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| home > pmps > autumn 2001 > recent advances in the cleaning and sterilisation of industrial freeze dryers |
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Pharmaceutical Manufacturing and Packing Sourcer
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Many new drugs are derived from biotechnology and cannot withstand terminal sterilisation. As a result, aseptic production methods are increasingly important. Where a drug is to be stabilised by lyophilisation, efficient cleaning and sterilisation of the freeze dryer (FD) is critical for the achievement of acceptable sterility assurance levels (SALs). Recent advances in cleaning and sterilising methodologies have mostly arisen from operating experience gained over the past 10 years.
In the past, the FD chamber and shelves were cleaned manually from the aseptic room, and sanitisation was by wipe-down with antiseptics, or by introducing gases such as formaldehyde or ethylene oxide. These methods have been superseded for many years. Although a small number of FDs continue to be sanitised in this way, the drawbacks are well-understood and include the following:
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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
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