints from biological material that can be interpreted using chemometrics and machine learning. In combination this powerful approach is being developed for the quantitative determination of multiple determinands in bioprocesses and for the characterisation of microorganisms.

The rise of Raman

22 August 2005 | By Marleen de Veij, Dr. Peter Vandenabeele and Prof. Dr. Luc Moens, Laboratory of Analytical Chemistry, Ghent University

Traditionally, analyses in pharmaceutical research and industry were often performed using Nuclear Magnetic Resonance (NMR) or Mass Spectrometry (MS). However, researchers are aware that Raman Spectroscopy possesses advantageous characteristics for the pharmaceutical world.

International standards: a tool for compliance

22 August 2005 | By Dr Hans H. Schicht, Dr. sc. techn., Dr. Hans Schicht Ltd. Contamination Control Consulting

Regulatory guidance documents, such as Annex 1 to the GMP guideline of the European Union1 and FDA's comparable Guidance for Industry2 establish the objectives to be met by pharmaceutical contamination control systems – especially those for the production of sterile medicinal drugs.

Exploring new sources of raw material

20 May 2005 | By Bernhard Schrader, Institut für Physikalische und Theoretische Chemie, Universität Duisburg-Essen and Hartwig Schulz, Federal Centre for Breeding Research on Cultivated Plants, Institute of Plant Analysis

Raman spectroscopy using excitation in the near infrared allows non-destructive Raman analyses of pharmaceutical products as well as of plant or animal tissues. This radiation excites only minimal fluorescence of the samples or impurities and has only minimal photo-physical and photochemical activity. Raman analysis of plants allows the efficient exploration…

Dosing and weighing in the pharmaceutical laboratory

7 March 2005 | By Dr. Ulrich Schopfer, Global Head of Compound Management, Dr. Frank Hoehn, Laboratory Head, Automation, Matthieu Hueber, Automation Engineer, Novartis Institutes for BioMedical Research

Dispensing of solids is still a demanding task in laboratory automation. The solubilisation of High Throughput Screening (HTS) libraries is one of the most challenging problems in this area, since millions of different substances have to be processed by the same technology.

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